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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT02367534
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients age 18 to 60 years of age.
* Ability to provide written informed consent.
* Clinical history compatible with type 1 diabetes (T1DM) as defined by the WHO guidelines(2007) on the Diagnosis and classification of Diabetes Mellitus.
* manifest signs and symptoms that are severe enough to be incapacitating.
* Basal C-peptide\<0.5ng/mL
* patients with poor diabetes control (HbA1c \>7% but \<12%)
* progressive diabetic complications.
Exclusion Criteria:
* age \<18 years or \>60 years
* diabetic history \<5 years
* BMI\>27
* body weight \>80kg
* exogenous insulin requirement \>1 unit/kg/day
* severe anemia (male \<8g/dl, female \<7g/dl)
* low white blood cell count (\<3000/dl)
* liver dysfunction
* Symptomatic peptic ulcer disease
* Any malignancy
* Active infection including hepatitis B, hepatitis C, HIV, or TB
* panel reactive antibody \>20%
* Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02367534
Study Brief:
Protocol Section:
NCT02367534