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

   Objective: 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. Research Design and Methods: 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. Results: 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 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. Conclusions: 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

Safety and Efficacy of Sustained Automated Insulin Delivery Compared to Sensor and Pump Therapy in Adults with Type 1 Diabetes at High Risk for Hypoglycemia: A Randomized Controlled Trial.

OBJECTIVE Assess the safety and efficacy of automated insulin delivery (AID) in adults with type 1 diabetes (T1D) at high risk for hypoglycemia. RESEARCH DESIGN AND METHODS Participants: 72 adults with T1D using insulin pump with Clarke score >3 and/or severe hypoglycemia during the previous 6 months; confirmed by time below range (TBR, defined as sensor glucose (SG) <70 mg/dL) of at least 5% during 2 weeks of blinded continuous glucose monitoring (CGM, Dexcom G6). Design: Parallel arm randomized trial (2:1) of AID (Tandem t:slim X2 with Control-IQ technology) vs. CGM & pump (S&P) therapy, for 12 weeks. The primary outcome was TBR change from baseline. Secondary outcomes included time in target range (TIR, 70-180 mg/dL), time above range (TAR), mean SG, and time <54 mg/dL. An optional 12-week extension on AID was offered to all participants. RESULTS Compared to S&P, AID resulted in significant: (i) reduction of TBR by -3.7% (95%CI -4.8, -2.6), p<0.001; (ii) increase of TIR by +8.6% (95%CI +5.2, +12.1), p<0.001, and (iii) decrease of TAR by -5.3% (95%CI -87.7, -1.8), p=0.004. Mean SG remained similar on AID vs S&P. During the 12-week extension, the effects of AID were sustained in the AID group and reproduced in the S&P group. Two severe hypoglycemic episodes occurred under AID. CONCLUSIONS In adults with T1D at high risk for hypoglycemia, AID reduced the risk for hypoglycemia more than 2-fold, as quantified by TBR, while improving TIR and reducing hyperglycemia. Hence, AID is strongly recommended for this specific population.</p