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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT04803357
Eligibility Criteria:
Inclusion Criteria:
1. Pregnancy and Gestation \< 30 weeks
2. Singleton pregnancy
3. Confirmed gestational diabetes (by 75g or 100g oral glucose tolerance test or HbA1c)
4. Able to read English and completed 6th grade
5. Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 \[HIPAA\] legislation), communicate with the investigator, and understand and comply with protocol requirements
Exclusion Criteria:
1. Pre-gestational Type 1 or Type 2 diabetes.
2. Newly diagnosed overt-diabetes in pregnancy \[HbA1c ≥ 48 mmol/mol (6.5%), fasting glucose ≥ 7.0 mmol/l, random glucose ≥ 11.1 mmol/l\].
3. Pregnancies with established fetal anomalies (aside from echogenic intracardiac foci and/or renal pyelectasis) or possible preterm delivery secondary to maternal disease besides GDM
4. Known endogenous/exogenous Cushing's syndrome
5. Known chronic infections
6. Current use of any oral form of steroid medication
7. Already receiving continuous glucose monitoring (CGM)
8. History of bariatric surgery
9. Gestational Age less than 14 weeks -
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT04803357
Study Brief:
Protocol Section:
NCT04803357