Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia (ePID-03)

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT00831389
First received: January 26, 2009
Last updated: September 10, 2012
Last verified: September 2012
  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

Study Type: Interventional
Study Design: 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:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • Plasma Glucose (PG) Response to Exercise [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    PG at start of exercise minus the subsequent PG nadir

  • Incidence of Hypoglycemia Immediately Following Exercise [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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.

  • Incidence of Nocturnal Hypoglycemia Following Exercise [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Peak Post-prandial Plasma Glucose (PG) [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    For each subject and study phase, the six peak PG following each of the six meals were determined. The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.

  • Nadir Plasma Glucose (PG) Immediately Following Exercise [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    The PG nadir observed following the start of exercise

  • Overnight Nadir Plasma Glucose (PG) [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    For each subject and study phase, the overnight nadir PG for each of two nights were determined. The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.

  • Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range. [ Time Frame: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. ] [ Designated as safety issue: Yes ]
    For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.

  • Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range. [ Time Frame: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. ] [ Designated as safety issue: Yes ]
    For each subject and study phase, the percentage of the PG curve > 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.

  • Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range. [ Time Frame: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. ] [ Designated as safety issue: Yes ]
    For each subject and study phase, the percentage of the PG curve < 70 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.


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: All participants Device: Closed Loop
Insulin pump controlled by closed loop unit and algorithm

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 by Medtronic Diabetes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00831389     History of Changes
Other Study ID Numbers: ePID-03
Study First Received: January 26, 2009
Results First Received: June 8, 2012
Last Updated: September 10, 2012
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

ClinicalTrials.gov processed this record on April 20, 2014