Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes

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

Research output: Contribution to journalArticle

613 Scopus citations

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. (ClinicalTrials.gov number, NCT00417989.)

Original languageEnglish (US)
Pages (from-to)311-320
Number of pages10
JournalNew England Journal of Medicine
Volume363
Issue number4
DOIs
StatePublished - Jul 22 2010

ASJC Scopus subject areas

  • Medicine(all)

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    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. (2010). Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. New England Journal of Medicine, 363(4), 311-320. https://doi.org/10.1056/NEJMoa1002853