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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT03887403
Eligibility Criteria:
Inclusion Criteria:
* Age range between 40 and 75 years.
* Patients with DM2 undergoing regular treatment with at least one type of OAD for the last 6 months.
* HbA1c ≥7.5% in the last laboratory test.
* PC patients that have attended consultation in at least 2 occasions for reasons related to their diabetes.
* Patients that will remain in the HC area during the follow-up period.
* Patients willing to provide Informed Consent to participate in the study.
Exclusion Criteria:
* Patients whose diabetes is monitored in specialized care consultations or private clinics, and attend the HC only for medical prescription.
* Patients diagnosed with a terminal disease and a survival prognosis of less than 1 year.
* Patients already taking part in another clinical trial.
* Patients on a surgery waiting list and/or not expecting to complete the follow-up period.
* Pregnant women.
* Patients with cognitive impairment.
* Patients suffering from severe chronic pathologies (kidney failure requiring hemodialysis; cardiac insufficiency of a degree equal to or higher than III/IV according to the classification by the New York Heart Association; respiratory insufficiency requiring treatment with continuous oxygen therapy and/or chemotherapy).
* Patients suffering from a psychiatric disorder that requires neuroleptics treatment.
* Drug use or alcohol abuse (\>60 gr/day).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03887403
Study Brief:
Protocol Section:
NCT03887403