American Diabetes Association
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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.

posted on 2023-09-20, 16:44 authored by Eric Renard, Michael Joubert, Orianne Villard, Bleuenn Dreves, Yves Reznik, Anne Farret, Jerome Place, Marc D. Breton, Boris P. Kovatchev

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.


This study is Protocol 2 of the of International Diabetes Closed-Loop (iDCL) Trial, funded by the U.S. National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK) by Grant UC4 DK108483. Material support: Tandem Diabetes Care, San Diego, CA.