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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT05015504
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years and \< 65 years
* With the diagnosis of type 2 diabetes
* A1c \>= 8.0 on the most recent test in the 3 months before enrollment
* Have been on stable antidiabetics in the 3 months before enrollment
* OhioHealth Patient
Exclusion Criteria:
* Pregnant or breastfeeding patients
* Severe hypoglycemic episodes (defined as having low blood glucose levels that requires assistance from another person to treat) in the past 12 months
* Unable to give informed consent
* Currently enrolled in another therapeutic study
* Thyroid dysfunction, as defined by abnormal thyroid function test results within the past 6 months
* Advanced stage of renal (stage 4 or above) or hepatic (cirrhosis) or respiratory (needs oxygen) or heart failure (NYHA class 3 or above)
* Active infection or malignancy
* Dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
* Clinician-reported history of patient non-adherence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05015504
Study Brief:
Protocol Section:
NCT05015504