Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments medtronic minimed closed loop (cl) system, snacking
Phase phase 0
Sponsor Yale University
Start date January 2015
End date June 2016
Trial size 15 participants
Trial identifier NCT02135068, 1403013588

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subject will consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System
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.
snacking Oral glucose
Up to 45 g of oral glucose via Gatorade
(Active Comparator)
Subject will not consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System
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.

Primary Outcomes

Measure
Nadir blood glucose levels during exercise
time frame: 75 minutes

Secondary Outcomes

Measure
Episodes of hypoglycemia (blood glucose <60mg/dL) during exercise
time frame: 75 minutes
Mean reduction in blood glucose during exercise
time frame: 75 minutes
Mean time blood glucose in target during exercise
time frame: 75 minutes
Mean time blood glucose levels are in target during the overnight period
time frame: 17 hours
Mean glucose values
time frame: 12 hours
Mean 24- hour glucose levels
time frame: 24 hours
insulin delivery during CL therapy
time frame: 24 hours
Incremental meal-related glucose Area Under the Curve
time frame: 24 hours
Nadir glucose levels following the meals
time frame: 24 hours
Area under the curve meal-related plasma insulin level excursion following meals
time frame: 24 hours
Nadir glucose levels overnight
time frame: 12 hours
Mean absolute relative difference (MARD) for each sensor
time frame: 24 hours
Mean daytime and nighttime glucose values
time frame: 24 hours

Eligibility Criteria

Male or female participants from 13 years up to 44 years old.

Inclusion Criteria: 1. Age 13-45 years 2. Clinical diagnosis of T1D (formal antibody and/or genetic testing will not be required) 3. Duration of T1D ≥ 1 year 4. HbA1c ≤ 9 % 5. Treated with continuous subcutaneous insulin infusion (pump) for at least 3 months 6. Body weight > 40 kg (to accommodate phlebotomy) 7. Able to tolerate a 75-minute exercise period of moderate intensity 8. Be willing to wear 2 subcutaneous glucose sensors (placed under the skin like a pump site) simultaneously during the inpatient portions of this study. 9. 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 10. Normal hematocrit 11. Able to give consent (for children <18 years, permission from parents and subject assent will be required) 12. Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods. Exclusion Criteria: 1. Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment) 2. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct 3. 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. 4. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control 5. History of hypoglycemic seizure within last 3 months 6. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy

Additional Information

Official title Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop
Principal investigator Jennifer Sherr, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Yale University.