Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop Trial. Elvira Isganaitis et al. Diabeterd Technology & Therapeutics DTT
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To assess the efficacy and safety of closed-loop control (CLC) insulin delivery system in adolescents and young adults with type 1 diabetes.
Design and Methods:
Prespecified subanalysis of outcomes in adolescents and young adults aged 14–24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial. Participants were randomly assigned 2:1 to CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM) and followed for 6 months.
Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1%. All 63 completed the trial.
Time in range (TIR) increased by 13% with CLC versus decreasing by 1% with SAP (adjusted treatment group difference = +13% [+3.1 h/day]; 95% confidence interval [CI] 9–16, P<0.001), which largely reflected a reduction in time >180mg/dL (adjusted difference -12% [-2.9h/day], P<0.001).
Time <70mg/dL decreased by 1.6% with CLC versus 0.3% with SAP (adjusted difference -0.7% [-10 min/day], 95% CI -1.0% to -0.2%, P = 0.002).
CLC use averaged 89% of the time for 6 months.
The mean adjusted difference in HbA1c after 6 months was 0.30% in CLC versus SAP (95% CI -0.67 to +0.08, P = 0.13). There was one diabetic ketoacidosis episode in the CLC group.
CLC use for 6 months was substantial and associated with improved TIR and reduced hypo- glycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group. The clinical trial was registered with ClinicalTrials.gov (NCT03563313).
From the Article Conclusion
Maximizing the proportion of time in automated insulin delivery mode is critical if closed-loop systems are to deliver on their promise of improving glycemic outcomes and less- ening patient burden. Indeed, higher time spent in CLC mode is correlated with improvements in TIR, lower HbA1c, and decreased glycemic variability.
... Strengths of our study include the 6 months of follow-up (which is to our knowledge longer than any previous rando- mized clinical trial (RCT) of closed-loop insulin delivery in this age group) and the 100% retention of participants.
... In conclusion, use of CLC for 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group.
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