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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT04642534
Eligibility Criteria:
Inclusion Criteria:
* Age 18-40 years
* Breastfeeding mothers at 4-8 week postpartum
* With or without gestational diabetes mellitus diagnosed at 24-32 gestational weeks, according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) consensus criteria
* Confident use of a smartphone and able to take regular pictures of food/drinks
Exclusion Criteria:
* Pre-existing diabetes (prior to pregnancy)
* Major illness/fever over the 2 weeks (prior to the visits with blood tests)
* Shift work or work at irregular hours planned after maternity leave
* Active cancer and/or oncologic treatment over the previous 12 months
* Coagulation disorder, on regular anticoagulant drug, skin disorder affecting wound healing
* Enrolled in a clinical trial / intervention study
* Major known mental illness, unable to give informed consent
* Inability to follow the study procedures
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04642534
Study Brief:
Protocol Section:
NCT04642534