期刊
NEW ENGLAND JOURNAL OF MEDICINE
卷 363, 期 4, 页码 311-320出版社
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa1002853
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资金
- Abbott Diabetes Care
- Amylin
- Bayer
- Calibra
- Eli Lilly
- Intarcia
- MannKind
- Medtronic
- Novo Nordisk
- Pfizer
- ResMed
- Roche
- Sanofi-Aventis
- Takeda
- Biodel
- Hygieia
- Intuity
- LifeScan
- UnitedHealth Group
- Valeritas
- GlaxoSmithKline
- Becton Dickinson
- Hoffmann-La Roche
- GlycoMark
- Wyeth
- Daiichi Sankyo
- Bristol-Myers Squibb
- Bayhill Therapeutics
- LipoScience
- MicroIslet
- Exsulin
- Abbott
- GI Dynamics
- Tolerex
- Osiris
- Novartis
- Halozyme
- Interkrin
- Merck
- Dexcom
- Johnson Johnson
- Fujisawa
- Boehringer Ingelheim
- Medtronic MiniMed
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.)
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