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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT02974816
Eligibility Criteria:
Inclusion Criteria:
1. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act (HIPAA) or other privacy authorization prior to any participation in study.
2. Subject has self-reported type 2 diabetes.
3. Subject has HbA1c ≥ 7.5% and ≤ 12.5% measured within 30 days of screening visit.
4. Subject is on a stable diabetes therapeutic regimen of two or more diabetic medications (e.g., metformin plus one other antihyperglycemic agent) and/or insulin therapy for at least 2 months before screening visit. Dose changes or adjustments made within 2 months is acceptable as long as the patient has been on the medication regimen for 2 months or longer.
5. Subject is ≥ 18 and ≤ 75 years of age.
6. Subject is a male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
7. If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study):
1. Condoms, sponge, diaphragm, or intrauterine device;
2. Oral or parenteral contraceptives for 3 months prior to screening visit;
3. Vasectomized partner;
4. Total abstinence from sexual intercourse
8. Subject is able to speak, read and write in English
9. Subject has a Glooko compatible smartphone/device with an active data plan or access to Wi-Fi and downloaded at least one mobile application on their phone on their own.
10. Subject has performed self-monitoring of blood glucose at least five (5) times within two (2) weeks prior to screening visit.
Exclusion Criteria:
1. Subject has type 1 diabetes.
2. Subject has advanced disease (physical or psychological) that would prevent them from being able to comply with study tasks and considered exclusionary by the study physicians.
3. Subject has been on medication or therapy within the last 2 months that severely affects blood glucose levels (e.g. corticosteroids).
4. Subject has visual impairment which severely limits his/her ability to see or use the mobile application.
5. Subject is a participant in another clinical study that has not been approved as a concomitant study by Glooko.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02974816
Study Brief:
Protocol Section:
NCT02974816