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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT00937703
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes since more than 3 years and claiming a strict balance glycemic;
* Patients treated since at least 3 months, by metformin and secreting insulinic (KNOWN or glinide);
* Patients uncontrolled with HbA1c ≥ 7.5% and \< 10% at the inclusion.
* BMI \< 40 ;
* Patients requiring a insulin treatment
* Patients agree to start a slow insulin treatment
* Patients already practising the glycemic self-monitoring or agree to learn it and practise it;
* Patients able to include/understand operation and to use the PDA-phone and/or the SVI;
* Patient not taking part in another biomedical research study
* Patients agree to carry out at least 2 finger sticks per day;
* More than 18 years, there is no higher age limit.
Exclusion Criteria:
* Patients introducing any evolutionary pathology associated and not stabilized, exhibitor with an uncontrolled diabetes during the year to come;
* Patients in a situation which justifies of a clinical follow-up diabetologic more frequent than that (quarterly) envisaged by the study
* Patients requiring a transitory passage to insulin;
* Patients needing a hospitalization for the adaptation of insulin doses;
* Patients presenting a cardiologic event
* Patients presenting a hemoglobinopathy interfering with the proportioning of HbA1c;
* Patients suffering from drug-addiction, alcoholism or psychological troubles
* Type 1 or secondary diabetes
* Patients who don't need strict metabolic objectives;
* Pregnant or parturient patients
* person with no freedom.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00937703
Study Brief:
Protocol Section:
NCT00937703