The investigators in this application propose to participate in the collaborative design and execution of a multi-center controlled clinical trial, the central aim of which is the assessment of the relationship between control of blood glucose levels and the development of microvascular complications in patients with insulin-dependent diabetes mellitus. A research plan is proposed for testing the feasibility of the full-scale clinical trial. Specifically, the study will determine 1) the feasibility of establishing and maintaining groups of patients randomly assigned to conventional or intensive therapy, 2) whether blood glucose is clinically and statistically significantly different in the treatment groups, 3) whether safety and patient acceptability of the treatments and patient adherence to protocols are sufficient to predict that a longer trial is likely to succeed. Conventional and intensive therapy will differ primarily in the mode of insulin delivery, i.e., up to two daily injection of insulin, or subcutaneous infusion by open loop infusion device, respectively. Degree of blood glucose control will be assessed by frequent daily determinations of blood glucose performed by the patients. A further important aspect of the study will be the identification, or development and validation, of psychological instruments to select patients, assess the impact of therapies, and assess the effectiveness of patient support programs. Baseline studies and methods of assessing ophthalmologic endpoints are proposed. Facilities, resources, and patient availability are described with a view toward the requirements of the full-scale clinical trial.
