A multicenter, nonrandomized clinical trial involving 305 adults with type 2 diabetes from 21 U.S. clinical centers demonstrated that 13 weeks of Omnipod 5 Automated Insulin Delivery System use significantly improved glycemic outcomes.

From the trial published in JAMA Network Open, researchers reported a mean HbA_1c reduction from 8.2% (mean [SD] = 1.3) at baseline to 7.4% (SD = 0.9) at week 13 (mean difference = −0.8 percentage points; 95% confidence interval [CI] = −1 to −0.7; P < .001). 

Participants with higher baseline HbA_1c (at least 9%) experienced the most substantial reductions (mean decrease = 2.1 percentage points; 95% CI = −2.3 to −1.9; P < .001), with consistent improvements across subgroups, including those using multiple daily injections (MDI), basal insulin, or continuous glucose monitoring. Additionally, the time spent in the target glucose range (70-180 mg/dL) increased from 45% (SD = 25) to 66% (SD = 17; mean difference = 20 percentage points; 95% CI = 18 to 22; P < .001).

Insulin requirements decreased from 0.80 U/kg/day to 0.57 U/kg/day (change = −0.23 U/kg/day; 95% CI = −0.27 to −0.20 U/kg/d; P < .001). Notably, participants reported reduced diabetes-related distress (decreased by −0.3 points; 95% CI = −0.4 to −0.2; P < .001) and slight improvements in sleep quality (PSQI score reduction of −0.4 points; 95% CI = −0.7 to 0.0 points; P = .04).

A high satisfaction rate was observed: 90% of participants indicated they would recommend the Automated Insulin Delivery (AID) system to others. Adverse events were minimal, and nonserious events such as skin irritation and hyperglycemia occurred in 14% of participants. Only one severe hypoglycemia episode was reported. There were no instances of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.

"Glycemia improved over 13 weeks of AID use with no increase in hypoglycemia. Improvement in HbA_1c levels was observed in participants using MDI and in those using basal insulin only at baseline, across diverse racial, ethnic, and socioeconomic backgrounds, and among individuals using noninsulin glucose-lowering medications, including GLP-1RAs and SGLT-2is," concluded Francisco J. Pasquel, MD, MPH, of Emory University School of Medicine in Atlanta, along with colleagues.

A full list of disclosures are available in the study.