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Clinical Trials in Canada / NCT04972955
Active, not recruiting Observational

Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Continuous Glucose Monitoring

NCT04972955 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2023-07-04
Last updated
2025-08-03

Condition(s) studied

Gestational DiabetesPrediabetes; Complicating PregnancyType 2 DiabetesPregnancy RelatedGlucose Metabolism DisordersMetabolic DiseaseEndocrine System Diseases

Investigational drug(s) / intervention(s)

Freestyle Libre 2Freestyle Libre 2

Freestyle Libre 2: Participants will wear a continuous glucose monitoring device, the Freestyle Libre 2, for two weeks following delivery.

Freestyle Libre 2: Participants will wear a second continuous glucose monitoring device, the Freestyle Libre 2, for two weeks at 4-6 months postpartum and before their standard of care postpartum bloodwork after having gestational diabetes.

Study summary

Gestational diabetes is one of the most common medical disorders in pregnancy and is a major risk factor for the postpartum development of dysglycemia. Despite the high risk of developing dysglycemia, 50-80% of women with gestational diabetes are not receiving testing within a year postpartum. The investigators will conduct a prospective cohort study to examine the use of continuous glucose monitoring immediately postpartum to estimate the risk of maternal dysglycemia postpartum.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Pregnant individuals age 18 and older * Diagnosed with gestational diabetes by the Diabetes Canada guidelines (including both the preferred or alternate testing approaches) or have an HbA1c of 6.0-6.4% during pregnancy * Have any of the following: have an elevated fasting glucose (≥ 5.3 mmol/L) on the diagnostic 75g OGTT in pregnancy; required insulin or metformin for treatment during pregnancy; body mass index (BMI) ≥ 25kg/m\^2, yes/no (\<27 weeks gestation BMI of ≥25 kg/m\^2 or ≥27 weeks gestation predicted BMI of ≥ 25 kg/m\^2 using (current weight in kg - 10kg)/height in meters\^2) * Planned in-hospital delivery * Able to provide informed consent * Willingness to use the study device and complete assessments postpartum * Have access to email in order to complete participant questionnaire through REDCap Exclusion Criteria: * A clinical diagnosis of non-gestational diabetes (i.e., pre-existing type 1 or 2 diabetes) prior to or during pregnancy * Planned x-ray, MRI or CT within 3 weeks postpartum * Has an implantable medical device (ex. pacemaker) * On medications known to affect glucose metabolism (for example glucocorticoids, metformin etc.) while wearing the CGM postpartum * On medications which may interfere with the Freestyle Libre 2 accuracy (for example Vitamin C \>1000mg/day) while wearing the CGM postpartum * Unable to speak and understand French or English * Unable to consent or declined informed consent

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
University of Calgary Calgary Alberta
University of Manitoba Winnipeg Manitoba
Mount Sinai Hospital Toronto Ontario
Universite Laval Québec Quebec

More University of Manitoba trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04972955 on ClinicalTrials.gov ↗ ← All trials in Canada