Phase 2 Study of Adaptive Insulin Meal Supervisor (AIMS) in Adults With Type 1 Diabetes Mellitus

The current study will probe the concept that if a Model Predictive Control insulin delivery strategy for closed-loop glucose control supervised by a safety system is coupled with a standard amylin replacement therapy in patients with type 1 diabetes the resulting combined treatment will unify the benefits of both individual therapies. In order to reduce post-meal blood glucose excursions in patients with type 1 diabetes mellitus, pramlintide (an analog of the human β-cell hormone, amylin) has been utilized, thus dealing with the problem or meal hyperglycemia more effectively than insulin infusion alone. Pramlintide has been successful in maintaining more normal blood glucose concentrations by significantly improving the postprandial glucose excursions in these patients when added to their mealtime insulin to mimic more closely the diurnal β-cell secretory pattern seen in normal physiology. However, pramlintide treatment can result in post-prandial hypoglycemia primarily due to overbolusing with insulin. Closed-loop systems have shown potential for significantly reducing hypoglycemia. A combined closed-loop insulin + pramlintide therapy could provide advantages over each of the individual therapies, and may also provide certain benefits with respect to weight control and improvement in sense of well being while decreasing glucose variability. A potentially important secondary benefit of combining the pramlintide treatment with a precise insulin delivery by the closed-loop system is that, based upon animal studies performed by the research team, a moderate inhibition of glucagon, as is usually achieved with pramlintide treatment, is anticipated to potentially improve the safety of insulin treatment as well by enhancing the glucagon response to hypoglycemia, which are usually impaired in type 1 diabetes, if it should occur in the early postprandial period.