Eligibility Module

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: 2025-12-24 @ 10:10 PM
Ignite Modification Date: 2025-12-24 @ 10:10 PM
NCT ID: NCT04854135
Eligibility Criteria: Inclusion Criteria: 1. 18 years of age or older 2. Have diabetes (type 1 diabetes mellitus, type 2 diabetes mellitus, cystic fibrosis related diabetes mellitus) 3. Hemoglobin A1c greater than or equal to 8.0% or history of hypoglycemia unawareness 4. Able and willing to sign informed consent form 5. Have a valid telephone number 6. Willing to purchase FreeStyle Libre 2 CGM sensors out of pocket after discharge from hospital (when insurance coverage isn't available) Exclusion Criteria: 1. Unable to sign informed consent form 2. Have altered mental status 3. Unable to manage diabetes independently at home 4. Have utilized CGM in the past 5. Pregnancy 6. New steroid-induced hyperglycemia 7. Unwilling to participate in the study 8. Have kidney disease requiring hemodialysis 9. Taking high doses of vitamin C daily (greater than 500 mg every day)
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT04854135
Study Brief:
Protocol Section: NCT04854135