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Sponsors and Collaborators: |
Medtronic Diabetes Juvenile Diabetes Research Foundation |
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Information provided by: | Medtronic Diabetes |
ClinicalTrials.gov Identifier: | NCT00831389 |
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.
Condition | Intervention |
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Type 1 Diabetes Mellitus |
Device: Closed Loop Insulin Delivery System Device: Standard of Care Insulin pump |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Safety Study |
Official Title: | Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia |
Estimated Enrollment: | 26 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Closed Loop: Experimental
Four day inpatient study with exercise (on second or third day based on randomization) with closed loop insulin delivery system for glycemic control.
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Device: Closed Loop Insulin Delivery System
Insulin pump controlled by closed loop unit and algorithm
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Open Loop: Active Comparator
Four day inpatient study with exercise (on second or third day based on randomization) with standard of care insulin pump for glycemic control.
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Device: Standard of Care Insulin pump
Insulin pump controlled by subject as per standard of care
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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.
Ages Eligible for Study: | 12 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subject using any of the following medications:
Subject has any of the following conditions
Contact: Stuart Weinzimer, MD | 203-785-7924 | stuart.weinzimer@yale.edu |
Contact: Joan Bosson-Heenan | 203-764-8451 | joan.heenan@yale.edu |
United States, Connecticut | |
Yale Pediatrics Diabetes Research | Recruiting |
New Haven, Connecticut, United States, 06519 | |
Contact: Stuart Weinzimer, MD 203-785-7924 stuart.weinzimer@yale.edu | |
Contact: Joan Bosson-Heenan 203-764-8451 joan.heenan@yale.edu | |
Principal Investigator: Stuart Weinzimer, MD | |
Sub-Investigator: William Tamborlane, MD | |
Sub-Investigator: Jennifer Sherr, MD | |
Sub-Investigator: Eda Cengiz, MD |
Responsible Party: | Medtronic Diabetes ( Clinical Research ) |
Study ID Numbers: | ePID-03 |
Study First Received: | January 26, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00831389 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Hypoglycemia Metabolic Disorder Insulin |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 Physiological Effects of Drugs |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Pharmacologic Actions Insulin |