title: Randomized controlled trial of insulin supplementation for correction of bedtime hyperglycemia in hospitalized patients with type 2 diabetes.
abstract: OBJECTIVE
  Clinical guidelines recommend point-of-care glucose testing and the use of supplemental doses of rapid-acting insulin before meals and at bedtime for correction of hyperglycemia. The efficacy and safety of this recommendation, however, have not been tested in the hospital setting.
  
  
  METHODS
  In this open-label, randomized controlled trial, 206 general medicine and surgery patients with type 2 diabetes treated with a basal-bolus regimen were randomized to receive either supplemental insulin (n = 106) at bedtime for blood glucose (BG) >7.8 mmol/L or no supplemental insulin (n = 100) except for BG >19.4 mmol/L. Point-of-care testing was performed before meals, at bedtime, and at 3:00 a.m. The primary outcome was the difference in fasting BG. In addition to the intention-to-treat analysis, an as-treated analysis was performed where the primary outcome was analyzed for only the bedtime BG levels between 7.8 and 19.4 mmol/L.
  
  
  RESULTS
  There were no differences in mean fasting BG for the intention-to-treat (8.8 ± 2.4 vs. 8.6 ± 2.2 mmol/L, P = 0.76) and as-treated (8.9 ± 2.4 vs. 8.8 ± 2.4 mmol/L, P = 0.92) analyses. Only 66% of patients in the supplement and 8% in the no supplement groups received bedtime supplemental insulin. Hypoglycemia (BG <3.9 mmol/L) did not differ between groups for either the intention-to-treat (30% vs. 26%, P = 0.50) or the as-treated (4% vs. 8%, P = 0.37) analysis.
  
  
  CONCLUSIONS
  The use of insulin supplements for correction of bedtime hyperglycemia was not associated with an improvement in glycemic control. We conclude that routine use of bedtime insulin supplementation is not indicated for management of inpatients with type 2 diabetes.
authors: Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, GA.
authors: Priyathama
authors: P
authors: Vellanki
authors: Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, GA.
authors: Rachel
authors: R
authors: Bean
authors: Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, GA.
authors: Festus A
authors: FA
authors: Oyedokun
authors: Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, GA.
authors: Francisco J
authors: FJ
authors: Pasquel
authors: Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, GA.
authors: Dawn
authors: D
authors: Smiley
authors: Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, GA.
authors: Farnoosh
authors: F
authors: Farrokhi
authors: Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, GA.
authors: Christopher
authors: C
authors: Newton
authors: Rollins School of Public Health, Emory University, Atlanta, GA.
authors: Limin
authors: L
authors: Peng
authors: Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, GA geumpie@emory.edu.
authors: Guillermo E
authors: GE
authors: Umpierrez
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D002940:Circadian Rhythm; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology; D004334:Drug Administration Schedule; D005260:Female; D006760:Hospitalization; D006801:Humans; D006943:Hyperglycemia / Q000453:epidemiology / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D061268:Insulin Lispro / Q000008:administration & dosage / Q000009:adverse effects; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects; D049528:Insulin, Long-Acting / Q000008:administration & dosage / Q000009:adverse effects; D061266:Insulin, Short-Acting / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D062407:Meals; D008875:Middle Aged; D012890:Sleep
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D061268:Insulin Lispro; D049528:Insulin, Long-Acting; D061266:Insulin, Short-Acting; D007336:Insulin, Isophane