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)
The diagnostic accuracy of CGM as a screening test for postpartum dysglycemia. — 1-14 days postpartum; 4-6 months postpartum Diagnostic accuracy will be measured as sensitivity, specificity, positive likelihood ratio and negative likelihood ratio.
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.
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