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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 +4 more·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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  • A trial comparing a sensor-augmented pump with multiple daily injection therapy showed significant improvement in HbA1C reduction with less hypoglycaemia in the sensor-augmented pump cohort.

    “A trial comparing a sensor-augmented pump with multiple daily injection therapy showed significant improvement in HbA1C reduction with less hypoglycaemia in the sensor-augmented pump cohort.88,94”

    From Type 1 diabetes (2014) · cites this paper as [88]

    The Results report a significantly greater HbA1c reduction with sensor-augmented pump therapy. But the Adverse Events section says hypoglycemia measures were similar between groups, and the Results report no significant difference in severe hypoglycemia rates; the claim of less hypoglycaemia is not supported. Page numbers were unavailable in our copy. (LLM, conf=0.90)

    Experimental — accuracy not yet measured

  • A randomised controlled trial in adults with type 1 diabetes reported lower HbA1C concentrations with sensor-augmented pump therapy than with injection therapy, and a greater proportion of patients reaching the targeted levels of HbA1C.

    “A randomised controlled trial in adults with type 1 diabetes reported lower HbA1C concentrations with sensor-augmented pump therapy than with injection therapy, and a greater proportion of patients reaching the targeted levels of HbA1C.88”

    From Type 1 diabetes (2014) · cites this paper as [88]

  • The use of rtCGM sensors has proved to be very beneficial for glycemic control.

    “The use of rtCGM sensors has proved to be very beneficial for glycemic control [10,16,17].”

    From Advanced Diabetes Management Using Artificial Intelligence and Continuous Glucose Monitoring Sensors (2020) · cites this paper as [16]

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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
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
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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