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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT02082028
Eligibility Criteria:
Inclusion Criteria:
* Males and females
* Age ≥ 45 years
* Type 2 diabetes
* First access at the diabetes clinic
* Any diabetes duration
* HbA1c \>7.0 and ≤ 9.0%
* Already treated with any oral antidiabetic agent (OAD) or requiring the initiation of therapy with OAD
* Patients not using SMBG or using SMBG with a frequency ≤1 test/week
* Written informed consent
Exclusion Criteria:
Treatment with insulin or need to start insulin regimens or continuous sub-cutaneous insulin infusion at the first access; Refusal or inability to give informed consent to participate in the study;
Conditions / situations such as:
* Patients with short life expectancy;
* Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment;
* Requirement for concomitant treatment that could bias primary evaluation (i.e. corticosteroid treatment);
* Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study;
* Current addition/abuse of alcohol or drugs;
* Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study;
* Pregnant or breast-feeding women;
* Patients living too far from investigational center or other conditions reducing the adherence to the protocol; Subjects unlikely or unable to comply with the Protocol requirements (e.g. illiterate, uncooperative, unable to return for follow-up visit, unable to use BGStar unlikely to complete the study)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT02082028
Study Brief:
Protocol Section:
NCT02082028