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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT02073058
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be at least 18 years of age.
2. Subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment.
3. Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily) for at least 6 months prior to enrollment.
4. Subject must be able to read and understand English.
5. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
6. Subject must be available to participate in all study visits.
7. Subject must be willing and able to provide written signed and dated informed consent.
Exclusion Criteria:
1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
2. Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).
3. Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
4. Subject currently is participating in another clinical trial.
5. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
6. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to:
• History of HIV, Hepatitis B or C
7. Subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding.
8. Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
9. Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02073058
Study Brief:
Protocol Section:
NCT02073058