A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes.

Abstract

Background: Automated insulin delivery (AID) systems have been shown to be beneficial for patients with type 1 diabetes, but data are needed from randomized, controlled trials regarding their role in the management of insulin-treated type 2 diabetes.

Methods: In this 13-week, multicenter trial, adults with insulin-treated type 2 diabetes were randomly assigned in a 2:1 ratio to receive AID or to continue their pretrial insulin-delivery method (control group); both groups received continuous glucose monitoring (CGM). The primary outcome was the glycated hemoglobin level at 13 weeks.

Results: A total of 319 patients underwent randomization. Glycated hemoglobin levels decreased by 0.9 percentage points (from 8.2±1.4% at baseline to 7.3±0.9% at week 13) in the AID group and by 0.3 percentage points (from 8.1±1.2% to 7.7±1.1%) in the control group (mean adjusted difference, -0.6 percentage points; 95% confidence interval [CI], -0.8 to -0.4; P<0.001). The mean percentage of time that patients were in the target glucose range of 70 to 180 mg per deciliter increased from 48±24% to 64±16% in the AID group and from 51±21% to 52±21% in the control group (mean difference, 14 percentage points; 95% CI, 11 to 17; P<0.001). All other multiplicity-controlled CGM outcomes reflective of hyperglycemia that were measured were significantly better in the AID group than in the control group. The frequency of CGM-measured hypoglycemia was low in both groups. A severe hypoglycemia event occurred in one patient in the AID group.

Conclusions: In this 13-week, randomized, controlled trial involving adults with insulin-treated type 2 diabetes, AID was associated with a greater reduction in glycated hemoglobin levels than CGM alone. (Funded by Tandem Diabetes Care; 2IQP ClinicalTrials.gov number, NCT05785832.).