Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Cont… (NCT04972955) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Continuous Glucose Monitoring
Canada240 participantsStarted 2023-07-04
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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
What they're measuring
1
The diagnostic accuracy of CGM as a screening test for postpartum dysglycemia.
Timeframe: 1-14 days postpartum; 4-6 months postpartum