Improved Glycemia with Hybrid Closed-Loop Versus Continuous Subcutaneous Insulin Infusion Therapy: Results from a Randomized Controlled Trial.

Barbara Davis Center for Diabetes, Aurora, Colorado, USA. Grunberger Diabetes Institute, Bloomfield Hills, Michigan, USA. Upstate Medical University, Syracuse, New York, USA. Children's Hospital of Eastern Ontario, Ottawa, Ontario, CAN. University of Washington, Seattle, Washington, USA. Indiana University-Riley Hospital for Children, Indianapolis, Indiana, USA. University of Michigan Health System-University Hospital, Ann Arbor, Michigan, USA. Scripps Whittier Diabetes Institute, La Jolla, California, USA. Diabetes and Glandular Disease Clinic, San Antonio, Texas, USA. Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, USA. Rainier Clinical Research Center, Renton, Washington, USA. Mayo Clinic, Rochester, Minnesota, USA. Stanford University School of Medicine, Stanford, California, USA. Washington University in Saint Louis, St. Louis, Missouri, USA. Park Nicollet International Diabetes Center, Minneapolis, Minnesota, USA. Diablo Clinical Research, Walnut Creek, California, USA. SoCal Diabetes, Torrance, California, USA. University of South Dakota-Sanford Research, Sioux Falls, South Dakota, USA. Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, USA. Atlanta Diabetes Associates, Atlanta, Georgia, USA. Medtronic, Northridge, California, USA.

Diabetes technology & therapeutics. 2023;(1):1-12

Abstract

Objective: To evaluate safety and effectiveness of MiniMed™ 670G hybrid closed loop (HCL) in comparison with continuous subcutaneous insulin infusion (CSII) therapy for 6 months in persons with type 1 diabetes (T1D). Methods: Adults (aged 18-80 years), adolescents, and children (aged 2-17 years) with T1D who were using CSII therapy were enrolled and randomized (1:1) to 6 months of HCL intervention (n = 151, mean age of 39.9 ± 19.8 years) or CSII without continuous glucose monitoring (n = 151, 35.7 ± 18.4 years). Primary effectiveness endpoints included change in A1C for Group 1 (baseline A1C >8.0%), from baseline to the end of study, and difference in the end of study percentage of time spent below 70 mg/dL (%TBR <70 mg/dL) for Group 2 (baseline A1C ≤8.0%), to show superiority of HCL intervention versus control. Secondary effectiveness endpoints were change in A1C and %TBR <70 mg/dL for Group 2 and Group 1, respectively, to show noninferiority of HCL intervention versus control. Primary safety endpoints were rates of severe hypoglycemia and diabetic ketoacidosis (DKA). Results: Change in A1C and difference in %TBR <70 mg/dL for the overall group were significantly improved, in favor of HCL intervention. In addition, a significant mean (95% confidence interval) change in A1C was observed for both Group 1 (-0.8% [-1.1% to -0.4%], P < 0.0001) and Group 2 (-0.3% [-0.5% to -0.1%], P < 0.0001), in favor of HCL intervention. The same was observed for difference in %TBR <70 mg/dL for Group 1 (-2.2% [-3.6% to -0.9%]) and Group 2 (-4.9% [-6.3% to -3.6%]) (P < 0.0001 for both). There was one DKA event during run-in and six severe hypoglycemic events: two during run-in and four during study (HCL: n = 0 and CSII n = 4 [6.08 per 100 patient-years]). Conclusions: This RCT demonstrates that the MiniMed 670G HCL safely and significantly improved A1C and %TBR <70 mg/dL compared with CSII control in persons with T1D, irrespective of baseline A1C level.

Methodological quality

Publication Type : Randomized Controlled Trial

Metadata