Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia - Full Text View

Sponsor:	Medtronic Diabetes
Collaborator:	Juvenile Diabetes Research Foundation
Information provided by:	Medtronic Diabetes
ClinicalTrials.gov Identifier:	NCT00831389

Purpose

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
Type 1 Diabetes Mellitus	Device: Closed Loop Insulin Delivery System Device: Standard of Care Insulin pump

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1 Exercise and Physical Fitness Hypoglycemia

Drug Information available for: Insulin Insulin beef

U.S. FDA Resources

Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:

Plasma glucose values (hypoglycemia, defined as reference blood glucose <60mg/dL). [ Time Frame: Incidence of hypoglycemia in the immediate post-exercise period and the night following exercise during closed-loop control will be compared with that of open-loop control. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Glycemic control, assessed by mean glucose level, percentage of glucose levels within target range, peak postprandial levels, and nadir glucose levels after exercise and overnight; and % of glucose levels below target range and above target range [ Time Frame: after exercise and overnight ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	January 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Closed Loop Four day inpatient study with exercise (on second or third day based on randomization) with closed loop insulin delivery system for glycemic control.	Device: Closed Loop Insulin Delivery System Insulin pump controlled by closed loop unit and algorithm Other Name: Closed Loop
Active Comparator: Open Loop Four day inpatient study with exercise (on second or third day based on randomization) with standard of care insulin pump for glycemic control.	Device: Standard of Care Insulin pump Insulin pump controlled by subject as per standard of care Other Name: Open Loop

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.

Eligibility

Ages Eligible for Study:	12 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects between 12-30 years of age.
Subjects must weigh at least 50 kg to accommodate phlebotomy.
Previously diagnosed Type 1 Diabetes Mellitus
Diabetes duration at least 1 year.
Currently treating their diabetes with an insulin pump.
A1C of ≤ 9.0 % at time of enrollment.
Willing to have an intravenous (IV) line inserted for frequent blood sampling and infusion of glucose if needed.
Willing to wear two (2) subcutaneous glucose sensors and two (2) transmitters simultaneously during closed-loop portion of the study.
Be in good general health without other acute or chronic illnesses except treated hypothyroidism or celiac disease and asthma not requiring glucocorticoid use.
Able to tolerate a 75-minute exercise period of moderate intensity.
Speak and understand English.
Subject and parent (if minor) must be able to comprehend and sign the informed consent form and other study documents.

Exclusion Criteria:

Pregnancy (urine pregnancy test) or lactation, if female.
Subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data.
Subject has a cardiac pacemaker or similar device that may be sensitive to radio frequency telemetry.
Subject using any of the following medications:
- glucocorticoids
- cyclosporine
- L-asparaginase
- niacin
- protease inhibitors
- anti-psychotics
- GnRH agonists
- beta-blockers
- calcium channel blockers
- immunosuppressants
- over-the-counter medications that may effect glucose metabolism.
Subject has any of the following conditions
- insulin allergy
- severe insulin resistance
- exercise-induced asthma
- musculoskeletal problems that may impact ability to complete exercise protocol
- substance abuse
- skin ulcers or poor wound healing
- bleeding disorders
- chronic infections
- eating disorders
- give a history of or are predisposed to major stress
- any other major organ system disease.
Subject has experienced two (2) or more severe hypoglycemic events -seizures/coma requiring assistance in the past six (6) months.
Subject has any other condition that in the investigator's opinion warrants exclusion from the study or precludes him/her from completing the protocol.
Subjects using dietary supplements within 14 days of study enrollment
Subject is currently enrolled in another study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831389

Locations

United States, Connecticut
Yale Pediatrics Diabetes Research
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Medtronic Diabetes

Juvenile Diabetes Research Foundation

Investigators

Principal Investigator:

Stuart Weinzimer, MD

Yale University

More Information

No publications provided

Responsible Party:	Clinical Research, Medtronic Diabetes
ClinicalTrials.gov Identifier:	NCT00831389 History of Changes
Other Study ID Numbers:	ePID-03
Study First Received:	January 26, 2009
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012