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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT02241993
Eligibility Criteria:
Inclusion Criteria:
1. Type 1 diabetes mellitus diagnosed for at least 6 months
2. Current usage of multiple daily injections or subcutaneous insulin pump treatment
3. Age 18-65 years
4. HbA1c of 6.0 - 9.5% at screening visit
5. BMI 21-35
6. Willingness to follow all study procedures, including attending all clinic visits
7. Willingness to sign informed consent and HIPAA documents
Exclusion Criteria: Subjects presenting with any of the following will not be included in the study.
1. Pregnancy or Lactation: for women of childbearing potential there is a requirement for a negative urine pregnancy test.
2. Renal insufficiency (serum creatinine of 2.0 mg/dL or greater). Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less the 3.3 g/dL; or serum bilirubin of over 2.
3. Hematocrit of less than or equal to 34%.
4. Congestive heart failure, NYHA class III or IV.
5. Visual impairment preventing reading of glucose meter values.
6. Active coronary artery disease as manifested by unstable angina, or a myocardial infarction or therapeutic coronary percutaneous procedure (e.g., PTCA, stent placement) or CABG within the past 4 months.
7. Active foot ulceration.
8. Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
9. Cerebrovascular accident within the past 6 months.
10. Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).
11. Active malignancy, except basal cell or squamous cell skin cancers.
12. Major surgical operation within 30 days prior to screening.
13. Seizure disorder (epilepsy).
14. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
15. Currently administration of oral or parenteral corticosteroids.
16. Use of an investigational drug within 30 days prior to screening.
17. Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02241993
Study Brief:
Protocol Section:
NCT02241993