TYPE 2 DIABETES SCREENING

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1 TYPE 2 DIABETES SCREENING WHOM TO TEST It is very important to identify Diabetes as early as possible: 50% of newly presenting people with Type 2 Diabetes already have 1 or more complications at diagnosis 1 Diabetes is often missed in the elderly At least half of people with Type 2 Diabetes are asymptomatic 2 PATIENTS PRESENTING WITH THE FOLLOWING SYMPTOMS: Excess thirst Polyuria (especially if nocturia) Weight loss Urinary incontinence Tiredness Pruritus Vulvae / recurrent candidiasis Recurrent infections / abscesses Balanitis Blurred Vision / changes in visual acuity Erectile Dysfunction Pain / Numbness / foot ulcers Non specific or unexplained symptoms Finger prick capillary results can not be used to diagnose Diabetes 3 Glycosuria on its own does not confirm Diabetes PATIENTS AT INCREASED RISK OF DIABETES: People with BMI > 30 People aged over 40 with BMI (overweight) People aged of South Asian, Chinese descent (especially those with BMI > 23) Women with polycystic ovary syndrome. Coronary disease, Cerebrovascular disease, peripheral vascular disease or hypertension/hyperlipidaemia. Patients on prolonged steroid therapy. Patients on atypical anti-psychotic drugs. 1. UKPDS Group. UK Prospective Diabetes Study 6. Complications in newly diagnosed Type 2 diabetic patients and their association with different clinical and biochemical risk factors. Diabetes Research. 1990;13: World Health Organisation. Report of a WHO Consultation The Expert Committee on the diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 1997;20 (7); PATIENTS AT HIGH RISK OF DIABETES: Women who have had Gestational Diabetes (screen at 6 weeks and one year post-partum, and then yearly) Those known to have impaired glucose tolerance, HbA1c 42-47mmol/mol or oral glucose tolerance test 2-hour value between 7.8 mmol/l and 11.1 mmol/l (Impaired Glucose Tolerance IGT) or fasting glucose mmol/l (Impaired Fasting Glucose IFG). V1.2 Date of preparation: May For review: May

2 TYPE 2 DIABETES DIAGNOSTIC CRITERIA ROUTINE DIAGNOSIS OF DIABETES DIAGNOSTIC CRITERIA FOR DIABETES Diabetes may be diagnosed on any of the following criteria (WHO 2006, John 2012). Diabetes High risk of Diabetes Normal HbA1c 48 mmol/mol mmol/mol < 42 mmol/mol Fasting glucose 7 mmol/l mmol/l 6 mmol/l * 2 hr glucose in OGTT 11.1 mmol/l mmol/l 7.7 mmol/l Random glucose 11.1 mmol/l A repeat confirmatory test is required in most cases, see below. * - WHO defines normal as <6.1 mmol/l, but truly normal is probably <5.6 mmol/l. As the UK aligns with WHO, we do not advise diagnosing pre-diabetes at 5.6 mmol/l, but mention this because of awareness from the Exeter Family Study. WHICH TEST IS BEST? National and international expert groups do not know. Relevant groups (WHO, ADA, UKDHADC) simply advise that HbA1c is now an option for diagnosing Diabetes. The CWHHE Diabetes strategy group recommend HbA1c except in those groups where HbA1c may be unreliable and glucose should be used. SHOULD A POSITIVE TEST BE REPEATED? For glucose yes, in most cases. This has always been advised, except if there are classical Diabetes symptoms. For HbA1c yes, in asymptomatic patients. National guidance now advises a repeat HbA1c within two weeks in asymptomatic cases, as mislabelled samples or lab error are possible. Both results must be 48 mmol/mol to diagnose Diabetes; if the results are discordant, the lower is used. The repeat sample must be sent with clinical detail (e.g. repeat HbA1c to confirm diagnosis of Diabetes ), as repeats within 30 days may be rejected by the lab. Do not delay urgent care while awaiting second test. For young, very symptomatic, or ill patients, check ketones and seek specialist advice if necessary. V1.2 Date of preparation: May For review: May

3 TYPE 2 DIABETES DIAGNOSIS ALGORITHM HOW TO TEST Diagnosis of Type 2 Diabetes can be made using HbA1c in those who are asymptomatic. It should not be used for diagnosis in children, pregnancy and those who are acutely ill or who have abnormal haemoglobins, anaemia and altered red blood cell lifespan. < 42 Normal Follow up as appropriate < 25 Code as at High risk of diabetes (XaZLG) Lifestyle advice Yearly follow up Check HbA1c Repeat HbA1c within 2 weeks High risk of Diabetes Diabetes UK Risk Score 25 Code as at High risk of diabetes (XaZLG) Refer to intensive lifestyle management programme At least yearly follow up 48 NO 48 Symptoms? YES Diabetes Code Diabetes type if possible Refer if Type 1/Pregnant Refer structured education Refer retinal screening Arrange regular follow up V1.2 Date of preparation: May For review: May

4 TYPE 2 DIABETES DIAGNOSIS USING HbA1c ROUTINE DIAGNOSIS OF DIABETES WHEN NOT TO USE HBA1C TO DIAGNOSE DIABETES These are the most common situations where HbA1c is not suitable. Except in pregnancy, diagnose by fasting glucose 7.0 mmol/l twice, or once with symptoms. In pregnancy, follow NICE guidelines. 1. Rapid onset of Diabetes an increase in HbA1c may not be detected until a few weeks later. a. Suspected Type 1 Diabetes rapid onset of symptoms, weight loss, ketosis. b. Children because most will have Type 1 Diabetes. c. Steroids. Antipsychotics & immunosuppressants can raise blood glucose, rarely precipitously. d. After pancreatitis or pancreatic surgery. 2. Pregnancy. Multiple factors make HbA1c lower in pregnancy. The diagnosis of gestational Diabetes should be made by using glucose measurements in line with NICE guidance. 3. Conditions with reduced red survival may lower HbA1c markedly: a. Haemoglobinopathy which will normally be detected by the lab, but should be suspected in racial groups where there is a high prevalence of sickle trait, sickle disease or thalassaemia. b. Haemolytic anaemia c. Severe blood loss d. Splenomegaly e. Antiretroviral drugs 4. Increased red cell survival may increase HbA1c e.g. splenectomy. 5. Renal dialysis patients have a markedly reduced HbA1c especially if treated with erythropoietin. 6. Iron and B12 deficiency and their treatment. May raise or lower HbA1c, but the effect is small. WHAT IF YOU HAVE GLUCOSE VALUES AND AN HBA1C ON A SINGLE PATIENT? This is confusing, so don t get into that situation use HbA1c alone, or glucose alone. If you already have both, WHO guidance diagnoses Diabetes if either result is high. References WHO John V1.2 Date of preparation: May For review: May

5 TYPE 2 DIABETES HIGH RISK OF DIABETES Endorsed Endorsed by CWHHE by Diabetes CWHHE Strategy Diabetes Group Strategy Group MANAGEMENT OF PEOPLE AT HIGH RISK OF DIABETES HOW SHOULD WE MANAGE THE PATIENT WITH HIGH RISK OF DIABETES, PRE-DIABETES, IMPAIRED GLUCOSE TOLERANCE OR GLUCOSE DYSREGULATION? Treat as high Diabetes risk: Give lifestyle advice Monitor for progression to Diabetes at least annually Refer to locally available programmes structured education, dietetics, exercise, weight loss, intensive lifestyle management Monitoring in this way can also be appropriate for individuals with HbA1c in the normal range. For example, patients with strong family history, overweight, previous gestational Diabetes, or transient elevated blood glucose after acute illness. We do not advise measuring glucose after an HbA1c of mmol/mol. You may be tempted to try another test in pursuit of a clear diagnosis, but it is likely to create diagnostic confusion. WHAT IF A PATIENT LOWERS THEIR HBA1C BELOW 48 MMOL/MOL THROUGH LIFESTYLE CHANGE? If a patient is diagnosed with Diabetes, and then drops their HbA1c below 48 mmol/mol without drugs we consider that they have excellently controlled Diabetes on diet alone, and recommend that they continue to receive care appropriate for patients with Diabetes. V1.2 Date of preparation: May For review: May

6 DIABETES TYPE 1 OR TYPE 2? WHEN AND HOW TO TEST FOR TYPE 1 DIABETES? Favours Type 2 Diabetes Favours Type 1 Diabetes Family history of Type 2 No family history of Type 1 Diabetes BMI > 28 kg/m2 Age > 45 yrs. Non-white ethnic group Dyslipidaemia, HDL < 1.0 No Need to test for Type 1 DM Test for Type 1 DM using GAD* antibodies, or refer to secondary care No family history of Type 2 1 st or 2 nd degree relative with Type 1 Diabetes BMI < 28 kg/m2 Age < 45 yrs. White European Any autoimmune disease HDL > 1.5 mmol/l GAD antibodies* are autoantibodies against the enzyme glutamic acid decarboxylase found in pancreatic islet cells. GAD antibodies are detectable in the serum 80% of patients with Type 1 diabetic at the onset of Diabetes V1.2 Date of preparation: May For review: May

7 DIABETES MATURITY ONSET DIABETES OF THE YOUNG (MODY) DIAGNOSING MODY Could the diagnosis be maturity-onset Diabetes of the young (MODY)? See Unusual Diabetes Very strong maternal or paternal family history of Diabetes often in three generations with early onset, before 30yrs. With some family members diagnosed with Type 1 others with Type 2 Diabetes Unusual response to treatment Highly sensitive to sulphonylurea. Or having excellent control on small amounts of insulin without having hypoglycaemia or becoming ketotic if stopping insulin No microvascular complications They and family members have few if any diabetic complications Refer to Secondary care where screening tests can be undertaken to make the diagnosis V1.2 Date of preparation: May For review: May

8 TYPE 2 DIABETES NEW DIAGNOSIS Endorsed Endorsed by CWHHE by Diabetes CWHHE Strategy Diabetes Group Strategy Group TREATMENT DECISION TREE FOR EARLY INSULIN INITIATION PRINCIPLES OF TREATMENT Offer structured education advice to all newly diagnosed patients according to local availability (i.e. X-PERT, DESMOND or conversation maps). Usually wait 6-12 weeks before glucose lowering agents are introduced unless patient is symptomatic. Symptoms of hyperglycaemia and a diagnostic blood glucose (random > 11.1mmol/L) YES Metformin is recommended for all patients at/soon after diagnosis in view of its cardioprotective effects (UKPDS legacy effect). However: Introduce oral hypoglycaemic agents early if fasting plasma glucose >15mmol/l and symptomatic. Ensure patients are shown how to monitor their own diabetes if appropriate, and know what to do if results do not fall in the target range. Regular monitoring will identify the need to actively titrate treatment. Measure HbA1c every 2-6 months. Target HbA1c 48mmol/mol/6.5% in newly diagnosed Type 2 Diabetes and those on up to 2 oral hypoglycaemic agents unless individual target more appropriate. Involve the person in discussions about individual HbA1c target. In South Asian people BMI underestimates adiposity. Weight measurements need to be considered. Range for healthy weight is BMI in South Asian people. Is the patient ill (vomiting, semiconscious or clinically dehydrated)? NO Does the urine test show moderate/heavy ketonuria? NO Are one or more of the following present? Severe osmotic symptoms (nocturia x 3-4) Short history (weeks) Marked weight loss (irrespective of absolute weight) A first degree relative with Type 1 Diabetes A personal history of autoimmune disease NO Is the patient under 30 years of age? NO There is no immediate need for insulin. Give dietary advice on healthy eating. Provide regular review. YES YES YES YES Arrange direct admission to hospital Very likely to need insulin. Discuss with specialist team within 24 hours. Two or more are a strong indication for insulin First degree relative on diet or tablets consider maturity Onset Diabetes of the Young (MODY). No immediate need for insulin but nonurgent referral to the specialist team for diagnostic consideration. V1.2 Date of preparation: May For review: May

9 TYPE 2 DIABETES STRUCTURED EDUCATION Endorsed Endorsed by CWHHE by Diabetes CWHHE Strategy Diabetes Group Strategy Group NICE recommends that well-designed and well-implemented structured education programmes are likely to be cost-effective for people with diabetes and should be offered to every person and/or their carer at and around the time of diagnosis, with annual reinforcement and review. Structured education programmes for people with Type 2 diabetes are an essential component of effective diabetes management. Most people will spend only 1.5 hours with a health care professional per year, the rest of the time they are required to make daily lifestyle decisions that may have a significant impact on their health and overall quality of life The aim of structured education is for people with diabetes to improve their knowledge, skills and confidence, enabling them to take increasing control of their own condition and integrate effective self-management into their daily lives. High-quality structured education can have a profound effect on health outcomes and can significantly improve quality of life. The referrer will play a huge role in successfully engaging the person with diabetes and increasing uptake of an education course. Diabetes UK patient focus groups have shown that the attitude of health care professionals and information given at time of diagnosis can have a profound impact on people s ability to self-manage their condition effectively. STRUCTURED EDUCATION COURSES DESMOND (not in CWHHE) X-PERT CONVERSATION MAPS Group education delivered by trained educators: 2.5 hr sessions over 6 weeks with annual follow-up sessions Group education delivered by trained educators: 2.5 hr sessions over 6 weeks with annual follow-up sessions Group education, four maps available. Two for newly diagnosed Managing my diabetes and Diabetes and healthy lifestyle. Sponsored by Eli Lilly and supported by Diabetes UK. Delivered by one trained health care professional usually a diabetes specialist nurse or dietitian for the second map based around food choices over 2 hrs. V1.2 Date of preparation: May For review: May

10 3 rd LINE 1 st LINE 2 nd LINE TYPE 2 DIABETES GLYCAEMIC MANAGEMENT ALGORITHM After diagnosis discuss lifestyle changes, refer to structured education and provide a newly diagnosed information pack. At ALL appointments reinforce lifestyle messages, check on medication adherence and develop/discuss collaborative care plan with the person who has Diabetes. METFORMIN (with dose titration) Start at a dose of 500mg daily. Increase to 500mg twice daily after 2 weeks and increase by 500mg every 2 weeks to reach a dose of 1g twice daily. Doses should be taken with meals to minimise GI side effects. If GI intolerance occurs, try Metformin modified release or reduce dose to previously tolerated dose. Before starting Metformin check egfr and remember renal precautions (see box overleaf for details). Check HbA1c after patient has been on maximum tolerated dose for 3 months OTHER OPTIONS FOR 1 st LINE THERAPY Consider sulphonylurea here if: not overweight (tailor the assessment of body-weight-associated risk according to ethnic group), or Metformin is not tolerated or is contraindicated, or a rapid therapeutic response is required because of hyperglycaemic symptoms (excess thirst/frequent urination/modest weight loss) HbA1c 48 mmol/mol (or agreed target HbA1c) METFORMIN + SULPHONYLUREA (SU e.g. Gliclazide) For Gliclazide, start at a dose of 40-80mg daily with meals (higher doses divided). Titrate dose every 2 weeks according to pre-meal blood glucose levels. Target pre-meal blood glucose level is 4-6mmol/l. If the patient is not self testing, titrate dose according to HbA1c level every 3 months. It is recommended that patients taking SUs self monitor their blood glucose in line with the CWHHE Self-Monitoring Blood Glucose Guidance. Check HbA1c after patient has been on maximum tolerated dose for 3 months OTHER OPTIONS FOR 2ND LINE THERAPY: Consider Metformin + gliptin, Metformin + SGLT-2 or Metformin + pioglitazone if considerable risk of hypoglycaemia with SU or an SU is contraindicated or not tolerated. Consider SU + gliptin or SU + pioglitazone if Metformin is contraindicated or not tolerated. Check HbA1c after 3 months and ONLY continue gliptin, SGLT-2 or pioglitazone if there is a reduction in HbA1c of 6mmol/mol (0.5%) and target HbA1c is achieved HbA1c 58 mmol/mol (or agreed target HbA1c) INSULIN INITIATION GLP-1 RECEPTOR AGONISTS (INJECTABLE AGENTS) ORAL AGENTS IN TRIPLE THERAPY Particularly if person is markedly hyperglycaemic (e.g. HbA1c 75) Refer to level 2 out of hospital service (OOHS)* Consider if BMI 35 or if BMI 35 where insulin is unacceptable for occupational reasons or weight loss would benefit other co-morbidities Refer to level 2 OOHS for initiation* Only continue GLP1 treatment if there is an HbA1c reduction of at least 11mmol/mol (1%) and a weight loss of at least 3% of initial body weight at 6 months. If a GLP-1 is continued, check HbA1c every 6 months and only continue if weight loss and target HbA1c are maintained. Consider adding gliptin or pioglitazone if insulin is unacceptable. Only continue gliptin or pioglitazone therapy if there is a reduction of 6mmol/mol (0.5%) in HbA1c at 6 months and target HbA1c is achieved. If target HbA1c is not achieved refer to level 2 OOHS for insulin start* HbA1c 58 mmol/mol (or agreed target HbA1c) INSULIN INTENSIFICATION GLP-1 RECEPTOR AGONISTS ORAL AGENTS Increase insulin dose and intensify regimen over time. * Or community Diabetes service where no available OOHS exists. Lixisenatide and Exenatide can be used with basal insulins Insulin Levemir can be used in addition to Liraglutide Consider DPP-4 or SGLT-2 or Pioglitazone with insulin if blood glucose control is inadequate with high dose insulin V1.2 Date of preparation: May For review: May

11 TYPE 2 DIABETES HBA1C TARGETS HBA1C TARGET RECOMMENDATIONS: Patients with Type 2 Diabetes should normally have their HbA1c maintained between 48 and 58 mmol/mol. INDIVIDUALISING HBA1C TARGETS APPROACH TO MANAGEMENT OF HYPERGLYCAEMIA Most intensive Least intensive Clinicians should aim to involve people in decisions about their individual HbA1c target level, which may in some cases be above that of mmol/mol set for people with Type 2 Diabetes in general. Target HbA1c level should be informed by a number of factors including duration of Diabetes, life expectancy, comorbidities including established vascular complications and available support. Tighter targets ( % / mmol/mol) younger, healthier Looser targets ( %+/ mmol/mol) older, comorbidities, hypoglycaemia prone, etc. Encourage the person to maintain their individual target unless the resulting side effects (including hypoglycaemia) or their efforts to achieve this impair their quality of life. Patient attitude and expected treatment efforts Hypoglycaemia risk Disease duration Highly motivated, adherent Excellent self-care capacities Low 42mmol/mol 53mmol/mol 64mmol/mol Less motivated, non-adherent Poor self-care capacities Moderate High Offer therapy (lifestyle and medication) to help achieve and maintain the HbA1c target level Inform a person with a higher HbA1c that any reduction in HbA1c towards the agreed target is advantageous to future health. Avoid pursuing highly intensive management particularly in elderly and frail patients in whom the risk of hypoglycaemia is high. HBA1C IFCC UNITS: HbA1c values should be expressed in mmol/mol instead of percentages as follows: DCCT (%) IFCC (mmol/mol) Life expectancy Important comorbidities Established vascular complications Resources, support system Long Absent Readily available From Ismail-Beigi, et al. Individualizing glycemic targets in Type 2 Diabetes mellitus: implications of recent clinical trials. Ann Intern Med Apr 19;154(8): Short None Few/Mild Multiple/Severe V1.2 Date of preparation: May For review: May Severe Limited

12 DIABETES MONITORING GLYCAEMIC CONTROL KEY PRINCIPLES OF PRACTICE 95% of the care people with Diabetes receive is self-care and all patients should have access to high quality structured education programmes eg. X-PERT, DESMOND, conversation maps The ability to monitor their own glucose level gives people with Diabetes the feedback they need in order to learn how to manage their condition optimally. Monitoring should be based on the individual s clinical needs and in the context of Diabetes education and self- management. People should receive appropriate training in the technique and the actioning of the results. The frequency of testing will be different for different people and will change with their circumstances. Any guidelines can only be used as a framework and then adapted to meet individual needs. People may move between different methods of monitoring dependent on their needs at that time. Equipment used for monitoring should be based on choice and agreed with patient. TYPE 2 DIABETES Routine self -monitoring of blood glucose is not usually required if patients are well controlled on therapy without the potential to cause hypoglycaemia (see the table). HbA1c is important in assessing the adequacy of blood glucose control and should be tested every 3-6 months. Structured education is essential for people with newly diagnosed and existing Diabetes. People with Type 2 Diabetes usually have more stable glycaemic control. In practice, the level of monitoring will vary according to the treatment regimen used and the target level of glycaemic control set for/with the patient. DVLA requirements for testing when driving apply to people with Type 2 Diabetes treated with insulin, Gliclazide, glimepiride, glibenclamide or another sulphonylurea, nateglinide or repaglinide. TYPE 1 DIABETES Approaches and targets should be individualised and agreed in consultation with patients, as part of the care planning process. In addition to self-monitoring, HbA1c should be measured every 3-6 months. People prescribed insulin should be taught how to adjust therapy in line with their blood glucose monitoring and recognise patterns in their test results. This facilitates adjustments to their medication to achieve targets for fasting and postprandial blood glucose, which both contribute to HbA1c values. All results should be recorded with the time and date to provide a cumulative record as a basis for day-to-day changes in therapy. Most meters will store this information and some will allow download to a computer or smart phone DIABETES AND DRIVING People with Diabetes must inform the DVLA. Those on insulin or oral hypoglycaemic agents which carry a risk of hypoglycaemia, such as sulphonylureas should monitor their blood glucose before driving. Must have awareness of hypoglycaemia. If there is a total loss of 'hypo' warning signs their license will be withdrawn. Must not have had more than one episode of hypoglycaemia requiring third party assistance within the preceding 12 months. If they have had more than one episode they must inform the DVLA and their licence will be withdrawn for one year following the first episode. Patients with blood glucose levels <5 should not drive until they have eaten. GROUP 2 ENTITLEMENT People with Diabetes on insulin can apply for any Group 2 licence providing the patient has: Had no episodes of hypoglycaemia requiring third party assistance within the previous 12 months. Full awareness of hypoglycaemia and can demonstrate understanding of its risks. Meter recorded evidence of regular monitoring (twice a day and at times relevant to driving). Been reviewed annually by an independent consultant diabetologist. Visit V1.2 Date of preparation: May For review: May

13 Usual monitoring Intensive monitoring Treatment Prescribing DIABETES FREQUENCY OF BLOOD GLUCOSE TESTING ADULTS WITH TYPE 2 DIABETES ADULTS WITH TYPE 1 DIABETES Diet and exercise Metformin Pioglitazone DPP-4 inhibitors 1 SGLT-2 inhibitors 2 GLP-1 analogues 3 * Sulphonylureas 4 alone or in combination with other hypoglycaemic agents except insulin Insulin for Type 2 Diabetes: basal, twice daily fixed regimens or mixed insulins For basal bolus regimens see table for Type 1 Diabetes overleaf Insulin: basal bolus or delivered by a pump Not usually necessary (* except when initiating exenatide, liraglutide or lixisenatide in people taking a sulphonylurea see next column) Do not offer a meter unless a clear action based on test results has been agreed and for short term use only, e.g. to allow patient to adjust lifestyle when newly diagnosed 4 tests per week, usually testing once week before each of the three daily meals and before bedtime See advice on Diabetes and driving on previous page. Before meals and 2 hours after evening meal *Intensive monitoring is essential during initiation of exenatide, liraglutide or lixisenatide for people already on sulphonylureas until stabilised Basal insulin: 1-2 tests per day Premixed insulin: 2-4 tests per day People who rely on others for administration of mixed insulins may require more frequent testing, which is recommended prior to administration. See advice on driving Before meals and 2 hours after main meal Tests before breakfast are essential to achieve the target fasting glucose Additional tests pre-meal or 2 hours after food are helpful if fasting glucose is at target but HbA1c remains high Usually 4 to 8 tests daily. Test before meals and at bedtime as a minimum Include two hour post meal testing to check correct carbohydrate ratios Additional testing may be required to enable people with Type 1 Diabetes to drive safely Additional post prandial tests may be required to optimise the dose of the rapid acting insulin; include testing before meals and 1-2 hours after the largest meals During periods of intensive monitoring additional supplies of strips may be required Prescribe the minimum appropriate number of strips on acute Prescribe on repeat Additional supplies may be necessary for driving and intensive monitoring Prescribe on repeat Additional supplies may be necessary for driving and intensive monitoring Prescribe on repeat. Restricting access to strips may destabilise control and adversely affect people s quality of life Intensive monitoring may be required in any of these situations During intercurrent illness Intermittent steroid therapy Osmotic symptoms Postprandial hyperglycaemia Terminal care/end of life To prevent development of acute complications Pre-conception and pregnancy Increased or regular intensive exercise When HbA1c testing is unavailable Impaired awareness of hypoglycaemia 1 Linagliptin, saxagliptin, sitagliptin, vildagliptin, 2 Dapagliflozin, canagliflozin 3 Exenatide, liraglutide, lixisenatide 4 Gliclazide, glibenclamide glimepiride, glipizide, tolbutamide, nateglinide or repaglinide V1.2 Date of preparation: May For review: May

14 TYPE 2 DIABETES CHOICE OF GLUCOSE METER Endorsed Endorsed by CWHHE by Diabetes CWHHE Strategy Diabetes Group Strategy Group PRINCIPLES CHOOSING A BLOOD GLUCOSE METER Patients and health care professionals should be clear about what they hope to achieve by self-monitoring blood glucose because monitoring in itself does not improve control. It is the interpretation of the result and the action taken that makes the difference. Assessment of monitoring at least once a year is desirable and should include: Self-monitoring skills The quality and frequency of testing The use made of the results obtained The continued benefit The impact on quality of life The equipment used If the patient does not benefit from monitoring or if it is adversely affecting their quality of life, then it should be stopped. Self-monitoring of blood glucose does not replace HbA1c testing, which should be carried out at suitable intervals as part of regular care. Remember other health education (healthy diet, regular physical activity, maintaining a normal body weight, avoiding tobacco) to help people reduce their risk of Diabetes-related complications. Provide Diabetes lifestyle leaflets and actively promote structured education. A wide variety of blood glucose meters are available for patient use. These guidelines aim to rationalise the choice where possible to a smaller number of meters which have been assessed for technical specification and accuracy, patient acceptability and cost effectiveness. The advantages of this are expected to be health professionals only need to be familiar with a limited number of meters which will facilitate better teaching of testing to patients patients will understand testing better and test more effectively reduced acquisition costs reduction in unnecessary testing and increase in necessary testing (optimisation) The blood glucose testing meters referred to in these guidelines meet the needs of the majority of people with Type 2 Diabetes. However, meters with specialist functions will still be required, mainly for people with Type 1Diabetes, people with Type 2 on a basal bolus insulin regime and patients with complicated needs. These are usually chosen and provided by secondary care, but GPs will be requested to continue to prescribe strips. The decision to change meters should be used as an opportunity to review the purpose of testing and the interpretation of results as well as provide basic lifestyle advice and leaflet. When a change in prescribed test strips is required, patients should be encouraged to use their current supply of test strips first as long as the strips have not reached their expiry date and the current meter is in working order. Repeats of current strips should be stopped and a new meter demonstrated and supplied from the preferred list and strips put onto repeat. The majority of test strips expire within 90 days of opening. If usage is low enough that one pot of strips lasts longer than 90 days, review of the need for blood glucose monitoring is recommended. Patients should be reminded to use control solutions/calibrate machines in line with the manufacturer s recommendations. Each meter is supplied with a lancer and a few lancets. Lancers (the finger pricking devices) are not available on prescription and replacement lancing devices are available from companies (usually free of charge). Lancets are for single use only and should be prescribed in quantities which correspond to the expected frequency of testing. V1.2 Date of preparation: May For review: May

15 DIABETES GLUCOSE TEST STRIP FORMULARY CWHHE GLUCOSE TEST STRIPS FORMULARY BLOOD GLUCOSE TEST STRIPS Endorsed Endorsed by CWHHE by Diabetes CWHHE Strategy Diabetes Group Strategy Group These guidelines aim to rationalise the choice where possible to a smaller number of meters which have been assessed for technical specification and accuracy, patient acceptability and cost effectiveness. Patients with Type 1 Diabetes or those with Type 2 who may be prone to episodes of ketosis require access to ketone strips TYPE 2 DIABETES Central London, West London, Hammersmith and Fulham, Hounslow Ealing TYPE 1 DIABETES AND GESTATIONAL DIABETES (SPECIALIST INITIATION) Central London, West London, Hammersmith and Fulham, Hounslow Ealing GlucoRx Nexus Glucomen GM Freestyle Optium / Optium Neo 3 Freestyle Optium / Optium Neo 3 Neon Glucolab Neon Glucolab Glucomen LX Plus 3 Glucomen LX Plus 3 Wavesense Jazz Accucheck Expert 4 / Performa Nano 6 Accucheck Expert 4 Supercheck 2 1 Supercheck 2 1 Freestyle Insulinx 4 Freestyle Insulinx 4 GlucoRx Nexus Voice 1 Contour XT Accu-check mobile 2 Contour Next Link 5 Accucheck Combo 5 1 For visually impaired 2 For patients with problems with manual dexterity 3 Measure ketones 4 Insulin dose advisor 5 For patients on pumps 6 Antenatal TEST STRIP REQUIREMENTS LANCET REQUIREMENTS NEEDLE REQUIREMENTS Strips come in packs of 50 which can not be split. This table indicates quantities for usual testing, additional supplies may be necessary for intensive testing or driving. If patients are required to test regularly please prescribe on repeat. Please encourage patients not to over order or stockpile supplies. Additional supplies should be prescribed on acute. Patients should use a fresh lancet for each test. Pack sizes vary between 100 and 200 for different brands. The cheapest brands of needles are currently GlucoRX, and MyLife Penfine Classic. These two brands cover most needle sizes and are compatible with all devices. Needles come in packs of 100. Tests per day 28 days Packs/frequency Tests per day 28 days Packs/frequency Injections per day 28 days Packs/frequency /yr x 200 or 4 x 100 /yr x 100 /yr /mth, 14 /yr x 200 or 8 x 100 /yr x 100 / yr /mth, 14 /yr x 200 or 15 x 100 /yr x 100 /yr x 200 or 22 x 100 /yr x 100 /yr x 200 or 30 x 100 /yr V1.2 Date of preparation: May For review: May

16 DIABETES CARE PLANNING (1) An ongoing process of two-way communication, negotiation and joint decision-making in which both the person with Diabetes and the healthcare professionals make an equal contribution to the consultation. THE HOUSE OF CARE: The house of care highlights the importance of each part of the process: Commissioning Engaged informed patients Health care professionals committed to partnership working Organisational processes Without any one of these the house collapses PATIENT CENTRED: If we want to be more helpful to people who are trying to make changes but are finding it difficult, we need to base consultations on their concerns, their goals and the practical actions they wish to follow. This does not mean that the HCP is passive, unresponsive or does not have a view the consultation shares the expertise and experience of both parties in order to influence the outcome. Send test results beforehand IT: Clinical record of care planning Organisational processes Contact numbers and safety netting Many people may not really have considered a lifestyle or behaviour change, or feel ambivalent about making a change. In this situation, pushing or encouraging them to plan to change may not be appropriate. Indeed, a possible goal for that person might be to decide whether they do want to make a change. Their action plan may be to work out the pros and cons of both making the change and not making the change, along with assessing its importance to them. Prepared for consultation Information / structured education Emotional and psychological support Engaged informed patient Identify and fulfil needs Collaborative care planning consultation Commissioning: The foundation Procured time for consultations, training and IT HCP committed to partnership working Quality assure and measure Consultation skills / attitudes Integrated multidisciplinary team and expertise Senior buy-in and local champions to support and role model Useful tools: Partners in Care: Diabetes UK guide to care planning Consultation Quality Index (CQI-2): a questionnaire for understanding patient s perception of clinician skills Goal setting and action planning are inextricably linked but they should be seen as separate stages. THE INFORMATION SHARING PROCESS: Information gathering: The patient attends for an appointment with the Health Care Assistant or Nurse to have their annual review tests (e.g. blood and urine tests, blood pressure, weight +/- foot and eye screening). Information sharing: The annual review test results are included into a letter and posted to the patient to arrive at least one week before the Care Planning consultation. Prompts and questions in the letter encourage the patient to consider the results and other aspects of their Diabetes before the consultation Consultation and joint decision making: The patient attends the Care Planning consultation with the practice nurse or GP, who have received training in partnership working. This should include the elements outlined later in the guide (goal setting and action planning.) Agreed and shared care plan: The agreed care plan is produced and shared with the patient either immediately or subsequently by post or electronically V1.2 Date of preparation: May For review: May

17 DIABETES CARE PLANNING (2) Gather and share stories Explore and discuss Goal setting Action planning Review GOAL SETTING: SUMMARISE AND PRIORITISE Goal setting involves summarising and prioritising the various issues that have been explored and discussed so far in the consultation. For instance the healthcare professional might say what, of all the concerns we have talked about, rise up for you as the important things to aim for in relation to your Diabetes, over this coming year? ASSESS IMPORTANCE When changing something is difficult, the reason for change, the place where someone would like to be, has to be worth the effort of changing. If the goal is of low importance, but the difficulty of achieving it is high, then it is unlikely to be successfully achieved. Why would you want to put yourself through that? The value to someone can be assessed quite simply by asking the person to consider how important the goal or outcome is for them using a rating scale of 0 10 where 0 is low and 10 is high importance. For instance: If I asked you to tell me how important this change is for you, where zero was not important at all and 10 was really, really important, where would you put yourself between zero and ten? AGREEING ACTIONS: FOLLOW PATIENTS PRIORITIES If we want to be more helpful to people who are trying to make changes but are finding it difficult, we need to base consultations on their concerns, their goals and the practical actions they wish to follow. This does not mean that the HCP is passive, unresponsive or does not have a view the consultation shares the expertise and experience of both parties in order to influence the outcome. SMART GOALS Key ingredients of successful action planning: Plans need to be SMART Success is addictive Barriers to success need to be considered Rating scales to assess confidence and readiness Success really is addictive Take the time to do it SMART is a well known acronym, the letters of which stand for the following: S = Specific M = Measurable A = Action R = Realistic T = Time-scaled If an action plan can tick the boxes of the above features, it is more likely to be successfully achieved REASSESS IMPORTANCE If the score is lower than 7 then the reason for picking that goal needs to be explored. ASSESS CONFIDENCE Rating confidence: Self efficacy theory holds that a key determinant of a person s ability to take action is the confidence they have in their ability to successfully undertake that action. So, a further way of assessing how realistic a plan is to ask the person to rate their confidence that they will be able to do it. This can be done in a similar way that we rated the importance of goals: If I asked you to rate how confident you feel you are to be able to do this, where zero was not at all and 10 was absolutely definitely, where would you put yourself between zero and ten? V1.2 Date of preparation: May For review: May

18 DIABETES MOTIVATIONAL INTERVIEWING PREMISES: POWERFUL PATIENT CENTRED CONSULTATION TOOL TO HELP PATIENTS TO HELP THEMSELVES You can't create motivation, patients have to find it Guilt is paralysing, therefore the aim is to remove I have to / ought to / should do and replace with I want to Do not push your ideas or agenda Keep focused on the goal not your specifics of achieving it The choice and responsibility always lies with the patient ENABLING QUESTIONS: What would you like to have happen? And is there anything else about that? (or is there anything else about X?) What is important to you about X? What kind of X is that X? What needs to happen for that to happen? Use this question to set small step goals And when that happens, then what happens? Can you?/ Will you? OVERCOMING RESISTANCE: I don t want I can t. I never.. I always I ve tried that before I must do/ should do It s because. What do you want? According to whom? When can you? What can you? What happens when you do? What happens when you don t? Never? When specifically? Always? When Specifically? So what did you learn? And knowing what you learnt then what needs to happen now? According to whom? What would happen if you did? Knowing this, what do you need to do now? TOOLS: Establish rapport Listen Remember the desired outcome Ask enabling questions KEY QUESTIONS: What would happen if you did? What would happen if you didn t? What wouldn t happen if you did? What wouldn t happen if you didn t? Allow the patient to set time bound goals and get them to confirm they will do it (shake on it) FOLLOW UP / REVIEW: Celebrate their achievements! Revisit why it is important to them NEXT STEPS: If they haven t achieved then get them to look forward to what needs to happen now not back on the reasons. So knowing all that you know from the last time we met what do you want to have happen now? Use the questions for them to identify the next steps or new goal and commit to it V1.2 Date of preparation: May For review: May

19 DIABETES PSYCHOLOGICAL ASPECTS OVERVIEW Approximately 40% of people with Diabetes suffer with poor psychological well-being The rate of depression is doubled in people with Diabetes compared with controls Costs of untreated depression in Diabetes are high due to: negative impact on Diabetes self-care and medication adherence hyperglycaemia and increased complications and healthcare costs, lost productivity and increased mortality. Other specific psychological conditions such as eating disorders, needle phobias and fear of selfinjecting also lead to poor glycaemic control and subsequent complications. Treatment for psychological conditions, including depression, has been shown to lead to reduced symptoms and improved glycaemic control, as well as reductions in both psychological distress and the costs of healthcare. CLINICIAN RECOMMENDATIONS Be alert to the development or presence of clinical or subclinical depression and/or anxiety, especially if there are problems with self-management. Detect and basically manage non-severe psychological disorders in people from different cultural backgrounds. Be familiar with counselling techniques and drug therapy, while arranging prompt referral to specialists, especially if there is significant interference with wellbeing or Diabetes selfmanagement. Be alert to eating disorders and insulin dose manipulation if there is either poor glucose control, low BMI or over concern with body shape and weight. Early, and occasionally urgent, referral to local eating disorder services should be considered. The aims of structured education and self-management programmes are to improve outcomes through addressing the individual s health beliefs, optimising metabolic control, addressing cardiovascular risk factors (helping to reduce the risk of complications), facilitating behaviour change (such as increased physical activity), improving quality of life and reducing depression. People with Type 2 Diabetes with psychological and/or depressive disorders should be identified by continuing professional awareness, and managed in accordance with current national guidelines. DIABETES DISTRESS (DD) Unique, often hidden emotional burdens and worries that are part of the spectrum of patient experience when managing a severe, demanding chronic disease like Diabetes. High levels of DD are common (18 35%) and persistent over time, and they are distinct from clinical depression in their linkages with glycaemic control and disease management. High levels of DD have been significantly associated with poor glycaemic control, poor self-care, low Diabetes self-efficacy, and poor quality-of-life, even after controlling for clinical depression. The Diabetes Distress Scale is a clinically valid tool for assessing for Diabetes distress and consists of a 2 item screening tool (DDS2) and a 17 item assessment tool (DDS17). The DDS17 targets different areas of potential Diabetes-specific distress and consists of four subscales: 1. Emotional burden (feeling overwhelmed by Diabetes) 2. Physician distress (worries about access, trust, and care) 3. Regimen distress (concerns about diet, physical activity, medications) 4. Interpersonal distress (not receiving understanding and appropriate support from others) An average score of signifies moderate distress and an average score of 3 for each question signifies high levels of Diabetes distress. Discussion around areas of concern would be recommended. Useful tool: Self assessment of Diabetes distress V1.2 Date of preparation: May For review: May

20 TYPE 2 DIABETES ORAL HYPOGLYCAEMIC AGENTS (1) ORAL HYPOGLYCAEMIC AGENTS METFORMIN SULPHONYLUREAS THIAZOLIDINEDIONES (PIOGLITAZONE) Reduces hepatic glucose production and appetite. Start with 500mg daily for 1-2 weeks. Titrate every 2-4 weeks to achieve glycaemic target. Usual maximum tolerated dose is 1 gram BD or 850mg TDS Tablets should be taken with or immediately after a meal. Not associated with weight gain, and associated with reduced cardiovascular disease in overweight or obese patients - hence first line therapy in these patients. Diarrhoea occurs in up to 10%, but is dose dependent and may resolve with dose reduction. Metformin MR is an option in patients poorly tolerant of generic Metformin, starting with 500mg with evening meal, and then slowly up-titrating to 1g BD. Metformin dissolvable powder should be used in preference to Metformin syrup. Do not initiate in patients with egfr <45 ml/min, severe heart failure, severe liver disease (because of the increased risk of lactic acidosis) or alcohol dependency. Stop if there is progressive renal impairment and egfr <30 ml/ min. Metformin reduces cardiovascular events in overweight and obese patients to a greater extent than predicted by its glucose lowering effects. Stimulate insulin release from the pancreas. Gliclazide initially mg OD, with titration every 4-6 weeks to achieve glycaemic target or until maximum dose of 160mg B.D is reached. In patients over 70 yrs start at 40mg OD and do not increase dose above 80mg bd due to hypoglycaemia risk. Glimepiride 1mg OD titrate up to 4mg OD Gliclazide M/R is associated with less hypoglycaemia than generic Gliclazide. Tablets should be taken before or with meals. Weight gain averaging 2-4 kg is a recognised consequence of sulphonylurea therapy; in some patients it may exceed 10kg. Always re-assess the patient and emphasise lifestyle issues before prescribing. ALL patients should be told about recognition and management of hypoglycaemia when prescribed a sulphonylurea. AVOID long acting sulphonylureas (Glibenclamide and Chlorpropamide) unless recommended by a consultant in either o 1) MODY (Maturity onset Diabetes of the young) o 2) pregnancy People on sulphonylureas should perform up to 4 tests per week, usually testing once a week before each of the three daily meals and before bedtime. Note recommendations about driving and the need for selftesting for patients on sulphonylureas. Pioglitazone should not be started or continued in any individual who has heart failure, is at risk of a bone fracture or bladder cancer. Reduces insulin resistance and increases glucose uptake into peripheral tissues. Pioglitazone is the only agent currently available. 30mg OD increasing to 45mg OD after 3 months. Contra-indicated in patients with heart failure or active liver disease, and women of child-bearing age considering pregnancy and post-menopausal women. Monitoring of liver function tests prior to commencing therapy, and periodically thereafter is recommended. Discontinue / do not commence glitazone therapy if the ALT is 2.5 times the upper limit of normal. Pioglitazone use is associated with weight gain but this may be attributable to fluid retention. Pioglitazone is licensed for use with insulin. Hypoglycaemia may occur in patients already taking a sulphonylurea, and in such circumstances the sulphonylurea dose needs reducing. Side effect profile includes fluid retention, increased fractures and a small fall in haemoglobin concentration. Continue pioglitazone only if there is a reduction in HbA1c of 5mmol/mol (0.5%) in 6 months unless substituting Pioglitizone for another hypoglycaemic agent. V1.2 Date of preparation: May For review: May

21 TYPE 2 DIABETES ORAL HYPOGLYCAEMIC AGENTS (2) SGLT-2 INHIBITORS: SODIUM GLUCOSE CO-TRANSPORTER 2 AGENTS SGLT-2 inhibitors are a new class of oral drugs for the treatment of Type 2 Diabetes. They inhibit glucose re-absorbtion in proximal renal tubules providing an insulin independent mechanism to lower blood glucose. Their use in clinical practice is associated with improved glycaemic control, weight loss and a low risk of hypoglycaemia. SGLT - 2 inhibitors prevent the reabsorption of glucose from the kidneys back into the blood, leading to increased glucose in the urine and reduced glucose levels in the blood. Dapagliflozin The starting dose for Dapagliflozin is 10 mgs once daily unless there is severe liver failure when a 5 mgs dose should be used and tolerance reviewed before dose titration. This preparation can only be used as monotherapy if Metformin is not tolerated or in combination with insulin or Metformin (dual therapy). If using Dapgliflozin in combination with insulin then the insulin dose /doses may need to be reduced to reduce the risk of hypoglycaemia Dapagliflozin cannot be used in combination with a loop diuretic or in combination with Pioglitazone. It should not be used if egfr is less than 60mls/ Min. Canagliflozin Canagliflozin is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control. Doses are 100mg (starting dose) and 300mg. Intensification to 300mg dose can be considered as alternative to adding further therapy or changing to injectable therapy (e.g. GLP-1). Canagliflozin can be used down to an egfr of 45ml/min/1.73m 2 NICE GUIDELINES (TAG315) - CANAGLIFLOZIN Canagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if: a sulfonylurea is contraindicated or not tolerated or the person is at significant risk of hypoglycaemia or its consequences. Canagliflozin in a triple therapy regimen is recommended as an option for treating type 2 diabetes in combination with: metformin and a sulfonylurea or metformin and a thiazolidinedione. Canagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes. DPP-4 INHIBITORS (INCLUDE SITAGLIPTIN*, SAXAGLIPTIN*, LINAGLIPTIN, VILDAGLIPTIN) DPP-4 Inhibitors stimulate insulin response to glucose and prevent glucagon release after meals. All DPP-4s are licensed for use in combination with Metformin. They are also licensed for use with Pioglitazone if treatment fails to achieve adequate glycaemic control (triple therapy). Sitagliptin and Saxagliptin are also licensed for use with insulin. Neutral effect on body weight. Low incidence of hypoglycaemia unless used in combination with sulphonylurea and/or insulin. Dosage: Sitagliptin 100mg OD Saxagliptin 5mg OD Linagliptin 5mg OD Vildagliptin 50mg BD DPP-4s are contra-indicated in women of child-bearing age considering pregnancy. Sitagliptin, Linagliptin and Vildagliptin are licensed for use in CKD5 patients. Vildagliptin is not recommended for prescribing in CWHHE (due to need for LFT monitoring and no evidence of superiority over other agents. USE IN CKD Linagliptin Can be used at all stages of CKD with no dose adjustment. There is limited data on use in dialysis patients. Saxagliptin In patients with moderate and severe renal insufficiency reduce dose to 2.5mg. It is not recommended in end stage renal disease (dialysis patients). Sitagliptin For moderate renal insufficiency (egfr >30-<50 ml/min) reduce dose to 50mg OD. For severe renal insufficiency (egfr <30ml/min) reduce to 25mg OD. Vildagliptin In patients with moderate or severe renal impairment and end stage renal disease the recommended dose is 50mg OD. There is limited data on use in dialysis patients - use with caution. Monitoring of renal function should be undertaken regularly in patients on Sitagliptin, Saxagliptin and Vildagliptin People with Diabetes are often taking numerous tablets and this should be considered when consultations take place. It may be useful to try and elicit their values and beliefs about their medication and their understanding of different tablets as this may influence their behaviour around medication. There may be practical problems which may need to be addressed to ensure concordance. Regular medication reviews should take place either by a doctor, practice nurse or pharmacist. V1.2 Date of preparation: May For review: May

22 TYPE 2 DIABETES CRITERIA FOR REFERRAL TO LEVEL 2 OOHS The aim of the Diabetes level 2 service is to provide a high quality service for safe initiation and optimization of injectable therapy within GP networks. INCLUSIONS Initiation or optimisation of injectable therapy will be provided to patients with Type 2 Diabetes who satisfy the following criteria: 1. Type 2 patients that are registered with a GP in the CCG over the age of Are not achieving HbA1c targets with maximum-tolerated oral combination hypoglycaemic therapy and/or insulin/glp-1, compliant with combination therapy without any significant improvement in HbA1c: Triple therapy (three different oral agents) Dual therapy (two different oral agents) 3. In patients who have significantly poor glycaemic control that is unlikely to respond to triple therapy OR in patients who express a desire to start injectable therapy OR need to do so for occupational reasons (e.g. GLP-1 in taxi drivers) 4. The patient or carer is deemed capable of safely managing their injectable, including being able to undertake home blood glucose monitoring, inject insulin and adjust their own dose 5. Express an intention to start injectable, having been advised of what this involves and the risks associated with the treatment EXCLUSIONS (REFERRAL TO ACUTE SPECIALIST CLINIC REQUIRED) 1. Pregnancy 2. Patients aged under 18 V1.2 Date of preparation: May For review: May

23 TYPE 2 DIABETES WOMEN OF CHILDBEARING AGE All women with Diabetes WOMEN OF CHILDBEARING AGE WITH DIABETES & PREVIOUS GESTATIONAL DIABETES (GDM) All women with Type 1 Diabetes actively seeking pregnancy All women with Type 2 Diabetes actively seeking pregnancy For women with a previous history of gestational Diabetes On confirmation of pregnancy 50% of all pregnancies are unplanned Offer contraceptive advice All forms of contraception may be used for women with Diabetes Pre-conception care Stress the importance of: Folic acid Good glycaemic control Medicines review (stop ACE, ARBs and statins) Ensure retinal screen and microalbuminuria test performed within the last 12 months Refer to secondary care for pre-conception counselling for consideration of pump therapy to optimise their glycaemic control. Start folic acid 5mg OD Refer to secondary or intermediate care for pre-conception counselling Discontinue all oral agents and injectable therapies except Metformin and insulin Optimise glycaemic control with a basal bolus regime if needed Start folic acid 5mg OD Emphasise importance of annual review Check a HbA1c yearly to exclude Diabetes Give dietary and weight management advice Explain the high probability that GDM will recur in any future pregnancy and need for early booking Refer immediately to the Diabetes Antenatal Clinic Refer to retinal screening Ensure folic acid 5mg OD is being taken and ACE, ARBs and statins stopped V1.2 Date of preparation: May For review: May

24 TYPE 2 DIABETES CARDIOVASCULAR RISK (1) CARDIOVASCULAR RISK FACTOR INTERVENTION All people with Diabetes are considered to be at high cardiovascular risk. All require lifestyle advice and multifactorial risk factor intervention. However note lipid guidelines now recommend QRISK2 assessment for statin initiation. LIFESTYLE INTERVENTION Smoking cessation should be encouraged, with use of Stop Smoking clinics as required. Dietary intervention Should include weight loss for those with high waist circumferences >94cm in Northern European white male >80cm in Northern European white females >90cm in South Asian males >80cm in South Asian females and, for all should include advice about a low fat diet high in fruit and vegetables (at least 5 portions per day). Should include advice to decrease total dietary fat to <30% of total energy intake Should include advice to decrease saturated fats to <10% of total fat intake. Should include advice about lowering salt intake to be less than 6g of salt (=2.4 g sodium chloride) per day. Alcohol intake should be discussed, with the advice for males to limit to 21 units per week and females to 14 units/week. Regular intake of oily fish and other sources of omega 3 fatty acids (at least 2 portions of fish per week) Exercise The benefits of regular exercise should be explained and patients should be advised to perform regular aerobic activity. Clinical studies show that walking for 30 minutes every day has cardiovascular benefits BLOOD PRESSURE All patients with Diabetes (Type 1 or Type 2) should be treated to a target of 140/80 with a combination of lifestyle intervention (see above) and drug therapy. If kidney, eye or cerebrovascular damage set a target <130/80. Up to half the patients with Type 2 Diabetes will need 3 or more antihypertensive agents, and it is important for patients to be made aware of this when discussion around hypertension occurs. ACE inhibitors and ARBs are preferred first line therapy in people with any degree of nephropathy (micro- or macroalbuminuria). In all patients measure renal functions and electrolytes 1-2 weeks after initiation of ACE inhibitors and ARBs and with each increase in dose. The British Hypertension Society s Guidelines should be followed. Assess blood pressure at least 3 monthly until targets are achieved, and monitor every 4-6 months once targets are achieved. Patients who do not achieve target should be referred for further management. Remember that, if the patient does not achieve target despite greatest efforts by the multidisciplinary team, any improvement towards the target is better than the patient s baseline. Smoking Please assess patients for smoking status and refer to Smoking Cessation Teams for patient support. Lifestyle advice is integral to the management of Diabetes and should be reinforced at every available opportunity. V1.2 Date of preparation: May For review: May

25 TYPE 2 DIABETES CARDIOVASCULAR RISK (2) Endorsed Endorsed by CWHHE by Diabetes CWHHE Strategy Diabetes Group Strategy Group LIPIDS PRIMARY PREVENTION IN TYPE 1 DIABETES: Consider statin treatment for the primary prevention of CVD in all adults with Type 1 Diabetes Offer statin treatment for the primary prevention of CVD to adults with Type 1 Diabetes who: are older than 40 years or have had Diabetes for more than 10 years or have established nephropathy or have other CVD risk factors. PRIMARY PREVENTION IN TYPE 2 DIABETES: Offer atorvastatin 20 mg for the primary prevention of CVD to people with Type 2 Diabetes who have a 10% or greater 10-year risk of developing CVD. Estimate the level of risk using the QRISK2 assessment tool. PEOPLE WITH CKD Increase the dose if a greater than 40% reduction in non-hdl cholesterol is not achieved and egfr is 30 ml/min/1.73 m 2 or more. Agree the use of higher doses with a renal specialist if egfr is less than 30 ml/min/1.73 m 2 EXCEPTION - WOMEN OF CHILD-BEARING POTENTIAL/PREGNANT In females who are planning a pregnancy or who are pregnant these drugs should be withheld until breast feeding has ceased There is no evidence supporting the use of ezetimibe so this is not recommended. If a greater than 40% reduction in non-hdl cholesterol is not achieved: discuss adherence and timing of dose optimise adherence to diet and lifestyle measures consider increasing the dose if started on less than atorvastatin 80 mg and the person is judged to be at higher risk because of comorbidities, risk score or using clinical judgement It is important to note that the target triglyceride level is a fasting target, so an individual with a non-fasting result >2.3 mmol/l should be invited back to have a fasting triglyceride estimation. HDL and triglyceride interventions include lifestyle (predominantly weight loss and exercise) and drug therapies. The drug of choice is a fibrate, usually Fenofibrate 160mg. If using a combination lipid lowering regimen, monitoring of ALT and CK is appropriate. Monitor lipids 6 weekly until targets have been achieved, and annually thereafter. Remember that, if the patient does not achieve target despite greatest efforts by the multidisciplinary team, any improvement towards the target is better than the patient s baseline. Lifestyle advice is integral to the management of Diabetes and should be reinforced at every available opportunity. TREATMENT TARGETS Dietary interventions alone only reduce cholesterol by <10%. To reach targets, often drug therapy will be required. The initial target is to achieve a total cholesterol of <4.0 mmol/l and an LDL of <2.0 mmol/l. Statins are first line drugs for this indication. In accordance with NICE guidelines Atorvastatin 20mg is first choice. Increase from atorvastatin 20mg/day to atorvastatin 40mg/day unless total cholesterol level is below 4.0mmol/l or LDL cholesterol level is below 2.0mmol/l. Also consider intensifying to atorvastatin 40mg/day if there is existing or newly diagnosed CV disease, or increased albumin excretion rate. If Atorvastatin is not tolerated consider using Rosuvastatin. Monitor LFTs 6 weeks post initiation of statin. If normal check annually Fibrates should not be commenced if egfr is <45. They should be discontinued with deterioration of renal function. ANTI-PLATELET AGENTS Aspirin 75 mg daily is indicated for all patients with Diabetes who have any form of cardiovascular disease. In those who are also hypertensive the blood pressure should be controlled to 145/90 or below before commencement of aspirin. If aspirin is not tolerated or is contraindicated, clopidogrel 75 mg daily should be considered. V1.2 Date of preparation: May For review: May

26 TYPE 2 DIABETES OBESITY (1) BACKGROUND POINTS Obesity is a major modifiable risk factor in the development of Type 2 Diabetes. Decrease in weight in those who are obese can improve Diabetes control enormously without the need for escalation in therapy. Weight loss can be effective enough to put Type 2 Diabetes into remission GUIDANCE Those people with Diabetes whose adipose tissue mass is likely to contribute to the progression of their Diabetes control should be offered the opportunity to discuss their weight. The benefits to the patient of weight loss should be made clear. If the individual does not wish to consider making any changes then this should be reviewed at future consultations. Any choice of weight loss intervention should be negotiated between patient and health care professional. Consideration of what has been tried before is important. OBESITY BARIATRIC SURGERY Bariatric surgery is a treatment option for people with obesity if all of the following criteria are fulfilled: They have a BMI of 40 kg/m 2 or more, or between 35 kg/m 2 and 40 kg/m 2 and other significant obesity related disease (for example, type 2 diabetes, high blood pressure, obstructive sleep apnoea, polycystic ovarian syndrome) that could be improved if they lost weight All appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss The person has been receiving or will receive intensive management in a tier 3 service The person is generally fit for anaesthesia and surgery Bariatric surgery is the option of choice (instead of lifestyle interventions or drug treatment) for adults with a BMI of more than 50 kg/m 2 when other interventions have not been effective Lifestyle advice is integral to the management of Diabetes and should be reinforced at every available opportunity. INTERVENTIONS Interventions include lifestyle advice, specific drug therapy and bariatric surgery. General points Realistic targets for weight loss should be discussed Maximum weekly weight loss of 0.5 1kg Aim to lose 5-10% of original weight Realistic targets for exercise will vary greatly depending on the individual. Ideally, individuals should be encouraged to take up to 45 minutes of exercise per day, 5 times per week. Encouragement to join a commercial weight loss organisation can be beneficial. Lifestyle intervention This is the mainstay of obesity management. Any advice offered is more likely to be accepted by the patient if we as health care professionals offer the advice in an enthusiastic manner. Ideally, a combination of reduction of calorie intake and an increase in energy expenditure should be considered. Orlistat may be used to maintain or reduce weight before surgery for people who have been recommended surgery as a first line option, if it is considered that the waiting time for surgery is excessive Recent onset diabetes (duration < 10 years) Offer an expedited assessment for bariatric surgery to people with a BMI of 35 or over who have recent-onset Type 2 Diabetes as long as they are also receiving or will receive assessment in a tier 3 service (or equivalent) Consider an assessment for bariatric surgery for people with a BMI of who have recent-onset Type 2 Diabetes as long as they are also receiving or will receive assessment in a tier 3 service (or equivalent) Consider an assessment for bariatric surgery for people of Asian family origin who have recent-onset Type 2 Diabetes at a lower BMI than other populations as long as they are also receiving or will receive assessment in a tier 3 service (or equivalent) V1.2 Date of preparation: May For review: May

27 TYPE 2 DIABETES OBESITY (2) OBESITY MEDICATION BACKGROUND POINTS Before deciding to start treatment, and choosing the drug, discuss with the patient the potential benefits and limitations, including the mode of action, adverse effects and monitoring requirements, and their potential impact on the patient s motivation. When prescribing, make arrangements for appropriate healthcare professionals to offer information, support and counselling on additional diet, physical activity and behavioural strategies. Give information on patient support programmes. Follow the drug s summary of product characteristics. DRUG THERAPY SPECIFIC ADVICE ON ORLISTAT NICE guidance available Use only in those with Diabetes or endocrine conditions who have a BMI >28kg/m2 Continue beyond 3 months of therapy only if the patient has lost at least 5% of their body weight. Continue beyond 12 months for weight maintenance only after discussion of potential benefits and limitations with the patient. Rates of weight loss may be slower in people with type 2 diabetes, so less strict goals than those for people without diabetes may be appropriate. Agree the goals with the person and review them regularly. Lifestyle advice is integral to the management of Diabetes and should be reinforced at every available opportunity. Pharmacological agents are only to be used once lifestyle interventions have been instigated and the patient has reached a plateau in their weight loss but still wishes to lose more weight. It is important to set achievable targets for weight loss of no more than 10% of body weight. When considering the use of pharmacological agents to aid weight loss, ensure that the patient: 1. wishes to lose weight (the benefits of weight loss should be discussed) 2. is prepared to make changes to their calorie intake following appropriate dietary advice, preferably from a dietitian with an interest in obesity 3. is prepared to increase the level of physical activity (if able), preferably up to 45 minutes of moderate exercise at least 5 times per week 4. is prepared to consider joining a commercial weight loss programme. 5. Understands that, if the drug is deemed not to be successful then it will be withdrawn. All studies showing the greatest benefit with the weight loss drugs involved lifestyle intervention as part of the management. CONTINUED PRESCRIBING AND WITHDRAWAL Review regularly, to monitor the effect of drug treatment, and to reinforce lifestyle advice and need for adherence. Drug treatment may be used to help people to maintain weight loss, as well as to continue to lose weight. Consider withdrawing drug treatment if the person does not lose enough weight. Agree goals with the person and review regularly If concerned about micronutrient intake, consider giving a supplement providing the reference nutrient intake for all vitamins and trace elements, particularly for vulnerable groups such as older people, who may be at risk of malnutrition. If withdrawing a person s drug treatment, offer support to help maintain weight loss because their self-confidence and belief in their ability to make changes may be low. V1.2 Date of preparation: May For review: May

28 TYPE 2 DIABETES FOOT EXAMINATION Endorsed by by CWHHE CWHHE Diabetes Diabetes Strategy Strategy Group Group All patients with Diabetes should be on a register and minimum data should include annual measures for microvascular disease. Please see Cardiovascular Risk for additional requirements FOOT EXAMINATION ASSESSMENT SIGNIFICANT FINDINGS USING A MONOFILAMENT Patient history Previous foot ulceration Apply the filament to a sensitive area of skin (e.g. the forearm) so Previous amputation that the patient is aware of the sensation they are supposed to feel. Diabetes > 10 years Test 5 sites*: HbA1c > 58mmol/mol Impaired vision / retinopathy Neuropathic symptoms Claudication Plantar surface of the hallux and 3 rd toe 1 st, 3 rd and 5 th metatarsal heads *If callus is present at any of the sites then test at the nearest non-calloused area. Ask the patient to close their eyes and say yes every time that they feel you touch the skin on the foot Dermatological examination Dry skin Place the monofilament at 90 to the skin surface Slowly push the monofilament until it has bent ~ 1cm (don t jab) Absence of hair Hold the monofilament in this position for 1-2 seconds, then slowly Ingrown nail edges, long or sharp nails release the pressure until the monofilament is straight Remove contact from the skin Interspace maceration / infection Repeat for all testing sites Ulceration If the patient does not respond, repeat the test at the site twice. If there is still no response, record as a negative response Neuropathy screening Lack of monofilament perception at one or Replace monofilament at least yearly more sites Vascular examination Biomechanical assessment Abnormal perception of vibration using 128Hz tuning fork Absent dorsalis pedis or posterior tibial pulses Ankle-brachial index (ABI) < 0.90 Diminished joint mobility Decreased vision, gait imbalance Ill-fitting footwear Patient s inability to see or reach his/her feet Corns, calluses, bunions Prominent metatarsal heads Hammer toes, claw toes V1.2 Date of preparation: May For review: May

29 TYPE 2 DIABETES FOOT MANAGEMENT ALGORITHM Endorsed by by CWHHE CWHHE Diabetes Diabetes Strategy Strategy Group Group FOOT SCREENING AND MANAGEMENT Annual Foot Review Assumed patient part of ongoing care and one to one education as per NICE Foot examination with shoes and socks/stockings removed Test foot sensation Inspect for any deformity Inspect footwear Check for signs of infection Palpate foot pulses Inspect for significant callus Ask about any pain Ask about previous ulceration Low Moderate Definition Normal sensation, palpable pulses One risk factor present e.g neuropathy or absent foot pulses or other foot changes Diabetic foot risk assessment Action Standard footcare advice and leaflets Surveillance 3-6 monthly by clinician with footcare competencies training Enhanced foot care education Inspect feet 3-6 monthly Advise on appropriate footwear Review need for vascular assessment Low threshold for further referral Risk Status Documented and patient provided with written and verbal education and emergency contact numbers Download PILs: Low risk Moderate risk High risk Ulcer High Previous ulcer or amputation or more than one risk factor e.g. neuropathy or absent pulses plus deformity or skin changes Increased surveillance 1-3 monthly by specialist podiatrist or member of the foot protection team At each regular Diabetes visit review education / footwear / vascular status Foot Ulceration Charcot Foot Presence of active ulceration/break in the skin, spreading infection, gangrene or unexplained hot, red, swollen foot with or without pain Rapid referral to multidisciplinary foot care team Admission to secondary care if patient systemically unwell V1.2 Date of preparation: May For review: May