A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes
Yogish C. Kudva, Dan Raghinaru, John W. Lum, Timothy E. Graham, David R. Liljenquist, Elias K. Spanakis, Francisco J. Pasquel, Andrew Ahmann, David Ahn, Grazia Aleppo, Thomas Blevins, Davida Kruger, Sue A. Brown, Carol J. Levy, Ruth S. Weinstock, Devin Steenkamp, Tamara Spaic, Irl B. Hirsch, Frances E. Broyles, Michael R. Rickels, Michael A. Tsoukas, Philip Raskin, Betül Hatipoğlu, Donna Desjardins, Adrienne Terry, Lakshmi G. Singh, Georgia M. Davis, Caleb Schmid, Jelena Kravarusic, Kasey Coyne, Luis Casaubon, Valerie Espinosa, Jaye K. Jones, Kathleen Estrada, Samina Afreen, Camilla Levister, Grenye O’Malley, Selina Liu, Sheryl Marks, Amy J. Peleckis, Melissa‐Rosina Pasqua, Vanessa Tardio, Corey Kurek, Ryan Luker, Jade Churchill, Farbod Zahedi Tajrishi, Ariel Dean, Brittany Dennis, Evelyn Fronczyk, Jennifer Perez, Shereen Mukhashen, Jasmeen Dhillon, Aslihan Ipek, Suzan Bzdick, Astrid Atakov-Castillo, Marsha Driscoll, Xenia Averkiou, Cornelia Dalton-Bakes, Adelyn Moore, Lin F. Jordan, Amanda Lesniak, Jordan E. Pinsker, Ravid Sasson-Katchalski, Tiffany Campos, Charles Spanbauer, Lauren Kanapka, Craig Kollman, Roy W. Beck
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.).