Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas
Condition: Type 1 Diabetes Mellitus; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      This is a randomized crossover trial with 1:1 randomization to the admission sequence of
      using the Control AP system (rMPC - Naïve Model Predictive Control) vs. Experimental AP
      system (EnMPC - Ensemble Model Predictive Control) over approximately 4 months. Eligible
      participants will proceed to the Data Collection Phase for approximately 28 days, during
      which they will participate in regimented exercise activities. If the participant collected
      adequate data during the Data Collection Phase, they will be randomized and undergo the study
      admissions in the assigned sequence. Each admission is approximately 36 hours in length and
      will consist of one afternoon of exercise and one without.
    

Detailed description: 
      Exercise remains a challenge to AP systems; more specifically, by the time exercise is
      detected it is often too late to avoid hypoglycemia without the ingestion of rapid
      carbohydrates or the use of rescue injections, such as glucagon. To this avail, the
      investigators propose to add a novel Model Predictive Control module to the proven USS
      system. This module is designed to compute insulin doses every 5 minutes that are designed to
      "optimally" maintain glycaemia around a target of 120mg/dL. The optimality is defined
      mathematically as minimizing deviations from basal rate injections and the distance between
      current and future (up to 2h) glycaemia from a physiologically feasible trajectory back down
      (or up) to a pre-specified target. Furthermore, the novel control system, labelled Multi
      Stage MPC or Ensemble MPC, accounts for a preset number of exercise scenarios during the
      prediction horizon, these scenarios being derived from the user historical record; this setup
      allows the control system to anticipate expected exercise bouts up to 2h in advance while
      maintaining the condition for optimal glycemic control.

      By adding such module to a well validated system, the investigators expect an improvement in
      protection against hypoglycemia during and immediately after physical activity without
      increase in hyperglycemia. To demonstrate the feasibility of this approach, the novel
      anticipatory system will be compared to a naïve AP system during highly supervised hotel
      admissions with afternoon exercise. Participants will be asked to exercise regularly in the
      late afternoon during a month of data collection to generate the patterns to be anticipated.
    

Intervention name(s): EnMPC (Ensemble Model Predictive Control) AP Controller; rMPC (Naïve Model Predictive Control) AP Controller
Intervention type(s): Device; Device
Intervention description(s): This AP controller has the ability to anticipate exercise activity by use of trends seen during the Data Collection Period.; This AP controller does not have the ability to anticipate exercise activity.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas; Continuous Glucose Monitor; Exercise; Exercise-Induced Hypoglycemia