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
Results First Received: June 8, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Type 1 Diabetes Mellitus
Intervention: Device: Closed Loop

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Participants All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.

Participant Flow:   Overall Study
    All Participants  
STARTED     13  
COMPLETED     12  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Study Participants Four day inpatient study with exercise (on second or third day based on randomization) with closed loop insulin delivery system for glycemic control.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     11  
Between 18 and 65 years     2  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  15.9  ± 3.8  
Gender  
[units: participants]
 
Female     6  
Male     7  



  Outcome Measures
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1.  Primary:   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. ]

2.  Primary:   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. ]

3.  Primary:   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. ]

4.  Secondary:   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. ]

5.  Secondary:   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. ]

6.  Secondary:   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. ]

7.  Secondary:   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. ]

8.  Secondary:   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. ]

9.  Secondary:   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. ]

10.  Post-Hoc:   Overall Incidence of Hypoglycemia   [ Time Frame: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Harry Clark
Organization: Medtronic Diabetes
phone: 818-576-5653
e-mail: bud.clark@medtronic.com


No publications provided by Medtronic Diabetes

Publications automatically indexed to this study:

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