Clinical studies with home glucose clamping.

OBJECTIVE

Self-blood glucose control is crucial to improving long term outcomes in diabetes. To facilitate this task, we offered patients access to a remote computer continuously online for data collection, dosing decision support, and medical monitoring. Imbedded algorithms for home glucose clamping were custom programmed for each patient. The objectives of the present work were to determine what proportion of patients chose to use such support and whether users benefited from the effort compared to non-users.

RESEARCH DESIGN AND METHODS

A single central computer system was used. Algorithms for home glucose clamping were custom programmed for each patient by their physician who set glucose targets, clamping factors and safety constraints. The systems were voice-interactive and required the remote patient to handle only a touch-tone telephone. Patients were free to access the system each day to report self-measured blood glucose levels or hypoglycemia symptoms together with carbohydrate counting, planned exercise, stress, illness or other life-style events. Clinical experience was in patients followed for 12 months in samples derived from three health-care environments.

RESULTS

Some 388 patients were offered access to the system. Sixty percent of patients (N=231) actively used the system. Among the 3 study centers, over 104,000 blood glucose measurements were received during the start-up year. Each call was processed instantly and automatically. Patients benefited from the 24 hours access. Those receiving algorithmic assistance for home glucose clamping adjusted daily therapy more effectively: prevalence of hyper-glycemia and hypo-glycemia fell ~ 2-fold (p<0.05) and glycated hemoglobin levels declined 1.3% (p<0.001).

CONCLUSIONS

Physicians and patients benefited. Patients with diabetes may be receptive to computer assistance. Many can accomplish glucose clamping at home and meet targets set by their physicians for self-blood glucose control while reducing the incidence of diabetic crises. The centralized system adds no costs for the patients and empowers physicians to provide safer and superior diabetes care.