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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT05922033
Eligibility Criteria:
Inclusion Criteria:
* Pregnant individuals with a diagnosis of Gestational diabetes mellitus (GDM) between 20 0/7 to 31 6/7 - 32 6/7 weeks and requiring initiation of basal insulin initiation as determined by provider
* Patients not on insulin or insulin initiation within 7 days of consent and randomization
* ≥ 18 years old with the ability to give informed consent
* Diagnosed with GDM during pregnancy by a one-hour 50-gram glucose challenge test ≥200 mg/dL at greater than 20 weeks of gestation or two elevated values on a 3-hour or a 100-gram glucose tolerance test at greater than 20 weeks of gestation.
* English or Spanish speaking
* Receiving prenatal care at OSU or an affiliated clinic where Electronic Health Records (EHR) can be accessed
Exclusion criteria:
* Type 1 or 2 diabetes
* Insulin allergy
* Not English or Spanish speaking
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05922033
Study Brief:
Protocol Section:
NCT05922033