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 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 1:13 AM
NCT ID:
NCT02687893
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of type 1 diabetes mellitus for at least 1 year.
2. Male or female subjects 21 to 45 years of age.
3. Physically active on a regular basis, i.e. at least 3 days of physical activity per week.
4. Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
5. Current use of an insulin pump.
6. Willingness to follow all study procedures, including attending all clinic visits.
7. Willingness to sign informed consent and HIPAA documents.
Exclusion Criteria:
1. Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an intrauterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
2. Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
3. Renal insufficiency (GFR \< 60 ml/min, using the MDRD equation as report by the OHSU laboratory).
4. Impaired liver function, defined as AST or ALT ≥2.5 times upper limit of normal, according to OHSU laboratory reference ranges.
5. Hematocrit of less than or equal to 34%.
6. History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator.
7. Adrenal insufficiency.
8. Any active infection.
9. Known or suspected abuse of alcohol, narcotics, or illicit drugs (except marijuana use).
10. Seizure disorder.
11. Active foot ulceration.
12. Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
13. Major surgical operation within 30 days prior to screening.
14. Use of an investigational drug within 30 days prior to screening.
15. Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
16. Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
17. Insulin resistance requiring more than 200 units per day.
18. Need for uninterrupted treatment with acetaminophen.
19. Current administration of oral or parenteral corticosteroids.
20. Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
21. C peptide level of ≥0.5 ng/ml
22. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
23. Beta blockers or non-dihydropyridine calcium channel blockers.
24. A positive response to any of the questions from the Physical Activity Readiness Questionnaire.
25. Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.
26. Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT02687893
Study Brief:
Protocol Section:
NCT02687893