Yogish C Kudva, Dan Raghinaru, John W Lum, Timothy E Graham, David Liljenquist, Elias K Spanakis, Francisco J Pasquel, Andrew Ahmann, David T Ahn, Grazia Aleppo, Thomas Blevins, Davida Kruger, Sue A Brown, Carol J Levy, Ruth S Weinstock, Devin W Steenkamp, Tamara Spaic, Irl B Hirsch, Frances Broyles, Michael R Rickels, Michael A Tsoukas, Philip Raskin, Betul Hatipoglu, Donna Desjardins, Adrienne N 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 L Liu, Sheryl Marks, Amy J Peleckis, Melissa-Rosina Pasqua, Vanessa Tardio, Corey Kurek, Ryan D Luker, Jade Churchill, Farbod Z 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 V 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
{"title":"A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes.","authors":"Yogish C Kudva, Dan Raghinaru, John W Lum, Timothy E Graham, David Liljenquist, Elias K Spanakis, Francisco J Pasquel, Andrew Ahmann, David T Ahn, Grazia Aleppo, Thomas Blevins, Davida Kruger, Sue A Brown, Carol J Levy, Ruth S Weinstock, Devin W Steenkamp, Tamara Spaic, Irl B Hirsch, Frances Broyles, Michael R Rickels, Michael A Tsoukas, Philip Raskin, Betul Hatipoglu, Donna Desjardins, Adrienne N 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 L Liu, Sheryl Marks, Amy J Peleckis, Melissa-Rosina Pasqua, Vanessa Tardio, Corey Kurek, Ryan D Luker, Jade Churchill, Farbod Z 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 V 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","doi":"10.1056/NEJMoa2415948","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2000,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"New England Journal of Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1056/NEJMoa2415948","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
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.).
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