| Conference on insulin pump therapy in diabetes. Multicenter study of effect on microvascular disease. Recruitment, Randomization, and baseline characteristics of the treatment groups. | |
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MedLine Citation:
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PMID: 3926567 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The general and ophthalmologic eligibility criteria were applied in the course of formal screening of selected members of clinic populations at the six treatment centers between August 1980 and November 1981. Patients eligible on the grounds of the history and general physical examination underwent a detailed ophthalmologic examination and determination of C-peptide status. Initial rates of recruitment were slow, which occasioned modifications of the eligibility criteria and a prolongation of the recruitment phase. All six clinics approached their goal of at least six patients in each of the continuous subcutaneous insulin infusion (CSII) and conventional insulin treatment (CIT) groups, with a final total of 70 randomized subjects. The method of paired randomization was acceptable, but led to some delay during periods of slow recruitment activity. Data from two patients who chose to drop out of the study shortly after randomization are included in the baseline characteristics. There was no difference between treatment groups with respect to age or duration of known diabetes, body weight, systolic blood pressure, proportion of cigarette smokers, retinopathy level as assigned by analysis of stereofundus photographs, or microaneurysm counts performed on fluorescein angiograms. A trend toward milder retinopathy in the CIT group proved to be statistically insignificant. Subsequent assessment of stereofundus photographs at the Fundus Photograph Reading Center indicated that six patients were misclassified by treatment center ophthalmologists with respect to ophthalmologic eligibility. We conclude that recruitment goals were met and randomization was successful. |
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Authors:
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M C Champion; J J Bending; N W Rodger; R W Bilous |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Diabetes Volume: 34 Suppl 3 ISSN: 0012-1797 ISO Abbreviation: Diabetes Publication Date: 1985 Aug |
Date Detail:
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Created Date: 1985-09-06 Completed Date: 1985-09-06 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 0372763 Medline TA: Diabetes Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 13-6 Citation Subset: AIM; IM |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Albuminuria / metabolism Costs and Cost Analysis* Diabetic Retinopathy / therapy* Diagnosis-Related Groups* Female Humans Insulin Infusion Systems* Male Random Allocation |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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