Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop
2 other identifiers
interventional
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 20, 2020
April 1, 2020
1.4 years
April 16, 2014
April 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nadir blood glucose levels during exercise
Difference in the nadir blood glucose levels during exercise between the two study conditions: Closed Loop alone vs. Closed Loop+ snacking.
75 minutes
Secondary Outcomes (13)
Episodes of hypoglycemia (blood glucose <60mg/dL) during exercise
75 minutes
Mean reduction in blood glucose during exercise
75 minutes
Mean time blood glucose in target during exercise
75 minutes
Mean time blood glucose levels are in target during the overnight period
17 hours
Mean glucose values
12 hours
- +8 more secondary outcomes
Study Arms (2)
CL and exercise with proactive snacking
EXPERIMENTALSubject will consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System
CL and exercise without proactive snacking
ACTIVE COMPARATORSubject will not consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Sherr, MD, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
April 16, 2014
First Posted
May 9, 2014
Study Start
January 1, 2015
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
April 20, 2020
Record last verified: 2020-04