Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      In this protocol the investigators plan to demonstrate management of glucose using a modular
      insulin management system based on continuous glucose monitoring and targeted towards the
      avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The
      protocol is designed to challenge the insulin management system with meals and mild exercise,
      so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic
      state. This system is designed to both

        -  monitor the meal boluses of the patient and correct it in case of observed/predicted
           under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and
           subjective knowledge of the meal amount, a precise understanding of the subject's day to
           day insulin treatment, continuous glucose monitoring, and past insulin injections;

        -  predict and avoid hypoglycemic events, based on continuous glucose reading and past
           insulin injection.

      The investigators plan to enroll 12 adolescent T1DM patients (expected retention 10/12) and
      compare glucose control performances under two treatments: standard vs. the new insulin
      management system. The protocol will include a total of 5 admissions per subject (3
      out-patients and 2 in-patients): screening, CGM insertion 1, CGM insertion 2, inpatient 1 and
      inpatient 2. During the 24h inpatient admissions the patients will be challenged with 30
      minutes of mild exercise and 3 meals, insulin coverage of these events will vary depending on
      the chosen treatment, each subject will be exposed to both studied treatments (repeated
      measure design). The order of treatment during the inpatient admissions will be randomized.
    


Intervention name(s): Open-Loop; Closed-Loop
Intervention type(s): Device; Device
Intervention description(s): This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).; In this study, the researchers compared the management of diabetes during physical activity and meals with the closed-loop system developed at the University of Virginia. This system uses two DexComTM Seven Continuous Glucose Monitor, a computer containing an investigational control algorithm (well-defined instructions that are expressed in mathematical equations), and an OmniPod Insulin Management System, a portable subcutaneous (under the skin) insulin pump. During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. The study included a challenge to the insulin management system with meals and mild exercise, so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic state.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care