Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced
      control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp
      setting will allow us to obtain pilot efficacy data.
    

Detailed description: 
      The first phase of this study will test the feasibility of initializing the DiAs CTR system
      in a clinical research center. We will test the procedures that will occur with the camp
      studies, from consenting the subjects, obtaining morning glucose readings, initializing the
      sensor in the early afternoon, having some light activity in the evening, a bedtime snack,
      and initializing the closed-loop system within 30 minutes before they go to bed. We will also
      test how the system performs using the same calibration and blood glucose monitoring that
      will be done at camp. In the inpatient study we will mimic some camp activities by having the
      subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after
      dinner. The data from the inpatient studies will be reviewed by the Data Safety Monitoring
      Board (DSMB) before we proceed with the Phase 2 summer camp studies.

      The second phase of this proposal is the "in-camp" studies. The same health care providers
      that conducted the inpatient studies will be conducting the camp studies. They will be
      monitoring all campers on closed-loop control in real-time. Participants will be randomized
      to either closed-loop (experimental) or sensor-augmented therapy (control) for the first
      night and then crossed over every other night to the other therapy over the course of the 5-
      to 6-day camp session (i.e. on DiAs CTR every other night). Those assigned to DiAs CTR
      control will be remotely monitored throughout the night. Those assigned to the control group
      will not have remote monitoring overnight, but they will be wearing a Dexcom G4Platinum
      sensor with active low and high sensor glucose alarms. Initial studies will be done at a camp
      with older children and camp staff who are aged 15-35 years of age, with at least 5 subjects
      between 15 to 18 years old. If these studies are safe (after DSMB review) we will do
      additional camps and include children 10-14 years old.
    

Intervention name(s): Diabetes Assistant (DiAs); Tandem t:slim Insulin Pump; Dexcom G4 Platinum sensor
Intervention type(s): Device; Device; Device
Intervention description(s): The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range.; FDA, market-approved insulin pump.; FDA, market-approved continuous glucose monitor (CGM)
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas Project; Diabetes Mellitus, Type 1; Insulin pump therapy; Continuous Glucose Monitors (CGM); Juvenile-Onset Diabetes; Autoimmune Diabetes; Closed-to-Range; Diabetes Assistant (DiAs)