Visual Abstract

Automated Insulin Delivery (AID) hybrid closed-loop systems have not been well studied in the context of psychological and physiological stress. We evaluated our interoperable artificial pancreas system with in-clinic stress challenges in a randomized crossover trial. Fourteen adults with type 1 diabetes were randomized to 2 weeks of AID-based control and two weeks of sensor augmented pump (SAP)l therapy at home in random order. The AID system used the Zone-Model Predictive Control algorithm with a continuous function of glucose velocity and insulin-on-board to gradually increase insulin infusion under conditions of sustained hyperglycemia. During each two-week period, in-clinic stress assessments for psychological stress (TSST and SECPT) and pharmacological stress (hydrocortisone 40-20-20 mg) were performed. Ten subjects completed the study per protocol, with 48 stress sessions completed in 12 subjects. AID increased time 70-180mg/dL from 63.1 to 74.4% (p=0.001), decreased time <70mg/dL from 1.5 to 0.8% (p=0.04) and decreased time >180mg/dL from 35.4 to 24.8% (p=0.001) during the 2 weeks outpatient use. AID decreased glycemic variability as measured by CV (p=0.037) and time <70mg/dL (p=0.014) during psychological stress (Table 1) AID improved glucose control during outpatient use and improved CV and % time <70mg/dL during in-clinic psychologic stress compared to SAP.

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Disclosure

R. Kaur: None. Y. C. Kudva: Research Support; Self; Dexcom, Inc. S. Deshpande: None. J. E. Pinsker: Advisory Panel; Self; Medtronic, Consultant; Self; Eli Lilly and Company, Tandem Diabetes Care, Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. S. K. Mccrady-spitzer: None. D. Desjardins: None. M. Church: None. W. K. Kremers: Research Support; Self; AstraZeneca, Biogen, Roche Pharma. F. J. Doyle: Advisory Panel; Self; Mode AGC, Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. E. Dassau: Consultant; Self; Eli Lilly and Company, Employee; Self; Eli Lilly and Company, Research Support; Self; Dexcom, Inc., Tandem Diabetes Care, Speaker’s Bureau; Self; Dexcom, Inc., Roche Diabetes Care, Stock/Shareholder; Self; Eli Lilly and Company.

Funding

JDRF (2-SRA-2017-503-M-B); The Leona M. and Harry B. Helmsley Charitable Trust; Dexcom, Inc. (IIS-2019-017)

© 2021 by the American Diabetes Association
2021
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