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Dr. John MacFadyen MD , FRCPC, MHPE

Dr. John MacFadyen MD , FRCPC, MHPE. PROGRAM FACULTY. Principal Author/Chair Alice Y. Y. Cheng, MD, FRCPC

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Dr. John MacFadyen MD , FRCPC, MHPE

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  1. Dr. John MacFadyenMD, FRCPC, MHPE

  2. PROGRAM FACULTY • Principal Author/Chair • Alice Y. Y. Cheng, MD, FRCPC • Division of Endocrinology and Metabolism, Credit Valley Hospital, Mississauga, Ontario; St. Michael’s Hospital, Toronto, Ontario; Assistant Professor in the Department of Medicine, University of Toronto, Toronto, Ontario • Expert Reviewer • Robyn L. Houlden, MD, FRCPC • Division of Endocrinology and Metabolism, Kingston General Hospital; Professor in the Department of Medicine, Queen’s University, Kingston, Ontario • Planning Committee • Jean-Marie Ekoé MD,CSPQ,PD • Service of Endocrinology, Metabolism and Nutrition. Hôpital Hôtel-Dieu du Centre Hospitalier Universitaire de Montréal, Montréal, Québec; Professor of Medicine, Endocrinology, Metabolism and Nutrition, University of Montréal, Québec • Nadine Lahoud, MD, MBA, FRCP, FACP • Division of Internal Medicine, Lasalle Hospital, Montreal, Quebec • Joo-Meng Soh, MD, FRPCP • Division of General Internal Medicine, Trillium Health Centre; Vice-Chair of the Section of Internal Medicine, Ontario Medical Association

  3. ACCREDITATION • This event is an Accredited Group Learning Activity (Section 1) as defined by the Maintenance of Certification program of The Royal College of Physicians and Surgeons of Canada and approved by the Canadian Society of Endocrinology and Metabolism.

  4. FACULTY DISCLOSURE • The faculty of this program have/had financial interest and/or affiliations with the following commercial organizations that have some interest in the content of this presentation: • Dr. Alice Cheng: Eli Lilly, Novo Nordisk, Sanofi-aventis • Dr. Robyn Houlden: Eli Lilly, Novo Nordisk, Sanofi-aventis • Dr. Jean-Marie Ekoé: No competing interests declared • Dr. Nadine Lahoud: No competing interests declared • Dr. Joo-Meng Soh: No competing interests declared

  5. SPEAKER DISCLOSURE • Dr. MacFadyen has/had financial interest and/or affiliations with the following commercial organizations that have some interest in the content of this presentation:

  6. PROGRAM OVERVIEW • Introduction: • The Implications of Hyperglycemia in Hospitalized Patients • Modules: • Goals and Strategies for Inpatient Management of Hyperglycemia in Non-Critically Ill Patients • Practical Insulin Strategies to Meet the Changing Physiologic Needs of Non-Critically Ill Patients • Barriers and Solutions to the Optimal In-hospital Management of Hyperglycemia

  7. INTRODUCTION:THE IMPLICATIONS OF HYPERGLYCEMIA IN HOSPITALIZED PATIENTS

  8. LEARNING OBJECTIVES • Following this introduction, participants will be better able to: • Discuss the relationship between hyperglycemia and acute illness • Describe the implications of hyperglycemia in non-critically ill hospitalized patients

  9. QUESTION:INTERACTIVE SYSTEM • In your practice, how common is hyperglycemia in non-critically ill hospitalized patients? • Very common • Common • Uncommon

  10. QUESTION:INTERACTIVE SYSTEM • In your opinion, how important is glycemic control in non-critically ill hospitalized patients? • Very important • Important • Somewhat important • Not important

  11. HYPERGLYCEMIA IS COMMON IN NON-CRITICALLY ILL MEDICAL/SURGICAL PATIENTS 12% 26% 62% n=2020 *Hyperglycemia: fasting BG > 7 mmol/L or random BG > 11.1 mmol/L x 2 BG: blood glucose Adapted from: Umpierrez G, et al. J ClinEndocrinolMetab 2002;87:978-82.

  12. HYPERGLYCEMIA AND ACUTE ILLNESS: A VICIOUS CYCLE • Increased stress hormone levels • Increased epinephrine • Increased cortisol • Glucocorticoid therapy • Continuous enteral nutrition • Parenteral nutrition • Decreased level of activity Acute illness Hyperglycemia Decreased immune function Decreased wound healing Increased oxidative stress Endothelial dysfunction Increase in inflammatory factors Procoagulant state Increased mitogen levels Fluid shifts Electrolyte fluxes Potential exacerbation of myocardial and cerebral ischemia Adapted from: Inzucchi SE. N Engl J Med 2006;355:1903-11.

  13. GLYCEMIC CONTROL IN NON-ICU SETTINGS • Most hospitalizations for patients with diabetes are not directly related to the metabolic state, and diabetes management is rarely the primary focus of care; as a result, glycemic control is often not adequately addressed • Few prospective randomized clinical trials in general medicine/surgical services • Fear of hypoglycemia and lack of established treatment algorithms in non-ICU areas leads to: • Holding patient’s usual diabetes treatment • Reliance on “sliding-scale” insulin regimens • Delayed starting of basal-bolus insulin therapy Umpierrez G, et al. J Hosp Med 2006;1:141-44; Clement S, et al. Diabetes Care 2004;27:553-91; Umpierrez G, et al. Am J Med 2007;120:563-67.

  14. QUESTION:INTERACTIVE SYSTEM • Does treating hyperglycemia affect outcomes in non-critically ill hospitalized patients? • Yes • No

  15. INPATIENT HYPERGLYCEMIA IS ASSOCIATED WITH INCREASED MORBIDITY/MORTALITY IN NON-CRITICALLY ILL PATIENTS AE: adverse events; CAP: community-acquired pneumonia; COPD: chronic obstructive pulmonary disease; FPG: fasting plasma glucose; ICU: intensive care unit; LOS: length of stay; RPG: random plasma glucose; TPN: total parenteral nutrition Baker EH, et al. Thorax 2006;61:284-9; Cheung NW, et al. Diabetes Care 2005;28:2367-71; McAlister FA, et al. Diabetes Care 2005;28:810-5; Umpierrez G, et al. J Clin Endocrinol Metab 2002;87:978-82.

  16. IN-HOSPITAL MANAGEMENT OF HYPERGLYCEMIA: AACE/ADA CONSENSUS STATEMENT “Hyperglycemia in hospitalized patients…is unequivocally associated with adverse outcomes…In the hospital setting, insulin therapy is the preferred method for achieving glycemic control in most clinical situations.” AACE: American Association of Clinical Endocrinologists ADA: American Diabetes Association Moghissi ES, et al. EndocrPract 2009;15:353-69.

  17. INSULIN: HOW DO WE IDEALLY MIMIC NORMAL PHYSIOLOGY? Need For Background and Mealtime Insulin Normal Physiology: Expected insulin changes during the day for individuals with a healthy pancreas Serum Insulin Level Time Analogue Basal: detemir, glargine Analogue Bolus: aspart, glulisine, lispro Human Basal: NPH Human Bolus: regular Insulin effect images are theoretical representations and are not derived from clinical trial data

  18. CHARACTERISTICS OF HUMAN INSULIN AND INSULIN ANALOGUES: BASAL AND BOLUS CDA Clinical Practice Guidelines Expert Committee. Can J Diabetes 2008; 32(Suppl 1):S1-S201.

  19. SUMMARY • In non-critically ill hospitalized patients: • Hyperglycemia is common, even in those without a previous history of diabetes • Hyperglycemia is associated with increased in-hospital complications, length of hospital stay and mortality • Insulin is the most appropriate agent for effectively controlling glycemia in-hospital

  20. MODULE 1:GOALS AND STRATEGIES FOR INPATIENT MANAGEMENT OF HYPERGLYCEMIA IN NON-CRITICALLY ILL PATIENTS

  21. LEARNING OBJECTIVES • Following this module, participants will be better able to: • Compare and contrast sliding-scale insulin and basal-bolus insulin strategies for the in-hospital management of hyperglycemia in non-critically ill patients with type 2 diabetes • Review guideline-recommended glycemic targets for non-critically ill hospitalized patients

  22. QUESTION:INTERACTIVE SYSTEM • Does the CDA provide glycemic targets for non-critically-ill patients? • Yes • No CDA: Canadian Diabetes Association

  23. The CDA 2008 CPGs do not provide glycemic targets for hospitalized non-critically ill patients (because of the lack of data to support such a recommendation) CDA: Canadian Diabetes Association CPGs: Clinical Practice Guidelines No!!

  24. QUESTION:INTERACTIVE SYSTEM • What type of blood glucose monitoring records does your hospital provide? • Handwritten, paper-based bedside clinical record • Electronic hospital database • Both 1. and 2.

  25. CASE STUDY • 69-year-old woman admitted to general medicine ward with pneumonia • Type 2 diabetes X 9 years; takes metformin 1 g bid and glyburide 10 mg bid • Weight: 97 kg, BMI: 31 kg/m2 • Random BG: 18 mmol/L • A1C: 8.1% • Creatinine: 150 µmol/L • eGFR: 45 mL/min/1.73 m2 • Patient is eating and drinking BMI: body mass index; BG: blood glucose; eGFR: estimated glomerular filtration rate; A1C: hemoglobin A1C

  26. CASE STUDY (CONTINUED) • Typical Hospital Bedside Diabetes Assessment Record

  27. QUESTION:INTERACTIVE SYSTEM • What would YOU recommend as glycemic targets for this non-critically ill patient? • Pre-meal BG < 7.8 mmol/L, random BG < 10 mmol/L • Pre-meal BG < 7.0 mmol/L, random BG < 8.0 mmol/L • Pre-meal BG < 6.0 mmol/L, random BG < 10 mmol/L • Pre-meal BG < 7.8 mmol/L, random BG < 8.0 mmol/L BG: blood glucose

  28. GLYCEMIC TARGETS IN HOSPITALIZED PATIENTS: AACE/ADA CONSENSUS STATEMENT • Non-critically Ill Patients: • Pre-meal BG < 7.8 mmol/L • Random BG < 10.0 mmol/L • More stringent targets may be appropriate in stable patients with previous tight glycemic control. Less stringent targets may be appropriate in terminally ill patients or in patients with severe comorbidities. • Critically Ill Patients: • BG between 7.8 to 10 mmol/L AACE: American Association of Clinical Endocrinologists ADA: American Diabetes Association BG: blood glucose • Moghissi ES, et al. Endocr Pract 2009;15:353-69.

  29. QUESTION:INTERACTIVE SYSTEM • How would you manage this patient’s hyperglycemia? • Maintain her current oral regimen and add sliding-scale insulin • Stop/reduce oral agents and initiate IV insulin therapy • Stop/reduce oral agents and initiate subcutaneous basal and bolus insulin therapy • Stop/reduce oral agents and initiate subcutaneous basal, bolus, and supplemental (correction) insulin therapy IV: intravenous

  30. QUESTION:INTERACTIVE SYSTEM • In your institution, which of the following insulin regimens is most commonly used in non-critically ill patients? • IV insulin • Sliding-scale insulin • Basal + bolus insulin • Basal + bolus + supplemental (correction) insulin IV: intravenous

  31. POTENTIAL ISSUES WITH ORAL ANTIHYPERGLYCEMIC AGENTS IN-HOSPITAL Metformin • Lactic acidosis risk (renal insufficiency, hypotension, heart failure) • Relatively slow onset of action • GI complications (nausea, abdominal pain, diarrhea) Insulin secretagogues • Hypoglycemia (long-acting) TZDs • Fluid overload, heart failure • Inability to titrate (very slow onset of action) Alpha-glucosidase inhibitors • Prandial/meal agent (no effect in the fasting patient) • GI complications (abdominal bloating, flatus) • Pure dextrose required to treat hypoglycemia with these agents GLP-1 receptor agonists and DPP IV inhibitors • New agents with limited inpatient experience IV: intravenous; GI: gastrointestinal; TZDs: thiazolidinediones; GLP-1: glucagon-like peptide-1; DPP: dipeptidyl peptidase-4 • Adapted from: Wesorick D, et al. J Hosp Med 2008;3(Suppl 5):S17-28.

  32. RECOMMENDED STRATEGIES FOR MANAGING HYPERGLYCEMIA IN HOSPITALIZED PATIENTS: AACE/ADA CONSENSUS STATEMENT • Non-critically ill patients: • Scheduled subcutaneous insulin dosing preferred • BBI regimens supplemented with correction doses as needed and adjusted daily with the guidance of frequent blood glucose monitoring • SSI regimens are not effective and should not be used, especially as this excludes a basal insulin component from the therapy • Critically ill patients: • Continuous variable-rate IV insulin drip BBI: basal-bolus insulin; SSI: sliding-scale insulin; IV: intravenous AACE: American Association of Clinical Endocrinologists ADA: American Diabetes Association Moghissi ES, et al. Endocr Pract 2009;15:353-69.

  33. INSULIN REQUIREMENTS CAN BE BROKEN DOWN INTO… • Scheduled insulin: • Doses of insulin given on a consistent basis • There are 2 types: • Basal insulin: Long-acting insulin required to maintain euglycemia, even when NPO. • Nutritional (or bolus) insulin: Rapid- or short-acting insulin given just before a meal in anticipation of the glycemic spike post carbohydrate ingestion; it is given even when BG is normal. It also refers to scheduled insulin given to cover the carbohydrate load from tube feeds or parenteral nutrition. • Supplemental (correction) insulin: • Rapid- or short-acting insulin that is given in addition to scheduled nutritional insulin in response to unusual hyperglycemia. If consistently required, increase the TDD the following day. NPO: nothing by mouth; BG: blood glucose; TDD: total daily dose of insulin

  34. INPATIENT INSULIN ADMINISTRATION Sliding scale insulin only uses this component Scheduled Total daily insulin needs Basal Nutritional Correctional Long-acting insulin Rapid-acting insulin • Adapted from: Trence DL, et al. J Clin Endocrinol Metab 2003;88:2430-37; Moghissi ES, et al. Endocr Pract 2009;15:353-69; Moghissi ES, et al. Curr Med Res Opin 2010;26:589-98; Clement S, et al. Diabetes Care 2004;27:553-91.

  35. SLIDING-SCALE INSULIN IS ASSOCIATED WITH HIGHER MEAN GLUCOSE LEVELS AND POORER CLINICAL OUTCOMES Mean BG (mmol/L) 11.8 p < 0.0001 7.2 7.2 Regularly scheduled insulin Sliding-scale insulin BG: blood glucose; CI: confidence interval; ICU: intensive care unit Adapted from: Becker T, et al. Diabetes Res ClinPract 2007;78:392-7.

  36. SLIDING-SCALE INSULIN (SSI) = EVIL • SSI without a basal insulin is purely REACTIVE and allows for hyperglycemia1 • Wastes time that could be used to “fine tune” an insulin regimen the patient could use at home • Prolonged therapy with SSI as the sole regimen is discouraged2 1. Queale WS, et al. Arch Int Med 1997;157:545-52. 2. Moghissi ES, et al. EndocrPract 2009;15:353-69.

  37. SLIDING-SCALE INSULIN:TIME TO STOP SLIDING “Medical professionals do not use sliding scale penicillin for fever or sliding scale oxygen for pulmonary edema. It is time to discontinue amusement park diabetes therapy so that decades from now clinicians are still not trying to abolish an illogical treatment. Perhaps next July or the following summer, when the senior resident is explaining to the intern hyperglycemia management for a newly admitted patient with pneumonia, the discussion will revolve around basal insulin, prandial insulin, and correction-dose insulin based on a protocol that all hyperglycemic patients receive throughout the entire health care system.” Hirsch IB. JAMA 2009;301:213-14.

  38. BASAL-BOLUS INSULIN (BBI) • Need to give ANTICIPATORY, physiologic insulin dosing prescribed as a basal-bolus insulin regimen • In other words, the right type of insulin, in the right amount, at the right time, to meet the insulin needs of the patient

  39. PROSPECTIVE, RANDOMIZED CONTROLLED TRIALS OF INSULIN IN NON-CRITICALLY ILL INPATIENTS † hypoglycemia < 3.9 mmol/L; *severe hypoglycemia < 2.2 mmol/L; MED: medical general services; T2DM: type 2 diabetes mellitus; SSI: sliding-scale insulin; OAD: oral antidiabetic drug; RABBIT 2: Randomized Study of Basal-Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes Adapted from: Dickerson LM, et al. Ann Fam Med 2003;1: 29-35; Umpierrez GE, et al. Diabetes Care 2007;30:2181-86; Umpierrez GE, et al. Diabetes Care 2011;34:256-61.

  40. Randomized Study of Basal-Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes (RABBIT 2 Trial) Umpierrez GE, et al. Diabetes Care 2007;30:2181-86. Randomized Study of Basal-Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes Undergoing General Surgery (RABBIT 2 Surgery) Umpierrez GE, et al. Diabetes Care 2011;34:256-61.

  41. RABBIT 2:INCLUSION CRITERIA RABBIT 2 • Adult non-surgical patients (18-80 years) admitted to medical general services • BG = 7.8–22.2 mmol/L • History of diabetes > 3 months • Insulin-naïve • Treated with diet alone or any combination of OADs • Absence of diabetic ketoacidosis RABBIT 2 Surgery • Adult patients (18-80 years) admitted to undergo general elective or emergency surgery, not expected to require ICU admission • BG = 7.8–22.2 mmol/L • History of diabetes > 3 months • Treated with diet alone, any combination of OADs or low-dose insulin (daily dose ≤ 0.4 U/kg) before admission • No history of diabetic ketoacidosis OADs: oral-antidiabetic drugs BG: blood glucose ICU: intensive care unit Umpierrez GE, et al. Diabetes Care 2007;30:2181-86. Umpierrez GE, et al. Diabetes Care 2011;34:256-61.

  42. RABBIT 2:BASAL-BOLUS INSULIN (BBI) REGIMEN • D/C oral antihyperglycemic agents on admission • Starting TDD of insulin: • Half of TDD as insulin glargine (basal) and half as glulisine (bolus) • Basal: once daily, at the same time of the day • Bolus: three equally divided doses (ac meals) (if patient not eating, bolus withheld until meals resumed) • Supplemental insulin (glulisine) following “SSI protocol” for BG > 7.8 mmol/L (see next slide) D/C: discontinue; BG: blood glucose; TDD: total daily dose: SSI: sliding-scale insulin ac: before meals; Cr: creatinine Umpierrez GE, et al. Diabetes Care 2007;30:2181-86. Umpierrez GE, et al. Diabetes Care 2011;34:256-61.

  43. RABBIT 2:SLIDING-SCALE INSULIN (SSI) REGIMEN • D/C oral antihyperglycemic agents on admission • Regular insulin QID (ac meals and bedtime as per “usual” protocol; every 6 h for patients not able to eat as per “sensitive” protocol) • Insulin adjustment:increase from sensitive” to “usual” or “usual” to “resistant” if fasting and pre-meal BG are persistently > 7.8 mmol/L and no hypoglycemia; if hypoglycemia, decrease regular insulin from “resistant” to “usual” or from “usual” to “sensitive” Supplemental insulin scale: QID: four times daily Adapted from: Umpierrez GE, et al. Diabetes Care 2007;30:2181-86. Adapted from: Umpierrez GE, et al. Diabetes Care 2011;34:256-61.

  44. CHANGE IN BG LEVELS WITH BBI VS. SSI RABBIT 2 RABBIT 2 Surgery 13.3 13.3 * 12.2 11.1 * 11.1 * SSI SSI * * ¶ 10.0 ¶ ¶ 10.0 ŧ ¶ ŧ † Blood glucose (mmol/L) 8.9 † 8.9 7.8 7.8 6.7 *p < 0.01; ¶p < 0.05. BBI *p < 0.001, ŧp = 0.02, †p = 0.01 BBI 6.7 5.6 Admit 1 2 3 4 5 6 7 8 9 10 Randomi-zation 1 2 3 4 5 6 7 8 9 Duration of treatment (days) Duration of treatment (days) SSI: sliding-scale insulin BBI: basal-bolus insulin BG: blood glucose Adapted from: Umpierrez GE, et al. Diabetes Care 2007;30:2181-86. Adapted from: Umpierrez GE, et al. Diabetes Care 2011;34:256-61.

  45. TREATMENT SUCCESS:PATIENTS ACHIEVING BG TARGET < 7.8 MMOL/L RABBIT 2 RABBIT 2 Surgery Patients with BG < 7.8 mmol/L (%) Patients with BG < 7.8 mmol/L (%) p < 0.01 p < 0.001 SSI: sliding-scale insulin BBI: basal-bolus insulin BG: blood glucose Adapted from: Umpierrez GE, et al. Diabetes Care 2007;30:2181-86. Adapted from: Umpierrez GE, et al. Diabetes Care 2011;34:256-61.

  46. HYPOGLYCEMIC EVENTS:PATIENTS WITH BG < 3.3 MMOL/L RABBIT 2 RABBIT 2 Surgery Patients with BG < 3.3 mmol/L (%) Patients with BG < 3.3 mmol/L (%) p = 0.005 SSI: sliding-scale insulin BBI: basal-bolus insulin BG: blood glucose Adapted from: Umpierrez GE, et al. Diabetes Care 2007;30:2181-86. Adapted from: Umpierrez GE, et al. Diabetes Care 2011;34:256-61.

  47. RABBIT 2: GLYCEMIC CONTROL RAPIDLY IMPROVED AFTER SWITCHING FROM SSI TO BBI • 14% of patients treated with SSI remained with BG > 13.3 mmol/L and were switched to BBI 16.7 SSI BBI 15.5 14.4 13.3 12.2 11.1 Mean BG (mmol/L) 10.0 8.9 7.8 6.7 5.6 Admit 1 2 3 4 1 2 3 4 5 6 7 p < 0.05 Days of Therapy SSI: sliding-scale insulin BBI: basal-bolus insulin BG: blood glucose Adapted from: Umpierrez GE, et al. Diabetes Care 2007;30:2181-86.

  48. RABBIT 2 SURGERY: HOSPITAL COMPLICATIONS AND HYPOGLYCEMIA WITH SSI VS. BBI SSI: sliding-scale insulin BBI: basal-bolus insulin BG: blood glucose Adapted from: Umpierrez GE, et al. Diabetes Care 2011;34:256-61.

  49. SUPPLEMENTAL (CORRECTION) SCALE = GOOD! • Supplement (correct) the standing dose of bolus insulin ac meals • Supplemental (correction) bolus insulin is given based on a higher-than-target pre-meal glucose • If supplemental (correction) bolus insulin is required regularly then the standing dose of bolus insulin should be re-visited • Adapted from: Moghissi ES, et al. Endocr Pract 2009;15:353-69.

  50. 6.0 EXAMPLE OF SSI: WHAT NOT TO DO 16.5 BG (mmol/L) What do you do? What do you do? + 4 U 14.0 +6 U SSI Protocol 10.0 6.0 4.0 What do you do? What do you do? 0 U 0 U 3.0 Breakfast Lunch Dinner Bedtime Bolus insulin QID • QID: four times daily; SSI: sliding-scale insulin; • BG: blood glucose

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