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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT05233592
Eligibility Criteria:
Inclusion Criteria:
1. Adult (age ≥18yo)
2. Type 1 Diabetes
3. Is already fully vaccinated against COVID-19 (e.g. received 2 doses of Pfizer or Moderna or one dose of Johnson \& Johnson)
4. Available to receive a COVID-19 booster vaccine (first or second booster dose)
Exclusion Criteria:
1. Has already received a COVID-19 booster vaccine dose
2. Known physical or psychological disorder which would prohibit the patient from complying with the study procedures (e.g. allergy to adhesive, profound skin disorder, known to have severe adverse reactions previously to CGMs, poorly controlled schizophrenia, etc.)
3. Recent, acute, or chronic medical condition which may significantly affect insulin resistance or measurements of glucose (e.g. severe cirrhosis, acute infection, cancer on chemotherapy, etc.)
4. On a medication known to cause significant hyperglycemia (e.g. supraphysiologic dose of steroids) or negatively affect readings of CGM (e.g. supraphysiologic doses of acetaminophen (e.g. \>4g/d)).
5. Pregnant or actively trying to get pregnant
6. Planned PET, CT, or MRI test in the next 10 days
7. Unwilling or unable to keep track of insulin usage during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05233592
Study Brief:
Protocol Section:
NCT05233592