A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes.
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Kudva Yogish C, Raghinaru Dan, Lum John W, Graham Timothy E, Liljenquist David, Spanakis Elias K, Pasquel Francisco J, Ahmann Andrew, Ahn David T, Aleppo Grazia, Blevins Thomas, Kruger Davida, Brown Sue A, Levy Carol J, Weinstock Ruth S, Steenkamp Devin W, Spaic Tamara, Hirsch Irl B, Broyles Frances, Rickels Michael R, Tsoukas Michael A, Raskin Philip, Hatipoglu Betul, Desjardins Donna, Terry Adrienne N, Singh Lakshmi G, Davis Georgia M, Schmid Caleb, Kravarusic Jelena, Coyne Kasey, Casaubon Luis, Espinosa Valerie, Jones Jaye K, Estrada Kathleen, Afreen Samina, Levister Camilla, O'Malley Grenye, Liu Selina L, Marks Sheryl, Peleckis Amy J, Pasqua Melissa-Rosina, Tardio Vanessa, Kurek Corey, Luker Ryan D, Churchill Jade, Tajrishi Farbod Z, Dean Ariel, Dennis Brittany, Fronczyk Evelyn, Perez Jennifer, Mukhashen Shereen, Dhillon Jasmeen, Ipek Aslihan, Bzdick Suzan, Atakov Castillo Astrid, Driscoll Marsha, Averkiou Xenia, Dalton-Bakes Cornelia V, Moore Adelyn, Jordan Lin F, Lesniak Amanda, Pinsker Jordan E, Sasson-Katchalski Ravid, Campos Tiffany, Spanbauer Charles, Kanapka Lauren, Kollman Craig, Beck Roy W, 2IQP Study Group
Аннотация
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.).