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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT01804803
Eligibility Criteria:
Inclusion Criteria:
* males and females
* age 18-70 yrs;
* insulin-treated diabetes (both type 1 and type 2 diabetes treated with at least 3 injections/day);
* diabetes diagnosis from at least 1 year;
* inadequate glycemic control (HbA1c ranging from 7.0% to 10.0%; local measurements within the last 6 weeks);
* ability and willingness to carry out SMBG;
* informed consent.
Exclusion Criteria:
* diagnosis of diabetes within less than 1 year;
* impending complications of diabetes: proliferative retinopathy or maculopathy (with significant loss of visual function), severe renal failure (eGFR \<30), severe neuropathy (autonomic dysfunction, peripheral neuropathy, gastroparesis);
* clinically significant, active (over the past 12 months) disease of the cardiovascular, gastrointestinal, neurological, genito-urinary, haematological systems or severe uncontrolled hypertension (SBP \>180 mmHg; DBP \>100 mmHg);
* diagnosis of active neoplasia within the last 5 years (history of chemotherapy or radiation treated malignancy within 5 years prior to study procedure, except for lymphoma);
* pregnancy or intention to become pregnant during the study;
* poor compliance to study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01804803
Study Brief:
Protocol Section:
NCT01804803