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Cited by 83Diabetes Management and ResearchDiabetes Treatment and ManagementDiabetes Management and Education

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

Kudva, Yogish C., Raghinaru, Dan, Lum, John W., Graham, Timothy E., Liljenquist, David, Spanakis, Elias K., Pasquel, Francisco J., Ahmann, Andrew +60 more·2025·New England Journal of Medicine
DOI 10.1056/nejmoa2415948
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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 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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Authors
Kudva, Y. C., Raghinaru, D., Lum, J. W., Graham, T. E., Liljenquist, D., Spanakis, E. K., Pasquel, F. J., Ahmann, A., Ahn, D. T., Aleppo, G., Blevins, T., Kruger, D., Brown, S. A., Levy, C. J., Weinstock, R. S., Steenkamp, D. W., Spaic, T., Hirsch, I. B., Broyles, F., Rickels, M. R., Tsoukas, M. A., Raskin, P., Hatipoglu, B., Desjardins, D., Terry, A. N., Singh, L. G., Davis, G. M., Schmid, C., Kravarusic, J., Coyne, K., Casaubon, L., Espinosa, V., Jones, J. K., Estrada, K., Afreen, S., Levister, C., O’Malley, G., Liu, S. L., Marks, S., Peleckis, A. J., Pasqua, M.-R., Tardio, V., Kurek, C., Luker, R. D., Churchill, J., Tajrishi, F. Z., Dean, A., Dennis, B., Fronczyk, E., Perez, J., Mukhashen, S., Dhillon, J., Ipek, A., Bzdick, S., Atakov Castillo, A., Driscoll, M., Averkiou, X., Dalton–Bakes, C. V., Moore, A., Jordan, L. F., Lesniak, A., Pinsker, J. E., Sasson-Katchalski, R., Campos, T., Spanbauer, C., Kanapka, L., Kollman, C., & Beck, R. W.
Affiliations
  • Mayo Clinic (US)
  • Jaeb Center for Health Research (US)
  • Diabetes and Endocrine Treatment Specialists, Sandy, UT
  • Rocky Mountain Clinical Research, Idaho Falls, ID
  • Baltimore VA Medical Center (US)
  • Emory University (US)
  • Oregon Health & Science University (US)
  • Hoag Memorial Hospital Presbyterian (US)
  • Northwestern University (US)
  • Texas Diabetes & Endocrinology (US)
  • Henry Ford Health (US)
  • University of Virginia (US)
  • Icahn School of Medicine at Mount Sinai (US)
  • SUNY Upstate Medical University (US)
  • Boston Medical Center (US)
  • Lawson Health Research Institute (CA)
  • University of Washington (US)
  • Rainier Clinical Research Center (US)
  • University of Pennsylvania (US)
  • Research Institute of the McGill University Health Centre (CA)
  • The University of Texas Southwestern Medical Center (US)
  • University Hospitals Cleveland Medical Center, Cleveland
  • Boston Medical Center, Boston
  • Division of Endocrinology, Diabetes, and Metabolism, University of Pennsylvania Perelman School of Medicine, Philadelphia
  • University Hospitals Cleveland Medical Center (US)
  • Tandem Diabetes Care (United States) (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2025-05-08
Volume
392
Issue
18
Pages
1801-1812
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2415948
OpenAlex
W4408616020
Cited by
83
References
10
Citations by year
2026: 46 · 2025: 37
FWCI
56.38
Type
journal article
Language
en
Open access
closed
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
Tandem Diabetes Care
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords
artificial pancreas, type 2 diabetes, insulin-treated diabetes, HbA1c, continuous glucose monitoring, glycemic control, hypoglycemia, time in target glucose range, insulin pump therapy
MeSH terms
Continuous Glucose Monitoring, Adult, Aged, Aged, 80 and over, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Middle Aged, Treatment Outcome, Young Adult

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