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.