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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Closed Loop
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus

Eligibility Criteria

12 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale Pediatrics Diabetes Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Closed Loop (CL) Phase

Standard of Care (OL) Phase

Arm Description

Closed Loop (CL) Phase

Standard of Care (OL) Phase or Open Loop Phase

Outcomes

Primary Outcome Measures

Plasma Glucose (PG) Response to Exercise
PG at start of exercise minus the subsequent PG nadir
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.
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.

Secondary Outcome Measures

Peak Post-prandial Plasma Glucose (PG)
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
The PG nadir observed following the start of exercise
Overnight Nadir Plasma Glucose (PG)
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.
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.
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.
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.

Full Information

First Posted
January 26, 2009
Last Updated
November 9, 2017
Sponsor
Medtronic Diabetes
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00831389
Brief Title
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
Acronym
ePID-03
Official Title
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed Loop (CL) Phase
Arm Type
Experimental
Arm Description
Closed Loop (CL) Phase
Arm Title
Standard of Care (OL) Phase
Arm Type
No Intervention
Arm Description
Standard of Care (OL) Phase or Open Loop Phase
Intervention Type
Device
Intervention Name(s)
Closed Loop
Intervention Description
Insulin pump controlled by closed loop unit and algorithm
Primary Outcome Measure Information:
Title
Plasma Glucose (PG) Response to Exercise
Description
PG at start of exercise minus the subsequent PG nadir
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.
Title
Incidence of Hypoglycemia Immediately Following Exercise
Description
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.
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.
Title
Incidence of Nocturnal Hypoglycemia Following Exercise
Description
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.
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.
Secondary Outcome Measure Information:
Title
Peak Post-prandial Plasma Glucose (PG)
Description
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.
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.
Title
Nadir Plasma Glucose (PG) Immediately Following Exercise
Description
The PG nadir observed following the start of 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.
Title
Overnight Nadir Plasma Glucose (PG)
Description
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.
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.
Title
Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.
Description
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.
Time Frame
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Title
Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.
Description
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.
Time Frame
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Title
Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.
Description
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.
Time Frame
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Weinzimer, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Pediatrics Diabetes Research
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23757427
Citation
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.
Results Reference
derived

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Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia

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