Automated Insulin Delivery Enhances Blood Sugar Control in Type 2 Diabetes: Randomized Trial Findings

"In the 13-week randomized controlled trial, adults with insulin-treated type 2 diabetes using AID showed a greater decrease in glycated hemoglobin levels compared to those using CGM alone," the researchers wrote.

Type 2 diabetes is a chronic condition affecting millions worldwide that often requires insulin therapy when blood sugar levels are not well controlled with oral medications or other injectable treatments. Managing insulin doses manually can be challenging, increasing the risk of blood sugar fluctuations. AID systems that automatically adjust insulin delivery based on glucose levels offer a more precise and personalized approach to diabetes management.

Against the above background, Yogish C. Kudva, Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN, and colleagues aimed to determine the effectiveness of automated insulin delivery in managing insulin-treated type 2 diabetes.

For this purpose, the researchers conducted a 13-week multicenter trial, randomly assigning adults with insulin-treated type 2 diabetes in a 2:1 ratio to either receive AID or continue their pretrial insulin-delivery method (control group), with both groups using continuous glucose monitoring. The primary outcome was the glycated hemoglobin level at the end of 13 weeks.

The study revealed the following findings:

• A total of 319 patients participated in the trial.
• Glycated hemoglobin levels dropped by 0.9 percentage points in the AID group (from 8.2±1.4% to 7.3±0.9%) and by 0.3 percentage points in the control group (from 8.1±1.2% to 7.7±1.1%), with a significant difference of –0.6 percentage points.
• The time spent in the target glucose range (70–180 mg/dL) increased from 48±24% to 64±16% in the AID group, while the control group showed a minimal change (51±21% to 52±21%), with a significant difference of 14 percentage points.
• Other CGM outcomes related to hyperglycemia showed greater improvement in the AID group than in the control group.
• Hypoglycemia events were rare in both groups.
• One patient in the AID group experienced a severe hypoglycemia event.

"The occurrence of hypoglycemia was low at the beginning of the study and remained unchanged throughout the trial, aligning with findings from previous research on type 2 diabetes," the researchers noted. They further stated that no new safety concerns specific to individuals with type 2 diabetes were identified.

Discussing the study's limitations, the researchers highlighted that the findings are specific to adults with type 2 diabetes who require insulin therapy. Additionally, they acknowledged the absence of data on the training time needed for using the AID device.

Reference:

Kudva YC, et al "A randomized trial of automated insulin delivery in type 2 diabetes" N Engl J Med 2025 DOI: 10.1056/NEJMoa2415948.