The use of information technology for the management of intensive insulin therapy in type 1 diabetes mellitus

Objective: The purpose of the study was to evaluate the safety of a computer program used by the patient for the adjustment of insulin doses to achieve tight glycemic control in type 1 diabetic subjects on intensive insulin therapy. Methods: Ten type 1 diabetic patients participated in the study. Using the basal-bolus (UL-Humalog(R)) insulin regimen, they were randomized in a crossover design to 2 intensive treatment periods of 8 weeks each, one with and the other without the assistance of a computer program via the Internet. They measured their capillary blood glucose regularly, and the results were entered on a daily basis into their log-book or in the computer. During intensive treatment with the computer, the software would provide recommendation for insulin dose adjustment according to specific algorithms. When on intensive treatment without computer assistance, they would adjust their own insulin dose according to the same algorithms. Results: The study subjects followed 89% of the recommendations made by the computer. With the computer, subjects made more insulin dose adjustments (98 versus 50) than without. Intensive treatments with and without computer assistance resulted in a similar improvement of pre-meal/post-prandial capillary blood glucose from 7.6 +/- 2.7/9.5 +/- 2.5 to 6.7 +/- 2.3/8.8 +/- 2.5 and 6.7 +/- 2.6/9.0 +/- 2.6 mmol/L, respectively. Glygated hemoglobin also improved from 7.7 +/- 0.9% to 7.2 +/- 0.7 and 7.3 +/- 0.8%, respectively. The incidence of minor hypoglycemia was similar under both intensive treatments (7.9 +/- 4.0 and 7.1 +/- 5.0/patient/28 days, respectively). Both treatments increased patient behavior while patient knowledge of their disease was improved only during computer assistance. There was no effect on quality of life. The study subjects greatly appreciated the software and wanted to continue using it. Conclusions: The study demonstrated that the use of computer software by the patient to adjust insulin doses for intensive insulin therapy is feasible and is not associated with increased adverse events.