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

August 1, 2025 updated by: Jennifer Yamamoto, University of Manitoba
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Gestational diabetes is one of the most common medical disorders in pregnancy and affects up to 18% of pregnancies. It is associated with an increased risk of both maternal and neonatal complications. Importantly, gestational diabetes is a major risk factor for the postpartum development of pre-diabetes or type 2 diabetes (together referred to as dysglycemia). Specifically, half of people with gestational diabetes will develop dysglycemia within 10 years of delivery. Despite the high risk of developing dysglycemia, 50-80% of women with recent gestational diabetes are not receiving testing within a year postpartum.

There are likely many factors contributing to this low screening rate. These include individual factors such as socioeconomic status and maternal age, as well as the nature of the guideline recommended test itself. The Diabetes Canada 2018 Clinical Practice Guidelines recommend screening for maternal dysglycemia between "6 weeks to 6 months postpartum" with a 75g oral glucose tolerance test (OGTT). This recommendation is based on expert opinion. While the 75g OGTT is thought to be the "gold-standard" for screening for dysglycemia postpartum, it has many pitfalls. First, the OGTT is widely disliked by women as it is time consuming and inconvenient. It requires consuming a sugary drink in addition to two separate venipunctures. Second, the 75g OGTT is notoriously unreproducible. Finally, it takes only a "snap shot" of a woman's glucose and insulin response with only two measurements over two-hours.

Emerging technologies are changing the landscape of diabetes care. Continuous glucose monitoring (Freestyle Libre 2) is one such technology. People easily insert a small cannula just under the skin using an applicator. While the device is in place, it measures interstitial glucose concentrations every 15 minutes. It is a small disc (~size of a quarter) and it can be worn during typical daily activities such as sleeping, showering, and exercising. The sensor can store up to 8 hours of glucose readings in 15-minute intervals. People scan the sensor using a smartphone or reader to upload glucose readings to the Freestyle Libre 2 app, which can be viewed by a clinician and/or researcher. Continuous glucose monitoring gives a detailed picture of glycemic excursions throughout the day including both fasting and postprandial states.

There are currently no published studies examining the use of continuous glucose monitoring postpartum. Furthermore, no studies have examined continuous glucose monitoring's potential role in diagnosis of maternal dysglycemia postpartum. There is an unmet need to improve postpartum screening for individuals with gestational diabetes so that high risk individuals do not miss the opportunity for early treatment. To address this, the investigators will perform a study examining the use of continuous glucose monitoring immediately postpartum to estimate the risk of maternal dysglycemia postpartum. This is an observational study which aims to see if CGM can be used to diagnose diabetes. The CGM device in this study will be used for diagnosis and not as an intervention.

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N1N4
        • University Of Calgary
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E3P4
        • University of Manitoba
    • Ontario
      • Toronto, Ontario, Canada, M5T3L9
        • Mount Sinai Hospital
    • Quebec
      • Quebec City, Quebec, Canada, G1V4G2
        • Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People who are currently pregnant and have been diagnosed with gestational diabetes during the current pregnancy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women diagnosed with gestational diabetes
Pregnant individuals who have been diagnosed with gestational diabetes during the current pregnancy
Device: Freestyle Libre 2
Participants will wear a continuous glucose monitoring device, the Freestyle Libre 2, for two weeks following delivery.
Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New diagnosis of maternal diabetes or prediabetes based on HbA1c alone, and a combination of the 75-gram OGTT and the HbA1c.
Time Frame: 4-6 months postpartum
Diabetes or prediabetes based on the postpartum 75-gram OGTT will be evaluated as fasting plasma glucose ≥7.0 mmol/L or 2-hour plasma glucose of ≥11.1 mmol/L or fasting plasma glucose 6.1-6.9 mmol/L or 2-hour plasma glucose of 7.8-11.1 mmol/L, respectively. Diabetes or prediabetes based on the postpartum HbA1c will be evaluated as ≥6.5 and ≥6.0%, respectively. Diabetes and prediabetes will be analyzed separately and together.
4-6 months postpartum
Acceptability of CGM based on an acceptability questionnaires after device return and after final testing.
Time Frame: 15-17 days postpartum; 4-6 months postpartum
The Acceptability Questionnaires for the Freestyle Libre 2 Postpartum will be completed at two points throughout the study. "Strongly agree/painless" and "agree/almost painless" will be considered as "rated favorably" in planned analyses.
15-17 days postpartum; 4-6 months postpartum
Dyslipidemia at time of postpartum bloodwork.
Time Frame: 4-6 months postpartum
Dyslipidemia is defined as abnormal levels of lipids in the bloodstream, which elevate cardiovascular risk. Lactation state will be recorded given impacts on lipid levels.
4-6 months postpartum
Glycemic variability reflected by coefficients of variation and standard deviations of blood glucose data.
Time Frame: 1-14 days postpartum; 4-6 months postpartum
Blood glucose data will be collected using the Freestyle Libre 2 continuous glucose monitoring system.
1-14 days postpartum; 4-6 months postpartum
Cardiometabolic and related health outcomes diagnosed by regular healthcare team.
Time Frame: 1, 2 and 5 years postpartum
Information on dysglycemia, hypertension, cardiovascular disease, and additional health outcomes will be obtained through administrative provincial databases and chart review.
1, 2 and 5 years postpartum
Cost component analysis of CGM vs. 75g OGTT.
Time Frame: 4-6 months to 5 years postpartum
Costs of assessing blood glucose via CGM versus lab-derived OGTT results will be compared.
4-6 months to 5 years postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Jennifer Yamamoto, MD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2023

Primary Completion (Actual)

July 25, 2025

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB20-1660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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