Home blood glucose prediction: validation, safety, and efficacy testing in clinical diabetes.

BACKGROUND Patients with diabetes do daily self-monitoring of blood glucose (SMBG). For such patients, we devised an engine that predicts not only the expected blood glucose level at the next meal but also the pending risks of hypoglycemia. The purpose of this study was to validate the predictions and provide evidence of the safety and efficacy of using predicted data in dosing decision support for routine patient care. RESEARCH DESIGN AND METHODS The prediction engine is a computer program that accesses a central database into which daily records of self-monitored blood glucose data are captured by direct access either across the WWW or by an interactive voice response service on-line 24/7. Validation was done by comparison of predicted values to the subsequently observed data using a Clarke Error Grid. Safety focused on body weight and the frequency of hypoglycemia. Efficacy was judged according to glycated hemoglobin and daily insulin dosages. The experimental design contrasted patients in the tight control (TC) group who had been recently converted to intensified (basal-bolus) therapy with patients in the poor control (PC) group on conventional therapy and who were referred to begin intensified therapy. Both groups accessed the remote database to report their daily SMBG. Predicted glucose values were used in dosing decision support for the PC but not the TC group. RESULTS Over the 6-month study period a total of 30,129 blood glucose levels were reported by the 54 study patients, and some 24,953 blood glucose predictions were made. Of these, 83% were in the clinically acceptable zones of the Clarke Error Grid. When these data were used for dosing decision support in the PC group, glycated hemoglobin levels fell significantly from 9.7 +/- 1.7% to 7.9 +/- 1.2%, and hypoglycemia dropped fourfold. Total daily insulin doses declined 22%, while body weight remained constant. In the parallel TC group (n = 24), glycated hemoglobin also fell, but only slightly from 7.6 +/- 0.9% to 7.2 +/- 1.1%, while daily insulin doses, rates of hypoglycemia and body weight remained constant. CONCLUSIONS A novel engine is capable of generating meaningful predictions of blood glucose levels. Use of these validated predictions in decision support for managing medication doses proved safe and efficacious.