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

Diabetes Mellitus, Type 1 Clinical Trial

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

Status Completed

Clinical Trial Summary

In this study, a closed-loop Adaptive Insulin Meal Supervisor system (AIMS) utilizing continuous glucose monitoring (CGM), a subcutaneous insulin pump and standard pramlintide therapy will be applied in individuals with type 1 diabetes. Pramlintide, a drug well recognized to help control hyperglycemia with meals, will be evaluated in both closed loop and open loop control. It is expected that the closed loop control condition with pramlintide will improve glycemia, thus combining better control with enhanced safety. In a recent pilot study, the investigators started testing this concept and collected data showing that in order to be successful such strategy must have a controller equipped with the ability to optimize the configuration and timing of meal boluses with concomitant administration of pramlintide. Our preliminary data and review of previously unavailable individual data from a German study indicate a large individual variability in the timing of the appearance of meal insulin needs. Thus, for both adequate safety and efficacy of meal insulin on pramlintide, the investigators have developed a new closed-loop controller that accounts for the variability in the individual responses to a meal and meal delays, the Adaptive Insulin Meal Supervisor system (AIMS). In this study, the performance of a combination between the AIMS system and a standard pramlintide treatment will be tested versus the standard pramlintide treatment alone.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

• NCT number: NCT01839370
• Study type: Interventional
• Source: University of Virginia
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Completion date: November 2013