Practical guidance to insulin management

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1 primary care diabetes 4, suppl. 1 (2010) S43 S56 Contents lists available at ScienceDirect Primary Care Diabetes journal homepage: Practical guidance to insulin management Luigi Meneghini a, *, Sara Artola b, Salvatore Caputo c, Taner Damci d, Grzegorz Dzida e, Marcel Kaiser f, Kamlesh Khunti g, Andreas Liebl h, Robert Ligthelm i, Alberto Maran j, Domingo Orozco-Beltran k, Stuart Ross l, Jean-François Yale m a University of Miami Miller School of Medicine, Miami, Florida, USA b Centro de Salud Hereza I de Madrid, Madrid, Spain c Policlinico Gemelli, Università Cattolica, Rome, Italy d Istanbul University Cerrahpasa Medical School, Istanbul, Turkey e Medical University of Lublin, Lublin, Poland f Private Practice, Frankfurt, Germany g University of Leicester, Leicester, UK h Diabeteszentrum Fachklinik Bad Heilbrunn, Bad Heilbrunn, Germany i EHM Clinic Hoofddorp, Rotterdam, The Netherlands j Università di Padova, Padua, Italy k University Miguel Hernández, Sant Joan d Alacant, Spain l University of Calgary, Calgary, Canada m McGill Nutrition Centre, McGill University, Montreal, Canada article info Keywords: Insulin initiation Insulin management Metabolic control Weight management Depression screening abstract The practical guidance to insulin management is a simple tool for health care providers, particularly primary care physicians (PCPs). Developed by experts in diabetes care at an international meeting, it aims to help physicians make key decisions to optimize insulin management and decrease long-term morbidity risk. With a growing role for PCPs in type 2 diabetes, the practical guidance focuses on confident, appropriate and timely insulin initiation. Using the acronym TIME (Targets, Insulin, Managing weight, Encouragement and support) the practical guidance aims, in a visually appealing format, to help physicians address the challenges of insulin management with their patients, from diagnosis through insulin initiation to follow-up Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved. 1. Introduction Rising patient numbers and changes in health care policy have shifted insulin initiation in type 2 diabetes from * Corresponding author. Luigi Meneghini. Division of Endocrinology & Diabetes, University of Miami School of Medicine, Diabetes Research Institute, 1450 NW 10th Avenue, Miami, Florida 33136, USA. Tel.: ; fax: address: lmeneghi@med.miami.edu (L. Meneghini). secondary to primary care. A major challenge for primary care physicians is to assimilate and utilize all relevant information regarding appropriate insulin initiation. The practical guidance presented here (reproduced on the following pages) is a simple reference tool for the clinic, reflecting insights gathered at a meeting organized by Novo Nordisk. Attended by leading experts from Europe, Canada, Israel and Turkey, the objective of this meeting was to formulate a call to action to help physicians overcome these challenges. The practical guidance has //$ see front matter 2010 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

2 S44 primary care diabetes 4, suppl. 1 (2010) S43 S56 been developed by experts in diabetes management to support all physicians, but especially those in primary care. Throughout the practical guidance, the key pillars of insulin management are visually organized using the acronym TIME as a helpful memory aid: Targets Insulin Managing weight Encouragement and support In terms of discussing insulin, these key pillars of TIME have often only been considered at the time of insulin initiation. The challenge is to ensure that insulin management is addressed throughout the diabetes continuum with a more proactive approach to increase awareness and acceptance of insulin therapy earlier rather than later. Therefore, the practical guidance is divided into four visual sections, according to time points where the role of insulin should be addressed: At diagnosis Before insulin is needed Insulin initiation Follow-up Every time physicians see a patient with type 2 diabetes, the practical guidance provides advice across all aspects of TIME appropriate to the specific time point. For each key time point and pillar, there are tricks of the trade and patient management tips, as well as important points for discussion with patients. These aspects make the information highly relevant to daily clinical practice. Consulting the relevant time point prior to an appointment with a patient, and thinking about each of the key pillars, will help physicians optimally manage diabetes through appropriate discussion and use of insulin. The practical guidance can be used to start the discussion about insulin early, build a strong partnership with patients, and ensure optimal diabetes care to decrease long-term morbidity risk. 2. How this practical guidance was developed and the role of Novo Nordisk All authors have been involved throughout the development of the practical guidance, from initial concept to providing final approval. At an international meeting, held in May 2009, 130 expert physicians gave their feedback on what important information should be included in a practical guidance for insulin management to formulate a call to action. The feedback was reviewed by the authors, and the content of the practical guidance developed. The meeting upon which the content of this practical guidance is based was funded by Novo Nordisk. The authors are all members of a Novo Nordisk advisory board, for which they are paid an honorarium. Medical writing assistance and layout concept support was provided by Eleanor Steele and Gary Burd at Complete HealthVizion; this assistance was funded by Novo Nordisk, who also had a role in the review of the practical guidance for scientific accuracy. Abbreviations ADA: American Diabetes Association EASD: European Association for the Study of Diabetes HbA1c: Glycosylated haemoglobin FPG: Fasting plasma glucose PPG: Post-prandial glucose LDL-cholesterol: Low-density lipoprotein cholesterol HDL-cholesterol: High-density lipoprotein cholesterol OAD: Oral anti-diabetic drug ITAS: Insulin Treatment Appraisal Scale NPH: Neutral protamine Hagedorn PCP: Primary care physician Conflict of interest statement Luigi Meneghini has received funding for research from Novo Nordisk, sanofi-aventis and Medtronic Minimed, has acted as a consultant to Novo Nordisk, is a member of an advisory board for Novo Nordisk, and is a member of a speaker bureau for Novo Nordisk, Eli Lilly and sanofi-aventis. Sara Artola has received honoraria from Novo Nordisk, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Servier, sanofi-aventis and Eli Lilly, is a member of advisory boards for Novo Nordisk, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Servier, sanofi-aventis and Eli Lilly, and has received research funding from Novo Nordisk, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Servier, sanofi-aventis and Eli Lilly. Salvatore Caputo has received honoraria from Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novo Nordisk and Takeda, has received consulting fees from Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novo Nordisk and Takeda, and has received funding for research from Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novo Nordisk and Takeda. Taner Damci has received honoraria from Novo Nordisk, Lilly, sanofiaventis, Merck Sharp & Dohme, Bristol Meyer Squibb, Servier, AstraZeneca, Abbott, Roche, Roche Diagnostics, Bilim Ilaç, Sanovel, Eczacibaůşi. Grzegorz Dzida is a member of an advisory board for Novo Nordisk. Marcel Kaiser owns stocks of Novo Nordisk and is a member of an advisory board for Novo Nordisk. Kamlesh Khunti has received funding for research from Lilly, MSD, Novartis, Novo Nordisk, Pfizer, sanofi-aventis and Unilever and has acted as a consultant to or received honoraria from AstraZeneca, BMS, Lilly, MSD, Novartis, Novo Nordisk, Pfizer, sanofi-aventis, Takeda and Unilever. Andreas Liebl has received honoraria for presentations from Eli Lilly, MSD, Roche, and Novo Nordisk, and is a member of

3 primary care diabetes 4, suppl. 1 (2010) S43 S56 S45 advisory boards for Eli Lilly, MSD, Roche, and Novo Nordisk. Robert Ligthelm is a member of advisory boards for Novo Nordisk, Eli Lilly and GlaxoSmithKline and has received funding for research from Novo Nordisk, GlaxoSmithKline, Pfizer, Novartis and sanofiaventis. Alberto Maran has received honoraria from Novo Nordisk. Domingo Orozco-Beltran has received research funding from Novo Nordisk, Merck Sharp & Dohme, Eli Lilly, GlaxoSmithKline and sanofi-aventis and has been a member of advisory boards for Novo Nordisk, Merck Sharp & Dohme, Eli Lilly, GlaxoSmithKline and sanofiaventis. Stuart Ross has received honoraria from Novo Nordisk and funding for research from Novo Nordisk, and is a member of an advisory board for Novo Nordisk. Jean- François Yale has received honoraria from Eli Lilly, Novo Nordisk and sanofi-aventis and is a member of advisory boards for Eli Lilly, Novo Nordisk and sanofi-aventis.

4 S46 primary care diabetes 4, suppl. 1 (2010) S43 S56 At diagnosis Before insulin is needed Insulin initiation Follow-up T TARGETS Involve your patient in achieving their glycaemic targets Achieving and maintaining good glycaemic control is realistic and important for long-term health Self-monitoring of blood glucose can assist in maintaining glycaemic control Beta-cell dysfunction is progressive and insulin therapy will be required eventually Explain rationale for reaching glycaemic targets Reduced symptoms Reduced complications, including stroke and heart attack [6 8] Better quality of life More energy I INSULIN Introduce your patient to the eventual need for insulin so that it is not used as a punishment Type 2 diabetes results from insufficient insulin secretion due to beta-cell dysfunction Over time, beta-cell function continues to deteriorate resulting in increasing blood glucose levels Elevated glucose levels can lead to diabetes complications, progression of disease and deteriorating health HbA1c 7% Tell your patient to monitor for Hypoglycaemia Hyperglycaemia Neuropathy Retinopathy Nephropathy Cardiovascular disease Diabetic foot problems Tell your patient who to contact if they experience symptoms associated with these conditions. Treatment of elevated blood sugars slows the gradual worsening of health Insulin injections will eventually be required to replace the body s own insulin, control blood sugars and slow disease progression Glycaemic treatment targets [1,2] HbA1c 7% FPG mg/dl ( mmol/l) PPG 180 mg/dl (10 mmol/l) Patients should achieve glycaemic targets within 3 6 months of diagnosis. After 3 months, if the patient has HbA1c 7%, consider adding additional therapy. Targets should be adhered to from diagnosis onwards. Individualized glycaemic goals [1,2] Consider setting less stringent glycaemic treatment targets with: Presence of advanced complications or co-morbidities Cardiovascular disease Cerebrovascular disease Advanced microvascular complications History/risk of severe hypoglycaemia Older patients A stricter target (HbA1c 6.5%) may be appropriate for some patients, e.g. young patients diagnosed early. Cardiovascular targets [3 5] Blood pressure 130/80 mmhg LDL-cholesterol 100 mg/dl (2.6 mmol/l); 70 mg/dl (1.8 mmol/l) with underlying macrovascular disease HDL-cholesterol Men: 40 mg/dl (1.0 mmol/l) Women: 50 mg/dl (1.5 mmol/l) Triglycerides 150 mg/dl (1.7 mmol/l) Regular screening for complications of: Eyes Blood pressure Kidneys Lipids Feet Metformin, in combination with lifestyle changes, is the first-line treatment of choice for type 2 diabetes. Guidelines recommend adding either basal insulin or a second anti-diabetic drug to ongoing metformin when additional therapy is necessary. Initiation of insulin at diagnosis is recommended for individuals presenting with weight loss or other severe hyperglycaemic symptoms or signs. Think about the next steps... Monitor glycaemic targets every 3 months Consider additional agents, including insulin, if glycaemic goals not met Consider when each patient may need to start insulin Weight and treatment decisions Consider patient weight when making treatment decisions Some agents are associated with a relative weight benefit [1,9 14] Address co-morbidities: Antilipemic therapy Smoking cessation therapy Antihypertension therapy Antiplatelet therapy

5 primary care diabetes 4, suppl. 1 (2010) S43 S56 S47 At diagnosis Before insulin is needed Insulin initiation Follow-up M MANAGING WEIGHT Every kilo counts Loss of just one kilo in patients with type 2 diabetes can have health benefits [15 18]: Average 3 4 months prolonged survival Improvements in lipid levels and blood pressure control Reduced risk of coronary heart disease Weight Small changes in weight can have a large impact on health Weight loss can lead to decreased need for medications Discuss the relationship between weight and other factors, including treatment options, calorie intake, activity and improving blood glucose Less weight gain is as important as weight loss A weight-loss goal should be realistic and achievable Expect gradual benefits, not instant results Discuss the relationship between patient weight and insulin resistance/glycaemic control Weight and waist circumference should be measured regularly Diet A healthy diet helps weight management: Food log/diary Give advice to improve diet (see Appendix) Arrange a consultation with a dietician, if possible Screen for eating disorders to identify patients who may be at risk (see Appendix) Exercise Increasing physical activity helps weight management: When giving advice on exercise, consider the FITT formula: Frequency, Intensity, Time and Type See Appendix for daily activity suggestions Patients should start with 10 minutes daily if new to exercise Patients should aim to accumulate at least 30 minutes of physical activity each day E ENCOURAGEMENT AND SUPPORT At diagnosis, information and support networks are important 5As [19,20] at diagnosis ASSESS the patient s beliefs and knowledge about type 2 diabetes and discuss how these beliefs may impact their diabetes and health ADDRESS their concerns (therapy, insulin, complications etc.) using educational resources ADVISE the patient on healthier lifestyle changes and negotiate their implementation ASSIST with suggestions to enable change and offer support Depression Depression: Patients with diabetes can experience some psychiatric disturbance (usually anxiety and/or depression). Screen your patient with a short depression questionnaire (see Appendix) and repeat as needed (changes in health, diabetes control or adherence). Screen for sexual dysfunction. Educational resources for physicians Discuss challenging cases with a local specialist or PCPs in your area Join a local PCP diabetes group Access online education modules: click on the Education tab Provide educational materials on diabetes management ARRANGE the next appointment to review targets and progress, and consider treatment adjustments. Follow up with the patient every 3 6 months Ongoing professional support arrange for the patient to see a diabetes nurse, dietician or other professional, if possible Suggest discussing treatment with family and friends Suggest joining a local patient support group Online resources to suggest

6 S48 primary care diabetes 4, suppl. 1 (2010) S43 S56 At diagnosis Before insulin is needed Insulin initiation Follow-up T TARGETS Indicators for insulin initiation [1,2]: HbA1c 7% on 1, 2 or more OADs (maximal doses) for 3 6 months. Glycaemic treatment targets [1,2] HbA1c 7% FPG mg/dl ( mmol/l) PPG 180 mg/dl (10 mmol/l) Cardiovascular targets [3 5] Blood pressure 130/80 mmhg LDL-cholesterol 100 mg/dl (2.6 mmol/l) for patients with diabetes; 70 mg/dl (1.8 mmol/l) with underlying macrovascular disease HDL-cholesterol Men: 40 mg/dl (1.0 mmol/l) Women: 50 mg/dl (1.5 mmol/l) Triglycerides 150 mg/dl (1.7 mmol/l) Targets may require modification dependent on status. Measuring blood glucose will be important FPG is the level of blood glucose taken on an empty stomach (usually on waking up) PPG is the level of blood glucose following a meal Regular self-monitoring of blood glucose can help determine whether the body s own production of insulin is sufficient to control blood sugars both when fasting and after a meal Review the patient s interpretation of their self-monitored blood glucose values and compare to target values. HbA1c 7% Insulin is an effective approach to reduce HbA1c start discussing insulin several months before it is needed I INSULIN Is it time for a change? If planned glycaemic control is not being achieved with 1 or 2 OADs within 3 6 months, it may be time to start insulin Actively address perceived barriers to insulin therapy Prepare patients for insulin to ensure a smooth transition Prepare for change Due to the progressive nature of beta-cell dysfunction the body is now producing insufficient insulin, resulting in rising levels of blood glucose Taking positive action with insulin is an effective method of ensuring good glycaemic control and preventing worsening of health An effective, simple and reliable option is once-daily basal insulin

7 primary care diabetes 4, suppl. 1 (2010) S43 S56 S49 At diagnosis Before insulin is needed Insulin initiation Follow-up M MANAGING WEIGHT Every kilo counts The benefits of weight management continue to be important [14,21 26]. Weight loss is associated with a reduced risk of death and cardiovascular disease Concern about weight gain can be a patient barrier to insulin initiation Weight management Discuss the lifestyle modifications you agreed: Celebrate success and try to overcome barriers Are you achieving your diet and exercise goals? Reassess and update weight management goals weight maintenance (or prevention of weight gain) may now be appropriate Re-emphasize the importance of diet and exercise in achieving optimum health benefits Are there other lifestyle changes you could make? E ENCOURAGEMENT AND SUPPORT 5As [19,20] before insulin is needed ASSESS patient expectations regarding diabetes control and feelings about insulin and lifestyle options ADDRESS knowledge deficits, patient expectations and barriers towards starting insulin therapy. Review the progressive nature of beta-cell dysfunction ADVISE the patient on their current treatment and future options for their treatment regimen, including the option of insulin initiation to improve glycaemia and prevent diabetes progression and complications ASSIST with maintaining lifestyle changes through negotiation, encouragement and suggestions; engage the patient in their diabetes management ARRANGE the next appointment, or a follow-up call, to monitor their status. Make sure to follow up with the patient every 3 6 months Insulin Treatment Appraisal Scale (ITAS) Begin assessing the potential barriers to insulin the patient may face. Use the ITAS questionnaire: ubmed&pubmedid= Support from other physicians Share insulin strategies with colleagues; learn from each other s experiences. Depression Screen your patient with a short depression questionnaire (see Appendix) and repeat as needed (changes in health, diabetes control or adherence). Breaking down the barriers Starting insulin at the right time will help with glycaemic control and slow disease progression Basal insulins have minimal risks Modern injection devices (insulin pens) are convenient, discreet and simple to use Insulin can fit in with daily life Suggest involving family and friends for support Give your patient materials they can take away and use at home Reassure your patient they have done nothing wrong You have not failed. Diabetes progression means insulin will be needed eventually Remember, every kilo counts. With small lifestyle changes, you can lose a kilo. Beta-cell dysfunction is progressive and insulin is an expected addition to blood glucose management Adding insulin does not mean health is deteriorating; rather, it is an effective step to prevent diabetes progression (complications) Lifestyle interventions continue to be important; they may delay the need to advance treatment and they reduce cardiovascular risk Insulin will help you control your blood sugars, prevent complications and improve quality of life and general health. Patient support Recommend that the patient joins a local patient group Encourage your patient to talk to someone successfully using insulin therapy

8 S50 primary care diabetes 4, suppl. 1 (2010) S43 S56 At diagnosis Before insulin is needed Insulin initiation Follow-up T Physician-driven titration and patient-driven titration Discuss and agree on day-to-day blood glucose targets with the patient. Empower the patient to assist in insulin dose adjustment. TITRATE TM study showed that self-titration with the 303 algorithm leads to effective control of blood glucose levels with low risk of hypoglycaemia Self-titration of insulin dose is based on average FPG over 3 days G et ge mmol/l (90 mg/dl) FPG target range mmol/l (70 90 mg/dl) 3.9 mmol/l (70 mg/dl) Increase dose 3 units 0 units Decrease dose 3 units 6.1 mmol/l (110 mg/dl) FPG target range mmol/l ( mg/dl) 4.4 mmol/l (80 mg/dl) HbA1c 7% TARGETS You have made the decision to start your patient on insulin because they are not achieving their targets [1,2] Glycaemic treatment targets [1,2] HbA1c 7% FPG mg/dl ( mmol/l) PPG 180 mg/dl (10 mmol/l) Cardiovascular targets [3 5] Blood pressure 130/80 mmhg LDL-cholesterol 100 mg/dl (2.6 mmol/l) for patients with diabetes; 70 mg/dl (1.8 mmol/l) with underlying macrovascular disease HDL-cholesterol Men: 40 mg/dl (1.0 mmol/l) Women: 50 mg/dl (1.5 mmol/l) Triglycerides 150 mg/dl (1.7 mmol/l) Targets may require modification dependent on status. 303 titration algorithm [12,27,28] Other algorithms may be more suitable for your patient [1,24,30 33] I INSULIN Basal insulin Basal insulin analogues have proven efficacy, once-daily dosing and lower risk of hypoglycaemia than alternative insulin therapies Also, the basal insulin analogue once-daily insulin detemir offers less weight gain than NPH or glargine [11,13,14,29,32] Pen devices for insulin delivery are convenient, painless and discreet Insulin initiation and adjustment recommendations Invite the patient to bring a family member or friend for support Show the patient how to use the insulin pen device (needle placement, dialling insulin, discharging dose) Ask the patient to self-inject a token amount of insulin (1 2 units) during an appointment Discuss initial insulin dose, timing (dinner, bedtime or morning) and dose adjustments including titration algorithm (such as 303) based on agreed blood glucose targets Review importance of glucose self-monitoring for insulin self-titration Suggest using a diary to record insulin dose and daily glucose levels Resolve any concerns or questions before the patient leaves Arrange a follow-up after 1 week (visit or phone) to review and adjust therapy

9 primary care diabetes 4, suppl. 1 (2010) S43 S56 S51 M MANAGING WEIGHT Every kilo counts Weight is a crucial consideration at the insulin initiation stage, with weight gain a perceived side effect of insulin use [9 12,23]: Consider screening for eating disorders or depression if the issue of weight worsens (see Appendix) Once-daily insulin detemir is associated with less weight gain than other available insulin options, and a potentially greater benefit in patients with higher baseline BMI [ 11,13,14,29,32 ] E ENCOURAGEMENT AND SUPPORT Weight Explain the effect of basal insulin therapy on weight Acknowledge weight maintenance or weight loss as a valuable achievement Update weight loss goal weight maintenance may now be appropriate Review and counsel your patient regarding eating habits, calorie intake and activity level if weight increases Re-visit diet and exercise At diagnosis Before insulin is needed Insulin initiation Follow-up Weight gain does not have to be inevitable 5As [19,20] for insulin initiation ASSESS what the patient believes about insulin and negotiate what they can achieve ADDRESS any outstanding barriers by discussing them and using educational resources ADVISE on insulin initiation, talking through dosing, injecting and avoiding hypoglycaemia, as well as recognizing and treating low blood glucose ASSIST the patient in initiating insulin, with support from a diabetes nurse, if possible ARRANGE for the timely follow-up to ensure patient adherence and identify and resolve any potential difficulties or challenges You and your team It is important to consider the organization of insulin initiation in your practice: Who is responsible for making the decision to start insulin? Who educates patients on the different aspects of insulin and diabetes? Who writes the prescriptions? Who will adjust the insulin dose? Discuss challenging and/or successful insulin initiation cases with your specialist partners and PCP peers. Engaging the patient with their insulin therapy It is a partnership we are working together to improve glucose control and reduce complications. Offer a 3-month trial to get them used to the idea Suggest using a diary to record insulin doses and glucose self-monitoring Once patients try insulin they rarely want to change, because it is successful Share successes with local patient support group, or family and friends Insulin pens make self-injection simple Explain benefits of using pen injection devices Demonstrate injection technique for subcutaneous injections with a practice pen Highlight sites for injection (abdomen, arm, buttock or thigh) Explain safe disposal of used needles Let the patient try an injection test Using an insulin pen is convenient, discreet and simple.

10 S52 primary care diabetes 4, suppl. 1 (2010) S43 S56 At diagnosis Before insulin is needed Insulin initiation Follow-up T TARGETS The importance of blood glucose self-monitoring FPG levels provide information about appropriateness of basal insulin replacement Change in blood glucose level between bedtime and the next morning can also assess appropriateness of basal insulin replacement (values should be similar) PPG levels provide information about the need for mealtime insulin coverage Monitoring PPG will help build a picture of the relationship between food and glucose control I INSULIN What happens next? Beta-cell dysfunction is progressive and changes to treatment, including different insulin options, may be required with time to ensure glycaemic control and prevent disease progression HbA1c increases (7%) are expected and should be managed accordingly, without implying patient fault Basal replacement may be sufficient initially, but will eventually need to be supplemented by bolus (prandial/mealtime) coverage HbA1c 7% Glycaemic treatment targets [1,2] HbA1c 7% FPG mg/dl ( mmol/l) PPG 180 mg/dl (10 mmol/l) Indicators for titration and intensification [1,2] Continue to titrate basal insulin to reach FPG targets. If target FPG achieved or sufficient basal dose administered ( units/kg/day), but HbA1c remains 7%, then address PPG levels. If the patient is unable to reach or maintain HbA1c below 7% after 3 6 months, consider intensifying insulin therapy. Cardiovascular targets that should continue to be monitored include [3-5]: Blood pressure 130/80 mmhg LDL-cholesterol 100 mg/dl (2.6 mmol/l) for patients with diabetes; 70 mg/dl (1.8 mmol/l) with underlying macrovascular disease HDL-cholesterol Men: 40 mg/dl (1.0 mmol/l) Women: 50 mg/dl (1.5 mmol/l) Triglycerides 150 mg/dl (1.7 mmol/l) Targets may require modification dependent on status. Using basal insulin Assess HbA1c and FPG levels at 3-monthly intervals to evaluate treatment effectiveness Optimize basal insulin with appropriate titration Intensifying therapy from basal insulin [1,2] Consider adding sequential bolus doses of rapid-acting insulin at mealtimes to help control PPG Or Transition to pre-mix analogue twice daily Or Refer to a specialist After any adjustments to treatment, review the patient s logs to assess daytime or overnight blood glucose control. FPG and PPG data can be used to better individualize and adjust insulin therapy Discuss relationship between insulin, food, activity and hypoglycaemia risk Discuss recognition and treatment of hypoglycaemia, including monitoring during physical activity Review patient s self-titration of insulin doses Basal insulin maintains blood glucose overnight (blood glucose mg/dl from bedtime to morning) Bolus (prandial, rapid-acting) insulin limits rise in blood glucose after meals (post-prandial blood glucose 180 mg/dl) Discuss treatment intensification options with the patient well in advance of any changes

11 primary care diabetes 4, suppl. 1 (2010) S43 S56 S53 M MANAGING WEIGHT Every kilo counts While on once-daily basal insulin therapy, maintaining current weight or limiting any weight gain are acceptable objectives: Regularly reassess weight, diet and exercise goals When the patient reaches or achieves a goal, even if that goal is to maintain their weight, congratulate and encourage them Engage the whole family in sustainable lifestyle changes Address defensive eating Ensure that these are realistic and achievable E ENCOURAGEMENT AND SUPPORT Follow-up after insulin initiation Keep in regular contact to ensure that the patient is monitoring their glucose, responding to treatment and not experiencing side effects or other treatment-related issues: First month Weekly contact, perhaps with a nurse, as the patient gets used to using insulin Try phone appointments or updates if time is a problem Long-term follow-up Regular 3-monthly HbA1c assessments to ensure target is maintained If HbA1c rises 7%, it may be time to consider treatment intensification, with a basal bolus regimen Consider referring the patient to see a specialist at this stage Next 5 months Monthly contact to ensure target is reached Reassess HbA1c at 3 months and 6 months to ensure treatment is optimized Weight management Discuss any effects of insulin therapy on weight Acknowledge weight maintenance or weight loss as a valuable achievement Re-emphasize the importance of diet and exercise in achieving optimum health benefits during insulin treatment The importance of moderation in food intake The interaction between insulin and exercise to limit hypoglycaemic risk At diagnosis Before insulin is needed Insulin initiation Follow-up Work with patients to reduce weight gain Continue to support patients using all available tools Patients can feel better taking insulin Have you noticed improvements in blood glucose, energy levels or sleep patterns? To improve blood glucose control during day or after meals: Involve the patient in insulin dose adjustments and decisions Suggest monitoring blood glucose 7 times a day on 3 days a month Review blood glucose logs and help the patient identify and interpret blood glucose patterns Discuss interaction between carbohydrate intake and PPG elevations

12 S54 primary care diabetes 4, suppl. 1 (2010) S43 S56 APPENDIX Advice for patients to improve their diet Suggestions for patients to increase daily activity Use a pedometer Use the stairs whenever you can Walk to buy your lunch or do your errands Stand when talking on the phone Walk to your co-worker s desk instead of calling or ing them Walk instead of driving, or use public transport Walk after dinner instead of sitting and watching TV Swap restaurant dates for activity dates Do housework Be active visit parks, museums, fresh food markets This website is for a 13-week programme specially designed for patients with type 2 diabetes who want to improve their lifestyle: Eating disorder screener (ESP [34 37]) Are you satisfied with your eating patterns? No = abnormal response Do you ever eat in secret? Yes = abnormal response Does your weight affect the way you feel about yourself? Yes = abnormal response Have any members of your family suffered with an eating disorder? Yes = abnormal response Do you currently suffer with or have you ever suffered in the past with an eating disorder? Yes = abnormal response Depression screener (modified PHQ-9 questionnaire) Over the last 2 weeks, how often have you been bothered by: Little interest or pleasure in doing things? Feeling down, depressed or hopeless? Score responses as follows: Not at all: 0 Several days: 1 Over half the days: 2 Nearly every day: 3 A total score of 3+ has the best trade-off between sensitivity and specificity for diagnosis of depression.

13 primary care diabetes 4, suppl. 1 (2010) S43 S56 S55 Acknowledgements All authors have been involved throughout the development of the practical guidance, from initial concept to providing final approval. The meeting upon which the content of this practical guidance is based was funded by Novo Nordisk. The authors are all members of a Novo Nordisk advisory board, for which they are paid an honorarium. Medical writing assistance and layout concept support was provided by Eleanor Steele and Gary Burd at Complete HealthVizion; this assistance was funded by Novo Nordisk, who also had a role in the review of the practical guidance for scientific accuracy. References [1] D.M. Nathan, J.B. Buse, M.B. Davidson, et al., Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the Association for the Study of Diabetes, Diabetologia 52 (2009) [2] American Diabetes Association, Standards of medical care in diabetes Diabetes Care 32, Suppl. 1 (2009) S13 S61. [3] L. Rydén, E. Standl, M. Bartnik, et al., Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the Association for the Study of Diabetes (EASD), Eur. Heart J. 28 (2007) [4] American Diabetes Association, Standards of medical care in diabetes 2008, Diabetes Care 31, Suppl. 1, (2008) S12 S54. [5] L. Monnier, H. Lapinski, C. Colette, Contributions of fast and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c), Diabetes Care 26 (2003) [6] R.R. Holman, S.K. Paul, M.A. Bethel, et al., 10-year follow-up of intensive glucose control in type 2 diabetes, N. Engl. J Med. 359 (2008) [7] Action to Control Cardiovascular Risk in Diabetes Study Group, H.C. Gerstain, M.E. Miller, R.P. Byington, et al., Effects of intensive glucose lowering in type 2 diabetes, N. Engl. J Med. 358 (2008) [8] The ADVANCE Collaborative Group, Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes, N. Engl. J Med. 358 (2008) [9] UK Prospective Diabetes Study (UKPDS) Group, Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33), Lancet 352 (1998) [10] D. Russell-Jones, Blood glucose and bodyweight in type 2 diabetes are these compatible treatment targets?, Eur. Endocrinol. 4 (2008) [11] J Rosenstock, M. Davies, P.D. Home, et al., Insulin detemir added to oral anti-diabetic drugs in type 2 diabetes provides glycemic control comparable to insulin glargine with less weight gain, Diabetes 55, Suppl. 1 (2006) A132. [12] L. Blonde, M. Merilainen, V. Karwe, P. Raskin; TITRATE Study Group, Patient-directed titration for achieving glycemic goals using once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets the TITRATE study, Diabetes Obes. Metab. 11 (2009) [13] A. Dornhorst, H.-J. Lüddeke, S. Screenan, et al., Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: subgroup analysis from PREDICTIVE study, Int. J Clin. Pract. 62 (2008) [14] J Mitri, O. Hamdy, Diabetes medications and body weight, Expert Opin. Drug Saf. 8 (2009) [15] D.F. 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