NCT01973413

Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 10 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Diabetes Assistant (DiAs)	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.
DEVICE	Tandem t:slim Insulin Pump	FDA, market-approved insulin pump.
DEVICE	Dexcom G4 Platinum sensor	FDA, market-approved continuous glucose monitor (CGM)

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-10-31
• Last updated: 2015-04-24
• Results posted: 2014-08-15

Locations

1 site across 1 country: United States