Starting and Helping People with Type 2 Diabetes on Insulin

Starting and Helping People with Type 2 Diabetes on Insulin Elaine Cooke, BSc(Pharm), RPh, CDE Pharmacist and Certified Diabetes Educator Maple Ridge, BC

Objectives After attending this session, participants will be able to: Understand the unique needs and challenges to consider when initiating insulin therapy in people with type 2 diabetes Recognize hypoglycemia, its causes and the physical and psychological impact it has on people with diabetes Explain how self-monitoring of blood glucose (SMBG) can assist people using insulin to recognize issues, problem solve and adjust their insulin when blood glucose (BG) is not at target Recognize SMBG best practices and counsel people with type 2 diabetes on insulin therapy accordingly 3

Diabetes Progression 4

Beta Cell Function (%) Type 2 Diabetes is a Progressive Disease 100 75 Stages of Type 2 Diabetes in Relationship to ß-cell Function 50 25 Impaired glucose tolerance Postprandial hyperglycemia Type 2 diabetes phase I Type 2 diabetes phase II Type 2 diabetes phase III -12-10 -6-2 0 2 6 10 14 Years from Diagnosis 50% of ß-cell function is already lost at diagnosis ß-cell function will continue to decline despite treatment Lebovitz HE Diabetes Rev 1999:7 139-53.

Issues, Barriers and Patient Needs 6

Barriers to Starting Insulin Therapy Clinician barriers to insulin therapy may be due to: Perceived complexity of the therapeutic regimen Belief that it is not effective in type 2 diabetes Fear of hypoglycemic episodes, weight gain and associated cardiovascular risks Fear that insulin therapy will require careful monitoring, more physician time, and other practice resources Davis SN, Renda SM. Diabetes Educator 2006; 32(4):146S-52S. 7

Barriers to Starting Insulin Therapy Insulin therapy may have negative connotations for some patients: Sense of loss of control over one s life Reduced quality of life Sense of personal failure to control the disease Side effects such as weight gain and hypoglycemia Daily, possibly painful, injections Establish a sense of patient control by informing patients that: Their symptoms will improve with insulin therapy They will be taking a more active role in managing their diabetes Basal insulin regimens are easy to administer and can be administered at bedtime There are strategies to prevent hypoglycemia Davis SN, Renda SM. Diabetes Educator 2006; 32(4):146S-52S. 8

Initiating Insulin in Type 2 Diabetes 9

Insulin in Type 2 Diabetes Insulin can be used: At diagnosis During illness, surgery or pregnancy CDA Clinical Practice Guidelines. Can J Diabetes 2013;37(Suppl 1):S1-S212; Harper W, et al. Can J Diabetes 2013;37(Suppl 1):S61-S68, Chapter 13. At any time glycemic targets are not being met - Glycemic targets must be individualized. Target for most individuals with diabetes is a glycated hemoglobin (A1C) 7.0% 10

Polling Question: Which of the following is not a barrier to starting insulin? A. Clinician fear it will require more time and practice resources B. Sense of personal failure to control diabetes C. Concerns over cost of therapy D. Concerns that injections will be painful

Insulin in Type 2 Diabetes Tailor treatment to the individual. There are many options: Start with a basal insulin in addition to oral antihyperglycemic agents Start with a premixed insulin in addition to oral antihyperglycemic agents Start with intensive insulin therapy (less common and not generally recommended) CDA Clinical Practice Guidelines. Can J Diabetes 2013;37(Suppl 1):S1-S212, Appendix 3. Resource Slide 12

Basal Insulin added to Oral Antihyperglycemic Insulin Neutral protamine hagedorn (NPH), glargine U-100, detemir, glargine U-300, degludec (U-100 and U-200) Dosing Starting dose is generally 10 units daily at bedtime. Can be administered at other times of day. Titration Several titration regimens are acceptable For glargine U-100 or detemir, one regimen is to increase dose by 1 unit every night until fasting BG has reached their individual target (e.g., 4.0-7.0 mmol/l [ADA 90-130 mg/dl]) Stop titrating if 2 episodes of hypoglycemia occur in a week or any nocturnal hypoglycemia Insulin glargine U-300 and insulin degludec should not be up-titrated more often than every 3-4 days due to their longer duration of activity CDA Clinical Practice Guidelines. Can J Diabetes 2013;37(Suppl 1):S1-S212, Appendix 3; CDA Insulin Prescription Tool for Healthcare Providers [http://guidelines.diabetes.ca/bloodglucoselowering/insulinprescriptiontool]; Toujeo Package Insert; Tresiba Package Insert Standards of Medical Care in Diabetes 2016 January 2016 Volume 39, Supplement 1-American Diabetes Association Garber, AJ, et al.endocrine Practice, 2013;19(Suppl 2):1-38. 13

What to discuss with the Patient Type and starting dose of insulin Explain onset, peak, duration, preparation and storage Titration schedule When to check and what BG targets are being used for titration How to use injection device Injection site and rotation of injections Hypoglycemia: symptoms, treatment, prevention Sick day guidelines Driving guidelines Follow-up date to discuss concerns Insulin Pen Start Checklist Help Sheet [http://www.diabetes.ca/cda/media/documents/clinical-practiceand-education/professional-resources/insulin-pen-checklist-help.pdf] Resource Slide 14

Getting Started with Insulin: Resource Slide Patient Handout 15

Insulin Type, Dose and Action Provide Patient Type and starting dose of insulin Onset, peak, duration and storage Basal Insulins Insulin Type Onset Peak Duration Intermediate-acting insulin (cloudy): Insulin NPH 1-3 h 5-8 h Up to 18 h Long-acting basal insulin analogues (clear) Insulin detemir Insulin glargine U-100 Insulin glargine U-300 Insulin degludec 90 min 90 min Up to 6 h 1 60 min Not applicable Up to 24 h (detemir 16-24 h) Up to 24 h (glargine 24 h) Up to 30 h Up to 42 h Harper W, et al. Can J Diabetes 2013;37(Suppl 1):S61-S68, Chapter 13; Toujeo Package Insert; Tresiba Package Insert 1Per Package Insert, onset of action develops over 6 hours after administration. Resource Slide 16

Insulin Pens Consult directions with each pen New pen needle for each injection Re-suspend cloudy insulin (NPH), tap to send any air bubbles to end of needle Prime with a 2 unit shot each time; a drop of insulin should appear. Repeat until a drop appears Dial dose and perform injection 90⁰ Count to at least 10, then remove needle and discard in sharps container Use pen needle length of 4 to 6 mm Insulin Pen Start Checklist Help Sheet [http://www.diabetes.ca/cda/media/documents/clinical-practice-andeducation/professional-resources/insulin-pen-checklist-help.pdf]; Gibney MA, et al. Curr Med Res Opin 2010;26(6):1519-30. Resource Slide 17

Injection Site Rotation Injection Site Abdomen fastest, most consistent absorption, followed by the outer arm, thigh and buttock Site Rotation Divide injection site into quadrants, use one quadrant weekly separating all injections by a finger width Site Preparation Clean with soap and water Alcohol is not required; if used let dry completely With 4-6 mm pen needles a skin lift is usually not required unless very lean; hold skin and lift until injection complete FIT Forum for Injection Technique Canada [https://www.bd.com/resource.aspx?idx=25063]; FIT Technique Plus Technique for All [http://www.fit4diabetes.com/files/8713/6544/1790/fit_technique_plus_-_technique_for_all.pdf] Resource Slide 18

Hypoglycemia Lower rates of hypoglycemia have been observed with rapid acting analogues than regular insulin Use of long-acting basal insulin analogues reduces the risk of nocturnal hypoglycemia compared to NPH Causes of hypoglycemia: Missed meals, smaller or delayed meals Too much medication Unplanned or extra activity Consuming alcohol CDA Clinical Practice Guidelines. Can J Diabetes 2013;37(Suppl 1):S1-S212; Meece J. Diabetes Educ 2006;32;9S-18S. 19

Symptoms of Hypoglycemia Symptoms vary from person to person Early Signs Trembling, shaking Dizzy, light headed Palpitations Sweating Anxiety Hunger Nausea Tingling Headache Blurred vision Late Signs Difficulty concentrating Confusion Changed behaviour Drunk-like behaviour Trouble speaking Loss of consciousness Clayton D, et al. Can J Diabetes 2013;37(Suppl 1): Chapter 14. 20

Hypoglycemia Treatment Check BG and treat if below 4.0 mmol/l (ADA 70 mg/dl) Give 15 g fast acting carbohydrate preferably as 3 to 4 dextrose tablets or: 15 ml (3 teaspoons) or 3 packets of table sugar 175 ml (3/4 cup) juice or regular soft drink 6 lifesavers (1=2.5 g of carbohydrate) 15 ml (1 tablespoonful) of honey 4 x dextrose 4 g tablets Wait 15 minutes, retest BG and retreat with another 15 g carbohydrate if BG < 4.0 mmol/l (ADA 70 mg/dl) If next meal is more than 1 hour away once hypoglycemia has been reversed, have a snack with 15 g carbohydrate and a protein source Briscoe V, et al. Clinical Diabetes 2006;24;115-21; CDA Clinical Practice Guidelines. Can J Diabetes 2013;37 (Suppl 1):S1-S212 Standards of Medical Care in Diabetes 2016 January 2016 Volume 39, Supplement 1-American Diabetes Association Garber, AJ, et al.endocrine Practice, 2013;19(Suppl 2):1-38.. 21

Prevention of Hypoglycemia for all Insulin- Treated Drivers Measure BG level immediately before and at least every 4 hours during long drives Do not drive when BG level is < 4.0 mmol/l (ADA 70 mg/dl) Do not begin to drive without having some carbohydrate-containing food when your BG level is 4.0 to 5.0 mmol/l (ADA 70 to 90 mg/dl) Stop and treat yourself as soon as hypoglycemia and/or impaired driving is suspected You should not drive for at least 45 to 60 minutes after effective treatment of mild to moderate hypoglycemia Insulin Pen Start Checklist Help Sheet; CDA Getting Started with Insulin 2013 Standards of Medical Care in Diabetes 2016 January 2016 Volume 39, Supplement 1-American Diabetes Association Garber, AJ, et al.endocrine Practice, 2013;19(Suppl 2):1-38.. 22

Polling Question: Which of the following should be discussed with patients starting insulin? A. Onset, peak, duration, preparation and storage of insulin B. Injection site selection and rotation C. Hypoglycemia recognition, treatment and prevention D. All of the above

Patient Education and Tools Patient should leave from insulin start session with: Insulin, pen or syringes and sharps container Dose of insulin, when to inject and titration protocol Knowing injection technique: how, where, site rotation Hypoglycemia sheet for signs, symptoms and treatment Log book, test times and BG targets Appointment for follow-up call 24

Intensifying Insulin Therapy 25

Basal Plus Strategy: Adding Bolus Insulin Dosing Starting dose: 2 to 4 units Patient can be taught self titration, or dose increase can be done by the health care practitioner The mealtime (bolus) insulin dose may be initiated at one meal daily (generally the largest meal of the day) Titration To safely increase dose, glucose levels should be measured at least prior to insulin dose, then titrated by 1 unit daily to either of the following targets: 2 hour post-meal glucose of 10.0 mmol/l (ADA 180 md/dl) (or 8.0 mmol/l [144 mg/dl] in certain cases) Pre-next meal glucose of 4.0 to 7.0 mmol/l (ADA 90 to 130 mg/dl) CDA Clinical Practice Guidelines. Can J Diabetes 2013;37(Suppl 1):S1-S212, Appendix 3; CDA Insulin Prescription Tool for Healthcare Providers [http://guidelines.diabetes.ca/bloodglucoselowering/insulinprescriptiontool]; Harper W, et al. Can J Diabetes 2013;37(Suppl 1):S61-S68, Chapter 13 Standards of Medical Care in Diabetes 2016 January 2016 Volume 39, Supplement 1-American Diabetes Association Garber, AJ, et al.endocrine Practice, 2013;19(Suppl 2):1-38.. 26

Using SMBG 27

Benefits of SMBG SMBG identifies glycemic excursions to allow for day-to-day adjustments of activity, diet and medication. It can: Determine preprandial and postprandial hyperglycemia Confirm hypoglycemia, allowing for appropriate treatment Detect glycemic excursions, providing immediate feedback to patients about the effect of food choices, activity and medication on glycemic control Awareness of SMBG and A1C provide the best information to assess glycemic control and help patients on insulin make changes and regain control CDA Clinical Practice Guidelines. Can J Diabetes 2013;37(Suppl 1):S1-S212; Parkin CG, et al. J Diabetes Sci Technol. 2009;3:500-8.. 28

Regular SMBG Frequency Situation Using multiple daily injections of insulin ( 4 times per day) SMBG Recommendation SMBG 4 times per day Using an insulin pump Using insulin < 4 times per day Pregnant (or planning a pregnancy), whether using insulin or not SMBG at least as often as insulin is being given SMBG individualized and may involve SMBG 4 times per day Hospitalized or acutely ill Starting a new medication known to cause hyperglycemia (e.g. steroids) SMBG individualized and may involve SMBG 2 times per day Experiencing an illness known to cause hyperglycemia (e.g. infection) CDA Clinical Practice Guidelines Expert Committee. Appendix 4. Can J Diabetes 2013;37(Suppl 1):S197-S212. http://guidelines.diabetes.ca/bloodglucoselowering/smbgrecommendationsheet 29

Increased SMBG Frequency Situation Using drugs known to cause hypoglycemia (e.g. sulfonylureas, meglitinides) Has an occupation that requires strict avoidance of hypoglycemia Not meeting glycemic targets Newly diagnosed with diabetes (< 6 months) Treated with lifestyle and oral agents and is meeting glycemic targets SMBG Recommendation SMBG at times when symptoms of hypoglycemia occur or at times when hypoglycemia has previously occurred SMBG as often as required by employer SMBG 2 times per day, to assist in lifestyle and/or medication changes until such time as glycemic targets are met SMBG 1 time per day (at different times of day) to learn the effects of various meals, exercise and/or medications on BG Some people with diabetes might benefit from very infrequent checking (SMBG once or twice per week) to ensure that glycemic targets are being met between A1C tests CDA Clinical Practice Guidelines Expert Committee. Appendix 4. Can J Diabetes 2013;37(Suppl 1):S197-S212. http://guidelines.diabetes.ca/bloodglucoselowering/smbgrecommendationsheet 30

Pattern Management Requires a review of all parameters that affect BG Involves reviewing a record of glucose values, food, physical activity, medication administration and other factors that may affect blood sugar Do not react to one BG value. 3 to 4 days of information are required to determine a pattern Organize results so that all BG values occurring at the same time of day can be seen and reviewed together Mensing C, Ed. The Art and Science of Diabetes Self Management Education, 2006 American Association of Diabetes Educators; Chapter 16, pp 357-370. Resource Slide 31

Prioritizing Treatment If more than one pattern appears, prioritize the work of bringing the pattern back into target range: 1. Always fix hypoglycemia (< 4.0 mmol/l [ADA 70 mg/dl]) first 2. Bring fasting BG into target next 3. Work on hyperglycemia patterns, usually looking at pre-meal values followed by post-meal values Remember to: Adjust only one insulin at a time Adjust the insulin dose by no more than 10% at a time Reassess BG values after several days before making further changes Rodbard D. J Diabetes Sci Technol 2007;1:62 71 Standards of Medical Care in Diabetes 2016 January 2016 Volume 39, Supplement 1-American Diabetes Association Garber, AJ, et al.endocrine Practice, 2013;19(Suppl 2):1-38. 32

Adjusting Insulin When adjusting insulin you need to adjust the insulin that affects the BG value you are concerned with Blood glucose value at: Fasting/pre-breakfast Pre-lunch Pre-supper Bedtime Adjust: Bedtime basal Breakfast bolus Lunch bolus Supper bolus CDA Clinical Practice Guidelines Expert Committee. Appendix 4. Can J Diabetes 2013;37 (Suppl 1):S197-S212. 33

Adjusting Insulin If on BID combinations of premixed insulin, typically pre-breakfast and pre-supper, you need to be aware of what insulin affects the BG value Blood glucose value at: Fasting/pre-breakfast Pre-lunch Pre-supper Bedtime Adjust: Pre-supper premix Pre-breakfast premix Pre-breakfast premix Pre-supper premix CDA Clinical Practice Guidelines Expert Committee. Appendix 4. Can J Diabetes 2013;37 (Suppl 1):S197-S212. 34

Polling Question: In what order should you address recognized patterns in blood glucose records? A. Fasting blood glucose, hypoglycemia then hyperglycemia B. Hypoglycemia, hyperglycemia then fasting blood glucose C. Hypoglycemia, fasting blood glucose then hyperglycemia

Summary Due to progressive beta cell loss, insulin will be required in the majority of individuals with type 2 diabetes Basal insulin at bedtime is the most common method of starting insulin in type 2 diabetes and patients can self-titrate Use Basal Plus strategy to intensify insulin therapy SMBG is essential in making changes to therapy using pattern management It is important to educate patients on the following: Insulin: action, dose, storage, titration, injection technique and site Hypoglycemia Driving guidelines 36

Insulin Initiation and Titration Resource Slide CDA Insulin Initiation and Titration Suggestions/Prescription Form 38

Getting Started with Insulin: Resource Slide Patient Handout 39

Sick Day Guidelines Resource Slide HealthLink BC Guidelines 40

Bolus Insulins Resource Slide Insulin Type Onset Peak Duration Bolus (prandial) Insulins Rapid-acting insulin analogues (clear): Insulin aspart Insulin glulisine Insulin lispro 10-15 min 10-15 min 10-15 min 1-1.5 h 1-1.5 h 1-2 h 3-5 h 3-5 h 3.5-4.75 h Short-acting insulins (clear): Insulin regular 30 min 2-3 h 6.5 h 41

Premixed Insulins HealthLink BC Guidelines Insulin Type Time action profile Resource Slide Premixed Insulins Premixed regular insulin NPH (cloudy): Regular 30%/NPH 70% Premixed insulin analogues (cloudy): Biphasic insulin aspart Insulin lispro/lispro protamine A single vial or cartridge contains a fixed ratio of insulin (% of rapid-acting or short-acting insulin to % of intermediate-acting insulin) 42

Insulin Pen Start Checklist and Help Sheet Resource Slide Checklist and Help Sheet 43

Fit Canada Injection Technique Resource Slide FIT Forum Best Practices FIT Technique for All 44

Driving Guidelines Getting Started with Insulin New Driving Guidelines Resource Slide 45

CDA SMBG Tools Resource Slide SMBG Recommendation Tool for Healthcare Providers Self-SMBG Frequency & Pattern Tool 46