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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03705260
Eligibility Criteria:
Inclusion Criteria:
* Michigan Medicine patient treated by a physician in the Family Medicine Department at the Chelsea Health Center
* Diagnosis of T2D as recorded in the patient's problem list or as documented by medication list and lab results
* HbA1C \>8 for the high-risk sub-cohort
Exclusion Criteria:
* Individuals for whom tight control (ie A1C \< 8) is not safe or recommended, including but not limited to older frail individuals at high-risk of hypoglycemia and falls or those with a life expectancy of less than 6 months due to a comorbid condition
* Individuals with cognitive or psychological diagnoses that might make CGM or low carbohydrate dieting risky, such as patients with eating disorders, uncontrolled psychotic - mental illness or those patients with dementia
* Women who are pregnant or breast feeding
* Individuals who had previous bariatric surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03705260
Study Brief:
Protocol Section:
NCT03705260