Using a double blind controlled clinical trial to evaluate the function of a Diabetes Advisory System: a feasible approach?

This paper assesses the feasibility of using a double blind controlled clinical trial to evaluate the function of a decision support system by applying such a design to the evaluation of a Diabetes Advisory System (DIAS). DIAS is based on a model of the human carbohydrate metabolism and is designed an interactive clinical tool, which can be used to predict the effects of changes in insulin dose or food intake on the blood glucose concentration in patients with insulin dependent diabetes. It can also be used to identify risk periods for hypoglycaemia. and to provide advice on insulin dose. The latter feature was evaluated in the present study. We believe double blind controlled clinical trials are prerequisites for clinical application of many decision support systems, and conclude that the present double blind controlled clinical trial is a suitable evaluation method for the function of DIAS.