Session: SUN 839-872-Diabetes & Obesity Management
Poster Board SUN-866
Methods: This multicenter, randomized, controlled trial enrolled 121 non-ICU medical and surgical patients with T2D treated with a basal-bolus insulin regimen with glargine once daily and aspart insulin before meals plus corrective (supplements) doses of aspart before meals for blood glucose (BG) > 140 mg/dL. POC testing was performed before meals, at bedtime and 3 AM. Half of the patients were randomized to receive bedtime supplements for BG >140 mg/dl and half received no insulin supplements. Outcomes included differences in mean fasting BG (primary outcome), mean daily BG, nocturnal and daily hypoglycemia, and hospital complications.
Results: There were no differences in mean BG and A1C at randomization between patients receiving bedtime supplements (212±52 mg/dl and 8.7±2.3%) and no-supplements (217±53 mg/dl and 8.9±2.2%), both p= NS. Compared to no-supplement group, those receiving bedtime supplements had similar daily BG (160±30 mg/dl vs. 166±31 mg/dl, p=0.24), mean fasting BG (159±37 mg/dl vs. 160±41 mg/dl, p=0.91), and percentage of patients with BG within target of 100-140 mg/dl (38.4±22 vs. 33.9±21%, p=0.313). The mean total dose of bedtime supplement was 2.2±1.8 U/day. There was no difference in total daily insulin dose between the supplement (0.4±0.2 U/kg/day) and no supplement group (0.5±0.3 U/kg/day), p=0.21. In addition, there were no differences in the percentage of patients with hospital complications (13% vs. 8%, p=0.54), severe hyperglycemia (BG >300 mg/dl, 20% vs. 21%, p=1.00), or hypoglycemia (BG <70 mg/dl, 32% vs. 29%, p=0.74) between groups. There were 62 episodes of hypoglycemia, with more events occurring before dinner (24%), followed by bedtime (21%), pre-breakfast (19%), pre-lunch (18%), 3 AM (11%), and other times (7%).
Conclusion: Our results indicate that performing POC testing is important in identifying hypoglycemic events; however, the use of bedtime insulin supplementation was not associated with a significant improvement in glycemic control, hypoglycemic events, severe hyperglycemia or hospital complications. Based on these findings, we conclude that the standard practice of bedtime insulin supplementation is not clinically indicated in the management of general medicine and surgery patients with T2D.
Disclosure: DS: Investigator, Sanofi, Investigator, Merck & Co.. GEU: Principal Investigator, Merck & Co., Principal Investigator, Sanofi. Nothing to Disclose: RM, FF, SA, FJP, SJ, SB, FO, OMU, LP
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