NCT04972955Active, not recruiting
Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Continuous Glucose Monitoring
Source: ClinicalTrials.gov · Last updated 3 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 240 (actual)
- First submitted
- 28 Jun 2021
- Start date
- 4 Jul 2023
- Primary completion date
- 25 Jul 2025
- Lead sponsor
- University of Manitoba
- Diseases
- Type 2 diabetes
- NCT number
- NCT04972955
What you commit to
- Study type: Observational
- Participants enrolled: 240
- From 4 Jul 2023 to the primary completion date, 25 Jul 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A clinical diagnosis of non-gestational diabetes (i.e., pre-existing type 1 or 2 diabetes) prior to or during pregnancy
- On medications which may interfere with the Freestyle Libre 2 accuracy (for example Vitamin C \>1000mg/day) while wearing the CGM postpartum
Lab values
- On medications known to affect glucose metabolism (for example glucocorticoids, metformin etc.) while wearing the CGM postpartum
Other
- Planned x-ray, MRI or CT within 3 weeks postpartum
- Has an implantable medical device (ex. pacemaker)
- Unable to speak and understand French or English
- Unable to consent or declined informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| University of Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.