JAMA network open

Automated Insulin Delivery in Adults with Type 2 Diabetes in a Nonrandomized Trial

Updated

Abstract

HbA1c levels decreased from a mean of 8.2% at baseline to 7.4% at 13 weeks among 305 participants with type 2 diabetes using an automated insulin delivery system.

  • The mean change in HbA1c was -0.8 percentage points with statistical significance for both noninferiority and superiority.
  • Improvements in HbA1c were observed across various subgroups, including age, sex, race, and insurance status.
  • Time in the target glucose range increased from 45% to 66% after 13 weeks of using the automated insulin delivery system.
  • The percentage of time spent in hypoglycemic ranges was comparable to that of standard therapy.
  • There was only 1 episode of severe hypoglycemia reported during the trial, with no occurrences of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.

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Funding

Competing interests

Conflict of Interest Disclosures: Dr Pasquel reported receiving grants through the institution from Insulet, Tandem Diabetes Care, Ideal Medical Technologies, Novo Nordisk, and Dexcom; receiving consulting fees from Dexcom; receiving consulting fees to the institution from Insulet; and serving as associate editor for JAMA Network Open outside the submitted work. Dr Davis reported receiving grants from Insulet during the conduct of the study as well as consulting for Medscape and receiving grants from Insulet outside the submitted work. Dr Huffman reported receiving speaker fees from Novo Nordisk and receiving research funding from Novo Nordisk, Arrowhead, Eli Lilly and Co, Biomea, CeCur, 89Bio, Gann & Lee, AstraZeneca, Kowa, Boehringer Ingelheim, and Fortrea outside the submitted work. Dr Peters reported receiving grants from Insulet during the conduct of the study; receiving research support from Abbott Diabetes Care; serving on advisory boards for Vertex and Medscape; and owning stock option in Omada Health outside the submitted work. Dr Parker reported receiving personal fees from Insulet during the conduct of the study; receiving research support from Corcept; receiving consulting fees and serving on the advisory board of Corcept; and receiving speaker fees from Novo Nordisk outside the submitted work. Dr Laffel reported receiving grants from Insulet during the conduct of the study; receiving consulting fees from Insulet, Novo Nordisk, Eli Lilly and Co, Roche, Janssen Pharmaceuticals, Dexcom, Boehringer Ingelheim, Medtronic, Vertex, and Provention Bio; receiving grants from Tandem Diabetes, Medtronic, and Dexcom; and receiving personal fees for serving on the advisory boards of Sequel Med Tech, Vertex, Tandem Diabetes, and Medtronic outside the submitted work. Dr Castorino reported receiving research support to the institution from Insulet, Dexcom, Medtronic, Abbott Diabetes, and MannKind; and receiving speaker, consulting, and other personal fees from Dexcom; and serving as a consultant and on the advisory board for MannKind outside the submitted work. Ms Kruger reported receiving grants from Tandem, Abbott, Insulet, Novo Nordisk, BetaBionics, and Embecta; receiving advisory and speaker fees from Abbott, Novo Nordisk, Eli Lilly and Co, and CeQur; receiving speaker fees from Dexcom; and receiving advisory fees from MannKind, Medtronic, Structure, Embecta, Insulet, and Pendulum outside the submitted work. Dr Dungan reported receiving grants paid to the employer from Insulet during the conduct of the study as well as receiving consulting fees from Eli Lilly and Co, Dexcom, Medscape, Oppenheimer, UpToDate, Elsevier, Med Learning Group, Impact Education, and Insulet and grants paid to the employer from Dexcom, Abbott, and Sanofi outside the submitted work. Dr Kipnes reported receiving research support from 89bio, Medtronic, Abbott, Akero Therapeutics, AstraZeneca, BioMea, Carmot, Dexcom, Fusion, Abbvie, Amgen, Biolinq, Diamyd, Endogenex, Fractyl, Gilead, Insulet, IONIS Pharmaceuticals, Kowa, MannKind, Novo Nordisk, Pfizer, Reata, Sinocare, Tandem, Trial Net, vTv Therapeutics, Zucara Therapeutics, Zydus, Boehringer Ingelheim, Corcept, and Eli Lilly and Co; receiving consulting fees from Corcept and Capillary Biomedical; serving on the advisory board of AP Stem and Corcept; and serving on the clinical events committee for the Jaeb Center for Health Research Foundation. Dr Jauch reported receiving grants from Insulet and Carmot Therapeutics during the conduct of the study. Dr Oser reported receiving a contract from Insulet study during the conduct of the study; consulting through the University of Colorado for Dexcom, Blue Circle Health, and MedScape; grants through the University of Colorado from the Helmsley Charitable Trust, the National Institute of Diabetes and Digestive and Kidney Diseases, Dexcom, and Abbott outside the submitted work. Dr Shah reported receiving grants and consulting from Insulet during the conduct of the study; grants from Dexcom and Enable Bioscience; and personal fees from Dexcom, Embecta, Ascensia Diabetes Care, Eli Lilly and Co, Sanofi, Novo Nordisk, Tandem Diabetes Care, Sequel Medtech, Genomelink, and Lumosfit outside the submitted work. Dr Horowitz reported receiving research support from Insulet and Bayer; receiving consulting fees from AbbVie; and serving on the speaker’s bureau for Eli Lilly and Co and Novo Nordisk. Dr Carlson reported grants to the institution from Medtronic, Insulet, Tandem, Abbott, Dexcom, MannKind, Novo Nordisk, Eli Lilly and Co, and Sanofi; receiving personal fees paid to the institution from Insulet, Tandem, Abbott, and Novo Nordisk; serving on the advisory board for MannKind and Zealand; and being an employee of International Diabetes Center at Park Nicollet. Dr Warren reported receiving grants from Medtronic during the conduct of the study and receiving grants from Eli Lilly and Co, Novo Nordisk, AstraZeneca, Amgen, Insulet, Novartis, Diasome, and Sensionics; serving on the advisory board of Eli Lilly and Co; receiving consulting fees from Insulet, Medtronic, Eli Lilly and Co, Novo Nordisk, Boehringer Ingelheim, Amgen, AbbVie, Regeneron, Bayer, Biomea, and AstraZeneca; and receiving speaker honoraria from Eli Lilly and Co, Amgen, and Abbott outside the submitted work. Dr Buse reported receiving personal fees from Dexcom during the conduct of the study; receiving personal fees from Alkahest, Altimmune, Anji, Aqua Medical Inc, AstraZeneca, Boehringer Ingelheim, CeQur, Corcept Therapeutics, Eli Lilly, Embecta, GentiBio, Glyscend, Insulet, Mediflix, Medscape, Medtronic MiniMed, Mellitus Health, Metsera, Moderna, Novo Nordisk, Pendulum Therapeutics, Praetego, ReachMD, Stability Health, Tandem, Terns Inc, and Vertex; owning stock options in Glyscend, Mellitus Health, Pendulum Therapeutics, Praetego, and Stability Health; and receiving research support from Bayer, Boehringer-Ingelheim, Carmot, Corcept, Dexcom, Lilly, Insulet, MannKind, Novo Nordisk, and vTv Therapeutics outside the submitted work. Dr Blevins reported receiving research support from Boehringer Ingelheim, vTv Therapeutics, Tandem, Dexcom, MannKind, Eli Lilly and Co, Novo Nordisk, Insulet, Medtronic, and Abbott; serving on the speaker bureau for Dexcom, Eli Lilly and Co, and Novo Nordisk; and serving as an advisor to MannKind and Insulet during the conduct of the study. Dr Bajaj reported receiving personal fees from Insulet during the conduct of the study; receiving research support from Eli Lilly and Co and Novo Nordisk; receiving consulting fees from Dexcom and Eli Lilly and Co; and serving as an advisory board member for Eli Lilly and Co outside the submitted work. Dr Kollman reported receiving grants to the institution from Insulet during the conduct of the study and receiving grants to the institution from Tandem, Juvenile Diabetics Research Foundation, MannKind, BT1D, and Dexcom outside the submitted work. Dr Ly reported being employed by and owning stock in Insulet. Dr Beck reported receiving grants from Insulet during the conduct of the study; receiving grants, study supplies, and consulting fees to the institution from Insulet, Tandem, and Beta Bionics; receiving grant funding and study supplies to the institution from Dexcom; grant funding to the institution from Bigfoot Biomedical, Embecta, Sequel Med Tech, and MannKind; receiving consulting fees and study supplies to the institution from Novo Nordisk; receiving consulting fees to the institution from Vertex, Hagar, Ypsomed, Sanofi, and Zucara; and receiving study supplies from Medtronic, Ascencia, Roche, and Eli Lilly and Co outside the submitted work. No other disclosures were reported.
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