Using continuous glucose monitoring to predict dysglycemia after gestational diabetes
Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Continuous Glucose Monitoring
This study is testing if continuous glucose monitoring can help women who had gestational diabetes find out if they have blood sugar problems after giving birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Manitoba Academic / other |
| Locations | 4 sites (Calgary, Alberta and 3 other locations) |
| Trial ID | NCT04972955 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the risk of dysglycemia in women who have experienced gestational diabetes by utilizing continuous glucose monitoring immediately postpartum. The study will involve a prospective cohort of pregnant individuals diagnosed with gestational diabetes, who will be monitored using the Freestyle Libre 2 device. The goal is to improve screening rates for dysglycemia, which is often overlooked despite its high prevalence in this population. By identifying risk factors and monitoring glucose levels, the study seeks to provide better postpartum care for these women.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 and older who have been diagnosed with gestational diabetes.
Not a fit: Patients with pre-existing diabetes or those who are unable to use the study device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and early intervention for dysglycemia in postpartum women, potentially reducing the risk of developing type 2 diabetes.
How similar studies have performed: Other studies have explored continuous glucose monitoring in various populations, but this specific approach for postpartum dysglycemia in gestational diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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/m2, yes/no (\<27 weeks gestation BMI of ≥25 kg/m2 or ≥27 weeks gestation predicted BMI of ≥ 25 kg/m2 using (current weight in kg - 10kg)/height in meters2) * Planned in-hospital delivery * Able to provide informed consent * Willingness to use the study device and complete assessments * Have access to email in order to complete participant questionnaire through REDCap Exclusion Criteria: * Non-gestational diabetes (i.e. pre-existing diabetes) * 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.) * On medications which may interfere with the Freestyle Libre 2 accuracy (for example Vitamin C \>1000mg/day) * Unable to speak and understand French or English * Unable to consent or declined informed consent
Where this trial is running
Calgary, Alberta and 3 other locations
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- University of Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- Universite Laval — Quebec City, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Jennifer Yamamoto, MD — University of Manitoba
- Study coordinator: Jennifer Yamamoto, MD
- Email: jennifer.yamamoto@umanitoba.ca
- Phone: (204) 789-3697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.