Automated Insulin Delivery Improves Glycemic Control in Diverse Adults with Type 2 Diabetes, Study Finds

"After 13 weeks, participants saw a notable reduction in HbA1c levels, dropping from 8.2% to 7.4%, while their time spent within the target glucose range rose from 45% to 66%. With minimal hypoglycemia, AID has shown potential as a promising solution for individuals with insulin-treated type 2 diabetes," the researchers reported.

There is a growing need for additional treatment options for individuals with type 2 diabetes who are being treated with insulin. Given the limited data on using automated insulin delivery systems in this population, studies that assess their safety and efficacy are crucial. Therefore, Francisco J. Pasquel, Emory University School of Medicine, Atlanta, Georgia, and colleagues to evaluate the association between AID and hemoglobin A1c (HbA1c) levels in a diverse group of adults with type 2 diabetes.

For this purpose, the researchers conducted a single-arm prospective trial at 21 clinical centers in the United States, involving individuals aged 18 to 75 years with type 2 diabetes who had been using insulin for at least 3 months before screening. Participants who were already using an AID system were excluded. The study began with a 14-day standard therapy phase, followed by 13 weeks of treatment with the investigational Omnipod 5 AID System. The first participant was enrolled on April 11, 2023, and the last follow-up visit was on February 29, 2024.

The trial's primary outcome was the change in HbA1c levels at 13 weeks, which was tested for noninferiority (with a 0.3% margin) and superiority compared to baseline.

The key findings of the study were as follows:

• A total of 305 participants were enrolled in the trial, with a mean age of 57 years; 57% were female. Two-hundred eighty-nine participants (95%) completed the trial.
• At baseline, 73% of participants were using multiple daily injections, 21% were on basal insulin without bolus, 6% were using an insulin pump, 62% were using continuous glucose monitoring, 55% were using glucagon-like peptide-1 receptor agonists (GLP-1RAs), and 44% were using sodium-glucose transport protein 2 inhibitors (SGLT-2is).
• After 13 weeks of AID use, HbA1c levels decreased from a mean of 8.2% to 7.4% (mean difference, −0.8 percentage points).
• The improvement in HbA1c was consistent across various subgroups, including age, sex, race, ethnicity, insurance status, and regardless of GLP-1RA or SGLT-2i use or pretrial mealtime insulin regimen.
• Time spent in the target glucose range (70-180 mg/dL) increased from 45% to 66% (mean difference, 20 percentage points).
• The percentage of time in hypoglycemic ranges (less than 54 mg/dL and less than 70 mg/dL) was noninferior compared to standard therapy.
• There was one episode of severe hypoglycemia, with no cases of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.

In a single-arm nonrandomized trial involving adults with type 2 diabetes, the use of automated insulin delivery over 13 weeks resulted in improved glycemic control without an increase in hypoglycemia. HbA1c levels showed significant improvement in participants using multiple daily injections and those on basal insulin only at baseline.

"These benefits were observed across diverse racial, ethnic, and socioeconomic backgrounds, as well as among individuals using non-insulin glucose-lowering medications, including GLP-1 receptor agonists and SGLT-2 inhibitors," the researchers concluded.

Reference:

Pasquel FJ, Davis GM, Huffman DM, et al. Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025;8(2):e2459348. doi:10.1001/jamanetworkopen.2024.59348