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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT01861756
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus for more than one year
* Agree to be followed for at least 6 months
* Willing to respond to survey questions immediately following the visit
* HbA1c value between 7.5% and 10%
* Need treatment intensification and there are more than one available treatment options
Exclusion Criteria:
* Decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment
* Is to transfer to another practice within the next 6 months
* Significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid
* Planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge
* Enrolled in other studies that require prolonged participation and follow-up
* Unable to speak Greek at a level necessary to complete the patient surveys and ensure involvement in decision making
* Women known to be pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01861756
Study Brief:
Protocol Section:
NCT01861756