Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT02135068
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
44 Years
Study:
NCT02135068
Study Brief:
Protocol Section:
NCT02135068