Journal article
Implementation of treatment protocols in the Diabetes Control and Complications Trial
Diabetes care, Vol.18(3), pp.361-376
03/01/1995
DOI: 10.2337/diacare.18.3.361
PMID: 7555480
Abstract
OBJECTIVETo describe the methods used to implement intensive and conventional therapies in the Diabetes Control and Complications Trial (DCCT) and the metabolic results that occurred with the different treatment regimens.RESEARCH DESIGN AND METHODSThe DCCT was a controlled clinical trial that demonstrated the beneficial effect of intensive therapy on the long-term complications of insulin-dependent diabetes mellitus (IDDM). A total of 1,441 volunteers with IDDM, aged 13-39, from 29 centers in the U.S. and Canada, were randomly assigned to conventional or intensive diabetes therapy. Intensive therapy, which used multiple daily injections (MDI) of insulin ( > or = 3 injections/day) or continuous subcutaneous insulin infusion (CSII), was implemented by a team that included diabetes nurses, dietitians, behavioral experts, and diabetologists. Volunteers in the intensive treatment group could use MDI or CSII, based on patient and clinic preference, and could switch between therapies over the course of the study. The volunteers were followed for a mean of 6.5 years (range 3-9 years).RESULTSA detailed analysis of implementation of the two treatments indicates that intensive and conventional treatment subjects adhered to their respective insulin injection regimens > 97% of the time. Adherence to other elements of intensive treatment was similarly high and resulted in median HbA1c values between 6.7 and 7.2, compared with 8.7-9.2 with conventional therapy, over the course of the study. Severe hypoglycemia occurred three times more often in intensively treated subjects. Although subjects on intensive treatment were not randomly assigned to MDI or CSII, we compared those subjects who used either of these methods for > or = 90% of the study time. CSII-treated patients maintained a mean HbA1c of 6.8 vs. 7.0 in MDI-treated subjects during the trial (P < 0.05). The frequency of hypoglycemia with coma and seizure and diabetic ketoacidosis was modestly higher with CSII than with MDI.CONCLUSIONSIntensive therapy was implemented successfully in the DCCT. The detailed description herein will serve to facilitate translation of the DCCT results to the clinical setting.
Details
- Title: Subtitle
- Implementation of treatment protocols in the Diabetes Control and Complications Trial
- Creators
- H Shamoon - DCCT Research Group, Box NDIC/DCCTH Duffy - DCCT Research Group, Box NDIC/DCCTN Fleischer - DCCT Research Group, Box NDIC/DCCTS Engel - DCCT Research Group, Box NDIC/DCCTP Saenger - DCCT Research Group, Box NDIC/DCCTM Strelyzn - DCCT Research Group, Box NDIC/DCCTM Litwak - DCCT Research Group, Box NDIC/DCCTJ Wylie-Rosett - DCCT Research Group, Box NDIC/DCCTA Farkash - DCCT Research Group, Box NDIC/DCCTD Geiger - DCCT Research Group, Box NDIC/DCCTH Engel - DCCT Research Group, Box NDIC/DCCTJ Fleischman - DCCT Research Group, Box NDIC/DCCTD Pompi - DCCT Research Group, Box NDIC/DCCTN Ginsberg - DCCT Research Group, Box NDIC/DCCTM Brisman - DCCT Research Group, Box NDIC/DCCTM Glover - DCCT Research Group, Box NDIC/DCCTE Walker - DCCT Research Group, Box NDIC/DCCTA Thomasunis - DCCT Research Group, Box NDIC/DCCTJ Gonzalez - DCCT Research Group, Box NDIC/DCCTDiabetes Control and Complications Trial Research Group
- Contributors
- R Zeitler (Contributor) - University of Iowa, Internal MedicineW Sivitz (Contributor) - University of Iowa, Internal Medicine
- Resource Type
- Journal article
- Publication Details
- Diabetes care, Vol.18(3), pp.361-376
- DOI
- 10.2337/diacare.18.3.361
- PMID
- 7555480
- ISSN
- 0149-5992
- eISSN
- 1935-5548
- Language
- English
- Date published
- 03/01/1995
- Academic Unit
- Fraternal Order of Eagles Diabetes Research Center; General Internal Medicine; Endocrinology and Metabolism; Internal Medicine
- Record Identifier
- 9984094317002771
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