Blinded Continuous Glucose Monitoring Device
DeviceSubjects will be asked to wear blinded continuous glucose monitoring device for 14 days.
NCT Number: NCT07034261
The aim of this study is to determine the ability of postpartum continuous glucose monitoring (CGM) for subjects with gestational diabetes (GDM) to predict dysglycemia on 4-12 week postpartum oral glucose tolerance test (OGTT).
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Gestational diabetes (GDM) is glucose intolerance that develops during pregnancy. In the US, GDM affected 8.3% of pregnancies in 2021. Persistent glucose intolerance is present in up to 20% of women at post-partum follow up and subsequent risk for type 2 diabetes is significantly increased. All patients with GDM should undergo post-partum oral glucose tolerance test (OGTT) at 4-12 weeks to identify persistence glucose intolerance or overt diabetes. Detecting postpartum dysglycemia in people with GDM is a critical step for reducing long-term risk of type 2 diabetes and its associated complications. However, <50% of people complete the postpartum OGTT due to barriers in transportation, finances, and childcare. Recent studies have examined the use of postpartum continuous glucose monitoring (CGM) and proposed CGM metrics to predict dysglycemia on postpartum OGTT in people with GDM. These findings should be validated in other cohorts to confirm broad applicability.
This pilot study aims to enroll subjects with GDM at the University of Chicago to wear a blinded CGM for 14 days postpartum (study intervention) and then complete a OGTT at 4-12 weeks postpartum (standard of care).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
There are no exclusion criteria for this study. Eligibility will be based on inclusion criteria.
Subjects will be asked to wear blinded continuous glucose monitoring device for 14 days.
Time frame: baseline to Day 70
Assess the validity of the continuous glucose monitoring metrics (percentage) proposed by Cabrera et al. (percent time >180 of >4%)
Contact information is provided by the study sponsor or research team.
University of Chicago
Other
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