Automated Insulin Delivery in Adults With Type 2 Diabetes
Authors: Pasquel Francisco J. , Davis Georgia M. , Huffman David M. , Peters Anne L. , Parker John C. , Laffel Lori M. , Romeo Giulio R. , Mathew Justin , Castorino Kristin N. , Kruger Davida F. , Dungan Kathleen M. , Kipnes Mark , Jauch Edward C. , Oser Tamara K. , Shah Viral N. , Horowitz Barry , Carlson Anders L. , Warren Mark L. , Deeb Wasim , Buse John B. , Reed John H. , Berner Jason , Blevins Thomas , Bajaj Chris , Kollman Craig , Raghinaru Dan , Ly Trang T. , Beck Roy W. ,   Omnipod 5 SECURE-T2D Consortium, Guerrero-Arroyo Lizda , Hughes-Palmer Jason , Walker Martha , Cannon Kevin , Wagner Ashlee , Isganaitis Elvira , Doolan Jade , Agarwal Shivani , Zybert David , Zavala Nathalie , Church Mei Mei , Gonzales Karla , Shuirman Maggie , Estrada Kathleen , Jones Jaye Kimberly , Cushman Terra , Muhkahsen Shereen , Faulds Eileen , Aldrich Lindsey , Beltran Stephanie , Lane Wendy , Wells Casey , Kaan Deirdre , Duncan Rachel , Friedman Sarah , Oser Sean M. , Kramer Erik Seth , Huss Kelsey , Kaye William , Amole Morolake , Diazgranados Sandy , Bergenstal Richard M. , Martens Thomas W. , Carlson Molly J. , Malaeb Samar , Lage Heather , Smith Lindsey , Dodis Regina , Hager Matthew , Kirk Elizabeth Ashley , Choate Lindsay , Brouillet Chelsea , Goldfaden Rebecca , Schaffner Hannah Noel , Niman Stephanie , Domingo Debbie , Klein Klara , Young Laura , Ghorbani Rodriguez Tahereh , Dostou Jean , Diner Jamie , Coviello Andrea , Curlin Emily , Borkovich Eileen C. , Tapia Jessica , Korey Lauralie , Reinecke Kirby , Caldwell Shannon , Espinosa Valerie , Casaubon Luis , Pandit Keta , Perez Jennifer , Tan Anjanette , Padilla Chelsea , Ruedy Katrina J. , Dumais Bonnie , Namati Jacqueline , Vienneau Todd , Miller Kellee M. , Huyett Lauren M. , Conroy Lindsey R. 
Published: February 2025

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 &amp;lt; .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 &amp;lt; .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