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 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT01411033
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed type 1 diabetes mellitus with features of complete insulin deficiency (serum C-peptide level \<0.05 ng/ml, acetonuria, blood gases disturbances such as: pH \<7.30, BE\< -6 mmol/l, HCO3 \<18 mmol/l)
* Age \< 35 years old
* Educational course in intensive insulin therapy started at the onset of the disease after treatment of ketoacidosis
* Written consent
Exclusion Criteria:
* Uncertain type of diabetes mellitus
* Kidney failure (serum creatinine level \> 1.1 mg/dl)
* Liver dysfunction (AspAt \> 31 U/l, AlAt \> 34 U/l)
* Acute inflammatory process
* Other concomitant diseases (i.e. neoplasm)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01411033
Study Brief:
Protocol Section:
NCT01411033