NCT00831389

Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 12 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.

Detailed description

This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop insulin delivery system using a subcutaneous glucose sensor and an external insulin pump and comparing it to an open-loop delivery system during aerobic exercise. Subject participation will be for a maximum of 16 weeks including an outpatient study (up to 6 days) and two inpatient studies (one closed-loop; the other open-loop). The closed- and open-loop visit consists of approximately 67 hours over 4 days and 3 nights.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Closed Loop	Insulin pump controlled by closed loop unit and algorithm

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-01-28
• Last updated: 2017-12-12
• Results posted: 2012-10-11

Locations

1 site across 1 country: United States