DIABETES CONTROL AND COMPLICATIONS TRIAL

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This grant proposal is a response to an NIH RFA to participate in a collaborative 20 center study, the ultimate objective of which is to determine whether the level of blood glucose control in insulin-dependent diabetic patients is a major factor in the development of "diabetic complications." This particular application focuses solely on the feasibility trial phase of this long term project. The specific objectives of this phase are to determine whether it is possible to (1) Randomize insulin dependent diabetic patients into two treatment groups, one a conventional treatment group and the other an intensive treatment group. (2) By increasing the intensity of education, diet control insulin therapy, exercise, etc., is it possible to significantly improve metabolic control, particularly normalization or near normalization of fluctuations in blood glucose. (3) Can this be done safely, effectively, and at reasonable cost and is it acceptable to the patients? (4) Are there adverse effects such as emotional distrubance which may be a consequence of intensive therapy? We expect to recruit 10 classical insulin-deficient diabetic patients from our diabetic clinic populations at the Children's Hospital of Pittsburgh and at the University Health Center, randomize them into two groups, maintaining conventional therapy in one and providing increasing attention, education, direction, and stimulation for improving metabolic control in the second group. The patients will be admitted to the Clinical Research Centers for inital, very complete evaluation and this will be done again at the completion of the study. Intervening hospital admissions will be arranged as deemed necessary. Detailed observations on metabolic control will be carried out in addition, psychological evaluation including cognitive assessment and emotional assessment will be carried out at entry and termination. Endpoint determinations also will be documented with entry and termination observations on retinal vascular changes, peripheral vascular alterations, peripheral nerve function, and detailed assessment of renal function and bone calcification.