NCT01271023

Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Control-to-Range Automated Insulin Management System	The devices that will be used in the Closed-Loop Control System are standardized across all study sites and include the DexCom Seven Plus Continuous Glucose Monitor (CGM), the OmniPod insulin pump, and the FreeStyle blood glucose meter. The Closed-Loop Control System will be used during all 3 admission visits.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-01-06
• Last updated: 2016-09-09

Locations

7 sites across 4 countries: United States, France, Israel, Italy