Type 1 Diabetes Clinical Trial
Official title:
Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System
The purpose of this study is to test an insulin management system ("Control-to-Range (CTR)
system") in an inpatient setting to see if the system is safe and effective enough to test
in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose
Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines
how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the
insulin.
The study will include two hospital stays consisting of meals and exercise scenarios. Both
hospital stays will be for 24+ hours during the day and night. The study will include about
50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.
Clinical Research Center (CRC) Session Detail (closed-loop control active for all elements)
Day 1 (24+ hours):
1. Admission at 7:00 AM
2. Standardized breakfast with normal bolus at 9:00 AM
3. Lunch with normal bolus at 1:00 PM
4. Dinner with normal bolus at 7:00 PM
5. Overnight sleep
6. Breakfast with missed meal bolus followed by user alert and correction bolus
7. Discharge
Day 2 (24+ hours):
1. Admission at 7:00 AM
2. Standardized breakfast with normal bolus at 9:00 AM
3. Lunch with normal bolus at 1:00 PM
4. Exercise
5. Dinner with normal bolus at 7:00 PM
6. Overnight sleep
7. Breakfast with overbolus at 7:00 AM
8. Discharge
Meal boluses will be semi-automated, with manual meal announcement by the physician/nurse,
automated bolus recommendation by the system, and automated delivery of the bolus following
confirmation of the recommendation. Between-meal insulin dosing will be fully automated;
bolus confirmation by the physician/nurse will be requested by the closed-loop controller
only when it determines that carbohydrates may be necessary to avoid hypoglycemia following
the bolus.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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