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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT03006666
Eligibility Criteria:
Inclusion Criteria:
* Having at least one HbA1c result in the prediabetic range (5.7-6.5%) in the 5 years prior to the start date of Phase 2.
Exclusion Criteria:
* A diagnosis of DM, based on ICD-9 codes applied during ambulatory encounters in the 2 years prior to Phase 2
* Treatment with DM medication other than metformin (e.g. insulin or oral agents)
* age greater than 75 years
* exclusion by patient's PCP due to contraindication for lifestyle intervention or CHW outreach.
* Does not speak English or Spanish (necessary to communicate with community health worker)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03006666
Study Brief:
Protocol Section:
NCT03006666