- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02135068
Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop
April 16, 2020 updated by: Jennifer Sherr, Yale University
This study is designed to look at how snacking during exercise may help prevent low blood sugars while subjects are on the "closed loop artificial pancreas."
This system uses a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the sensor glucose level.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will be a randomized cross-over study as subjects will be studied under both study conditions - Closed Loop (CL) alone vs. CL + proactive snacking protocol).
Differences in the nadir blood glucose levels during exercise between the two study conditions will be the primary outcome measure.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 44 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 13-45 years
- Clinical diagnosis of T1D (formal antibody and/or genetic testing will not be required)
- Duration of T1D ≥ 1 year
- HbA1c ≤ 9 %
- Treated with continuous subcutaneous insulin infusion (pump) for at least 3 months
- Body weight > 40 kg (to accommodate phlebotomy)
- Able to tolerate a 75-minute exercise period of moderate intensity
- Be willing to wear 2 subcutaneous glucose sensors (placed under the skin like a pump site) simultaneously during the inpatient portions of this study.
- Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
- Normal hematocrit
- Able to give consent (for children <18 years, permission from parents and subject assent will be required)
- Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods.
Exclusion Criteria:
- Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
- Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- Use of any medications (besides insulin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 2 weeks of the closed loop admissions. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites.
- Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
- History of hypoglycemic seizure within last 3 months
- Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CL and exercise with proactive snacking
Subject will consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System
|
The Medtronic MiniMed Closed Loop (CL) System is an investigational system that uses some commercially available products.
An investigational Enlite 2 glucose sensor measures the sensor glucose.
The glucose sensor signal is sent to the insulin pump.
From the insulin pump the sensor glucose is sent through the translator, which then relays the signal on to a controller.
An Android Mobile Device (off the shelf) has the control algorithm installed.
This device is known as the controller.
The controller serves as the control center for the Android system, receiving data from the sensor and pump components, feeding the data to its control algorithm, issuing delivery commands to the pump to apply the algorithm's recommend therapy, and providing a means to monitor the system.
Up to 45 g of oral glucose via Gatorade
Other Names:
|
Active Comparator: CL and exercise without proactive snacking
Subject will not consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System
|
The Medtronic MiniMed Closed Loop (CL) System is an investigational system that uses some commercially available products.
An investigational Enlite 2 glucose sensor measures the sensor glucose.
The glucose sensor signal is sent to the insulin pump.
From the insulin pump the sensor glucose is sent through the translator, which then relays the signal on to a controller.
An Android Mobile Device (off the shelf) has the control algorithm installed.
This device is known as the controller.
The controller serves as the control center for the Android system, receiving data from the sensor and pump components, feeding the data to its control algorithm, issuing delivery commands to the pump to apply the algorithm's recommend therapy, and providing a means to monitor the system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nadir blood glucose levels during exercise
Time Frame: 75 minutes
|
Difference in the nadir blood glucose levels during exercise between the two study conditions: Closed Loop alone vs. Closed Loop+ snacking.
|
75 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Episodes of hypoglycemia (blood glucose <60mg/dL) during exercise
Time Frame: 75 minutes
|
Percentage of subjects that required treatment for hypoglycemia during the exercise period between the two study conditions
|
75 minutes
|
Mean reduction in blood glucose during exercise
Time Frame: 75 minutes
|
Mean Reduction in blood glucose from baseline blood glucose during exercise
|
75 minutes
|
Mean time blood glucose in target during exercise
Time Frame: 75 minutes
|
Comparison of the mean time blood glucose levels were between 70-180mg/dL during exercise between the two study conditions
|
75 minutes
|
Mean time blood glucose levels are in target during the overnight period
Time Frame: 17 hours
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Comparison of the mean time blood glucose levels are in target (70-180mg/dL) during the overnight period after mid-afternoon exercise.
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17 hours
|
Mean glucose values
Time Frame: 12 hours
|
Comparison of the mean daytime and nighttime glucose values
|
12 hours
|
Mean 24- hour glucose levels
Time Frame: 24 hours
|
Comparison of the mean 24- hour glucose levels
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24 hours
|
insulin delivery during CL therapy
Time Frame: 24 hours
|
Differences between insulin delivery during CL therapy during the two study conditions (pro-active snacking vs. no snacking) will be assessed.
|
24 hours
|
Incremental meal-related glucose Area Under the Curve
Time Frame: 24 hours
|
Assessment of incremental meal related glucose area under the curve will be conducted.
|
24 hours
|
Nadir glucose levels following the meals
Time Frame: 24 hours
|
Nadir glucose levels following meals will be compared between the two study conditions
|
24 hours
|
Area under the curve meal-related plasma insulin level excursion following meals
Time Frame: 24 hours
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Area under the curve meal-related insulin excursion following meals.
|
24 hours
|
Nadir glucose levels overnight
Time Frame: 12 hours
|
Difference between nadir glucose levels between the two study conditions will be assessed.
|
12 hours
|
Mean absolute relative difference (MARD) for each sensor
Time Frame: 24 hours
|
Calculation and comparison of the mean absolute relative difference for each sensor will be performed and comparisons between accuracy of the sensors will be done.
|
24 hours
|
Mean daytime and nighttime glucose values
Time Frame: 24 hours
|
Comparison of the mean daytime and nighttime glucose levels
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Sherr, MD, PhD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
April 16, 2014
First Submitted That Met QC Criteria
May 7, 2014
First Posted (Estimate)
May 9, 2014
Study Record Updates
Last Update Posted (Actual)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 16, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1403013588
- T32DK063703 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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