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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT05161793
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of type 1 or type 2 diabetes for at least 6 months
2. HbA1C \>8% or any episode of level three hypoglycemia or diabetic ketoacidosis (DKA) in the past 6 months or at least once weekly episodes of level 1 or 2 hypoglycemia
3. Age \>18 years old
4. On medication for treatment of diabetes-any oral or injectable agents on a stable dose of medication for at least 3 months.
5. If on insulin performing blood glucose monitoring (BGM) at least 3 times per week
6. Patients may be current continuous glucose monitor (CGM) users, prior CGM users or naïve to CGM.
7. No serious illnesses where life expectancy is \<1 year
8. Understand the study requirements and agree to comply with all study visits and procedures, including the use of the study CGM.
9. Fluent in English or Spanish
10. Must have a smart phone or access to a computer that can connect to LibreView.
11. Under the care of a Los Angeles County + University of Southern California provider who can prescribe diabetes medications and make dose adjustments/medication intensification as needed.
Exclusion Criteria:
1. Severe tape allergy
2. Visual impairment such that CGM data cannot be viewed.
3. On dialysis
4. History of an adverse reaction to wearing CGM in the past (e.g., increased anxiety and/or an increase in acute diabetes complications such as DKA/severe hypoglycemia).
5. Subject is currently pregnant or lactating or plan on becoming pregnant during the course of the study.
6. Subject cannot follow instructions due to a medical condition or mental illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05161793
Study Brief:
Protocol Section:
NCT05161793