Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00831389

Run by

Medtronic MiniMed, Inc.

People needed

13

Starts

2009-01-01

Expected to finish

2010-11-01

Last updated by the study team

2017-12-12

Who can join

Age: 12 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Yale Pediatrics Diabetes Research — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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