Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia

NCT ID: NCT00831389

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-11-30

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 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Closed Loop (CL) Phase

Closed Loop (CL) Phase

Group Type: EXPERIMENTAL

Closed Loop

Intervention Type: DEVICE

Insulin pump controlled by closed loop unit and algorithm

Standard of Care (OL) Phase

Standard of Care (OL) Phase or Open Loop Phase

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Closed Loop

Insulin pump controlled by closed loop unit and algorithm

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart Weinzimer, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Pediatrics Diabetes Research

New Haven, Connecticut, United States

Countries

United States

References

Sherr JL, Cengiz E, Palerm CC, Clark B, Kurtz N, Roy A, Carria L, Cantwell M, Tamborlane WV, Weinzimer SA. Reduced hypoglycemia and increased time in target using closed-loop insulin delivery during nights with or without antecedent afternoon exercise in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2909-14. doi: 10.2337/dc13-0010. Epub 2013 Jun 11.

Reference Type: DERIVED

PMID: 23757427 (View on PubMed)

Other Identifiers

ePID-03

Identifier Type: -

Identifier Source: org_study_id