NCT01161862

Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas

Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management of Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boston University Charles River Campus · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that our closed-loop glucose-control system can provide BG control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the input signal to the controller.

Detailed description

To test the safety and efficacy of our control system in the bi-hormonal configuration in regulating BG in adults (18 years of age or older) and in children (12-17 years of age) with type 1 diabetes based on interstitial-fluid (ISF) glucose data from a CGM. Experiments will be 51 hours in length incorporating 6 meals and two (night) sleep periods. In order to evaluate the effect of exercise on BG control, the last 48 hours of the experiment will be divided into two 24 hour blocks, the second of which will contain a period of structured exercise near the beginning of the block.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Bi-hormonal (insulin and glucagon) artificial pancreas	Subjects wore a bionic pancreas consisting of a continuous glucose monitor, an insulin pump and a glucagon pump

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-12-01
• Completion: 2013-06-01
• First posted: 2010-07-14
• Last updated: 2017-11-14
• Results posted: 2017-11-14

Locations

1 site across 1 country: United States