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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT02127827
Eligibility Criteria:
Inclusion Criteria:
1. Subject is 18 to 70 years of age at time of screening
2. Subject's weight is between 50 and 120 kg
3. A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
4. Subject has ongoing use of an insulin pump ≥ 6 months prior to screening
5. Subject has an glycated hemoglobin value ≤ 9.0% demonstrated at the time of enrollment.
6. Subject uses a rapid-acting analogue insulin in his/her pump
7. Patient is willing to undergo all study procedures
Exclusion Criteria:
1. Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
2. Subject has unresolved adverse skin condition, or unable to tolerate tape adhesive, in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
3. Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
4. Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
5. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), congestive heart failure, ventricular rhythm disturbances, or thromboembolic disease within the past 6 months
6. Subject has a presence of a cardiac pacemaker or any other device that may be sensitive to radio frequency telemetry
7. Subject has any condition, including screening lab values that in the opinion of the Investigator may preclude him/her from participating in the study and completing study related procedures
8. Subject is actively participating in other investigational study (drug or device)
9. Subjects who consume alcohol daily
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02127827
Study Brief:
Protocol Section:
NCT02127827