Insulin Therapies: An Educational Toolkit

Transcription

1 University Hospitals of Leicester, Department of Diabetes and Leicester Diabetes Centre: Insulin Therapies: An Educational Toolkit This document is designed for use by those trained and competent in insulin initiation and management in patients with Type 1 and Type 2 diabetes

2 Acknowledgements This document has been updated in line with the National Institute for Health and Care Excellence (NICE) recommendations that: Trained healthcare professionals initiate and manage therapy with insulin within a structured programme that includes dose titration by the person with diabetes (Quality Standards in Diabetes 2011). The clinical guidance given is based on NICE Guidance (CG 66) The document is designed to enable HCPs to gain information on elements of insulin initiation and management on a single page to facilitate ease of access. This work is based on the previous excellent guidelines developed by Heather Daly, Nurse Consultant and Professor Melanie Davies. The document is not a guideline but is an educational toolkit and resource for healthcare professionals. For specific guidance on formulary choices and preferences please see your local formulary. For Leicestershire see Many thanks to Shehnaz Jamal for developing this revision of the educational toolkit and to Helen Sharp for revising and proof reading the document. June James - Nurse Consultant in Diabetes and Dr Rob Gregory, Diabetes Consultant Date of Preparation: 25th November 2013 Date of Approval: 5th December 2013 Amended: 8th January 2014 Review Date: 2015 Revised and updated: October rd Edition revised July2018 Page 2

3 Contents Page Background 4 Indications for Insulin Initiation and Management in Adults 5 Overcoming Barriers 5 Type 2 Algorithm Use of Oral and Non-Insulin Therapies in Combination with Insulin 7 Section 1: Introduction to Insulin 9 Actions of Insulin 10 Different Insulin Formulation and Concentration 12 Section 2: Potential Insulin Regimens for Type 2 diabetes 1. Basal Insulin with Oral Hypoglycaemic Agents: Once Daily Basal Insulin Twice Daily Pre-mixed Insulin Basal Bolus Regimen Type 1 Diabetes 19 Section 3: General Advice 20 Lifestyle Factors 21 Hypoglycaemia 22 Hypos and Driving 23 Treating Hypos 24 Section 4: Managing Insulin During Illness in Type 1 and Type 2 25 General Principles of Managing Sick Days 27 Sick Day Management 28 Section 5: Insulin Administration and Devices 29 Types of Insulin Delivery Devices: Pumps 31 Injecting Insulin 33 Section 6: Insulin Safety - Safe Use of Insulin 35 Insulin Safety: Sharps 36 Help and Support 37 Appendices Appendix 1: TREND-UK Competency document 38 Appendix 2: End of Life Diabetes Management - Algorithm for Glycaemic Control 39 Appendix 3: End of Life Diabetes Management - Managing Glucose Control on Once Daily Steroids 40 Appendix 4: Steroid algorithm for people with know diabetes 41 Appendix 5: Insulin chart 42 Appendix 6: patient leaflets 43 Page 3

4 Background There are 3.7 million and up to 1 million are yet to be diagnosed with diabetes in the United Kingdom 10% of these people will have Type 1 diabetes and these people will require insulin within 24 hours after diagnosis and continue it life long It is estimated that 30-40% of people with Type 2 diabetes are insulin treated Page 4

5 Indications for Insulin Initiation and Management in Adults Consider starting insulin in People with Type 2 diabetes (T2DM) People with Type 1 diabetes (T1DM) If there is failure to reach glycaemic targets using diet and non- Insulin therapies (Ref: NICE NG28) If the individual is symptomatic e.g. rapid weight loss, polyuria, nocturia If the individual has Gestational diabetes (these women need to be managed in specialist care) LGH In steroid induced diabetes (see Insulin and steroid section page 20) If the patient is post myocardial infarction If the individual is intolerant to non-insulin therapies If the individual has acute neuropathies such as femoral amytrophy In Type 1 diabetes Insulin needs to be started within 24 hours of diagnosis - (Ref: NICE NG17) If the patient is severely ketotic and or vomiting, pregnant, or a child urgent referral / telephone contact to the specialist team or acute on call medical team is required LGH or hospital switchboard ( ) and ask to speak to a diabetologist or paediatrician or acute on call medical team Out of hours may well be the on call medical team who deal with this People with Type 1 diabetes whether cared for in hospital or community clinics should receive ongoing review by a Diabetologist. (Ref: ABCD position statement 2016) Where and when to initiate insulin Allaying fears of starting insulin Insulin therapy can be initiated in the community or hospital setting but it needs to be initiated by an appropriately trained and competent health care professional (See appendix 1 for TREND-UK 2015) Insulin can be initiated in a group session or in a one to one consultation There should be protected time for initiation and follow up Appropriate equipment and educational material including information on where to seek advice and on going support should be available Different insulin regimens and delivery devices should be tailored to the individual s clinical need and preferences Barriers to starting insulin These often centre on an individual s prior understanding of the use of insulin and can include: Fear of injections Fear of hypoglycaemia Concerns about potential weight gain Concerns about the individual s job (e.g. those who drive for a living, taxis, lorries or if the patient is a member of the armed forces) Cultural issues Feelings of guilt related to lack of education To allay some of these fears in T2DM it is important to introduce the possible progression to insulin soon after diagnosis Healthcare professionals initiating insulin should be trained and competent (An integrated Career and Competency Framework TREND-UK) Discussion on the need to start insulin should be approached sensitively and should be tailored to an individual s level of understanding and language The benefits and challenges of using insulin must be discussed with the individual The decision to start insulin must be done in agreement with the individual and / or their family or carer The choice of regimens should be made in accordance with the patient s clinical needs and preferences Insulin initiation should be part of a structured care and education plan including appropriate follow up Individuals commencing insulin should have a dietary review Page 5

6 Glucose Lowering Therapies Algorithm - Type 2 Diabetes Algorithm for blood glucose lowering therapy in adults with type 2 diabetes Reinforce advice on diet, lifestyle and adherence to drug treatment. Agree an individualised HbA1c target based on: the person s needs and circumstances including preferences, comorbidities, risks from polypharmacy and tight blood glucose control and ability to achieve longer-term risk-reduction benefits. Where appropriate, support the person to aim for the HbA1c levels in the algorithm. Measure HbA1c levels at 3/6 monthly intervals, as appropriate. If the person achieves an HbA1c target lower than target with no hypoglycaemia, encourage them to maintain it. Be aware that there are other possible reasons for a low HbA1c level. Base choice of drug treatment on: effectiveness, safety (see MHRA guidance), tolerability, the person s individual clinical circumstances, preferences and needs, available licensed indications or combinations, and cost (if 2 drugs in the same class are appropriate, choose the option with the lowest acquisition cost). Do not routinely offer self-monitoring of blood glucose levels unless the person is on insulin, on oral medication that may increase their risk of hypoglycaemia while driving or operating machinery, is pregnant or planning to become pregnant or if there is evidence of hypoglycaemic episodes. If the person is symptomatically hyperglycaemic, consider insulin or an SU. Review treatment when blood glucose control has been achieved. ADULT WITH TYPE 2 DIABETES WHO CAN TAKE METFORMIN If HbA1c rises to 48 mmol/mol (6.5%) on lifestyle interventions: Offer standard release metformin Support the person to aim for an HbA1c level of 48 mmol/ mol (6.5%) FIRST INTENSIFICATION If HbA1c rises to 58 mmol/mol (7.5%): Consider dual therapy with: - metformin and a DPP-4i - metformin and pioglitazone a - metformin and an SU - metformin and an SGLT-2i b Support the person to aim for an HbA1c level of 53 mmol/ mol (7.0%) SECOND INTENSIFICATION If HbA1c rises to 58 mmol/mol (7.5%): Consider: - triple therapy with: o metformin, a DPP-4i and an SU o metformin, pioglitazone a and an SU o metformin, pioglitazone a or an SU, and an SGLT-2i b - insulin-based treatment Support the person to aim for an HbA1c level of 53 mmol/ mol (7.0%) If standard-release metformin is not tolerated, consider a trial of modified release metformin If triple therapy is not effective, not tolerated or contraindicated, consider combination therapy with metformin, an SU and a GLP-1 mimetic c for adults with type 2 diabetes who: - have a BMI of 35 kg/m 2 or higher (adjust accordingly for people from black, Asian and other minority ethnic groups) and specific psychological or other medical problems associated with obesity or - have a BMI lower than 35 kg/m 2, and for whom insulin therapy would have significant occupational implications, or weight loss would benefit other significant obesity-related comorbidities METFORMIN CONTRAINDICATED OR NOT TOLERATED If HbA1c rises to 48 mmol/mol (6.5%) on lifestyle interventions: Consider one of the following d : - a DPP-4i, pioglitazone a or an SU - an SGLT-2i b instead of a DPP-4i if an SU or pioglitazone a is not appropriate Support the person to aim for an HbA1c level of 48 mmol/mol (6.5%) for people on a DPP-4i, SGLT-2i or pioglitazone or 53 mmol/mol (7.0%) for people on an SU FIRST INTENSIFICATION If HbA1c rises to 58 mmol/mol (7.5%): Consider dual therapy e with: - a DPP-4i and pioglitazone a - a DPP-4i and an SU - pioglitazone a and an SU Support the person to aim for an HbA1c level of 53 mmol/mol (7.0%) SECOND INTENSIFICATION If HbA1c rises to 58 mmol/mol (7.5%): Consider insulin-based treatment Support the person to aim for an HbA1c level of 53 mmol/mol (7.0%) Insulin-based treatment When starting insulin, use a structured programme and continue metformin for people without contraindications or intolerance. Review the continued need for other blood glucose lowering therapies f. Offer NPH insulin once or twice daily according to need. Consider starting both NPH and short-acting insulin either separately or as pre-mixed (biphasic) human insulin (particularly if HbA1c is 75 mmol/mol (9.0%) or higher). Consider, as an alternative to NPH insulin, using insulin detemir or glargine g if the person: needs assistance to inject insulin, lifestyle is restricted by recurrent symptomatic hypoglycaemic episodes or would otherwise need twice-daily NPH insulin in combination with oral blood glucose lowering drugs. Consider pre-mixed (biphasic) preparations that include short-acting insulin analogues, rather than pre-mixed (biphasic) preparations that include shortacting human insulin preparations, if: the person prefers injecting insulin immediately before a meal, hypoglycaemia is a problem or blood glucose levels rise markedly after meals. Only offer a GLP-1 mimetic c in combination with insulin with specialist care advice and ongoing support from a consultant-led multidisciplinary team h. Monitor people on insulin for the need to change the regimen. An SGLT-2i in combination with insulin with or without other antidiabetic drugs is an option b. Abbreviations: DPP-4i Dipeptidyl peptidase-4 inhibitor, GLP-1 Glucagon-like peptide-1, SGLT-2i Sodium glucose cotransporter 2 inhibitors, SU Sulfonylurea. Recommendations that cover DPP-4 inhibitors, GLP 1 mimetics and sulfonylureas refer to these groups of drugs at a class level. a. When prescribing pioglitazone, exercise particular caution if the person is at high risk of the adverse effects of the drug. Pioglitazone is associated with an increased risk of heart failure, bladder cancer and bone fracture. Known risk factors for these conditions, including increased age, should be carefully evaluated before treatment: see the manufacturers summaries of product characteristics for details. Medicines and Healthcare products Regulatory Agency (MHRA) guidance (2011) advises that prescribers should review the safety and efficacy of pioglitazone in individuals after 3 6 months of treatment to ensure that only patients who are deriving benefit continue to be treated. b. See NICE technology appraisal guidance 288 & 418, 315 and 336 on dapagliflozin, canagliflozin and empagliflozin, respectively. All three SGLT-2 inhibitors are recommended as options in dual therapy regimens with metformin under certain conditions, as options in triple therapy regimens and in combination with insulin. All three are also options as monotherapies in adults in whom metformin is contraindicated or not tolerated. Serious and life-threatening cases of diabetic ketoacidosis have been reported in people taking SGLT-2 inhibitors (canagliflozin, dapagliflozin or empagliflozin) or shortly after stopping the SGLT-2 inhibitor. MHRA guidance (2015) advises testing for raised ketones in people with symptoms of diabetic ketoacidosis, even if plasma glucose levels are near normal. c. Only continue GLP-1 mimetic therapy if the person has a beneficial metabolic response (a reduction of HbA1c by at least 11 mmol/mol [1.0%] and a weight loss of at least 3% of initial body weight in 6 months). d. Be aware that, if metformin is contraindicated or not tolerated, repaglinide is both clinically effective and cost effective in adults with type 2 diabetes. However, discuss with any person for whom repaglinide is being considered, that there is no licensed non-metformin-based combination containing repaglinide that can be offered at first intensification. e. Be aware that the drugs in dual therapy should be introduced in a stepwise manner, checking for tolerability and effectiveness of each drug. f. MHRA guidance (2011) notes that cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for the development of cardiac failure. It advises that if the combination is used, people should be observed for signs and symptoms of heart failure, weight gain, and oedema. Pioglitazone should be discontinued if any deterioration in cardiac status occurs. g. The recommendations in this guideline also apply to any current and future biosimilar product(s) of insulin glargine that have an appropriate Marketing Authorisation that allows the use of the biosimilar(s) in the same indication. h. A consultant-led multidisciplinary team may include a wide range of staff based in primary, secondary and community care. Type 2 diabetes in adults: management, NICE guideline NG28. Published December 2015, last updated April National Institute for Health and Care Excellence All rights reserved. Ref: Page 6

7 Introduction to Insulins Use of Oral and Non-insulin Therapies in Combination with Insulin Often the treatment of people with Type 2 diabetes over time will result in individuals requiring a combination of non-insulin therapies and insulin. Lifestyle changes and diet are a key factor in management throughout an individual s treatment plan and individuals are usually commenced on. Metformin as mono-therapy if targets are not achieved, unless there is contraindication or there are other management or clinical issues. If glycaemic control is not optimised then various options are given for consideration with the introduction of insulin recommended usually as second intervention treatment unless the individual has osmotic symptoms. The algorithm shown on page 6 gives examples where combination therapy may be appropriate. Factors influencing the choice of insulin regimen T2DM The individuals lifestyle consider: Usual meal times Does the patient work shifts? Is travel involved in their daily work? Do they drive a taxi or hold an HGV licence? (Consider driving restrictions) Is the number of injections per day an issue? Are they at risk of hypoglycaemia? Will dexterity be a problem? Is weight an issue? Health beliefs and culture Factors influencing the choice of insulin regimen T1DM The individuals lifestyle consider: Usual meal times Does the patient work shifts? Is travel involved in their daily work? Do they drive a taxi or hold an HGV licence? Consider driving restrictions Is the number of injections per day an issue? Are they at risk of hypoglycaemia? Will dexterity be a problem? Is weight an issue? Health beliefs and culture In Type 1 patients a basal bolus regimen is usually commenced in the majority of individuals. This would however depend on the individual patients preference and convenience In the early weeks and months following the diagnosis of T1DM the amounts of insulin required are often very small (honeymoon phase) Which insulin should be used initially for T2DM Animal insulin is no longer used for insulin starts Begin with human NPH insulin injected at bed-time or twice daily according to need such as Insuman Basal, Humulin I or Insulatard Consider, as an alternative, using a long-acting insulin analogue such as Insulin Detemir, Insulin Glargine if: The person needs assistance from a carer or healthcare professional to inject insulin, and use of a long-acting insulin analogue (Insulin Detemir, Insulin Glargine) would reduce the frequency of injections from twice to once daily, or The person s lifestyle is restricted by recurrent symptomatic hypoglycaemic episodes, or The person would otherwise need twice-daily NPH insulin injections in combination with oral glucose-lowering drugs, or The person cannot use the device to inject NPH insulin Consider twice daily pre-mixed (biphasic) human insulin (particularly if HbA1c 75 mmol/mol or 9%) Consider pre-mixed preparations that include short-acting insulin analogues, rather than pre-mixed preparations that include shortacting human insulin preparations, if: A person prefers injecting insulin immediately before a meal, or Hypoglycaemia is a problem, or Blood glucose levels rise markedly after meals Consider initiation of pre-mixed insulin if the A1c is high particularly above 75 mmol/mol or 9% This would however depend on the individual patients preference and convenience. Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 7

8 Use of Oral and Non-Insulin Therapies in Combination with Insulin Table 1: Use of oral and non-insulin therapy in combination with insulin Oral and non-insulin therapy Metformin Sulphonylureas (SU) DPP-4 Inhibitors (DPP-4Is) Use with insulin Normal and overweight people with Type 2 diabetes can be continued on Metformin as there is evidence that this combination is insulin sparing and has other benefits including weight management glycaemic control and cardiovascular disease (CVD) Continue with regular dose reviews if the individual is on a daily isophane or analogue insulin. Otherwise the dose is usually halved or discontinued All DPP-4s are licensed for use with insulin: Alogliptin (Vipidia), Linagliptin (Trajenta), Saxagliptin (Onglyza), Sitagliptin (Januvia), Vildagliptin (Galvus) Contraindications Do not use Metformin if the individual is: Intolerant of Metformin In heart failure Do not start if egfr is less than 45 mls/min Discontinue if egfr is <30 mls/min Use with caution/do not use in vulnerable people that are at risk of hypoglycaemia, e.g. elderly, dementia, those with deteriorating renal function and those who live alone DPP-4Is are contraindicated in women of child bearing age considering pregnancy* Acarbose Pioglitazone Caution as there is a risk of fluid retention and weight gain Not recommended in combination with insulin Do not use if there is a history of heart failure / bladder cancer/bone fractures or if the patient has macroscopic haematuria* Glucagon-like peptide-1 receptor agonists. (GLP-1 Agonists) Exenatide extended release Exenatide twice daily, Liraglutide once daily Lixisenatide Requires careful monitoring particularly if GLP-1 agonists are commenced after insulin initiation, in these cases the insulin dosage is normally halved when the GLP-1 is commenced. Lixisenatide and Exenatide are short acting GLP-1s and affect post prandial blood glucose. Bydureon and Liraglutide are long acting and predominately affect fasting glucose. (Refer to manufacturers instructions for each individual product for use with insulin) Do not use if there is a history of acute pancreatitis Use in CKD patients varies according to specific GLP-1. (e.g. Lixisenatide CR/CL >or equivalent to 30 mls/min. Liraglutide > 15 mls/min Do not use in Type 1 diabetes Severe gastrointestinal disease Pregnancy Sodium glucose co-transporter 2 (SGLT-2) There are 3 agents in this class and all can be used in combination with insulin: Canagliflozin Dapagliflozin Empagliflozin *Please review individual manufacturers guidance on use in pregnancy Use with care in older people (see individual SPC). Patient with no CVD, and patients for whom initial SGLT2 induced diuresis poses a risk Not recommended in renal impairment see individual SPC for each manufacturer Not recommended for severe hepatic impairment Dapagliflozin - do not use with loop diuretic or with Pioglitazone Sodium Glucose co-transporter 2 inhibitors (SGLT-2 inhibitors) Be aware that there have been a small number of reports relating to the development of DKA inpatients. The blood glucose may not be higher than 15 mmol/l when this occurs. These cases seems to be related to the use SGLT2s in people who either have Type 1 diabetes late onset Type 1 Diabetes, LADA or who are insulin and or nutrition depleted people (Type 2 diabetes). Patients should be made aware of the risk of DKA, signs and symptoms and risk factors. (Ref: The effect on cardiovascular risk look promising - in the results of the EMPA-REG OUTCOME trial (Zinman et al). The EMPA Reg study randomized 4687 patients to treatment with empagliflozin versus placebo (n=2333) In the treatment arm there was: A reduced in hospitalisation for heart failure by 35% A reduction in CV death by 38% Improved survival by reducing all cause mortality by 32% It is not yet known whether these results are generalisable in this class of drugs. The CANVAS Program integrated data from two trials involving a total of 10,142 participants with type 2 diabetes and high cardiovascular risk. Participants in each trial were randomly assigned to receive Canagliflozin or placebo and were followed for a mean of weeks. (Neal et al N Engl J Med 2017; 377: August 17, 2017 DOI: /NEJMoa ) The primary endpoint which was the first occurrence of heart attack, stroke, or cardiovascular death showed 14% reduction in the cardiovascular outcome, which was highly statistically significant for non inferiority and statistically significant for superiority. There were trends toward benefits on the other subanalyses so cardiovascular death, heart attacks, strokes, and total mortality as well as a statistically significant reduction in kidney endpoints, specifically albuminuria. (Buse J 2017) There is an increased risk of foot/ toe amputation in people taking Canagliflozin. It is not yet know whether this is a class effect- All people taking any SGLT2i should be made aware of this risk and advised to check their feet daily. Ref: Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015; 373: Page 8

9 Introduction to Insulins Section 1: Introduction to Insulin Background There are over 30 different types of insulin; these fall into four main types: Rapid-acting Intermediate-acting Short-acting Long-acting The right insulin regimen is required to address both basal, i.e. Fasting and pre-prandial glucose levels and post-prandial (post meal) excursions. Table 2: Insulin preparations Rapid acting insulin analogues: Such as NovoRapid (Aspart) and Humalog (Lispro) and Apidra (Glulisine) have advantages in terms of convenience can be injected with food, or indeed, post prandial. They are better at controlling post prandial glucose with less need for snacks and have a lower risk of hypoglycaemia. FIASP is an ultra rapid acting insulin which needs to be given within 2 minutes of eating. Short acting non-analogue insulins: Addresses post-prandial glucose excursions, either used alone or in combination as a mixed insulin. The disadvantages are that some have to be injected minutes before a meal. Patients may need to snack between meals and there is a risk of hypoglycaemia. Intermediate acting insulin: A traditional isophane, given twice daily such as Humulin I, Insuman Basal and Human Insulatard addresses basal hyperglycaemia. Intermediate-acting insulin has a longer life span than rapid or short-acting insulin but is slower to reach a peak. Cloudy insulin always contains some intermediate acting insulin. Long acting insulin analogues: Insulin Glargine (Lantus), Insulin Detemir (Levemir) and Insulin Degludec (Tresiba), and U300 Toujeo 300 Units/mL have the advantage of greater predictability, potentially less weight gain, and lower risk of hypoglycaemia, particularly at night compared to intermediate acting insulin. They can be given as a basal insulin or in a Basal Bolus regimen. Mixed insulins: Such as NovoMix 30, Insuman Comb 15 and Humalog Mix 25 will contain a proportion of rapid or short acting and intermediate acting insulin Mixed Insulin contain a mixture of isophane which is intermediate acting insulin and short or rapid acting insulin the number given. (e.g. NovoMix 30 indicates the proportion of rapid and intermediate acting insulin included in the preparation.) Higher Concentration Insulin: The majority of insulin preparation are based on 100 units per ml (U100). Higher strength insulin is becoming more common and contain the same amount of insulin in less volume. These include: Humalog 200 units/ml, Tresiba 200 units/ml, Toujeo 300 units/ml These preparations are administered using a pen device - insulin must not be drawn out of the pen using a syringe or the dose will be inaccurate and may lead to an overdose. Targets of therapy T2DM Agree individual glycaemic targets with the patient and where possible in line with NICE guidance. NICE recommends: Aim for a pre-breakfast or fasting glucose level of <5.5mmol/l and pre-prandial levels at other times of the day at <6mmol/l Aim for post-prandial (i.e. 2 hours after a main meal) <8mmol/l but this will depend on the individual, (e.g. in the elderly or end of life care these targets may not be appropriate) HbA1c of 48 mmol/mol following diagnosis. If the HbA1c increases to 58 mmol/mol add in a second intervention and then aim for 53 mmol/mol Treatment targets must take into account the clinical needs of the individual as well as co morbidities, for example in the frail older person tight diabetes control would not be appropriate Titrating doses - key principles Review capillary blood glucose (CBG) trends using the monitoring diary/ meter memory to establish if patterns exist at different times of the day Consider any comments discussed or recorded in the monitoring diary. (e.g. eating patterns, changes in activity) View CBG results in relation to the type of insulin and timing of injections Is the problem dose related or does it indicate that the regimen is not meeting that person s needs? Generally, increases are made in 10% increments Hypo prevention takes precedence and where no other cause is found a 20% insulin dose reduction is required with careful monitoring Look for other presenting factors (i.e. Deteriorating renal function, adrenal function, thyroid, weight loss, or significant change in lifestyle or diet) Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 9

10 Insulin Activity Insulin Activity Insulin Activity Insulin Activity Actions of Insulin Metformin can be continued in combination with all insulin regimens, as outlined here, in patients with Type 2 diabetes: Rapid-acting insulin action e.g. NovoRapid, Humalog, Apidra Onset: 5-15 mins Peak: hours Duration: 3-5 hours hours Rapid-acting insulin begins working very quickly inside the body, usually within 5-15 minutes. This type of insulin should be taken just before eating. It peaks between 30 and 90 minutes and its duration is typically between 3 and 5 hours. As the activity of rapid-acting insulin starts and finishes so quickly, it is recommended to be taken with food or straight after eating, therefore it is less likely to lead to hypoglycaemia compared with other insulin preparations. Ultra fast acting insulin (FIASP) should be given within 2 minutes of eating. Be aware doses may need reducing 1 hour before planned exercise and subsequent doses within a 24hr period. Short-acting insulin action e.g. Soluble Human Insulin: Actrapid, Humulin S, Insuman Rapid Onset: 30 mins Peak: 2-4 hours Duration: 6-8 hours Short-acting insulin begins working in the body between 30 and 60 minutes after injection. Typically, short-acting insulin peaks between 2 and 4 hours, and its duration is typically 6-8 hours. As a result of its relatively short lifespan, short-acting insulin may need be injected several times during the day Hours Can put patients at risk of hypos late in the morning or early hours of the night (2am) depending on the timing of the dose. Intermediate-acting insulin action e.g. Humulin I, Human Insulatard, Insuman Basal This type of insulin is cloudy and has a longer lifespan than short-acting insulin but it is slower to start working. Intermediate-acting insulin usually starts working within 2-4 hours after injection, peaks somewhere between 4 and 8 hours and remains working for approximately 16 hours. Occasionally this insulin is given twice daily. Onset: 2-4 hours Peak: 4-8 hours Duration: hours Re-suspension of intermediate acting insulin is critical. If this is not done glycaemic control can be erratic hours Long-acting Insulin Action e.g. Glargine (Lantus), Detemir (Levemir),Insulin Degludec (Tresiba), Insulin Glargine 300 units/ml (Toujeo) This type of insulin starts working within 2 hours and provides a continuous level of insulin activity for up to hours depending on the specific preparation (Please refer to the manufacturers guidance for individual products). Onset: 0-2 hours Peak: None Duration: hours Insulin Degludec (Tresiba) can last for up to 42 hours Hours Page 10

11 Insulin Activity Insulin Activity Insulin Activity Insulin Activity Introduction to Insulins Example of Insulin Regimens Insulin regimen: Basal Bolus e.g. Intermediate and short-acting Once or twice daily basal insulin in combination with OHA or prandial insulin Twice daily basal bolus Long acting Insulin Duration: up to 24hrs Basal bolus using B.D. isophane and prandial insulin - 4 injections per day 3 analogue rapid / short + 1 non-analogue intermediate acting insulin Long acting Insulin Short acting Insulins Peak: 2-6 hrs Duration: up to 24hrs Long acting Insulin Hours 8am 12pm Breakfast Lunch 6pm 8pm Dinner bedtime Hours of action Night time Insulin regimen: Twice daily pre-mixed insulin This includes conventional mixtures of short-acting and isophane insulin, e.g. Insuman Comb 15, Comb 25, Comb 50 and Humulin M3. The most commonly used ratio is 30/70. Insulin analogue mixtures are available with a percentage of short-acting insulin of 25%, 30% and 50%. Short-acting insulin analogue mixtures such as Novomix 30, Humalog Mix 25 and Humalog Mix 50, are now available. These analogue preparations may have particular advantages in terms of patient convenience (no need to wait before eating) and control of post-meal glucose. If an individual has a higher HbA1c, head to head studies have shown greater efficacy if pre-mixed regimens are used and particularly evident in those with a less high BMI. Pre-mixed Analogues e.g. NovoMix 30, Humalog Mix 25, Humalog Mix 50 Pre-mixed Human insulin e.g. Humulin M3, Insuman Comb 15, Comb 25, Comb 50 Rapid acting Long acting Onset: 5-15mins Peak: 1-4 hours Duration: 14 hours Short acting Onset: 30 mins Peak: 2-8 hrs Duration: up to 24hrs Hours of action The peak of action varies with individual products Long acting Hours of action Biosimilar insulin Biosimilar insulin has now been included in the BNF A biosimilar is a biological copy that is not identical, but demonstrates similarity to the original product, in terms of quality, efficacy, cost and safety. The only biosimilar insulin available in the UK is Abasaglar which is similar to but not exactly the same as Lantus. Be aware: The two insulin products, Lantus and Toujeo are not interchangeable You must always prescribe insulin using the brand name More biosimilar insulin products are soon to be made available in the UK Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 11

12 Different Insulin Formulation and Concentration 100 units/ml Insulin 300 units/ml insulin 100 units/ml insulin is the preparation most commonly used in the UK, this delivers 100 units of insulin in 1ml. However a low volume concentration is now available. (See Leicestershire Medicines Formulary formulary.co.uk) 200 units/ml Insulin There are two insulin preparations that deliver 200 units/ml insulin in the UK; Insulin Degludec (Tresiba) and Humalog 200 units/ml KwikPen (Insulin Lispro). Insulin Degludec (Tresiba) is a long acting insulin that delivers the correct amount of insulin in units but in half the volume. The 200 units/ml insulin preparation is available in an insulin Flex Touch pen only. This device can be used to dial up to 160 units. Toujeo (300 Units/mL insulin glargine injection) Solostar Each 1mL contains 300 units insulin glargine Each pen contains 1.5mL of solution for injection, equivalent to 450 units Pen dials 0-80 units. An air shot is 3 units There are 3 pens in each pack Always prescribe using the brand name Insulin glargine 100units/ml & Toujeo are not bio-equivalent & not directly interchangeable. Dose adjustments may be required when switching Insulin Degludec (Tresiba) is also available in the traditional 100 units/ ml insulin for people on smaller doses (up to 80 units) and is available in a cartridge or a Flex Touch pen device Be aware the packaging is similar! * Please note this preparation has been sanctioned by NICE and can be found on the Leicestershire Medicines Formulary ( co.uk) 500 units/ml insulin Always check that the correct strength of Degludec (Tresiba) is prescribed Humalog 200 units/ml (Insulin Lispro) is rapid acting insulin and available in the KwikPen device It's also available in U100 strength The National Patient Safety Agency (NPSA) advise to always write the word strength in when prescribing U200 insulin (e.g. U200 strength Insulin Degludec). If patients dial up this insulin by counting the clicks they should be advised that each click accounts for 2 units of insulin 500 units/ml insulin e.g. Humulin R is sometimes used in people who are insulin resistant and require the equivalent or more than 300 units of 100 units/ml strength insulin per day. This product is not licensed in the UK but is still sometimes prescribed. It: Is soluble Is five times (5x) more concentrated than 100 units/ml insulin Is normally injected three times a day The U500 pen measures in units and not in marks Must be prescribed by a Diabetes Specialist on an named patient basis An independent nurse or pharmacist prescriber or Diabetes Specialist Nurse can adjust the dosage (local guidance only) Can be used in an insulin pump Warning! Insulin should NEVER be drawn up from an insulin cartridge or pre-filled pen using a syringe as the dose given would not be accurate. Page 12

13 Potential Insulin Regimens for Type 2 Diabetes Section 2: Potential Insulin Regimens for Type 2 Diabetes: Basal insulin with oral hypoglycaemic agents Offer NPH insulin injected once or twice daily according to need consider starting NPH and short acting insulin if the HbA1c is 75 mmol/mol or more. Consider as an alternative to NPH insulin using insulin detemir or insulin glargine if: The person needs another carer or healthcare professional to inject The person has recurrent hypoglycaemic episodes Otherwise the person would need twice daily NPH in combination with oral non-insulin therapies 1. Insulin regimen: Once-daily basal insulin in combination with oral hypoglycaemic agent Blood glucose targets for type 2 diabetes. Aim for HbA1c 48mmol/l at diagnosis. If the HbA1c levels are not adequately controlled using a single drug and rises to 58 mmol/l: -- Reinforce lifestyle measures -- Aim for 53 mmol/l -- Intensify drug treatment Once-daily basal insulin in combination with oral hypoglycaemic agent to include either a Sulphonylurea or a prandial glucose regulator with Metformin if tolerated. Evidence suggests that conventional isophane insulin when used in this regimen is best administered either in the evening or before bed. Factors to consider when using an analogue insulin: Once a day insulin analogues are designed to work throughout a 24 hour period with a peakless action. The length of action varies with each of these, refer to manufacturers guidelines Pre-breakfast (fasting) blood glucose readings are a good indicator of their effectiveness, but remember that some individuals may require a BD dose of a long acting analogue, e.g. BD dosing more likely with Detemir. 30% of patients in the 4T study required a second dose of insulin Detemir (Ref: Holman R et al 2009, NEJM 361: ) The peakless insulins are not effective in lowering meal-time (prandial) rises in blood glucose. If this cannot be adequately controlled with long-acting insulin and oral hypoglycaemic agents, short-acting insulin will need to be added Basal insulin analogues should not be mixed in syringes with other insulins Should ideally be injected at approximately the same time every day Your choice of oral hypoglycaemic agent, particularly the insulin secretagogue (SU), may be important if choosing this regimen. Always continue Metformin in the normal and overweight patients at the current dose unless contra-indicated or not tolerated. Always check for symptoms of Metformin intolerance in patients. Pioglitazone can be continued when commencing basal insulin Continue previous Sulphonylurea at unchanged dose. For ease of therapy one may wish to consider a change to once daily Glimepiride titrated up to a dose of 4-6 mg or Gliclazide MR. This is a good choice if ease of administration is an issue. If weight or hypoglycaemia is an issue consider an SGLT-2 or DPP-4 with basal insulin The insulin cannot be drawn up and left for injection later (RCN) Advantages The 4T study indicates that in patients with Type 2 diabetes and a baseline HbA1c < 8.5% a once daily basal insulin regimen is effective and safe with a lower risk of hypoglycaemia and weight gain It is simple and easy for early facilitation to insulin Potentially less weight gain Disadvantages Individuals may not achieve optimal control and may require a BD dose The regimen may not offer optimum control of post-meal (post prandial hyperglycaemia) Some individuals may require a more intensified insulin regimen Potential for less risk of hypoglycaemia Relatively easy regimen for healthcare professionals to support Useful for symptom relief if tight control is not a major issue Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 13

14 1. Once-Daily Basal Insulin In Combination With Oral Hypoglycaemic Agent Simple approach to initiation of insulin therapy Use 10 units once daily usually given at bedtime (9-10pm) or with evening meal for isophane You may need to consider a higher dose in people with insulin resistant Type 2 diabetes depending on their weight Most individuals will ultimately require between units of insulin per kilogram of weight, so in an individual weighing 100kg a daily dose of units may be required Long-acting analogues may be given morning or evening at a time suitable for the patient, but it ideally should be consistent from day-to-day There is some debate regarding the use of analogue versus non analogue insulin. Data suggests that analogues are more effective at lowering plasma glucose and have a lower rate of nocturnal hypoglycaemia compared with non-analogue insulin Consideration should be given to transfer to an analogue insulin if the individual is experiencing hypoglycaemia Group starts for introducing insulin therapy are a cost effective way of using resources also individuals may benefit from group interaction and receive consistent training in dose titration Titration of doses Indication for change of regimen Basal Insulin Regimen Aim for fasting plasma glucose level mmol/l, increase insulin Glargine or Insulin Detemir dose 2 units every 3 days until agreed targets are reached and there is no nocturnal hypoglycaemia Although basal analogues are designed to work throughout a 24 hour period, this may vary between hours If the insulin is taken in the morning consider that raised fasting glucose levels may be due to inappropriate diet and or the insulin running out rather than inadequate dosage N.B. Raised fasting glucose levels may also be due to nocturnal hypoglycaemia! Remember: Use three consecutive self-monitored fasting glucose levels (before breakfast) to adjust doses Wait 3-4 days between dose adjustments Reduce the dose if fasting glucose falls below 4mmol/L or an unexplained hypoglycaemic episode was experienced. The amount of decrease needs to be at least 2-4 units or 20%, whichever is greater You may need to advise blood glucose testing during the night if you suspect nocturnal hypoglycaemia (3am) 'Basal plus' regimens Fasting glucose levels are at target but if postprandial glucose levels remain high despite maximum tolerated oral agents, it may be appropriate to stop these and change to a formal basal bolus regimen. (See relevant guidances) Control remains suboptimal Recurrent unresolved hypoglycaemia Patient s preference or need for greater flexibility with regard to lifestyle (e.g. exercise, employment) Choice of oral hypoglycaemic agent Your choice of oral hypoglycaemic agent, particularly the insulin secretagogue (SU), may be important if choosing this regimen. Always continue Metformin in the normal and overweight patients at the current dose unless contra-indicated or not tolerated Always check for symptoms of Metformin intolerance in patients Continue previous Sulphonylurea at unchanged dose unless you are giving a pre-mixed regimen or prandial insulin then discontinue the Sulphonylurea. Or consider DPP-4 or SGLT-2 in combination with insulin if weight or hypo is an issue A basal plus regimen is sometimes required in individuals to improve glycaemic control this would comprise of a once daily intermediate/ long acting insulin with a prandial dose of fast acting insulin given with either the main meal or the meal that produces the greatest post prandial glucose excursion. The starting dose of the prandial insulin is usually 10% of the total daily dose of the basal insulin and is limited to a dose of between 4 and 6 units. Page 14

15 Potential Insulin Regimens for Type 2 Diabetes 2. Twice Daily Pre-Mixed Insulin Consider transferring to a twice daily pre-mixed insulin if: The person prefers to inject immediately before a meal Hypoglycaemia is a problem Blood glucose levels rise markedly after meals 2. Twice daily pre-mixed insulin Either conventional short-acting and isophane insulin (e.g. Insuman Comb 15, Comb 25, Comb 50, Humulin M3) or analogue mixed insulin, (e.g. NovoMix 30, Humalog Mix 25 or Humalog Mix 50). The advent of short-acting insulin analogue mixtures means that this regimen is now available as fast acting in the analogue insulins, either as: NovoMix 30 with 30% short-acting insulin analogue or Humalog Mix 25 (25% short acting insulin analogue), or Humalog Mix 50 ( 50% short acting insulin analogue). The particular choice of which pre-mixed insulin is used may be influenced by: Choice of insulin injection device Perceived convenience for individuals Potential for weight gain and risk of hypoglycaemia Advantages This regimen is relatively easy to teach and simplefor the patient to understand It has potential for better postprandial glucose control Is more effective in lowering HbA1c than basal insulin alone Particularly if the patient has a higher HbA1c (>9%), as most head to head studies have shown greater efficacy if pre-mixed and particularly in those patients with not such a high BMI NovoMix 30 can be administered up to three times a day if clinically appropriate Disadvantages There is less flexibility (i.e. Unable to adjust the short or basal component of insulin independently) Patients may not achieve optimal glycaemic control Time delay of injection with conventional mixture (need to inject minutes before a meal) The need for snacks between meals (with the new analogue mixture the delay in injection time is not required and the need for snacks may be reduced) Titration may get complicated and difficult to teach Increased risk of hypoglycaemia and weight gain (Ref: Holman R et al 2009, NEJM 361: ) Simple approach Initiation of insulin therapy in Type 2 diabetes Before breakfast and before evening meal: Use 10 units BD. Consider a lower starting dose in some circumstances, (e.g. frail, elderly or slim patients) Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 15

16 Titration of doses Morning dose of insulin titrated against pre-lunch and pre-evening meal blood glucose tests: suggest 2 unit increments or 10% increase with a target glucose of < 6mmol/l before lunch and before evening meal Evening dose titrated against pre-bed and pre-breakfast test. Titrate by 2 unit increments or 10% increments to try to achieve a before breakfast blood glucose of 5.5-6mmol/l -- Beware of before bed tests of < 6mmol/l : aim for a before bed test between 6mmol/l and 8mmol/l -- Watch carefully for the risk of nocturnal hypoglycaemia In patients with Type 2 diabetes and BMI >19, Metformin therapy should be continued at the maximum tolerated dose, as long as there is no contra-indication, (e.g. egfr <30ml/min, unstable heart failure) (It is important to check that the person has no symptoms of intolerance of Metformin therapy) Indication for change of regimen If glycaemic targets are not reached after titration, change may be required. For example:- If control remains suboptimal (HbA1c targets or fasting blood glucose or both) Hypoglycaemia (particularly during the night) Excessive weight gain despite continued Metformin Patients preference or lack of flexibility with the regimen for patients to undertake lifestyle (e.g. erratic job or exercise) If before the evening meal dose blood glucose remains high but further titration causes mid-morning hypoglycaemia, there are several options: 1. Continue premixed insulin and add in rapid/short-acting insulin at lunchtime if high blood glucose before evening meal 2. Stick to pre-mix twice a day but change the proportions of insulin (e.g. Humalog Mix 50) 3. Offer the patient free mixing of insulin. However, the disadvantage of this is that it is complicated to explain and teach to patients, accuracy is an issue, and the patients would need to move away from a pen device back to a needle and syringe 4. Basal Plus 5. Once you add prandial insulin whether in pre-mix or as once daily prandial, you should discontinue the Sulphonylurea. You should make sure that the basal insulin has been adequately titrated. With the basal plus you tend to add the first injection of prandial insulin to the largest meal or the meal that produces the greater post prandial glucose excursion and the starting dose is 10% of the total daily dose of basal insulin limited to a minimum of 4 and a maximum of 6 units Alternative approaches to insulin initiation for advanced practitioners The approach to insulin therapy is continuously changing. Recent evidence suggesting a more proactive and calculated dose and titration may be appropriate for those experienced in insulin management. To adopt this approach see the Leicestershire Diabetes website for education / training details e.g. the EDEN project. An accredited Masters level training module on insulin initiation and management is available. See for details Page 16

17 Potential Insulin Regimens for Type 2 Diabetes 3. Basal Bolus Regimen Offer NPH insulin injected once or twice daily according to need. Consider starting NPH and short acting insulin if the HbA1c is 75 mmol/mol or more. Consider as an alternative to NPH insulin using insulin detemir or insulin glargine if: The person needs another carer or healthcare professional to inject The person has recurrent hypoglycaemic episodes Otherwise the person would need twice daily NPH in combination with oral non-insulin therapies 3. Basal bolus regimen At least four injections of insulin per day Short-acting non analogue or a rapid-acting analogue before each meal (either once or twice daily isophane or long-acting insulin analogues, (e.g. Glargine, Detemir or Tresiba) Often used in people with Type 1 diabetes Rarely a first choice in patients with Type 2 diabetes Useful for patients who require flexibility on a daily basis, with irregular lifestyles, varied mealtimes or irregular eating patterns or shift work An example of someone in whom this may be useful is an active, motivated person with an erratic lifestyle to improve glycaemic control. Advantages Offers optimum flexibility in terms of diet and activity Reduces the risk of hypoglycaemia Potential for better metabolic control if used optimally Closely mimics normal insulin physiology Potential for the best control of basal and postprandial hyperglycaemia Potential for better weight management and lifestyle choice Disadvantages Requires multiple insulin injections More complicated to support and teach Requires more regular glucose testing Simple approach to transfer to basal bolus insulin therapy If already taking once or twice daily basal insulin - continue this and simply add quick acting insulin or quick acting analogue before each main meal If taking premixed insulin, calculate how the present dose of pre-mixed insulin is divided into short and long acting, and use this to influence decision Or change to: See next page for options Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 17

18 Change to: Option 1 Change to: Option 2 Basal bolus regimen with basal analogue (Glargine, Detemir, Tresiba) Basal bolus regimen with twice daily intermediate insulin (Humulin I, Insuman basal, Insulatard) Add up the total daily dose of the existing pre-mixed insulin regimen and then common practice is to reduce this dose by 20% In some circumstances it may not be appropriate to take off 20%, (e.g. very poor glycaemic control or symptomatic of high blood glucose) Give 50% of the total daily dose as a basal insulin Divide remainder to cover meals with a rapid acting insulin dependent on their eating habits Example: Insuman Comb 25 or Humulin M3 50 units am, 50 units pm. Total daily dose = 100 units - 20% = 80 units Give 40 units as basal insulin remainder given as units of quick acting insulin with each meal dependant on eating habits Add total daily dose of premixed insulin. Usually take off 20% In some circumstances it may not be appropriate to take off 20%, (e.g. very poor glycaemic control or symptomatic of high blood glucose). Give 50% as basal insulin divided into two equal doses Divide remainder to cover meals with quick acting insulin dependant on their eating habits Example: Insuman Basal or Humulin I: 50 units am, 50 units pm. Total daily dose = 100 units - 20% = 80 units 50% of dose divided into two injections of intermediate insulin 20 units am and 20 units pm Remainder given as quick acting insulin with units each meal dependant on eating habits Titration of doses Indication for change of regimen Adjust the basal insulin (long acting) to achieve satisfactory prebreakfast blood glucose levels, waiting 3-4 days between adjustments Although basal analogues are designed to work throughout a 24 hour period, this may vary between hours If the insulin is taken in the morning consider that raised fasting glucose levels may be due to inappropriate diet and or the insulin running out rather than inadequate dosage Also need to rule out nocturnal hypoglycaemia which can manifest as raised fasting glucose levels Offer dietary advice on role of carbohydrates portion size, timing of meals and snacks Reduce the dose if blood glucose is too low during the night or pre-breakfast blood glucose result is 5mmol/l on more than one occasion or < 4.5mmol/l on one occasion Adjust the short / rapid acting insulin to achieve satisfactory blood glucose levels 2 hours after the meal or before the next meal Difficulty in giving multiple injections More regimented lifestyle, where patient does not require the flexibility If post prandial blood glucose readings are raised consider using a basal plus regimen (See page 14). Your Record My Diabetes Doctor / Nurse is: Date HbA1c (your Target... mmol/mol & %) Target mmol/mol (6.5%- 7.0%) Caution mmol/mol (7.5%-8.0%) Stop Review 75 + mmol/mol (9.0%-10%) leicestershirediabetes.org.uk Page 18

19 Potential Insulin Regimens for Type 2 Diabetes 4. Type 1 Diabetes See NICE NG17 Guidance aim for: A fasting plasma glucose level of 5-7 mmol/l on waking and A plasma glucose level of 4-7 mmol/l before meals at other times of the day Measure HbA1c levels every 3-6 months in adults with Type 1 diabetes Aim for a target HbA1c level of 48 mmol/mol (6.5%) or lower, to minimise the risk of long term vascular complications Ensure that aiming for an HbA1c target is not accompanied by problematic hypoglycaemia in adults with Type 1 diabetes Insulin regimens: -- Offer twice daily insulin detemir as basal insulin therapy for adults with Type 1 diabetes -- Offer multiple daily injection basal-bolus insulin regimens, rather than twice daily mixed insulin regimens, as the insulin injection regimen of choice for all adults with Type 1 diabetes. Provide the person with guidance on using multiple daily injection basal-bolus insulin regimens -- Do not offer adults newly diagnosed with Type 1 diabetes non basal-bolus insulin regimens (that is, twice daily mixed, basal only or bolus only) Consider, as an alternative basal insulin therapy for adults with Type 1 diabetes if: An existing insulin regimen being used by the person that is achieving their agreed targets Once-daily insulin glargine or insulin detemir if twice daily basal insulin injection is not acceptable to the person, or if once daily insulin glargine if insulin Detemir is not tolerated Rapid acting insulin Offer rapid acting insulin analogues injected before meals, rather than rapid acting soluble human or animal insulins, for mealtime insulin replacement for adults with Type 1 diabetes People with Type 1 Diabetes whether cared for in hospital or community clinics should receive ongoing review by a diabetologist (Ref: ABCD position statement 2016) For peer support a useful resource is the ABCD Type 1 Diabetes Clinical Collaborative UK group - link here to access and register for this type1collaborative Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 19

20 Lifestyle Factors Section 3: General Advice Hypoglycaemia Hypoglycaemia Hypo is the most common side effect of insulin treatment and impacts on an individual s well being, quality of life and lifestyle. (See page 21 & 22, for specific advice on hypoglycaemia, prevention treatment and hypos and driving). Driving Patients do not have to give up driving but do need to plan in advance before getting behind the wheel. The Law: Insulin users must inform the DVLA when commenced on insulin - ensure the patient knows it is their responsibility. ( accessed 2018 Insurance - For your car insurance to be valid, you MUST inform your insurance company as soon as you are diagnosed with diabetes. If your insurance company asks about diabetes you must tell them that you have it The DVLA recommends a blood glucose of more than 5 mmol/l before driving (TREND-UK Driving leaflet Advise patient to carry easily accessible glucose treatments in the car (e.g. Glucojuice, glucose tablets) By Law individuals must inform the DVLA if they have had more than one episode of disabling hypoglycaemia (requiring the assistance of another person) and be advised not to drive. No matter how diabetes is treated insurance companies must be informed when someone has diabetes. People with diabetes MUST inform the DVLA if they are on insulin treatment If they are on insulin treatment: Individuals on insulin temporarily (less than 3 months) do not need to inform the DVLA Give Safe Driving and the DVLA leaflet ( Flash Glucose Monitoring Flash glucose monitoring has the potential to improve quality of life for patients and support self-management. At the present time the Freestyle Libre is the only meter available in the UK. At the present time the use of this monitoring system is being reviewed by the LMGS in Leicestershire. National recommendation for use are that: Flash glucose monitoring (Freestyle Libre ) should only be used for people with Type 1 diabetes, aged four and above, attending specialist Type 1 care using multiple daily injections or insulin pump therapy. Individuals should have been assessed by the specialist clinician and deemed to meet one or more of the following: Individuals who undertake intensive monitoring >8 times daily including use in pregnancy Those who meet the current NICE criteria for insulin pump therapy (HbA1c >8.5% (69.4mmol/mol) or disabling hypoglycaemia as described in NICE TA151) where a successful trial of flash glucose monitoring may avoid the need for pump therapy Those who have recently developed impaired awareness of hypoglycaemia. It is noted that for persistent hypoglycaemia unawareness, NICE recommend continuous glucose monitoring with alarms and Freestyle Libre does currently not have that function Frequent admissions (>2 per year) with DKA or hypoglycaemia Those who require third parties to carry out monitoring and where conventional blood testing is not possible In addition, all patients (or carers) must be willing to undertake training in the use of Freestyle Libre and commit to ongoing regular follow-up and monitoring (including remote follow-up where this is offered). Adjunct blood testing strips should be prescribed according to locally agreed best value guidelines with an expectation that demand/frequency of supply will be reduced. Drivers will still need to test using a point of care system Monitoring Self Blood Glucose Monitoring (SBGM) is recommended in people on insulin therapy Those unable to perform SBGM may require more frequent HbA1c testing- (See monitoring glycaemic control guidelines) All people with Type 1 diabetes should be issued with ketostix Alcohol Government guidelines on alcohol intake are the same for people on insulin as they are for those not on insulin Alcoholic beverages have different effects on blood glucose levels The risk of delayed hypoglycaemia needs to be discussed with the patient Where alcohol intake exceeds recommended levels, people need appropriate advice to minimise risks. Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 20

21 Lifestyle Factors Exercise Special occasions and cultural issues Physical activity is a key element in the prevention and management of Type 2 diabetes. Regular physical activity improves blood glucose control and can positively affect lipids, blood pressure, cardiovascular events, mortality, and quality of life All types of activity including regular walks or gym workouts will have an effect on glycaemic control If the individual takes strenuous exercise and is insulin treated, the dose of insulin may need to be reduced over the next 24 hour period Exercise should be undertaken regularly to have continued benefits. Most people with Type 2 diabetes can perform Exercise safely (Practical Diabetes September 2013, Volume 30, Issue wiley.com/doi/ /pdi.v30.7/issuetoc) (See Exercise and Sports section on: Travel Insulin use does not restrict travel opportunities, but planning is required Consider destination, climate, illness, time changes and zones, inactivity, mode of travel, availability and storage of supplies (See page 33). Carry adequate identification. A supporting letter from a healthcare professional on headed paper may be necessary Healthy eating Patients may need additional advice to manage these situations, especially around feasting and fasting Ramadan advice should be given 2 months before - if the patient says they feel hypo at anytime during the fast, they should break the fast. Test blood glucose levels every 4 hours (Ref: Looking after diabetes during Ramadan: A guide for patients Cultural awareness and sensitivity are essential Participation in events does not have to be restricted Further information is available from: Leicestershire diabetes website - Diabetes UK website - Insulin and steroid use Steroid therapy is sometimes used in people with other long-term conditions such as COPD and is frequently used in palliative care for symptom control. The impact of steroids is to increase blood glucose, which can cause additional hyperglycaemic symptoms Once-daily steroid therapy taken in the morning tends to cause a late afternoon or early evening rise in glucose levels which can be managed by isophane insulin (e.g. Human Insulatard, Humulin I or Insuman Basal) (Please see algorithm Appendix 3 for managing patients on once daily steroid in end of life care) Attention should be paid to the role of carbohydrate and insulin action on blood glucose levels. Additional snacks are not automatically required and should be tailored to the individuals needs Care must be taken to ensure that advice given about changing eating habits is not detrimental to the individuals weight management goals Consider referring to the diabetes specialist dietitians Some healthcare professional find it useful to compile a checklist to document advice given when initiating and managing insulin. An example of one can be found on the Leicestershire website: Page 21

22 Lifestyle Factors Hypoglycaemia Hypos Patients who are injecting insulin may be at risk of hypos. A hypo is when blood glucose levels drop to below 4mmol/L Some but not all patients will experience symptoms such as sweating, palor, trembling and headaches but people with a long duration of diabetes may not have any symptoms of hypoglycaemia. If early signs of hypoglycaemia are missed the symptoms may worsen and the individual may lose cognitive function. Identifying those at risk These include all insulin, Sulphonylurea (e.g. Gliclazide, Glipizide, Glimepiride) and prandial regulator users (Nataglinide, Repaglinide) Other non-insulin therapies when added to a Sulphonylurea and / or insulin can increase the risk of hypoglycaemia. People on an SU must be advised on the risk of hypoglycaemia and given advice on how to recognise and treat hypoglycaemia. In addition it is important to inform the individual that an SU must always be given with food (See Hypo leaflet appendix 6). Patients who are at particularly high risk include those who also have one or more of the following: Poor appetite/erratic eating pattern Weight loss Renal deterioration Liver impairment/carcinoma Dementia The elderly They may look pale, become confused, have a change in behaviour, become very drowsy, and lose consciousness. Sweating, fits, and skin colour change in a drowsy or unconscious person may be due to hypoglycaemia. Causes of 'Hypo' A number of situations can cause a hypo, people particularly at risk include those with: Impaired renal function Too much insulin Specific glucose lowering therapies including SU, whether used alone or in combination with other diabetes treatments Delayed or missed meals or fasting Eating less starchy foods than usual Unplanned or strenuous activity Drinking too much alcohol or drinking alcohol without food Sometimes there is no obvious cause, but treatment should always be carried out immediately, as advised. Symptoms hypos Some individuals, particularly those with long duration diabetes and/or persistent hypoglycaemia may not experience any symptoms. Early signs and symptoms of a hypo include: Sweating heavily Feeling anxious Trembling and shaking Tingling of the lips Hunger Going pale Palpitations Symptoms may vary from person to person, particularly in the older patient, symptoms include: Slurring of words Behaving oddly Being unusually aggressive or tearful Having difficulty in concentrating If the hypo is not treated at this stage, the person may become unconsciousness Hypos during end of life Hypoglycaemia can be troublesome for individuals at any time and particularly during end of life care. Every effort should be made to avoid this side effect. (See Appendix 2 for glycaemic control during end of life care) Factors that should be considered at this time are: Do not aim for tight control in these individuals, blood glucose readings between 6-15mmol/l are acceptable Aim for symptomatic relief Tailor insulin therapy to clinical needs Rationalisation of glucose-lowering treatment for diabetes Involve an experienced community dietitian Early identification of risk factors for hypoglycaemia Treat pain effectively Assess impact of weight loss Assess influence of nutritional deficits Assess influence of opiates / other painkillers on appetite Consider community DSN support if appropriate Do not assume if the patient is comatose that it is due to the end of life primary condition. Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 22

23 Hypos and driving Hypos whilst driving Informing the DVLA Complications with diabetes can affect ability to drive as well as risk of hypos and accidents. See previous section on driving (page 20). Blood glucose levels should always be more than 6 mmol/l (local guidance), always test before driving due to risk of hypos whilst driving Plan for long journeys and take regular breaks and test 2 hourly Patient Advice: If you a have a hypo whilst driving 1. Stop car as soon as possible 2. Remove keys 3. Move to the passenger seat if safe 4. Treat the hypo Give patient Safe Driving and the DVLA leaflet Advise patient to carry easily accessible glucose treatments in the car Advise patients not to drive for at least 45 minutes following a hypo By Law Group 1 driver (car/motorcycle) who has had two or more episodes of hypoglycaemia requiring assistance from another person at any time in waking hours in a year, must inform the DVLA, and be advised not to drive. In these cases the Licence will be withdrawn for 3 months following the last episode By Law Group 2 driver (bus/lorry) with one or more episode(s) of hypoglycaemia requiring the assistance of another person in the previous 12 months must inform the DVLA and be advised not to drive. They must also tell the DVLA if they or their medical team feels they are at high risk of developing hypoglycaemia. ( guidance/diabetes-mellitus-assessing-fitness-to-drive accessed 2018) What are a doctor s responsibilities? When any doctor is aware that a patient is not fit to drive, they should advise the person not to drive and to notify the DVLA If a doctor becomes aware that someone in their care does not notify the DVLA, or refuses to do so, the doctor is allowed under General Medical Council guidelines to notify the DVLA (ref: It would be good practice to confirm this conversation in writing to the person concerned so that there is no doubt about the advice. This should be documented in the notes The doctor may also want to inform the patient that their insurance is no longer valid It is up to the DVLA to revoke/renew a licence If the doctor has concerns but are not sure if the person is fit to drive, they should advise the individual to notify the DVLA and document this in the notes Page 23

24 Lifestyle Factors Treating hypos in the community Treating Hypoglycaemia Is the individual conscious and able to swallow? Yes Give one of the following: 60ml Glucojuice 200 ml of pure smooth orange juice (small carton) 5 glucotabs 6 dextrose tablets mls Fortijuice If after 15 minutes, the blood glucose level is still less than 4 mmol/l, repeat the treatment. Repeat treatments up to 3 times. Every 15 minutes If the person still has a BG < 4 mmol/l after 3 treatments seek medical advice Once the blood glucose is above 4 mmol/l, give a starchy snack like a banana or glass of milk or 2 biscuits unless a meal will be eaten in the next 1 to 2 hours No Is the individual conscious and not able to swallow? Yes People on enteral feeds: If conscious and feeding tube in place: You should stop the feed Flush the tube with water Insert 60mls of Glucojuice or mls Fortijuice or Ensure Plus Avoid use of Glucogel Flush the tube with 30 mls water Flush tube with 30 ml water Wait 15 minutes and re-check blood glucose level Repeat this procedure every minutes and up to 3 times, until the blood glucose is above 4 mmol/l Once blood glucose level is above 4mmol/l, resume feed If hypoglycaemia occurs between feeds, treat as above and once blood glucose is above 4 mmol/l, connect the feed and give enough to deliver 20g of carbohydrate (see the feed label) No If unconscious: Put the person in the recovery position and maintain airway - do not put glucose in the mouth. Give 1mg glucagon intra-muscularly if available and carer trained. If glucagon is not available or is ineffective, and IV access is available, give 75-80ml of 20% glucose (over minutes). If not available, call paramedics. Note: Glucagon may not be effective in people with liver disease Once fully conscious and able to swallow: Give a starchy snack such as a banana or 2 slices of bread Continue to monitor as these is an increased risk of recurrent hypoglycaemia in those receiving Glucagon After an episode of hypoglycaemia: Consider discontinuing insulin (unless type 1 diabetes) or reducing insulin or oral hypoglycaemia agents. Review management plan with patient and relatives to clarify/confirm goals of diabetes management for their stage of life. Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 24

25 Section 4: Managing Insulin During Illness in Type 1 and Type 2 Diabetes TYPE 2 DIABETES: MANAGING YOUR INSULIN WHILST UNWELL Type 2 diabetes & feeling unwell? Test blood glucose levels every 4 hours Sip sugar-free liquids, at least 100ml/hour Eat as normal if possible, if not see meal replacement suggestions (page 10) You need food containing carbohydrate (carbs), insulin and fluids to avoid dehydration and serious complications If your blood glucose is less than 4mmol/l treat as a hypoglycaemia episode Blood glucose between 4-11mmol/l Blood Glucose more than 11mmol/l Take your insulin as normal Take your usual insulin dose and if your blood glucose level is above 11mmol/l take additional insulin as below: Blood glucose Insulin dose 11-17mmol/l Add 2 extra units to each dose 17-22mmol/l Add 4 extra units to each dose More than 22mmol/l Add 6 extra units to each dose Call your GP or Nurse if still elevated. If you are taking more than 50 units in total daily, you should double the adjustments This algorithm has been adapted from the booklet Insulin self adjustment advice for people on basal insulin regimen. The Intermediate Diabetes Service, Enfield Community Services BEH-MHT, Page 8 Ref: What to do when you have diabetes and are ill Nov UHL, Leicester Diabetes Centre Page 25

26 Managing Sick Days when on Insulin treatment MANAGING YOUR DIABETES WHILST UNWELL Type 1 diabetes & feeling unwell? Test blood glucose and ketones *Total Daily Dose (TDD) Add up all the doses of insulin (rapid and long acting) that you took in the previous 24 hours, for example: Levemir: 12 units twice daily NovoRapid: 10 units - breakfast, 12 units - lunchtime, 8 units - dinner time Total: 42 Units TDD 10% TDD 20% units 2 unit 15 units 3 units units 3 units 20 units 4 units units 4 units 25 units 5 units units 5 units 30 units 6 units units 6 units 35 units 7 units units 7 units 40 units 8 units Ketones (negative or trace) Less than 1.5mmol/l on blood ketone meter Ketones present More than 1.5mmol/l on blood ketone meter Sip sugar-free liquids, at least 100ml/hour Eat as normal if possible, if not see meal replacement suggestions (page 8) You need food containing carbohydrate (carbs), insulin and fluids to avoid dehydration and serious complications Sip sugar-free liquids, at least 100ml/hour Eat as normal if possible, if not see meal replacement suggestions (page 8) You need food containing carbohydrate (carbs), insulin and fluids to avoid dehydration and serious complications Test blood glucose levels and ketones every 4-6 hours (pre-meal including throughout the night) Test blood glucose and ketones every 2 hours Take your usual insulin dose & if your blood glucose level is above 11mmol/l take additional insulin as below: Calculate total daily dose (TDD)* of insulin from previous day Blood glucose Insulin dose 11-17mmol/l Add 2 extra units to each dose 17-22mmol/l Add 4 extra units to each dose more than 22mmol/l Add 6 extra units to each dose Call your GP or Nurse if still elevated If you start vomiting, are unable to keep fluids down or unable to control your blood glucose or ketone levels, you must seek urgent medical advice. DON T STOP TAKING YOUR INSULIN EVEN IF YOU ARE UNABLE TO EAT. Urine ketones + to ++ (1.5-3mmol/l on blood ketone meter) If on rapid acting insulin give 10% TDD every 2 hours plus your normal mealtime dose if eating If on a mix insulin only give 10% extra at each meal time (4-6 hours) plus your normal mealtime dose if eating Urine ketones +++ to ++++ (more than 3mmol/l on blood ketone meter) If on rapid acting insulin give 20% TDD every 2 hours & basal as normal if eating If on a mix or basal insulin give 20% extra at each meal time (4-6 hours) This algorithm has been adapted from the booklet Insulin self adjustment advice for people on basal insulin regimen. The Intermediate Diabetes Service, Enfield Community Services BEH-MHT, Page 6 Page 7 Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 26

27 General Principles of Managing Sick Days Introduction Sick days for insulin pump users When a person with diabetes is unwell, it is likely that their blood glucose levels will rise and the signs and symptoms of hyperglycaemia may still occur even if the person is not eating. If someone does not know how to manage their diabetes during periods of illness, it can lead to other serious conditions such as diabetic ketoacidosis (DKA) in people with Type 1 diabetes and hyperglycaemic hyperosmolar state (HHS) in those with Type 2 diabetes. The correct advice for care during intercurrent illness may prevent this happening. General principles of managing diabetes during inter-current illness When managing a person with diabetes during inter-current illness the aims are to: Continue to manage the person s diabetes and blood glucose levels Ensure the person receives sufficient carbohydrate intake and address dehydration with fluid replacement Test for and manage any ketones present in the body Recognise whether the person requires additional medical attention Insulin pump users can rapidly develop diabetic ketoacidosis (DKA) if their insulin pump fails. If a person s blood glucose level rises rapidly they should: Monitor for blood or urine ketones (pump users are more likely to get euglycaemic ketosis) Check the pump to ensure that it is working properly Check to see if the pump tubing is blocked or disconnected Check that the cannula is in the correct place and is secure All pump users should be advised to carry an insulin pen device with them containing quick-acting insulin that is in date for use in emergencies. Insulin pump users will be under specialist diabetes care and will have an emergency contact telephone number to use should any issues arise. (Ref: TREND-UK career and competency doc 3rd edition) Sick pregnant women and children Seek urgent specialist advice/or admit See pre-pregnancy planning a for women with diabetes and Gestational diabetes antenatal care patient information leaflets on www. leicestershirediabetes.org.uk Food and fluid replacement If the individual is unwell and unable to eat their usual meals, it is important that they continue to eat or drink some carbohydrate (starchy or sugary foods) as a source of energy. The individual should try to take two to three servings from the list provided approximately four to five times a day. They should also be encouraged to drink at least 4-6 pints ( L) of sugar-free fluid in 24 hours (at least 100mL each hour) in order to avoid dehydration. Table 3: Food Alternatives Type of food alternative Amount (Each serving provides approximately 10g of carbohydrate) Fruit Juice* 100mL ½ glass 4 fl oz Milk 200mL 1 glass 7 fl oz Soup 200mL 1 mug 7 fl oz Plain toast 2 medium pieces 15 gms carbs per slice - Ice cream 50g 1 large scoop 2 fl oz Complan - 3 level teaspoons (as a drink) - Drinking Chocolate* - 2 level teaspoons (as a drink) - Ovaltine or Horlicks - 2 level teaspoons (as a drink) - *Sugar quantities may vary widely according to brand However, if the individual starts vomiting or is unable to keep fluids down, urgent medical advice should be immediately sought. Ref: What to do when you have type 2 diabetes and are ill - Nov (See appendix) Page 27

28 Managing Sick Days when on Insulin treatment Sick Day Management - T2DM Specific advice on insulin management with or without combined use with glucose lowering therapies Table 3: Ref: adapted from TREND-UK Managing diabetes during inter-current illness in the community (2013) Drug class General advice for all people with diabetes Biguanides (Metformin) Sulphonylureas (Glibenclamide, Gliclazide, Glimepiride, Glipizide, Tolbutamide) Meglitinides (Nateglinide, Repaglinide) Thiazolidinediones (Pioglitazone) Glucagon-like peptide-1 (GLP-1) receptor agonists. (Exenatide extended release (Bydureon) Exenatide (Byetta) twice daily,lixisenatide (Lyxumia),Liraglutide once daily) General recommendations for carers and healthcare professionals on the authors experience Blood glucose levels should be tested if a meter is available. If it is not available, be mindful of the symptoms of hyperglycaemia. The person should continue to take their medication while the blood glucose level is normal or high unless they are feeling severely unwell (e.g. vomiting, diarrhoea or fever) or are dehydrated, in which case, Metformin should be temporarily stopped. The dose should be restarted once the person is feeling better. Metformin should also be stopped in individuals where the severity of their illness requires hospitalisation or confinement to bed. The person should continue to take their medication while the blood glucose level is normal or high. If they are unable to eat or drink, they may be at risk of hypoglycaemia (low blood glucose levels) and the medication may need to be reduced or stopped temporarily. The person should continue to take their medication while the blood glucose level is normal or high. If they are unable to eat or drink, they may be at risk of hypoglycaemia (low blood glucose levels) and the medication may need to be reduced or stopped temporarily. The person should continue to take their medication while the blood glucose level is normal or high. Medical advice should be sought if the person experiences unusual shortness of breath or localised swelling as this may be a sign of possible heart failure, particularly in the elderly. The person should continue to take their medication while the blood glucose level is normal or high. Medical advice should be sought if the person is vomiting, dehydrated or experiencing severe abdominal pain. Severe abdominal pain may indicate pancreatitis. There is a risk of UTI and genital tract infection in people using SGLT-2s Be aware of postural hypo-tension particularly in the elderly Sodium glucose co-transporter 2 (SGLT-2) inhibitors (Dapagliflozin) Be aware that there have been a small number of reports relating to the development of DKA in patients. This seems to be related to the use of this therapy in people who either have Type 1 diabetes late onset Type 1 Diabetes, LADA or in insulin depleted people with Type 2 diabetes. Patients should be informed that if they become acutely unwell and particularly if they develop breathlessness or are admitted to hospital for any reason they should discontinue these drugs and seek urgent medical advice. SGLT2 Advice for healthcare professionals When treating patients who are taking a sodium-glucose co-transporter 2 (SGLT2) inhibitors (Canagliflozin, Dapagliflozin, or Empagliflozin): Inform them of the signs and symptoms of diabetic ketoacidosis (DKA) -see below - and advise them to seek immediate medical advice if they develop any of these Discuss the risk factors for DKA with patients (see below) Discontinue treatment with the SGLT2 inhibitor immediately if DKA is suspected or diagnosed Do not restart treatment with any SGLT2 inhibitor in patients who experienced DKA during use, unless another cause for DKA was identified and resolved Interrupt treatment with the SGLT2 inhibitor in patients who are hospitalised for major surgery or acute serious illnesses; treatment may be restarted once the patient s condition has stabilised Report suspected side effects to SGLT2 inhibitors or any other medicines on a Yellow Card Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 28

29 Section 5: Insulin Administration and Devices Introduction Practical points for consideration Insulin always has to be injected and so every device needs to be used with a needle. Sharps injuries are common and can affect the user, carer or healthcare professional administering the insulin. The UK market supports patient choice with many different devices available that can be used to administer insulin. These include: Insulin syringes Insulin pen devices Insulin pumps As you know that there are over 20 different types of insulin. It is therefore imperative that you choose and use the right type of insulin and device. Having made the decision to start insulin the following points may influence choice of regimen and devices. The choice and type of delivery system used will depend on the individual persons: Preference Manual dexterity Visual capacity Lifestyle Type of insulin used to effectively treat their diabetes Eating patterns Occupation Agreed frequency of injections Ability to grasp technique Choice may be influenced by availability of insulin (e.g. 10ml vials for use with syringe, 3ml cartridges for use with pens or pre-loaded disposable pens, or the need for low volume insulin such as Insulin Degludec, (U200) or Humulin R (U500) in those on high doses) (See page 12) Structured education All patients should have been offered comprehensive structured education programmes. There is evidence that these programmes are best delivered in groups and facilitate peer support People with Type 2 diabetes should already have attended a structured education programme that meets NICE criteria. If not please refer. People with Type 1 diabetes may benefit from attending the DAFNE course which focuses on dose titration and carbohydrate counting Leicester City patients can be referred to the Intermediate Community Diabetes Service for advice and support in dose titration of insulin for both Type 1 and Type 2 diabetes Page 29

30 Insulin Administration, Devices Insulin delivery devices: Syringes Syringes are suitable for people: Who want to mix two insulins together in one device Who inject high doses Who want a back up device Who require third party injections Who need to be reassured by seeing the dose delivered Using a vial of insulin and a syringe requires the user or their carer to have good eyesight Who have ability to read measurements on the syringe Who have dexterity to withdraw the insulin from the vial It is important that an insulin syringe is always used for insulin injections as the use of an intramuscular injection syringe leads to a risk of a 10 fold overdose of insulin. Never draw up insulin with a syringe from a pen device or cartridge In the UK, U100 insulin is mostly available for use in people with Diabetes. This means that there are 100 units per 1ml of insulin. U100 insulin syringes therefore provide the correct unit markings for U100 insulin. Insulin syringes always have a needle attached - these come in different lengths. Other insulin strengths are available for those requiring large doses. (see page 12) See Appendix 5 for Insulins chart Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 30

31 Types of Insulin Delivery Devices: Pumps Insulin delivery devices: Insulin pumps Insulin pumps are usually recommended as a treatment by consultants for patients with Type 1 diabetes. Pumps are the most accurate, precise, and flexible insulin delivery system currently available. In some pump users this tool can be effective in optimising blood glucose control. An Insulin Pump is a small programmable device that holds an insulin cartridge/reservoir and delivers a continuous flow (basal rate) of insulin to the body through a thin plastic tube inserted in the body. A pump is programmed to automatically deliver small pulses of insulin over 24 hours to keep blood glucose in the desired ranges between meals and overnight. Extra insulin is then given by the patient at the touch of a button to cover meal times. Most infusion sets are worn in the abdominal area and a tiny flexible tube called a cannula is inserted easily into the skin. Patients generally refill their insulin reservoir and change their infusion sets every 2-3 days. Benefits The benefits of using pump control in patients A pump can help patients avoid hyperglycaemia, (high blood glucose) which in the long term can cause diabetic complications Fewer fluctuations in blood glucose levels during the course of the day A person managing their diabetes with an insulin pump can more easily adapt their treatment to changes in their daily routine, for example through travel or variable working hours, exercise Less nocturnal hypoglycaemia, which in the long term can cause diabetic complications Pump therapy can also help prevent nocturnal hypoglycaemia Improved long term control (HbA1c and weight) Disadvantages Who can use insulin pumps Insulin pumps can be used in children and adults When a child under 12 years is struggling with multiple daily injections insulin pump therapy maybe considered If long term blood glucose levels (HbA1c) managed with multiple injections continue to cause severe hypos HbA1c levels have remained high on multiple injection therapy even after regular support from healthcare professionals including NICE recommended Structured Education Programmes (i.e. DAFNE) (See NICE guidance: Insulin pump therapy is NOT generally recommended for patients with Type 2 diabetes The pump may fail The cannula may become blocked or disconnected A supply of insulin pens should be kept just in case the pump fails More expensive Doesn t suit everyone Emergencies All pump users should be advised to carry an insulin pen device with them containing quick-acting insulin that is in date for use in emergencies Specialist care Insulin pump users will be under specialist diabetes care and will have an emergency contact telephone number to use should any issues arise. (Ref: TREND-UK Career and Competency Framework 4th edition) Diabetes Specialist Nurses specialising in Pump Therapy are based at the Leicester General Hospital Tel: Page 31

32 Insulin Administration, Devices Insulin delivery devices: Pens Insulin pens are a very useful way to carry and administer insulin. They allow users to administer insulin when they are on the on the move or whenever it suits them Insulin pens are either disposable one-shot devices or they have replaceable cartridges of insulin The tip of insulin pens include a fine, short needle and so users can turn a dial to select the correct dosage Insulin pens come in 2 types of delivery systems: a. Pre-filled pens which are disposed of when empty b. Pens where the insulin is given via a cartridge The type of insulin cartridge used will determine the type of pen needed as different insulin manufacturers have different fittings on their pen. (See example opposite) For all insulin products refer to the appendix 5 Screw cap Push Cap Insulin pen devices alleviate some user error in insulin measurement and reduce the need for dexterity and good eyesight Some pens have a memory function so the user can be reminded as to how much insulin they last took and when, (e.g. the NovoPen Echo) Some pens dial up in increments of 1 Unit and others in 2 Units Children and young people can use pen devices that dial up in 0.5 Unit increments, (e.g. Luxura HD, NovoPen4, NovoPen, Junior Cartridges) Be aware that different manufacturers use a different type of cartridge and so their pens only take their make of insulin Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 32

33 Injecting Insulin Injecting: Direct subcutaneous Direct subcutaneous insulin injection remains the most common form of delivery, using a needle and syringe. Insulin syringes are available in a number of needle lengths. The capacity of the syringe should be chosen depending on the dosage of insulin required The markings down the side of the syringe shows how many units of insulin are in the syringe Injection sites The most common injection site are the: Stomach Thigh Buttocks Arms (Diagrams kindly supplied by Beckton Dickinson Ltd) Arms should be used with caution due to rapid onset of insulin action Injection sites should be checked regularly Injection sites should be checked regularly Encourage the practice of rotating place if injecting within a chosen site Rotating injection sites may result in differing rates of absorption between sites and needs to be taken into consideration, (e.g. insulin is absorbed more quickly from the abdomen than the thighs) Lipohypertrophy can effect the absorption of insulin and lead to erratic glycaemic control - if a patient stops using a lumpy injection site, blood glucose levels should be monitored closely as a reduction in insulin may be required to avoid hypoglycaemia. Page 33

34 Insulin Administration, Devices How to inject Dial or draw up the correct dose of insulin as per chosen device Remember to agitate insulin if required Choose injection site (see diagram on opposite page) No lifted skin fold required for 4mm, 5mm or 6mm needles Lifted skin fold subcutaneous fat for 8mm needles and above (see diagram opposite) Insert needle directly into raised area at 90o Depress plunger or button to deliver insulin as per manufacturers instructions Hold needle in place for 10 seconds then remove Change insulin pen needle every time they inject Give patient the Keeping safe with insulin booklet ( available from or booklet and passport/ insulin safety cards and discuss content with them Never withdraw insulin from a cartridge or pen with an insulin syringe - the dose will not be correct and with higher strength insulin it will lead to an overdose/harm Storing insulins syringes, insulin pens and cartridges The pen currently being used can be kept at room temperature for up to 4-8 weeks depending on the individual preparation The insulin vial that is in current use may be kept at room temperature for 28 days/1 month, insulin remaining in the vial after this should be disposed of Spare vials, pre-filled pens and cartridges that are not in use can be stored in the fridge Insulin is affected by extremes of temperature (i.e. very hot or freezing). Avoid keeping in contact with direct heat or sunlight or risk of freezing (e.g. in the hold of an aircraft) Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Remember that between injections some insulin particles separate and to ensure correct concentration /consistency these Insulin needs to be mixed by inverting 20 times or rolling prior to injecting them. Page 34

35 Section 6: Insulin Safety Common insulin errors Wrong syringe Wrong insulin Incorrect insulin name Omitted doses Use of U when prescribing insulin can lead to dose error (see section The Right Dose opposite) Inaccurate transcription or documentation Inappropriate timing of injection or meals The incorrect insulin product was described in 2,201 incidents over a six year period (NPSA) The right insulin There are over 30 different types of insulin. The packaging of insulin is often very similar and so are insulin names. This table shows some insulin names that are often confused: Humalog Humulin S Humalog with with with NovoRapid with NovoMix 30 Levemir with Lantus Hypurin Porcine Neutral with Humalog Mix 25 or Humalog Mix 50 Humulin I or Humulin M3 Humulin I or Humulin S or Humulin M3 Hypurin Porcine 30 / 70 Mix The right dose Insulin comes in vials for use with insulin syringes and pumps, in cartridges for insulin pens or pre-filled pens Each should be clearly labelled with the name of the insulin Patient should be advised to keep a record of the amount of insulin units they are taking There are 2 different designs of insulin cartridge so not all cartridges can be used in all insulin pens. If the individual uses cartridges they need to know which pen is right and safe for them to use Pre-filled pens should contain an individual s prescribed insulin Advise the individual to check the name of the insulin is correct with their Pharmacist before they leave the pharmacy If insulin is prescribed using the letter U after the dose needed instead of writing the word units in full, the U can be mistaken for an 0. This can lead to a risk of you having an overdose of insulin. (e.g. 40 units instead of 4) If someone else administers the individual s insulin always ask them to check the dose The right time Healthcare professionals should discuss with patients when they need to take their insulin Advise patients if they are admitted to hospital and they are well enough: ask to keep insulin with them so they can self manage their diabetes - this is really important if an insulin pump is used Advise patients if they can t give or keep their own insulin, don t be afraid to ask staff when they need it In 2010 the National Patient Safety Agency (NPSA) issued a Rapid Response Report stating that: A training programme should be put in place for all healthcare professionals (including medical staff) expected to prescribe, prepare and administer insulin Insulin passports help identify an individual s prescribed Insulin details A free e- learning module on the safe use of insulin is available called Six steps to insulin safety available on www. diabetesonthenet.com Ref: Safe use of Insulin and you leaflet Page 35

36 Insulin Safety The safe use of insulin and patient safety information 1. Adult patients on insulin therapy should receive a patient information booklet and an Insulin safety card to help provide accurate identification of their current insulin products and provide essential information across healthcare sectors 2. When prescriptions of insulin are prescribed, dispensed or administered, healthcare professionals should cross-reference available information to confirm the correct identity of insulin products These are free to download from the Trend-UK website KEEPING SAFE WITH INSULIN THERAPY k WHY IS THIS LEAFLET FOR YOU? Insulin treatment improves the quality of life in many people and saves the lives of others. It is used to lower blood glucose levels. However, insulin management and prescribing errors are very common and can lead to patient harm. These are often as a result of not having: The right person The right insulin The right dose This leaflet can help you to get the most out of your insulin treatment and keep YOU safe The right time The right device The right way Insulin Safety: Sharps Safe disposal of sharps Sharps injury: the cost Prescribe the patient a sharps disposal box There is national guidance for disposal of sharps (See www leicestershirediabetes.org.uk) guidance should include advice around : Prescribing and disposal of sharps boxes Do not dispose of sharps in general refuse to prevent needle stick injuries Your CCG/prescribing lead will have local guidelines on sharps disposal Insulin safety needles must be used if insulin needs to be given by a HCP See New European guide for sharps - Initial cost of a sharp injury is estimated as 1540 for Hepatitis B 235 For Hepatitis C 932 for HIV positive The psychological costs to the healthcare professional are not so easily measured but can include: Depression Anxiety, Inability to work Relationship problems What should you do if you have a sharps injury? Encourage the wound to gently bleed ideally whilst holding it under running water Wash the wound using plenty of soap and running water Don t scrub the wound Don t suck the wound Dry the wound and cover it with a waterproof plaster or dressing Seek urgent medical advice e.g. from Occupational Health Always report the injury to your manager/employer REMEMBER! Never re-sheath an insulin syringe or pen needle Never draw insulin from a pen cartridge or device using a syringe Always keep a sharps bin at the point of care Leicester Diabetes Insulin Therapies: An Educational Tool Kitt 3rd Edition Page 36

37 Help and support Supporting literature is available from: Supporting Documents Leicestershire Diabetes website For healthcare professionals, carers and people with diabetes Diabetes UK Tel: website: NovoCare Customer Care centre Tel: Website: Lilly Diabetes Care UK Tel: Sanofi- Aventis Customer Service Tel: Trend-UK - Patient leaflets developed by TREND-UK are mostly available from the sponsoring company for each one - please contact your local representative for hard copies Excluded are the: Keeping safe with Insulin booklet & The Enteral feeding and diabetes. These have to be downloaded Leicestershire Diabetes website - Leicestershire Diabetes Management Guidelines for Type 1 and Type 2 4T Study Ref: Holman R et al 2009, NEJM 361: Insulin passports Driving and hypos leaflet DVLA - ABCD type 1clinical collaboration group -type-1-standards-care-0 Page 37

38 Appendix 1- An Integrated Career and Competency Framework for Diabetes Nursing 6 Competency statements Competency statements 6.1. SCREENING, PREVENTION AND EARLY DETECTION OF TYPE 2 DIABETES Competency statements For the prevention and early detection of type 2 diabetes you should be able to: 1. Unregistered practitioner Describe the risk factors for developing type 2 diabetes PROMOTING SELF-CARE Explain the importance of prevention or delay of onset of type 2 diabetes in individuals at risk. Explain the role of exercise in the prevention or delay in progression to type 2 diabetes. To support Explain the the person importance to self-care of weight for control their and diabetes the role you of diet should in the prevention be able to: or delay in progression to type 2 diabetes. Competency statements 1. Unregistered practitioner Support the person to develop self-care skills with guidance from a registered nurse. 2. Competent nurse As 1, and: Observe and report any concerns that might affect the ability of the person with diabetes to self-care. Make a comprehensive assessment Encourage of an people individual s to use risk their of individualised type 2 diabetes 6.4. and utilising agreed NUTRITION a care valid plans. diabetes risk assessment tool. 2. Competent nurse As 1, and: Sign-post people to information and support to encourage lifestyle changes to prevent or delay progression Assess the ability of the person with diabetes to To self-care meet the and person s work with individual them or their nutritional carer to optimise needs you should be able to: to type 2 diabetes. self-care skills. Competency statements Identify individuals at risk of type 2 diabetes (e.g. long-term use of steroid 1. and Unregistered antipsychotic medication, Follow the individual nutritional plan and report any related problems. Sign-post people to information and support to encourage previous gestational diabetes) and initiate appropriate screening/diagnostic tests. practitioner informed decision-making Recognise foods about and living drinks with high in carbohydrate and refined sugar. diabetes and managing life events (e.g. peer-reviewed structured education Provide advice to people at risk of type 2 diabetes with regard to lifestyle changes, including exercise Measure programmes). and record waist circumference, 6.6. BLOOD height and weight GLUCOSE accurately. AND KETONE MONITORING Support the person with diabetes in setting realistic goals and in the achievement programmes and dietary changes for the prevention of type 2 diabetes. Understand of those the goals. importance of regular meals, avoiding long periods without food. 3. Experienced Keep a or register and ensure As appropriate 2, and: follow-up/system of recall is in place for those at risk to identify the Report if meals are not eaten, For especially the safe carbohydrates, use of blood if the glucose patient and is taking ketone insulin monitoring or sulphonylureas. and associated equipment you should be able to: proficient progression nurse to type 2 diabetes. Assess the person with diabetes and their carer 2. and Competent provide tailored, nurse structured As 1, and: education and support Competency statements Discuss the care pathway for to individuals optimise self-care with newly skills diagnosed and promote type informed 2 diabetes. decision-making about lifestyle choices. 1. Unregistered practitioner Perform the test according to manufacturers instructions and local guidelines if trained and competent List the principles of a healthy, balanced diet, including low sugar, high fibre, low salt and low fat elements. Demonstrate knowledge of the Provide available information tests the and diagnosis support of to type encourage 2 diabetes the and person understand with diabetes the results. to make informed choices about to do so. Calculate and interpret BMI against the healthy range. Outline the long-term health controlling consequences and of monitoring type 2 diabetes. their diabetes, including: choice of treatment and follow-up; risk reduction; Perform the test unsupervised, 6.7. if trained ORAL and competent to THERAPIES do so, at the request of a registered nurse. Understand which foods contain carbohydrate and how these affect blood glucose levels. Describe the symptoms of type monitoring 2 diabetes. control; and complications. Document and report the result according to local guidelines. Identify people at risk of malnutrition and situations where healthy eating advice is inappropriate. Describe the links between type Identify 2 diabetes psychosocial and other barriers conditions to self-care (e.g. and cardiovascular refer on where disease). necessary. Follow local policy for safe disposal Refer the person with diabetes to a dietitian where appropriate. For of the sharps. safe administration and use of oral antihyperglycaemic medication you should be able to: Be aware aware of local policy Facilitate regarding the vascular development screening of an and individualised diabetes prevention. and agreed care plan. Recognise and follow local quality assurance procedures. Competency statements 3. Experienced or As 2, and: Recognise hypoglycaemia and be 1. able Unregistered to administer glucose. Describe the effect of common oral antihyperglycaemic agents on blood glucose levels. 3. Experienced or 4. Senior As 2, practitioner and: As 3, and: proficient nurse Work in partnership with the individual and/or group with diabetes Understand to identify the realistic normal and range achievable of glycaemia practitioner dietary and report readings Demonstrate outside this an range understanding to the appropriate of the progressive person. nature of type 2 diabetes and the need for proficient nurse or expert Interpret nursetest results and, if Demonstrate diagnostic, make knowledge appropriate of theoretical referral. frameworks and educational philosophies changes underpinning to help individuals to manage their glucose levels in the short and long term. treatment intensification Educate other HCPs and care behaviour workers change. with regard to the risks of developing type 2 diabetes. 2. Competent nurse As 1, and: 6.8. over time. INJECTABLE THERAPIES Know the dietary factors that affect BP and lipid control. Describe common side-effects of antihyperglycaemic agents. Participate in, and refer people Demonstrate to, programmes knowledge in conjunction and understanding with other of agencies bio-physical that and address psychosocial the role factors affecting selfmanagement prevention of or long-term delay in progression conditions. to type 2 diabetes. Teach the test procedure to a person with diabetes or their carer. For hypoglycaemia the safe administration and administer and the appropriate use of insulin treatment and GLP-1 (see Hypoglycamia receptor agonists you should be able to: Interpret the results and report readings outside the acceptable range to the appropriate person. Be aware of local policy on the care of people undergoing enteral feeding and how different feeding regimens Recognise the signs of of lifestyle intervention in the impact on blood glucose levels. competency, section 6.9). Participate in, and refer people Demonstrate to, screening knowledge programmes and skills in conjunction to facilitate with behaviour other agencies modification. for the early Identify and demonstrate an understanding of when testing for ketones is appropriate. Know when to refer to 1. or Unregistered seek guidance practitioner from a colleague. Describe the effect of insulin on blood glucose levels. detection of type 2 diabetes Develop (e.g. care/residential and ensure delivery homes). of educational materials, 4. Senior supportive practitioner networks As and 3, and: models of diabetes care that 3. Experienced or As 2, and: Describe the effect of GLP-1 receptor agonists on blood glucose levels. Be aware of the need to refer foster people empowerment with newly diagnosed and lifelong diabetes learning to about a peer-reviewed or diabetes. expert nurse structured Perform an assessment of how lifestyle (i.e. diet and physical activity) and pharmacological agents impact 2. Competent nurse As 1, and: proficient nurse Interpret results and assess other parameters and take appropriate action, including initiating further tests, Show an understanding of the ongoing education programme. Work with the person with diabetes to facilitate lifestyle adjustment in response glycaemic to changes control. in their diabetes Assess suitability of drugs depending on current egfr level and specific contraindications nature INJECTABLE of the therapy. THERAPIES continued such as HbA 4. Senior practitioner or As 3, and: or circumstances. Support the person with diabetes to make informed decisions about appropriate nutritional 1c. Administer insulin injections competently using a safety-engineered device, where supported by local policy. choices. Demonstrate knowledge of the range of oral antihyperglycaemic agents currently available and their Teach people with diabetes or their carer to interpret test results and take appropriate action. Administer GLP-1 receptor agonist expert nurse Provide expert advice on the Provide benefits education of screening for other programmes/procedures HCPs and care workers for high-risk in diabetes groups self-care to HCPs skills. Teach the person with diabetes and/or their carer the principles of carbohydrate counting and medication dose mode of action. For injections the safe competently administration using and a safety-engineered use of insulin device, and GLP-1 where receptor supported agonists you should be able to: and Interpret blood ketone results, assess other parameters and take appropriate, timely action. by local policy. adjustment. Demonstrate knowledge of therapeutic doses and recommended timing of doses. 5. Consultant care workers, nurse those at risk As of 4, developing and: type 2 diabetes and commissioners. Demonstrate knowledge and skills 4. Senior to facilitate practitioner behaviour change. As 3, and: Report identified problems appropriately. 4. Senior practitioner As 3, and: Administer or supervise the administration of prescribed medication. Contribute to the evidence base Identify and service implement shortfalls evidence-based and develop practice strategies in relation with the to local the prevention commissioning of Demonstrate bodies to address knowledge them. of how to or manage expert nurse the specific needs of people Use with results diabetes to optimise undergoing treatment enteral interventions feeding. according to evidence-based practice, while incorporating Be aware of the local Sharps Disposal or Policy. expert nurse Demonstrate expert knowledge of insulin and GLP-1 receptor agonist therapies and act as a resource Assess and convey to the patient the risks and benefits of taking, or not taking, a medicine. type 2 diabetes. Initiate and lead research through leadership and consultancy. the preferences of the person with diabetes. Be aware of the European Directive on prevention from sharp injuries for in people the hospital with diabetes, and healthcare their carer sector and HCPs. Be aware which oral antihyperglycaemic agents carry a higher risk of hypoglycaemia. Contribute to the evidence Work base and with implement stakeholders evidence-based to develop and practice implement in 5. relation Consultant local to guidelines, type nurse 2 diabetes promoting As 4, and: evidence-based practice Initiate continuous blood glucose monitoring, if appropriate or available locally, and interpret the results. (available at: Initiate insulin pump therapy if trained and competent and in line with local and national policy. Complete documentation accurately. screening in high-risk groups. and cost-effectiveness. Work with stakeholders to develop and implement local guidelines, promoting evidence-based practice Where individually acceptable, deliver structured group education to people with diabetes, their carers Develop specific guidelines for use in different situations. Demonstrate knowledge 2. Competent of which oral nurse agents may be safely As 1, and and: effectively combined. Participate in the development Work of in local collaboration guidelines and with programmes higher educational of education institutions and care and for other education and cost-effectiveness providers to meet with regard to appropriate nutrition advice. and HCPs. If a registered non-medical prescriber, prescribe medications, Demonstrate as required, within an understanding own competencies of how the efficacy of various Demonstrate agents are a most basic appropriately knowledge of measured insulin and GLP-1 receptor agonists (e.g. drug type, action, side-effects) screening/prevention and early educational detection needs of type of other 2 diabetes. HCPs. Lead on developing, auditing and reporting on patient-related experience and patient-related outcome measures, Empower and support a person with diabetes to achieve an individualised level of self-management and scope of practice. (e.g. through self-monitoring of blood glucose or by HbAand Work with stakeholders to develop a culture of patient-centred care and development. and be able to produce information on the outcomes of diabetes nursing contribution to nutrition care, including 1c ). administration devices used locally. and an agreed glycaemic target. 5. Consultant nurse As 4, and: Influence national policy regarding the promotion of self-care. contributing to national data collections 5. Consultant and nurse audits. As 4, and: Demonstrate a high level of competency in the safe administration of insulin or GLP-1 receptor agonists. 3. Experienced or As 2, and: Maintain active knowledge of current practice and new developments. Work with stakeholders to develop and implement local guidelines for early identification and management Identify and implement systems to promote your contribution and demonstrate Initiate the and impact lead research of advanced in effectiveness of diabetes nursing on nutritional Work with needs stakeholders through to leadership develop and consultancy. implement local guidelines, promoting evidence-based practice Demonstrate and be able to teach the correct method of insulin or GLP-1 receptor agonist self-administration, proficient nurse Describe indications for the initiation of oral antihyperglycaemic agents. Establish local guidelines or policies according to local needs. of non-diabetic hyperglycaemia (NDH), promoting evidence-based practice and cost-effectiveness. level nursing to the healthcare team and the wider health and social care sector. Identify service shortfalls in the provision of adequate diabetes nutrition and cost-effectiveness and advice and in develop the use strategies of blood with glucose the monitoring. including: Demonstrate understanding of the various factors that impact on the pharmacodynamics and Investigate all incidents and report to the relevant agencies, develop an action plan to prevent recurrence. Lead on developing, auditing and reporting on patient-related experience and patient-related outcome Identify the need for change, proactively generate practice innovations, and local lead commissioning new practice and bodies service to address them. Lead on developing, auditing and reporting on patient-related experience and patient-related outcome Correct choice of needle type and length for the individual. pharmokinetics of antihyperglycaemic agents. If a registered non-medical prescriber, prescribe medications, as required, within own competencies measures, and be able to produce information on the numbers of people with NDH and outcomes redesign solutions to better meet the needs of patients and the service. Identify the need for change, proactively generate practice innovations measures, and lead and new be able practice to produce and service information redesign on the outcomes of use of blood glucose monitoring, Appropriate use of a lifted skin fold, where necessary. Assess the impact of multiple pathologies, comorbidities, existing medications and contraindications and scope of practice according to legislation and local guidelines. of interventions, including contributing to national data collections and audits. solutions to better meet the needs of people with diabetes, the diabetes including population contributing as a whole to national and the data diabetes collections and audits. Correct method for site rotation. on management options. Adjust insulin treatment according to age, diagnosis and individual circumstances as appropriate, Initiate and lead research in identification and management of NDH through leadership and consultancy. service. Initiate and lead research into use of blood glucose monitoring Demonstrate through leadership awareness and of issues consultancy. Storage of insulin. related to polypharmacy and drug interactions (e.g. use of steroids). following local policies or individual clinical management plans. Identify service shortfalls in screening for, and management of, people with NDH and develop strategies Influence national policy regarding nursing contribution to provision Identify of appropriate service shortfalls diabetes in nutrition the provision and advice. of appropriate blood Demonstrate glucose monitoring knowledge and of how develop to detect strategies and with Single use of needles and safe sharps disposal (according to local policy). report adverse drug reactions. Be aware of emerging research relating to injection technique and be competent to implement outcomes with the local commissioning bodies to address them. Work in collaboration with higher educational institutions and other education local commissioning providers to bodies meet to educational address them. Examine injection procedure and injection sites at least annually for detection of lipohypertrophy, and needs Demonstrate understanding around the potential for adverse effects and how to avoid, minimise, recognise into daily practice. Identify the need for change, proactively generate practice innovations and lead new practice and service of other HCPs. Identify the need for change, proactively generate practice innovations and manage and lead them. new practice and service redesign be able to give appropriate advice for resolving poor injection sites. redesign solutions to better meet the needs of people at risk of developing type 2 diabetes. solutions to better meet the needs of patients, the diabetes population Apply the as a principles whole and of the evidence-based diabetes service. Be aware of common insulin and 5. management Consultant errors. nurse As 4, and: practice including clinical and cost-effectiveness. Lead on liaising with local and national public health networks and diabetes teams in the development of Influence national policy regarding appropriate blood glucose Demonstrate monitoring. Identify correct reporting system for injectable therapy errors. Work with stakeholders to develop and implement local guidelines, promoting evidence-based practice knowledge of, and work within, national and local guidelines (e.g. upcoming NICE guidance on type 2 NDH integrated care pathways or the National Diabetes Prevention Programme (NDPP), including the Work in collaboration with higher educational institutions and diabetes; other see: education providers to meet educational Provide evidence of insulin safety training. and cost-effectiveness for the use of injectable therapies. development of integrated IT solutions and systems for NDH that record individual needs to support needs of other HCPs. Describe circumstances in which insulin use might be initiated or altered Lead on and developing, make appropriate auditing referral. and reporting on patient-related experience and patient-related outcome Evaluate treatment outcomes in a timely and appropriate fashion, making changes as required. measures, and be able to produce information on the outcomes of diabetes nurses involvement in prescribing MDT care across service boundaries. Influence national policy regarding early identification and management of people at risk of developing See: Blood Glucose Monitoring Guidelines: Consensus Document 4. ( Senior practitioner As 3, and: 3. Experienced or As 2, and: and use of injectable therapies, including contributing to national data collections and audits. or expert nurse Explain the rationale behind proficient and the nurse potential risks and benefits Demonstrate of different a broad therapies. knowledge of different insulin types (i.e. action, Initiate use in and regimens). lead research in diabetes prescribing and use of injectable therapies through leadership type 2 diabetes. Demonstrate awareness of the need to optimise or add in Demonstrate other glucose-lowering a broad knowledge therapies, including of different insulin, GLP-1 in a receptor agonists and (e.g. consultancy. drug type, action, side-effects). Work in collaboration with higher educational institutions and other education providers to meet timely manner. Be proficient in providing necessary education relating to commencement Identify of service injection shortfalls therapy. in the provision and effective use of injectable therapies and develop strategies educational needs of other HCPs. Facilitate and support structured evidence-based education Initiate relating insulin to oral or antihyperglycaemic GLP-1 receptor agonist agents therapy for where clinically appropriate. with the local commissioning bodies to address them. See: NICE Guideline PH35 (NICE, 2011a). individuals or groups. Assess individual patients self-management and ongoing educational Identify needs the and need meet for these change, needs proactively or generate practice innovations and lead new practice and service An Integrated Career and Competency Framework for Diabetes Nursing 9 Demonstrate awareness of current research in new oral therapies. make appropriate referral. redesign solutions to better meet the needs of patients, the diabetes population as a whole and the diabetes Disseminate evidence-based information that informs practice. Support and encourage self-management wherever appropriate. service. If a registered non-medical prescriber, prescribe medications, Recognise as required, when injection within own therapy competencies needs to be adjusted or changed. Influence national policy regarding use of injectable therapies for diabetes. and scope of practice, ensuring that the appropriate level Recognise of supervision the potential and support psychological is in place impact to fulfil of insulin or GLP-1 receptor Work in agonist collaboration therapies with and higher offer educational institutions and other education providers to meet educational this role safely and effectively. support to the person with diabetes or their carer. needs of other HCPs. Adjust oral treatment according to individual circumstances, Recognise following signs local of needle policies fear/needle or individual phobia clinical and offer strategies to help manage this. 10 An Integrated Career and Competency Framework for Diabetes Nursing management plans. See: NICE Guideline NG17 (NICE, 2015a) Audit outcomes of care against accepted national and/or local standards (e.g. NICE, 2011b). See: Upcoming NICE guidance on type 2 diabetes ( 5. Consultant nurse As 4, and: See: The UK Injection Technique Recommendations, 3rd edition ( Work with stakeholders to develop and implement local guidelines, promoting evidence-based practice and costeffectiveness in the provision of oral antihyperglycaemic agents. See: The Six Steps to Insulin Safety CPD module ( Lead on developing, auditing and reporting on patient-related experience and patient-related outcome measures, 12 An Integrated Career and Competency Framework for Diabetes Nursing and be able to produce information on the outcomes of diabetes nurses involvement in See: prescribing NHSIQ and e-learning use of oral modules ( antihyperglycaemic agents, including contributing to national data collections and audits. See: Education for Health Diabetes Injection Technique and Safety modules ( Initiate and lead research in diabetes nursing and use of oral antihyperglycaemic agents through leadership and consultancy. Identify service shortfalls in provision and effective use of oral antihyperglycaemic agents and develop strategies with 14 An Integrated Career and Competency Framework for Diabetes Nursing the local commissioning bodies to address them. Influence national policy regarding the use and provision of oral antihyperglycaemic agents. Work in collaboration with higher educational institutions and other education providers to meet educational needs of other HCPs. An Integrated Career and Competency Framework for Diabetes Nursing An Integrated Career and Competency Framework for Diabetes Nursing An Integrated Career and Competency Framework for Diabetes Nursing 17 An Integrated Career and Competency Framework for Diabetes Nursing 4th Edition For copies of this booklet please visit the website:

39 Appendix 2 - End of Life Diabetes Management - Algorithm for Glycaemic Control Discuss changing the approach to diabetes management with individual and/or family if not already explored. If the person remains on insulin ensure the Diabetes Specialist Nurses (DSN) are involved and agree monitoring strategy Type 2 diabetes Diet controlled or Metformin treated Type 2 diabetes on other tablets and/or insulin /or GLP1 Agonist Type 1 diabetes always on insulin Stop monitoring blood glucose Stop tablets and GLP1 injections Consider stopping insulin if the individual only requires a small dose Continue once daily morning dose of Insulin Glargine (Lantus ), Insulin Degludec (Tresiba ) with reduction in dose Key * Humalog/Novorapid /Apidra ^ Humulin I /Insulatard/Insuman Basal/ Insulin Degludec/ Insulin Glargine If insulin stopped: Urinalysis for glucose daily - If over 2+ check capillary blood glucose If blood glucose over 20 mmols/l give 6 units rapid acting insulin * Re-check capillary blood glucose after 2 hours If insulin to continue: Prescribe once daily morning dose of isophane insulin^ or long acting Insulin Glargine (Lantus ) or Insulin Degludec (Tresiba ) based on 25% less than total previous daily insulin dose Check blood glucose once a day at teatime: If below 8 mmols/l reduce insulin by 10-20% If above 20 mmols/l increase insulin by 10-20% to reduce risk of symptoms or ketosis If patient requires rapid acting insulin* more than twice consider daily isophane insulin^ or an analogue e.g Glargine (Lantus ) or Insulin Degludec (Tresiba ) Keep tests to a minimum. It may be necessary to perform some tests to ensure unpleasant symptoms do not occur due to low or high blood glucose It is difficult to identify symptoms due to hypo or hyperglycaemia in a dying patient If symptoms are observed it could be due to abnormal blood glucose levels Test urine or blood for glucose if the patient is symptomatic Observe for symptoms in previously insulin treated patient where insulin has been discontinued. Flash glucose monitoring may be useful in these individuals to avoid finger prick testing Page 39

40 Appendix 3 - End of Life Diabetes Management - Managing Glucose Control on Once Daily Steroids No known diabetes Check random glucose before starting on steroids to identify individuals at risk Random capillary blood glucose over 8 mmol/l needs further checking with venous blood Random venous glucose over 7.8 mmol/l means at risk of developing diabetes with steroid therapy Random venous glucose over 11 mmol/l needs a second check to confirm pre-existing unknown diabetes Known Diabetes Reassess glucose control and current therapy Diet controlled or Metformin alone or Metformin + Gliptin Sulphonylurea treated (e.g. Gliclazide) Insulin treated Test before evening mealtime If develops repeated high readings (urine glucose>2+ or blood glucose >15mmol/l) add Gliclazide 40mg with breakfast Increase morning dose by 40mg daily increments Aim blood glucose 6-15mmols/l or <1+ trace glycosuria before evening meal If no hypoglycaemia symptoms, day or night, taking 240mg and still above target Consider adding evening meal dose of Gliclazide or move to morning insulin If no hypoglycaemia symptoms, day or night and taking less than 320mg/day Adjust balance of twice daily doses of Gliclazide by giving up to a max 240mg in morning dose plus 80mg pm) Aim blood glucose 6-15 mmol/l or <1+ glycosuria before evening meal If no hypoglycaemic symptoms, day or night and taking full dose 320mg/day Switch to morning Insulatard, Humulin I or Insuman Basal 10 units Aim blood glucose 6-15 mmol/l before evening meal If glucose above 15 mmol/l before evening meal Increase dose by 4 units Review daily until stable increasing dose as necessary If glucose >15 mmol/l before evening meal Consider increasing dose depending on risk of hypoglycaemia overnight Review daily until stable increasing dose as necessary Twice daily insulin Morning dose will need to increase according to glucose reading before evening meal Aim blood glucose 6-15 mmol/l before evening meal unless patient has hypo before meals despite mid-meal snacks If glucose above 15 mmol/l before evening meal Increase dose Review daily until stable increasing dose as necessary If glucose >15 mmol/l before evening meal Consider increasing dose depending on risk of hypoglycaemia Review daily until stable increasing dose as necessary Basal bolus insulin Breakfast & lunchtime rapid acting insulin may need to increase to avoid high readings before lunch or evening meal Aim blood glucose 6-15 mmol/l before lunch and evening meal unless patient has hypo before meals despite mid-meal snacks or has long gaps between meals If glucose above 15 mmol/l before lunch or evening meal Increase breakfast or lunchtime dose Review daily until stable increasing dose as necessary If glucose >15 mmol/l before lunch or evening meal Consider increasing breakfast or lunchtime dose depending on risk of hypoglycaemia Review daily until stable increasing dose as necessary If steroids are reduced or discontinued: Review any changes made and consider reverting to previous therapy or doses If unsure at any stage about next steps or want specific advice on how to meet with patients needs or expectations please contact the Diabetes Specialist Team If steroids are reduced and the individual is on a sulpholylurea agent or insulin there is a significant risk of hypoglycaemia. Please reduce the dose of these drugs in tandem with the steroid dose reduction Assuming no hypoglycaemia, pre-meal time glucose is above 10mmol/l an increase in dose is needed: Increase dose by 10-20% if dose below 20 units Increase dose by 10-20% units if dose units Increase dose by 10-20% units if dose units Review daily until stable increasing dose as necessary Page 40

41 Appendix 4 Steroid algorithm for people with know diabetes Discuss changing the approach to diabetes management with individual and/or family if not already explored. If the person remains on insulin ensure the Diabetes Specialist Nurses (DSN) are involved and agree monitoring strategy Type 2 diabetes Diet controlled or Metformin treated Type 2 diabetes on other tablets and/or insulin /or GLP1 Agonist Type 1 diabetes always on insulin Stop monitoring blood glucose Stop tablets and GLP1 injections Consider stopping insulin if the individual only requires a small dose Continue once daily morning dose of Insulin Glargine (Lantus ), Insulin Degludec (Tresiba ) with reduction in dose Key * Humalog/Novorapid /Apidra ^ Humulin I /Insulatard/Insuman Basal/ Insulin Degludec/ Insulin Glargine If insulin stopped: Urinalysis for glucose daily - If over 2+ check capillary blood glucose If blood glucose over 20 mmols/l give 6 units rapid acting insulin * Re-check capillary blood glucose after 2 hours If insulin to continue: Prescribe once daily morning dose of isophane insulin^ or long acting Insulin Glargine (Lantus ) or Insulin Degludec (Tresiba ) based on 25% less than total previous daily insulin dose Check blood glucose once a day at teatime: If below 8 mmols/l reduce insulin by 10-20% If above 20 mmols/l increase insulin by 10-20% to reduce risk of symptoms or ketosis If patient requires rapid acting insulin* more than twice consider daily isophane insulin^ or an analogue e.g Glargine (Lantus ) or Insulin Degludec (Tresiba ) Keep tests to a minimum. It may be necessary to perform some tests to ensure unpleasant symptoms do not occur due to low or high blood glucose It is difficult to identify symptoms due to hypo or hyperglycaemia in a dying patient If symptoms are observed it could be due to abnormal blood glucose levels Test urine or blood for glucose if the patient is symptomatic Observe for symptoms in previously insulin treated patient where insulin has been discontinued. Flash glucose monitoring may be useful in these individuals to avoid finger prick testing Page 41

42 Insulin Activity Hours Insulin Activity Hours Insulin Activity Hours Insulin Activity Hours Insulin Activity Hours Appendix 5 DEVICE BRAND NAME GENERIC Vial Disposable pen Cartridge RAPID ACTING INSULIN ANALOGUES/SHORT ACTING SOLUBLE INSULINS Novorapid Insulin Aspart FLEXPEN & FLEXTOUCH Insulin Lispro 100 units/ml KWIKPEN Humalog 200 units/ml KWIKPEN Apidra Insulin Glulisine SOLOSTAR Fiasp Insulin Aspart FLEXTOUCH Actrapid Humulin S Human soluble insulin Insuman Rapid LONG ACTING INSULIN ANALOGUES/INTERMEDIATE ACTING INSULINS Levemir Insulin Detemir FLEXPEN & INNOLET Abasaglar KWIKPEN Insulin Glargine Lantus SOLOSTAR Toujeo Insulin Glargine 300 units/ml SOLOSTAR Insulin Degludec 100 units/ml FLEXTOUCH Tresiba 200 units/ml FLEXTOUCH Insuman Basal SOLOSTAR Insulatard Isophane insulin INNOLET Humulin I KWIKPEN PRE-MIXED BIPHASIC INSULIN ANALOGUES/ PRE-MIXED BIPHASIC INSULIN Novomix 30 Biphasic insulin Aspart FLEXPEN Humalog Mix 25 Biphasic insulin Lispro KWIKPEN Humalog Mix 50 KWIKPEN Humulin M3 KWIKPEN Insuman Comb 15 Soluble and Isophane insulin Insuman Comb 25 SOLOSTAR Insuman Comb 50 TIME PROFILE DOSING SCHEDULE Usually THREE times a day Onset: Less than 15 mins Peak: mins Duration: 2-5 hours IMMEDIATELY before, or just after food Or When required for Hyperglycaemia Onset: Within 30 mins Peak: 2-4 hours Duration: Up to 8 hours Usually THREE times a day 30 minutes before, or just after food Onset: 2 hours Peak: None Duration: hours ONCE or Onset: 2 hours Peak: 4-6 hours Duration: 8-14 hours TWICE a day Onset: Within 30 mins Peak: 2-4 hours Duration: Up to 14 hours TWICE or THREE times a day 15 minutes before, or just after food Time profile varies on the proportion of short acting insulin TWICE daily 30 minutes, before food V Ref: Diabetes UK Insulin degludec U100 Novo Nordisk Analogue Pen cartridge touch pen Insulin degludec U200 Novo Nordisk Analogue Insulin pen only (touch pen) Page 42

43 Appendix 6 - Leicestershire Patient information booklets WHAT TO DO WHEN YOU HAVE TYPE 1 DIABETES AND ARE ILL Information Booklet WHAT TO DO WHEN YOU HAVE TYPE 2 DIABETES AND ARE ILL Information Booklet Page 1 Page 1 HYPOGLYCAEMIA OR HYPOS ALL YOU NEED TO KNOW! Information Booklet GUIDE TO MANAGING YOUR DIABETES DURING RAMADAN Information booklet for patients and healthcare professionals Page 1 Page 1 For copies of these patient booklets contact the UHL Diabetes clinic - Leicester General Hospital. Page 43