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 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT01889706
Eligibility Criteria:
Inclusion Criteria:
* age \> 18 years \<60 years,
* duration of diabetes \>3 years,
* lack of metabolic control- HbA1C\>7,5% (despite participation in 5-day WHO education program)
* treated with intensive insulin therapy
Exclusion Criteria:
* metabolically decompensate diabetes with acetonuria,
* suspected lack of compliance,
* lack of glucose and ketones self-monitoring,
* hypoglycaemic unawareness or recurrent severe hypoglycemia (defined as more than two episodes of hypoglycemia lowered than 60 mg/dl with loss of consciousness, required assistance to treat) in the past 3 months,
* recurrent diabetic ketoacidosis (more than two episodes in the past year)
* another serious medical illness,
* pregnancy or sexually active woman unwilling to take birth control.
* renal impairment (estimated on the value calculated glomerular filtration rate using the MDRD formula-estimated glomerular filtration rate, eGFR\<45 mL / min
* liver cell damage Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) greater than twice the upper normal limit),
* history of drug or alcohol abuse or those who used this drug before
* changes in the way of antihypertensive and antihyperlipemic treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01889706
Study Brief:
Protocol Section:
NCT01889706