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Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes

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Bergenstal, Richard M., Tamborlane, William V., Ahmann, Andrew, Buse, John B., Dailey, George, Davis, Stephen N., Joyce, Carol, Peoples, Tim, Perkins, Bruce A., Welsh, John B., Willi, Steven M., Wood, Michael A.·2010·New England Journal of Medicine

DOI 10.1056/nejmoa1002853

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Abstract

BACKGROUND: Recently developed technologies for the treatment of type 1 diabetes mellitus include a variety of pumps and pumps with glucose sensors. METHODS: In this 1-year, multicenter, randomized, controlled trial, we compared the efficacy of sensor-augmented pump therapy (pump therapy) with that of a regimen of multiple daily insulin injections (injection therapy) in 485 patients (329 adults and 156 children) with inadequately controlled type 1 diabetes. Patients received recombinant insulin analogues and were supervised by expert clinical teams. The primary end point was the change from the baseline glycated hemoglobin level. RESULTS: At 1 year, the baseline mean glycated hemoglobin level (8.3% in the two study groups) had decreased to 7.5% in the pump-therapy group, as compared with 8.1% in the injection-therapy group (P<0.001). The proportion of patients who reached the glycated hemoglobin target (<7%) was greater in the pump-therapy group than in the injection-therapy group. The rate of severe hypoglycemia in the pump-therapy group (13.31 cases per 100 person-years) did not differ significantly from that in the injection-therapy group (13.48 per 100 person-years, P=0.58). There was no significant weight gain in either group. CONCLUSIONS: In both adults and children with inadequately controlled type 1 diabetes, sensor-augmented pump therapy resulted in significant improvement in glycated hemoglobin levels, as compared with injection therapy. A significantly greater proportion of both adults and children in the pump-therapy group than in the injection-therapy group reached the target glycated hemoglobin level. (Funded by Medtronic and others; ClinicalTrials.gov number, NCT00417989.)

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Authors: Bergenstal, R. M., Tamborlane, W. V., Ahmann, A., Buse, J. B., Dailey, G., Davis, S. N., Joyce, C., Peoples, T., Perkins, B. A., Welsh, J. B., Willi, S. M., & Wood, M. A.
Affiliations: Park Nicollet Health Services (US)
Yale University (US)
Oregon Health & Science University (US)
University of North Carolina at Chapel Hill (US)
University of Maryland, Baltimore (US)
Memorial University of Newfoundland (CA)
Toronto General Hospital (CA)
Children's Hospital of Philadelphia (US)
Helen DeVos Children's Hospital (US)
ORCID: Bergenstal, Richard M.
Tamborlane, William V.
Ahmann, Andrew
Buse, John B.
Dailey, George
Davis, Stephen N.
Perkins, Bruce A.
Welsh, John B.
Willi, Steven M.
Wood, Michael A.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2010-07-22
Volume: 363
Issue: 4
Pages: 311-320
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1002853
OpenAlex: W2142433802
Cited by: 894
References: 12
Citations by year: 2026: 18 · 2025: 25 · 2024: 38 · 2023: 28 · 2022: 41 · 2021: 50 · 2020: 43 · 2019: 55 · 2018: 66 · 2017: 62 · 2016: 71 · 2015: 78 · 2014: 63 · 2013: 65 · 2012: 88
FWCI: 61.06
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
UNC Libraries
Funders: National Institute of Diabetes and Digestive and Kidney Diseases (P30DK079637)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords: type 1 diabetes, sensor-augmented insulin pump therapy, multiple daily insulin injections, HbA1c, glycemic control, hypoglycemia, insulin analogues, children and adults, weight gain
MeSH terms: Adolescent, Adult, Analysis of Variance, Child, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Injections, Subcutaneous, Insulin, Insulin Infusion Systems, Male, Middle Aged, Diabetic Ketoacidosis, Treatment Outcome, Monitoring, Ambulatory, Young Adult

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