Automated Insulin Delivery in Adults With Type 2 Diabetes
Authors: Francisco J. Pasquel, Georgia M. Davis, David M. Huffman, Anne L. Peters, John C. Parker, Lori M. Laffel, Giulio R. Romeo, Justin Mathew, Kristin N. Castorino, Davida F. Kruger, Kathleen M. Dungan, Mark Kipnes, Edward C. Jauch, Tamara K. Oser, Viral N. Shah, Barry Horowitz, Anders L. Carlson, Mark L. Warren, Wasim Deeb, John B. Buse, John H. Reed, Jason Berner, Thomas Blevins, Chris Bajaj, Craig Kollman, Dan Raghinaru, Trang T. Ly, Roy W. Beck, Lizda Guerrero-Arroyo, Jason Hughes-Palmer, Martha Walker, Kevin Cannon, Ashlee Wagner, Elvira Isganaitis, Jade Doolan, Shivani Agarwal, David Zybert, Nathalie Zavala, Mei Mei Church, Karla Gonzales, Maggie Shuirman, Kathleen Estrada, Jaye Kimberly Jones, Terra Cushman, Shereen Muhkahsen, Eileen Faulds, Lindsey Aldrich, Stephanie Beltran, Wendy Lane, Casey Wells, Deirdre Kaan, Rachel Duncan, Sarah Friedman, Sean M. Oser, Erik Seth Kramer, Kelsey Huss, William Kaye, Morolake Amole, Sandy Diazgranados, Richard M. Bergenstal, Thomas W. Martens, Molly J. Carlson, Samar Malaeb, Heather Lage, Lindsey Smith, Regina Dodis, Matthew Hager, Elizabeth Ashley Kirk, Lindsay Choate, Chelsea Brouillet, Rebecca Goldfaden, Hannah Noel Schaffner, Stephanie Niman, Debbie Domingo, Klara Klein, Laura Young, Tahereh Ghorbani Rodriguez, Jean Dostou, Jamie Diner, Andrea Coviello, Emily Curlin, Eileen C. Borkovich, Jessica Tapia, Lauralie Korey, Kirby Reinecke, Shannon Caldwell, Valerie Espinosa, Luis Casaubon, Keta Pandit, Jennifer Perez, Anjanette Tan, Chelsea Padilla, Katrina J. Ruedy, Bonnie Dumais, Jacqueline Namati, Todd Vienneau, Kellee M. Miller, Lauren M. Huyett, Lindsey R. Conroy
Journal: JAMA Network Open (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 A 1c (HbA 1c ) 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 HbA 1c 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, HbA 1c 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;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;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, HbA 1c 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