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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT01578460
Eligibility Criteria:
Inclusion Criteria:
* First Nations (self-identified)
* On-reserve (living or receiving care)
* Informed consent to participate
* Adults aged 18 years or older
* Diagnosed with gestational diabetes (GDM) or type 2 diabetes (T2DM)
* Pregnant (less than or equal to 36 weeks o gestation)
* Consent to have primary care giver informed of participation in teh project
* Willingness to perform required study and data collectin procedures and adhere to the operating requirements of the iPro2 and/or the glucose meter
* Willingness to wear the iPro 2 continuous glucose monitor (CGM) for 5 days for the 28th, 32nd, 36th week of pregnancy (for participants in the CGM group)
* Willingness to perform at least 4 finger prick testing per day during the Monitoring Week of the 28th, 32nd, 36th week of pregnancy (for CGM and control group)
Exclusion Criteria:
* Lack of decision making capacity to provide consent
* Participating in another diabetes and/or lifestyle improvement research project
* Non-First Nations descent
* Pregnant diagnosed with type 1 diabetes
* Pregnant not diagnosed with GDM or T2DM
* Pregnant women past 36th week of gestation
* Participants who do not consent to have their primary care giver informed of project participation
* The participant has a history of tape allergies that have not been resolved
* The participant has any skin abnormality (e.g. Psoriasis, rash, staphylococcus infection) that has not been resolved and would inhibit her from wearing the sensor
* Any other condition (s) that in the Investigator's opinion would warrant exclusion from the study or prevent the participant from completing the project
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01578460
Study Brief:
Protocol Section:
NCT01578460