Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop (NCT02135068) | Clinical Trial Compass
CompletedEarly Phase 1
Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop
United States15 participantsStarted 2015-01
Plain-language 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.
Who can participate
Age range13 Years – 44 Years
SexALL
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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.
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