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:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT03320993
Eligibility Criteria:
Inclusion Criteria:
Patients with type 1 diabetes mellitus for more than one year, aged between 18 and 60 years; on intensive insulin therapy by means of CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for at least 6 months before screening; glycosylated haemoglobin of 6-8.5%; without severe chronic micro- and macroangiopathic diabetic complications and with a body mass index (BMI) between 18 and 30 kg/m2.
Exclusion Criteria:
* Pregnancy and lactation
* Hypoglycemia unawareness
* Fatal or progressive disease
* Drugs or alcohol abuse
* HIV, active hepatitis B, active hepatitis C
* Hepatic disease (aminotransferases AST or ALT \>2 times above normal)
* Clinically relevant microangiopathic disease, or other diseases that may interfere with participation in the study or data analysis
* Pre-planned surgery
* Blood donation in the previous 3 months for men and 6 months for women
* Mental conditions that may interfere with the subject's comprehension of the aims and possible consequences of the study
* Non-compliant subjects
* Use of experimental medications or devices during the previous 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03320993
Study Brief:
Protocol Section:
NCT03320993