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Search / Trial NCT04972955

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

Launched by UNIVERSITY OF MANITOBA · Jul 12, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Gestational Diabetes Pregnancy Prediabetes Prospective Cohort Study Type 2 Diabetes Cgm Continuous Glucose Monitoring Flash Glucose Monitoring Screening

ClinConnect Summary

This clinical trial is studying how continuous glucose monitoring (a device that tracks blood sugar levels) can help predict the risk of high blood sugar (dysglycemia) in women who have had gestational diabetes immediately after giving birth. Gestational diabetes is a condition that can occur during pregnancy and may increase the chances of developing diabetes later on. Many women do not get tested for high blood sugar after their pregnancy, even though it’s important for their health. The researchers want to see if using this monitoring device right after delivery can improve screening and help manage health risks.

To join the study, participants need to be at least 18 years old and have been diagnosed with gestational diabetes during their pregnancy. They also need to have specific health conditions, such as high blood sugar levels or a certain body weight. Participants will be asked to use a glucose monitoring device and complete some questionnaires online, and they should be comfortable communicating in English or French. This trial is currently recruiting participants, and it aims to improve awareness and management of blood sugar levels after pregnancy for better long-term health outcomes.

Gender

FEMALE

Eligibility 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

About University Of Manitoba

The University of Manitoba, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive expertise in medical research, public health, and community engagement to conduct rigorous and ethical clinical studies. The institution aims to translate scientific findings into practical applications that enhance patient care and improve health outcomes. Committed to fostering a culture of excellence and integrity, the University of Manitoba prioritizes participant safety and scientific validity in all its clinical research endeavors.

Locations

Calgary, Alberta, Canada

Calgary, Alberta, Canada

Toronto, Ontario, Canada

Winnipeg, Manitoba, Canada

Quebec City, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Jennifer Yamamoto, MD

Principal Investigator

University of Manitoba

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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