An observational study in Gestational Diabetes, Prediabetes; Complicating Pregnancy and Type 2 Diabetes, sponsored by University of Manitoba. Active, not recruiting at 4 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by University of Manitoba · Observational
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 240 is above the median of 200 across 269 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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People who are currently pregnant and have been diagnosed with gestational diabetes during the current pregnancy
Exclusion Criteria:
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.
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.
The diagnostic accuracy of CGM as a screening test for postpartum dysglycemia.
Diagnostic accuracy will be measured as sensitivity, specificity, positive likelihood ratio and negative likelihood ratio.
Time frame: 1-14 days postpartum; 4-6 months postpartum
New diagnosis of maternal diabetes or prediabetes based on HbA1c alone, and a combination of the 75-gram OGTT and the HbA1c.
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.
Time frame: 4-6 months postpartum
Acceptability of CGM based on an acceptability questionnaires after device return and after final testing.
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.
Time frame: 15-17 days postpartum; 4-6 months postpartum
Dyslipidemia at time of postpartum bloodwork.
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.
Time frame: 4-6 months postpartum
Glycemic variability reflected by coefficients of variation and standard deviations of blood glucose data.
Blood glucose data will be collected using the Freestyle Libre 2 continuous glucose monitoring system.
Time frame: 1-14 days postpartum; 4-6 months postpartum
Cardiometabolic and related health outcomes diagnosed by regular healthcare team.
Information on dysglycemia, hypertension, cardiovascular disease, and additional health outcomes will be obtained through administrative provincial databases and chart review.
Time frame: 1, 2 and 5 years postpartum
Cost component analysis of CGM vs. 75g OGTT.
Costs of assessing blood glucose via CGM versus lab-derived OGTT results will be compared.
Time frame: 4-6 months to 5 years postpartum
Plan to share: No
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University of Manitoba