Bio-Behavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-Life Database Analysis

Abstract

<p> </p> <p><u>Objective:</u> Document glycemic and user-initiated bolus changes following transition from predictive-low glucose suspend (PLGS) system to automated insulin delivery (AID) system during real-life use.</p> <p><u>Research Design and Methods:</u> Analysis of 2,329,166 days (6,381 patient-years) of continuous glucose monitoring (CGM) and insulin therapy data for 19,354 individuals with Type 1 Diabetes, during 1-month PLGS (Basal-IQ technology) use followed by 3-month AID use (Control-IQ technology). Baseline characteristics: 55.4 percent female, age (median/quartiles/range) 39/19-58/1-92 years, glucose management indicator (GMI) 7.5±0.8. Primary outcome: time in target range (TIR 70-180mg/dL). Secondary outcomes: CGM-based glycemic control metrics; frequency of user-initiated boluses.</p> <p><u>Results</u>: Compared to PLGS, AID increased TIR on average from 58.4 to 70.5 percent. GMI and percent time above/below target range improved as well, 7.5 to 7.1; 39.9 to 28.1 percent, and 1.66 to 1.46 percent, respectively, all p-levels <0.0001. Stratification of outcomes by age and baseline GMI revealed clinically significant differences. Glycemic improvements were most pronounced in those <18 years old (TIR improvement 14.0 percentage points), and those with baseline GMI >8.0 (TIR improvement 13.2 percentage points). User-initiated correction boluses decreased from 2.7 to 1.8 per day, while user-initiated meal boluses remained stable at 3.6 to 3.8 per day.</p> <p><u>Conclusions:</u> Observed in real life of over 19,000 individuals with type 1 diabetes, transitions from PLGS to AID resulted in improvement of all glycemic parameters, equivalent to improvements observed in randomized clinical trials, and reduced user-initiated boluses. However, glycemic and behavioral changes with AID use may differ greatly across different demographic and clinical groups. </p>