Status:
COMPLETED
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
Lead Sponsor:
Medtronic Diabetes
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
12-30 years
Phase:
NA
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00831389
Start Date
January 1 2009
End Date
November 1 2010
Last Update
December 12 2017
Active Locations (1)
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1
Yale Pediatrics Diabetes Research
New Haven, Connecticut, United States, 06519