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

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ClinicalTrials.gov Identifier: NCT00831389
Recruitment Status : Completed
First Posted : January 28, 2009
Results First Posted : October 11, 2012
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Medtronic Diabetes

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Closed Loop Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
Study Start Date : January 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Closed Loop (CL) Phase
Closed Loop (CL) Phase
 Device: Closed Loop
Insulin pump controlled by closed loop unit and algorithm
No Intervention: Standard of Care (OL) Phase
Standard of Care (OL) Phase or Open Loop Phase


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    PG at start of exercise minus the subsequent PG nadir

  2. 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. ]
    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.

  3. 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. ]
    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 :
  1. 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. ]
    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.

  2. 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. ]
    The PG nadir observed following the start of exercise

  3. 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. ]
    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.

  4. 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. ]
    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.

  5. 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. ]
    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.

  6. 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. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831389


Locations
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United States, Connecticut
Yale Pediatrics Diabetes Research
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Medtronic Diabetes
Juvenile Diabetes Research Foundation
Investigators
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Principal Investigator: Stuart Weinzimer, MD Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00831389    
Other Study ID Numbers: ePID-03
First Posted: January 28, 2009    Key Record Dates
Results First Posted: October 11, 2012
Last Update Posted: December 12, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases