Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia

NCT00831389 | Completed Results

• 1 other identifier: ePID-03
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Plasma Glucose (PG) Response to Exercise

  PG at start of exercise minus the subsequent PG nadir

  Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.

• Incidence of Hypoglycemia Immediately Following Exercise

  Tally of episodes where either plasma glucose (PG) \< 60 mg/dL, or supplemental glucose was administered to prevent imminent PG \< 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.

  Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.

• Incidence of Nocturnal Hypoglycemia Following Exercise

  Tally of episodes where either plasma glucose (PG) \< 60 mg/dL, or supplemental glucose was administered to prevent imminent PG \< 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.

  Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.

Secondary Outcomes (6)

• Peak Post-prandial Plasma Glucose (PG)

  Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.

• Nadir Plasma Glucose (PG) Immediately Following Exercise

  Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.

• Overnight Nadir Plasma Glucose (PG)

  Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.

• Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.

  Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.

• Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.

  Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.

Study Arms (2)

Closed Loop (CL) Phase

EXPERIMENTAL

Closed Loop (CL) Phase

Device: Closed Loop

Standard of Care (OL) Phase

NO INTERVENTION

Standard of Care (OL) Phase or Open Loop Phase

Interventions

Closed Loop DEVICE

Insulin pump controlled by closed loop unit and algorithm

Closed Loop (CL) Phase

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Medtronic Diabetes: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Yale Pediatrics Diabetes Research

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• 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.

  PMID: 23757427 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Harry Clark
• Organization: Medtronic Diabetes

bud.clark@medtronic.com

818-576-5653

Study Officials

• Stuart Weinzimer, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 12, 2017
• Results First Posted: October 11, 2012

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)