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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT02940418
Eligibility Criteria:
Inclusion Criteria:
1. Adult Patients with Type 1 Diabetes Mellitus.
2. Age from 18 years to 35 years either gender.
3. Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml
4. C-Peptide at inclusion base line should not be less than 0.5 ng/ml
5. No clinical evidence of renal, retinal, vascular or skin complications
6. Body Mass Index not exceeding 30
7. Any HbA1c
8. At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2)
9. Informed Consent by patient
Exclusion Criteria:
1. Age less than 18 years and more than 35 years
2. Pregnancy
3. Married women or women expected to be married within the study period
4. History of allergy, Cancer, bronchial asthma, liver disease or hepatitis
5. Diabetic coma or pre-coma current or recent within the last 2 months
6. C-Peptide less than 0.5 ng/ml
7. Disease duration more than 3 yrs.
8. Complication mentioned in 5 above in inclusion
9. Non-consenting patient or withdrawal of consent.
10. Bleeding disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02940418
Study Brief:
Protocol Section:
NCT02940418