Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell
      Phone + Closed Loop Control) can successfully control blood sugar in people with type 1
      diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be
      studying to see if information about heart rate can help the AP Platform reduce hypoglycemia
      related to exercise.
    

Detailed description: 
      The combination of the Control to Range system and the cell phone is called the "Artificial
      Pancreas (AP) Platform". The purpose of this study is to see if this investigational
      technology can help control blood sugar in people with type 1 diabetes mellitus on insulin
      pump therapy can be successfully used and supervised in a hospital setting. This study is
      also being done to see if giving information about heart rate to the Closed-to-Range System
      can reduce hypoglycemia as it relates to exercise. Subjects will exercise on an exercise bike
      in the clinical research unit. During one exercise testing session, the Closed-to-Range
      System will receive information about your heart rate (Experimental Condition). During the
      other exercise testing session, the Control to Range System will not receive information
      about your heart rate (Control Condition). This part of the study is being done to see
      whether heart rate information helps the Closed-to-Range System reduce the occurrences of
      exercise-related hypoglycemia.

      The Closed-to-Range system has two parts (modules) that can work together or separately.

      A. The Safety Supervision Module (SSM) helps to prevent low blood sugars. It can reduce the
      amount of basal insulin that the pump is delivering and alert you if carbohydrates are needed
      to help prevent a low blood sugar. This module will be active at all times during the
      operation of the Closed-to-Range System.

      B. The Hyperglycemia Mitigation Module (HMM) helps to prevent high blood sugars. It can
      instruct the insulin pump to deliver small boluses to help prevent high blood sugar. It can
      also help warn you of a possible pump problem if the blood sugar level is not responding to
      the insulin as it should.

      The Closed-to-Range System works with the insulin pump and continuous glucose monitor to help
      keep the blood sugar in a desired range (80-180 mg/dL) during the day and help avoid
      hypoglycemia during the night.
    

Intervention name(s): Heart rate informed SSM+HMM
Intervention type(s): Device
Intervention description(s): The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas Project; AP Platform; Insulin Pump; Continuous Glucose Monitor; Closed-Loop Control; Control-to-Range