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

Satish K. Garg, George Grunberger, Ruth Weinstock, Margaret L. Lawson, Irl B. Hirsch, Linda A. Dimeglio, Rodica Pop-Busui, Athena Philis-Tsimikas, Mark Kipnes, David R. Liljenquist, Ronald L. Brazg, Yogish C. Kudva, Bruce A. Buckingham, Janet B. McGill, Anders L. Carlson, Amy B. Criego, Mark P. Christiansen, Kevin B. Kaiserman, Kurt J. Griffin, Greg P. ForlenzaBruce W. Bode, Robert H. Slover, Ashleigh Keiter, Chenxiao Ling, Briggitte Marinos, Toni L. Cordero, John Shin, Scott W. Lee, Andrew S. Rhinehart, Robert A. Vigersky

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

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.

Original languageEnglish
Pages (from-to)1-12
Number of pages12
JournalDiabetes Technology and Therapeutics
Volume25
Issue number1
DOIs
StatePublished - Jan 1 2023

Keywords

  • A1C
  • Adult
  • Diabetes treatment satisfaction
  • Hybrid closed loop
  • Pediatric
  • Time below range
  • Time in range
  • Type 1 diabetes

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