Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4

Jordan E. Pinsker, Eyal Dassau, Sunil Deshpande, Dan Raghinaru, Bruce A. Buckingham, Yogish C. Kudva, Lori M. Laffel, Carol J. Levy, Mei Mei Church, Hannah Desrochers, Laya Ekhlaspour, Ravinder Jeet Kaur, Camilla Levister, Dawei Shi, John W. Lum, Craig Kollman, Francis J. Doyle

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Automated insulin delivery (AID) systems have proven effective in increasing time-in-range during both clinical trials and real-world use. Further improvements in outcomes for single-hormone (insulin only) AID may be limited by suboptimal insulin delivery settings. Methods: Adults (≥18 years of age) with type 1 diabetes were randomized to either sensor-augmented pump (SAP) (inclusive of predictive low-glucose suspend) or adaptive zone model predictive control AID for 13 weeks, then crossed over to the other arm. Each week, the AID insulin delivery settings were sequentially and automatically updated by an adaptation system running on the study phone. Primary outcome was sensor glucose time-in-range 70-180 mg/dL, with noninferiority in percent time below 54 mg/dL as a hierarchical outcome. Results: Thirty-five participants completed the trial (mean age 39 ± 16 years, HbA1c at enrollment 6.9% ± 1.0%). Mean time-in-range 70-180 mg/dL was 66% with SAP versus 69% with AID (mean adjusted difference +2% [95% confidence interval: -1% to +6%], P = 0.22). Median time <70 mg/dL improved from 3.0% with SAP to 1.6% with AID (-1.5% [-2.4% to -0.5%], P = 0.002). The adaptation system decreased initial basal rates by a median of 4% (-8%, 16%) and increased initial carbohydrate ratios by a median of 45% (32%, 59%) after 13 weeks. Conclusions: Automated adaptation of insulin delivery settings with AID use did not significantly improve time-in-range in this very well-controlled population. Additional study and further refinement of the adaptation system are needed, especially in populations with differing degrees of baseline glycemic control, who may show larger benefits from adaptation.

Original languageEnglish
Pages (from-to)635-642
Number of pages8
JournalDiabetes Technology and Therapeutics
Volume24
Issue number9
DOIs
StatePublished - 1 Sep 2022

Keywords

  • Adaptation
  • Artificial pancreas
  • Automated insulin delivery
  • Glycemic control
  • Type 1 diabetes

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