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:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT00605592
Eligibility Criteria:
Inclusion Criteria:
* Type I Diabetes Mellitus for at least 5 years
* Unstable control of diabetes despite intensive care by an endocrinologist, including episodes of dangerously low blood sugars
* Group I must have healthy kidneys
* Group II (islet after kidney) must have a stable kidney allograft for at least 6 months
Exclusion Criteria:
* Unstable diabetic eye disease
* Poor kidney function
* Type II Diabetes as determined by blood tests
* Any history of cancer, except certain skin cancers
* Pregnant or unwilling to use adequate birth control
* Very high hemoglobin A1c levels
* Poor control of blood pressure, despite use of medications
* Very high insulin requirements
* History of exposure to HIV
* Active Hepatitis B or Hepatitis C infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00605592
Study Brief:
Protocol Section:
NCT00605592