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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT07269405
Eligibility Criteria:
Inclusion Criteria:
1. Women with a history of gestational diabetes mellitus and one additional risk factor (obesity, family history of diabetes, impaired fasting glycemia and/or impaired glucose tolerance and/ and or risk understanding by yourself RUBY score of ≥ 8) at 6-12 weeks postpartum
2. Singleton pregnancy
3. Willingness, ability and commitment to comply with study procedures
4. In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
5. Normally residing in Hong Kong
6. Able to communicate in Chinese
7. Written informed consent to participate in the study provided by the patient
Exclusion Criteria:
1. Known current diabetes
2. Current or previous use of glucose-lowering or weight loss drugs at screening
3. Concurrent participation in other weight loss or lifestyle intervention programmes
4. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study
5. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff
6. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device
7. Known uncontrolled thyrotoxicosis
8. Current use of steroids
9. Known current or recent alcohol or drug abuse
10. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection
11. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07269405
Study Brief:
Protocol Section:
NCT07269405