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Inpatient Hyperglycemia in non-critical care setting

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Inpatient Hyperglycemia in non-critical care setting

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  1. Clinical Guidelines for the Management of Hyperglycemia in Hospitalized Patients in a Non-Critical Care SettingWork in ProgressThe Endocrine Society, European Endo Society, American Heart Association, American Diabetes Association, Society of Hospitalist Medicine, American Association of Diabetes Educators

  2. Inpatient Hyperglycemia in non-critical care setting • What is the frequency of hyperglycemia and diabetes? • What diagnosis criteria should we use? • What is the association between hyperglycemia and outcomes? • How should we manage hyperglycemia in non-ICU setting?

  3. Hyperglycemia: Scope of the Problem No Diabetes Diabetes 50 40 30 20 10 0 50 40 30 20 10 0 26% Patients, % 78% <110 110-140 140-170 170-200 >200 <110 110-140 140-170 170-200 >200 Mean BG, mg/dL Kosiborod M, et al. J Am Coll Cardiol. 2007;49(9):1018-183:283A-284A.

  4. Hyperglycemia*: A Common Comorbidity in Medical-Surgical Patients in a Community Hospital 12% 26% 62% Normoglycemia n = 2,020 * Hyperglycemia: Fasting BG  126 mg/dl or Random BG  200 mg/dl X 2 Known Diabetes New Hyperglycemia Umpierrez G et al, J Clin Endocrinol Metabol 87:978, 2002

  5. New and Stress hyperglycemia • Patients with hyperglycemia without a previous history of diabetes should be tested with a hemoglobin A1C during the hospital stay or with an oral glucose tolerance test after discharge to confirm the diagnosis of diabetes. • Less than 35% of patients had normal glucose tolerance after 3 to 12 months of follow-up. Norhammar et al. Lancet 2002; 359(9324): 2140-4. Arora et al. Endocr Pract 2009; 15(5): 425-30. Greci et al. Diabetes Care 2003; 26(4): 1064-8.

  6. IGT and Undiagnosed T2DM are Common in Acute MI and Stroke 2-hour OGTT IGT Undiagnosed T2DM Myocardial infarction 66 70 60 50 40 30 20 10 0 Stroke 31 39 Patients (%) 16 35 23 Norhammar(n=181) Matz(n=238) Norhammar A, et al. Lancet 2002;359:2140−4.Matz K, et al. Diabetes Care 2006;792−7.

  7. Epidemiology of Inpatient Hyperglycemia in non-critical care setting • What is the frequency of hyperglycemia and diabetes? • What diagnosis criteria should we use? • What is the association between hyperglycemia and outcomes? • How should we manage hyperglycemia in non-ICU setting?

  8. ADA 2010 - Categories of Increased Risk for Diabetes* ADA Clinical Practice Recommendations, January 2019

  9. A1C for Diagnosis of Diabetes in the Hospital • Inhospital hyperglycemia is defined as an admission or inhospital BG > greater 140 mg/dl. • HbA1c > 6.5% can be identified as having diabetes, and patients with A1C 5.7%-6.4% can be considered as being at risk for diabetes. • Implementation of A1C testing can be useful: • assess glycemic control prior to admission • assist with differentiation of newly diagnosed diabetes from stress hyperglycemia • designing an optimal regimen at the time of discharge

  10. Comparison of sensitivity and specificity achieved for the diagnosis of diabetes based on FPG, at various levels of HbA1c, from NHANES III and 1999–2004 NHANES J Clin Endocrinol Metab, July 2008, 93(7):2447–2453

  11. Factors influencing A1c

  12. Epidemiology of Inpatient Hyperglycemia in non-critical care setting • What is the frequency of hyperglycemia and diabetes? • What diagnosis criteria should we use? • What is the association between hyperglycemia and outcomes? • How should we manage hyperglycemia in non-ICU setting?

  13. Hyperglycemia and Pneumonia Outcomes Admission glucose (mg/dl) * * % * * BG (mg/dl) < 110 110 - <198 198 - <250 ≥250 *p: < 0.05 vs BG < 198 mg/dl (11 mmol/L) N= 2,471 patients with CAP McAllister et al, Diabetes Crae 28:810-815, 2005

  14. Community Acquired Pneumonia Outcomes in Patients with Diabetes * 93 Diabetes No Diabetes 78 * 53 % 40 * * 31 * 18 17 8 Hospitalization Mortality Pleural Effusion Concomitant Illnesses P: < 0.001 N= 660 (DM: 106 & non-DM: 554) No differences in microorganisms and bacteremia rates Falguera et al, Chest 128:3233-3239, 2005

  15. A case control study of 108,593 patients who underwent noncardiac surgery. • *Odds ratio for perioperative mortality is 1.19 (95% CI 1.1–1.3) per mmol/l increase of glucose level

  16. Thirty Day Mortality and Inhospital Complications in diabetic and non-diabetic subjects * * * % * * † # †p = 0.1 * p= 0.001 #p=0.017 A Frisch et al. Diabetes Care, May 2010

  17. Hyperglycemia and mortality Mean POSTSURGERY blood glucose and ODDS RATIOS for 30 day mortality in diabetic and non diabetic patients A Frisch et al. Diabetes 58 (suppl 1) A27, 2009

  18. Hyperglycemia: An Independent Marker of In-Hospital Mortality in Patients with Undiagnosed Diabetes Total In-patient Mortality 16.0% * Mortality (%) 3.0% 1.7% Normoglycemia Known New Diabetes Hyperglycemia * P < 0.01 Umpierrez GE et al, J Clin Endocrinol Metabol 87:978, 2002

  19. AACE/ADA Target Glucose Levels in Non–ICU Patients Glucose Target in non–ICU setting: Premeal glucose targets <140 mg/dL Random BG <180 mg/dL To avoid hypoglycemia, reassess insulin regimen if BG levels fall below 100 mg/dL Occasional patients may be maintained with a glucose range below and/or above these cut-points Moghissi ES, et al; AACE/ADA Inpatient Glycemic Control Consensus Panel. Endocr Pract. 2009;15(4). http://www.aace.com/pub/pdf/guidelines/InpatientGlycemicControlConsensusStatement.pdf

  20. Epidemiology of Inpatient Hyperglycemia in non-critical care setting • What is the frequency of hyperglycemia and diabetes? • What diagnosis criteria should we use? • What is the association between hyperglycemia and outcomes? • How should we manage hyperglycemia in non-ICU setting?

  21. Recommendations for Managing Patients With Diabetes in the Hospital Setting Antihyperglycemic Therapy Insulin Recommended OADsNot Generally Recommended IV Insulin Critically ill patients in the ICU SC Insulin Non-critically ill patients • ACE/ADA Task Force on Inpatient Diabetes. Diabetes Care. 2006 & 2009 • Diabetes Care. 2009;31(suppl 1):S1-S110..

  22. AACE/ADA Consensus StatementNon-insulin therapies in the hospital? • Sulfonylureas are a major cause of hypoglycemia • Metformin contraindicated in setting of decrease renal blood flow and with use of iodinated contrast dye • Thiazolidinediones associated with edema and CHF • αglucosidase inhibitors are weak glucose lowering agents • Pramlintide and GLP1-directed therapies can cause nausea and have a greater effect on postprandial glucose Moghissi ES, et al; AACE/ADA Inpatient Glycemic Control Consensus Panel. Endocr Pract. 2009

  23. Management of Hyperglycemia and Diabetes in non-ICU Setting • Non-ICU • Sliding Scale Short-Acting Insulin • Basal/bolus therapy (MDI) • NPH and Regular insulin • Long-acting and rapid-acting insulin • Premix insulin

  24. Study Type: Prospective, multicenter, randomized, open-label trial Patient Population: 130 subjects with DM2 Diet and/or oral hypoglycemic agents Umpierrez et al, Diabetes Care 30:2181–2186, 2007

  25. Randomized Basal Bolus versus Sliding Scale Regular Insulin in patients with type 2 Diabetes Mellitus(RABBIT-2 Trial) • D/C oral antidiabetic drugs on admission • Starting total daily dose (TDD): • 0.4 U/kg/d x BG between 140-200 mg/dL • 0.5 U/kg/d x BG between 201-400 mg/dL • Half of TDD as insulin glargine and half as rapid-acting insulin (lispro, aspart, glulisine) • Insulin glargine - once daily, at the same time/day. • Rapid-acting insulin- three equally divided doses (AC) Umpierrez et al, Diabetes Care 30:2181–2186, 2007

  26. Sliding Scale Insulin Regimen • Before meal: Supplemental Sliding Scale Insulin (number of units) • Add to scheduled insulin dose • Bedtime: Give half of Supplemental Sliding Scale Insulin Umpierrez GE et al. Diabetes Care. 2007;30:2181-2186.

  27. Rabbit 2 Trial: Changes in Glucose Levels With Basal-Bolus vs. Sliding Scale Insulin 240 220 a a 200 a b b b 180 b BG, mg/dL Sliding-scale 160 140 Basal-bolus 120 100 3 4 5 6 7 8 9 10 2 Admit 1 aP<.05. Days of Therapy bP<.05. • Sliding scale regular insulin (SSRI) was given 4 times daily • Basal-bolus regimen: glargine was given once daily; glulisine was given before meals. • 0.4 U/kg/d x BG between 140-200 mg/dL • 0.5 U/kg/d x BG between 201-400 mg/dL Umpierrez GE, et al. Diabetes Care. 2007;30(9):2181-2186.

  28. Persistent hyperglycemia (BG>240 mg/dl) is common (15%) during SSI therapy Hypoglycemia rate: Rabbit 2 Trial: Treatment Success With Basal-Bolus vs. Sliding Scale Insulin Sliding-scale Basal-bolus 300 280 260 240 • Basal Bolus Group: • BG < 60 mg/dL: 3% • BG < 40 mg/dL: none • SSRI: • BG < 60 mg/dL: 3% • BG < 40 mg/dL: none 220 BG, mg/dL 200 180 160 140 120 100 1 2 3 4 1 2 3 4 5 6 7 Admit Days of Therapy Umpierrez GE, et al. Diabetes Care. 2007;30(9):2181-2186.

  29. Study Type: Prospective, randomized, open-label trial Patient Population: 130 subjects with DM2 Oral hypoglycemic agents or insulin therapy Study Sites: Grady Memorial Hospital, Atlanta, GA Rush University Medical Center, Chicago, IL Umpierrez et al, J Clin Endocrinol Metab 94: 564–569, 2009

  30. Detemir–Aspart Insulin Regimen • D/C oral antidiabetic drugs on admission • Starting total daily dose (TDD): • 0.4 U/kg/d x BG between 140-200 mg/dL • 0.5 U/kg/d x BG between 201-400 mg/dL • Half of TDD as insulin detemir and half as aspart • Insulin detemir - once daily, at the same time of the day. • Insulin aspart - three equally divided doses (AC) Umpierrez et al, J Clin Endocrinol Metab 94: 564–569, 2009

  31. NPH–Regular Split-Mixed Regimen • D/C oral antidiabetic drugs on admission • Starting total daily dose (TDD): • 0.4 U/kg/d x BG between 140-200 mg/dL • 0.5 U/kg/d x BG between 201-400 mg/dL • Three-fifth of TDD as insulin NPH and two-fifth as regular • NPH insulin– twice daily, 2/3 before breakfast, 1/3 before dinner • Regular insulin- twice daily, 2/3 before breakfast, 1/3 before dinner Umpierrez et al, J Clin Endocrinol Metab 94: 564–569, 2009

  32. DEAN Trial: Changes in Mean Daily Blood Glucose Concentration 240 Detemir + aspart NPH + regular 220 200 P=NS 180 BG, mg/dL 160 140 120 100 Pre-Rx 0 1 2 3 4 5 6-10 Duration of Therapy, d BG Data are means SEM. Basal-bolus regimen: detemir was given once daily; aspart was given before meals. NPH/regular regimen: NPH and regular insulin were given twice daily, two thirds in AM, one third in PM. Umpierrez GE, et al. J Clin Endocrinol Metab. 2009;94(2):564-569.

  33. DEAN-Trial Detemir + Novolog NPH + Regular Blood glucose (mg/dL)

  34. DEAN Trial: Hypoglycemia • NPH/Regular • BG < 40 mg/dl: 1.6% • BG < 60 mg/dl: 25.4% • Detemir/Aspart • BG < 40 mg/dl: 4.5% • BG < 40 mg/dl: 32.8% To determine risk factors for hypoglycemic events during SC insulin therapy Umpierrez et al, J Clin Endocrinol Metab 94: 564–569, 2009

  35. Summary of Univariate Analyses *p-values are from Wilcoxon Two-Sample Test Umpierrez et al, ADA Scientific Meeting, Poster #516, 2009

  36. RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes Undergoing General Surgery: RABBIT Surgery Trial Guillermo E Umpierrez, Dawn Smiley, Sol Jacobs, Limin Peng, Angel Temponi, Christopher Newton, Denise Umpierrez, Patrick Mulligan, Darin Olson, Jana MacLeod, Monica Rizzo. Umpierrez et al, Preliminary data- ADA Scientific Session 2010

  37. Research Design and Methods • Study Type: Multi-center, prospective, open-label randomized clinical trial • Patient Population: Patients with type 2 DM admitted to general surgery services • Study Sites: Grady Memorial Hospital, Veterans Affairs Medical Center and Emory University Hospital, Atlanta, GA • Treatment Groups: • Group 1: basal/bolus regimen with glargine once daily and glulisine before meals • Group 2: sliding scale regular insulin (SSRI) four times daily Umpierrez et al, Preliminary data- Abstract submitted to ADA Scientific Session 2010

  38. Primary outcome: • Differences between groups in mean daily BG concentration • Composite of hospital complications including: postoperative wound infection, pneumonia, respiratory failure, acute renal failure, and bacteremia. • Secondary outcome: • Differences between groups in any of the following measures: • Mean fasting and pre-meal BG, number of hypoglycemic (BG < 70 mg/dL and < 40 mg/dL) and hyperglycemic (BG > 200 mg/dL) events , length of hospital stay, need for ICU care, and rate of complications including wound infection, pneumonia, acute renal failure, and mortality.

  39. 211 Patients with type 2 DM that underwent general surgery OPEN - LABELED RANDOMIZATION Sliding scale insulin Glargine + Glulisine (SSRI) (Gla+Glu) N= 107 N= 104 Group 2: Group 1: 0.5 U/kg 4 times/day for BG >140 mg/dl Half as glargine once daily Half as glulisine before meals RABBIT SURGERY TRIAL

  40. RABBIT 2 SURGERY Umpierrez et al, Preliminary data- Abstract to be submitted_ADA Scientific Session 2010

  41. Rabbit Surgery Trial Glucose levels during Basal Bolus and SSRI Therapy SSI GLA+GLU * p<0.001 † p: 0.01 ŧ p: 0.02

  42. Glucose levels Before meals and Bedtime SSI Basal Bolus

  43. Differences in BG Concentration Within Target During Hospital Stay and After 24 Hours of Treatment

  44. Hospital Complications: Primary outcome

  45. Hypoglycemic Events Umpierrez et al, Preliminary data- Abstract to be submitted_ADA Scientific Session 2010

  46. RABBIT 2 SURGERY Summary & Conclusion Treatment with glargine once daily plus glulisine before meals improved glycemic control and reduced hospital complications compared to SSRI in general surgery patients with T2DM. Our study indicates that basal/bolus insulin regimen is the preferred insulin regimen in the hospital management of general surgery patients with type 2 diabetes.

  47. Management Recommendations • All patients with T1DM must receive insulin treatment with basal bolus, multi-dose insulin combination of NPH plus regular insulin or continuous insulin pump. • Patients treated with insulin at home should be continued with insulin therapy in the hospital. • Scheduled subcutaneous basal bolus insulin regimen is preferred for the majority of non-critically ill patients with hyperglycemia. • The practice of using sliding scale insulin (SSI) as a single form of therapy is undesirable.

  48. Strategies for Preventing Hypoglycemia • In-service training on new treatment modalities and the actions of new antihyperglycemic agents • Reducing outpatient insulin dose in patients treated with insulin prior to admission • Basal Bolus is preferred over SSRI and NPH/regular combination Braithwaite SS, et al. Endocr Pract. 2004;10(suppl 2):89-99.

  49. Basal Bolus Insulin Regimen in T2DM: Summary • D/C oral antidiabetic drugs on admission • Starting total daily dose (TDD): • 0.3 U/kg/d in elderly and renal failure (lean?) • 0.4 U/kg/d x BG between 140-200 mg/dL • 0.5 U/kg/d x BG between 201-400 mg/dL • Half of TDD as insulin glargine and half as rapid-acting insulin (lispro, aspart, glulisine) • Decrease outpatient insulin dose by 20-25% Umpierrez et al, Diabetes Care 2007; JCEM 2009; Diabetes 2010

  50. Rabbit Surgery Trial Glucose levels during Basal Bolus and SSRI Therapy Mainly Basal (Glargine) Insulin * p<0.001 † p: 0.01 ŧ p: 0.02

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