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 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT03083795
Eligibility Criteria:
Inclusion Criteria:
* Willingly provide your full informed consent to participate;
* Are at least 19 years of age;
* Have an established diagnosis of Type 2 diabetes mellitus;
* Have a Diabetes Distress Screening Scale (a score of 2-3 is considered moderate distress, 3-4 is considered high)
* Have a Social Provisions Scale score less than 60 (a score of 80-90 is considered high, 60-80 moderate and less than 60 sub-optimal)
* Have an A1c greater than 8.5% in the last 2 months (a score of 6-7 is considered optimal, 7-8 sub-optimal and \>8.0 inadequate)
Exclusion Criteria:
* Are unable to easily communicate in oral and written English.
* Have a physical disability or psychiatric diagnosis which would limit the ability to participate in the study;
* Are a prisoner, or in pre-trial;
* Do not have a fixed address;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03083795
Study Brief:
Protocol Section:
NCT03083795