SIMPLIFIED MEAL BOLUS STRATEGIES FOR THE OMNIPOD® 5 AUTOMATED INSULIN DELIVERY (AID) SYSTEM IN PEOPLE WITH TYPE 2 DIABETES (T2D): SUB-ANALYSIS OF THE SECURE-T2D STUDY

Document Type

Conference Proceeding

Publication Date

3-1-2025

Publication Title

Diabetes Technol Ther

Keywords

carbohydrate, glucagon like peptide 1, hemoglobin A1c, insulin, adult, conference abstract, drug therapy, female, Food and Drug Administration, glucose blood level, Hispanic, human, insulin dependent diabetes mellitus, insulin pump, male, meal, middle aged, non insulin dependent diabetes mellitus

Abstract

Background and Aims: Many people with T2D may not use carbohydrate counting for meal bolusing, so it is important to understand whether simplified meal bolus approaches can be used with AID. The Omnipod® 5 AID System demonstrated safety and efficacy in adults (≥18y) with T2D and was recently cleared by the US FDA for use in this population (also FDA cleared/CE marked for ages ≥2y with type 1 diabetes). This SECURE-T2D sub-analysis evaluated outcomes by bolus strategy with AID use. Methods: This multicenter single-arm trial enrolled insulintreated adults aged 18-75y with T2D with HbA1c <12.0%. After a 14-day period to capture baseline data, participants received carbohydrate counting training and were advised to carbohydrate count or use a simplified bolus strategy during the 13-week AID period. Glycemic outcomes according to bolus strategy used with AID were evaluated: carbohydrate counting, small/medium/large carbohydrate entry, or fixed carbohydrate entry. Results: A total of 305 participants (mean age 57-11y, 24% Black, 22% Hispanic/Latino, 21% using basal insulin without mealtime insulin, 55% using GLP1-RA) initiated AID. of the 289 who completed the study, 59% used carbohydrate counting, 35% used small/medium/large carbohydrate entry, 4% used fixed carbohydrate entry, and 2% used other or a combination strategy. Similar improvements in HbA1c, time in range, and time >250mg/dL (>13.9 mmol/L) were achieved across strategies, with time <70mg/dL (<3.9mmol/L) unchanged (Table). Participants delivered 3.2-1.7 (mean-SD) boluses/day. Conclusions: These results provide evidence that glycemic improvements among people with T2D using simplified bolus strategies are comparable to a carbohydrate counting based bolus strategy with the Omnipod 5 System.

Volume

27

First Page

e101

Last Page

e102

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