| Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. | |
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MedLine Citation:
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PMID: 20587585 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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:
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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; |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2010-06-29 |
Journal Detail:
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Title: The New England journal of medicine Volume: 363 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2010 Jul |
Date Detail:
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Created Date: 2010-07-27 Completed Date: 2010-08-05 Revised Date: 2011-05-04 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 311-20 Citation Subset: AIM; IM |
Copyright Information:
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2010 Massachusetts Medical Society |
Affiliation:
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International Diabetes Center at Park Nicollet, Minneapolis, MN 55416, USA. richard.bergenstal@parknicollet.com |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00417989 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Analysis of Variance Child Diabetes Mellitus, Type 1 / blood, drug therapy* Diabetic Ketoacidosis / etiology Female Hemoglobin A, Glycosylated / analysis Humans Hypoglycemia / chemically induced, prevention & control Injections, Subcutaneous Insulin / administration & dosage*, adverse effects Insulin Infusion Systems* Male Middle Aged Monitoring, Ambulatory Treatment Outcome Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Hemoglobin A, Glycosylated; 11061-68-0/Insulin |
| Investigator | |
Investigator/Affiliation:
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W S Lane / ; K Arey / ; T Przestrzelski / ; S Mehta / ; L Laffel / ; J Aggarwal / ; K Pratt / ; J B Buse / ; M Duclos / ; J Largay / ; K Osei / ; C Casey-Boyer / ; H Breedlove / ; R Slover / ; S Kassels / ; S Sullivan / ; J B Green / ; J English-Jones / ; M A Wood / ; E Gleason / ; L Wagner / ; R J Tanenberg / ; C Knuckey / ; D R Liljenquist / ; J E Liljenquist / ; B Sulik / ; R L Houlden / ; T LaVallee / ; A Breen / ; R Barrett / ; G Dailey / ; R Rosal / ; J Shartel / ; L Myers / ; D Ballard / ; M Meredith / ; C Trantow / ; L F Meneghini / ; J Sparrow-Bodenmiller / ; R Agramonte / ; R M Bergenstal / ; A B Criego / ; S Borgman / ; M E May / ; S N Davis / ; C Root / ; S A Weinzimer / ; L Carria / ; J Sherr / ; M Daniels / ; J S Krantz / ; H Speer / ; J Less / ; S M Willi / ; T Calvano / ; E Garth / ; A Ahmann / ; C Bogan / ; V Chambers / ; B Wollam / ; Y C Kudva / ; B Wirt / ; C Orlowski / ; S Bates / ; B Johnson / ; J C Reed / ; J Tapia / ; K Wardell / ; S Newsome / ; C Joyce / ; D Gibbons / ; J O'Leary / ; N H White / ; M Coleman / ; R C McEvoy / ; C Girard / ; C M Foster / ; T Brown / ; E Nuttall / ; B A Perkins / ; A Orszag / ; H Tildesley / ; B Pottinger / ; R A Guthrie / ; J Dvorak / ; B Childs / ; T Battelino / ; S N Davis / ; E S Horton / ; S W Lee / ; R R Rubin / ; K A Schulman / ; W V Tamborlane / |
| Comments/Corrections | |
Comment In:
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N Engl J Med. 2010 Jul 22;363(4):383-4
[PMID:
20587584
]
N Engl J Med. 2010 Nov 18;363(21):2070-1; author reply 2071 [PMID: 21083395 ] N Engl J Med. 2010 Nov 18;363(21):2070; author reply 2071 [PMID: 21083396 ] Evid Based Med. 2011 Apr;16(2):46-8 [PMID: 21224281 ] |
Erratum In:
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N Engl J Med. 2010 Sep 9;363(11):1092 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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