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:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT04430660
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Ages 18-40 years
* Diagnosed with type 1 diabetes with positive antibodies or dependent on insulin therapy
* HbA1c of ≤8.5%
* Modified Clarke's Hypoglycemia Questionnaire score of 12-24
* Willing to participate in continuous glucose monitoring (CGM)
Exclusion Criteria:
* Contraindication to MRI
* Consume \>10 alcoholic drinks/week
* Current use of CGM
* Current use of insulin pump
* Current use of any diabetes medication other than insulin, e.g. SGLT1/2 inhibitors.
* Current use of steroids, e.g. cortisone, and prednisone.
* History of chronic smoking or have quit less than 10 years ago
* History of cancer in the past 5 years (individuals with basal cell or squamous cell skin cancer would be allowed)
* History of seizures
* Significant, cardiac, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic, or psychiatric disease
* Significant liver disease as defined as more than twice the upper limit of normal for liver enzymes
* Significant renal disease as defined as a estimated glomerular filtration rate less than 30
* Pregnant, planning to become pregnant, or breastfeeding
* Have been hospitalized or treated in the past 3 months for severe hypoglycemia
* Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04430660
Study Brief:
Protocol Section:
NCT04430660