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Clinical Trial
. 2025 Feb 3;8(2):e2459348.
doi: 10.1001/jamanetworkopen.2024.59348.

Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial

Francisco J Pasquel  1 , Georgia M Davis  1 , David M Huffman  2 , Anne L Peters  3 , John C Parker  4 , Lori M Laffel  5 , Giulio R Romeo  5 , Justin Mathew  6 , Kristin N Castorino  7 , Davida F Kruger  8 , Kathleen M Dungan  9 , Mark Kipnes  10 , Edward C Jauch  11 , Tamara K Oser  12 , Viral N Shah  12 , Barry Horowitz  13 , Anders L Carlson  14 , Mark L Warren  15 , Wasim Deeb  16 , John B Buse  17 , John H Reed  18 , Jason Berner  19 , Thomas Blevins  20 , Chris Bajaj  21 , Craig Kollman  22 , Dan Raghinaru  22 , Trang T Ly  23 , Roy W Beck  22 ; Omnipod 5 SECURE-T2D Consortium
Collaborators, Affiliations
Clinical Trial

Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial

Francisco J Pasquel et al. JAMA Netw Open. .

Abstract

Importance: There is a need for additional treatment options for people with type 2 diabetes treated with insulin. Given the limited data on the use of automated insulin delivery (AID) systems in type 2 diabetes, studies evaluating their safety and efficacy are important.

Objective: To evaluate the association of AID with hemoglobin A1c (HbA1c) levels in a diverse cohort of adults with type 2 diabetes.

Design, setting, and participants: This single-arm prospective trial was conducted at 21 clinical centers in the United States among individuals aged 18 to 75 years with type 2 diabetes who had been using insulin for at least 3 months prior to screening. Participants with AID system use were excluded. The study started with a 14-day standard therapy phase, followed by 13 weeks of treatment with the investigational device. The first participant was enrolled April 11, 2023, and the last participant follow-up visit was February 29, 2024.

Intervention: Participants used the Omnipod 5 AID System for 13 weeks following the 14-day standard therapy phase.

Main outcomes and measures: Primary outcome was change in HbA1c level at 13 weeks, tested sequentially for noninferiority (0.3% margin) and superiority, compared with baseline.

Results: Among 305 participants (mean [SD] age, 57 [11] years; 175 [57%] female; 72 [24%] Black, 66 [22%] Hispanic or Latino, and 153 [50%] White), 289 (95%) completed the trial. At baseline, 223 (73%) were using multiple daily injections, 63 (21%) were using basal insulin without bolus, 17 (6%) were using an insulin pump, 188 (62%) were using continuous glucose monitoring, 168 (55%) were using glucagon-like peptide-1 receptor agonists (GLP-1RAs), and 134 (44%) were using sodium-glucose transport protein 2 inhibitors (SGLT-2is). Following AID use, HbA1c levels decreased from a mean (SD) of 8.2% (1.3) at baseline to 7.4% (0.9) at 13 weeks (mean difference, -0.8 [95% CI, -1.0 to -0.7] percentage points; P < .001 for noninferiority and superiority). Improvement was seen across various subgroups (age, sex, race and ethnicity, insurance), and notably with or without use of GLP-1RAs or SGLT-2is and regardless of pretrial mealtime insulin regimen. Time in target glucose range (70-180 mg/dL) increased from a mean (SD) of 45% (25) to 66% (17) (mean difference, 20 [95% CI, 18 to 22] percentage points; P < .001). Percentage of time in hypoglycemic ranges of less than 54 mg/dL and less than 70 mg/dL was noninferior compared with standard therapy. There was 1 episode of severe hypoglycemia and none of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.

Conclusions and relevance: In this nonrandomized clinical trial, HbA1c levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation, suggesting that AID may be a beneficial and safe option for people with type 2 diabetes using insulin.

Trial registration: ClinicalTrials.gov Identifier: NCT05815342.

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Conflict of interest statement

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.

Figures

Figure 1.
Figure 1.. Trial Flow Diagram
aHemoglobin A1c (HbA1c) analyses included all participants who had values at both baseline and 13 weeks or early withdrawal if done 42 to 119 days from the initiation of automated insulin delivery system. bContinuous glucose monitoring (CGM) analyses included all participants with at least 168 hours of CGM data during each of the standard therapy period and the 13-week treatment period.
Figure 2.
Figure 2.. Change in Hemoglobin A1c (HbA1c) Levels in Demographic and Clinical Subgroups
To convert C-peptide to nanograms per mililiter, divide by 0.331; HbA1c to proportion of total hemoglobin, multiply by 0.01. AID indicates automated insulin delivery; CGM, continuous glucose monitoring; GED, General Educational Development; GLP-1RA, glucagon-like peptide-1 receptor agonist; MDI, multiple daily injections; SGLT-2i, sodium-glucose transport protein 2 inhibitor; ST, standard therapy. aA total of 9 participants are missing a final HbA1c result and are excluded from this analysis. bInteraction P values were adjusted for false discovery rate and compare the change in outcome between the characteristic levels after adjusting for baseline HbA1c, except for the stratification by baseline HbA1c group. cPrior insulin therapy and prior CGM use subgroups were added to the interaction testing post hoc. dPost hoc interaction P values were adjusted for false discovery rate for prior insulin therapy and prior CGM use subgroups within their own category.
See this image and copyright information in PMC

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