Gestational DiabetesPREDISPOSENCT04972955
Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Continuous Glucose Monitoring
An observational study of Gestational Diabetes and Prediabetes; Complicating Pregnancy, run by University of Manitoba at 4 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Prediabetes; Complicating Pregnancy, Type 2 Diabetes
- What is being tested?
- Freestyle Libre 2
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 4 sitesCanada
- Study dates
- 4 Jul 2023to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: People who are currently pregnant and have been diagnosed with gestational diabetes during the current pregnancy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
University of Calgary
Calgary, Alberta, T2N1N4
Universite Laval
Québec, Quebec, G1V4G2
Mount Sinai Hospital
Toronto, Ontario, M5T3L9
University of Manitoba
Winnipeg, Manitoba, R3E3P4
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes, Prediabetes; Complicating Pregnancy, Type 2 Diabetes, Pregnancy Related, Glucose Metabolism Disorders, Metabolic Disease
- Being tested
- Freestyle Libre 2
- Keywords
- Gestational Diabetes, Pregnancy, Prediabetes, Prospective Cohort Study, Type 2 Diabetes, CGM, Continuous Glucose Monitoring, Flash Glucose Monitoring, Screening
- Medical subject headings
- Diabetes, Gestational, Prediabetic State, Pregnancy Complications, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle Libre 2Device
Participants will wear a continuous glucose monitoring device, the Freestyle Libre 2, for two weeks following delivery.
Freestyle Libre 2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women diagnosed with gestational diabetes | Pregnant individuals who have been diagnosed with gestational diabetes during the current pregnancy Receives: Device: Freestyle Libre 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-14 days postpartum; 4-6 months postpartum
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-6 months to 5 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start4 Jul 2023
- Primary completion25 Jul 2025
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Yamamoto, University of Manitoba
- Investigators
- Jennifer Yamamoto, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972955
- Sponsor's protocol ID
- REB20-1660
- Acronym
- PREDISPOSE
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2021
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
PubMed 18463375Sellers EA, Dean HJ, Shafer LA, Martens PJ, Phillips-Beck W, Heaman M, Prior HJ, Dart AB, McGavock J, Morris M, Torshizi AA, Ludwig S, Shen GX. Exposure to Gestational Diabetes Mellitus: Impact on the Development of Early-Onset Type 2 Diabetes in Canadian First Nations and Non-First Nations Offspring. Diabetes Care. 2016 Dec;39(12):2240-2246. doi: 10.2337/dc16-1148. Epub 2016 Oct 4.
PubMed 27703026Lowe WL Jr, Scholtens DM, Lowe LP, Kuang A, Nodzenski M, Talbot O, Catalano PM, Linder B, Brickman WJ, Clayton P, Deerochanawong C, Hamilton J, Josefson JL, Lashley M, Lawrence JM, Lebenthal Y, Ma R, Maresh M, McCance D, Tam WH, Sacks DA, Dyer AR, Metzger BE; HAPO Follow-up Study Cooperative Research Group. Association of Gestational Diabetes With Maternal Disorders of Glucose Metabolism and Childhood Adiposity. JAMA. 2018 Sep 11;320(10):1005-1016. doi: 10.1001/jama.2018.11628.
PubMed 30208453Ferrara A, Peng T, Kim C. Trends in postpartum diabetes screening and subsequent diabetes and impaired fasting glucose among women with histories of gestational diabetes mellitus: A report from the Translating Research Into Action for Diabetes (TRIAD) Study. Diabetes Care. 2009 Feb;32(2):269-74. doi: 10.2337/dc08-1184. Epub 2008 Nov 4.
PubMed 18984776McGovern A, Butler L, Jones S, van Vlymen J, Sadek K, Munro N, Carr H, de Lusignan S. Diabetes screening after gestational diabetes in England: a quantitative retrospective cohort study. Br J Gen Pract. 2014 Jan;64(618):e17-23. doi: 10.3399/bjgp14X676410.
PubMed 24567578Butalia S, Donovan L, Savu A, Johnson J, Edwards A, Kaul P. Postpartum Diabetes Testing Rates after Gestational Diabetes Mellitus in Canadian Women: A Population-Based Study. Can J Diabetes. 2017 Dec;41(6):613-620. doi: 10.1016/j.jcjd.2016.12.013. Epub 2017 May 12.
PubMed 28506815Diabetes Canada Clinical Practice Guidelines Expert Committee; Feig DS, Berger H, Donovan L, Godbout A, Kader T, Keely E, Sanghera R. Diabetes and Pregnancy. Can J Diabetes. 2018 Apr;42 Suppl 1:S255-S282. doi: 10.1016/j.jcjd.2017.10.038. No abstract available.
PubMed 29650105Neiger R, Coustan DR. The role of repeat glucose tolerance tests in the diagnosis of gestational diabetes. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):787-90. doi: 10.1016/0002-9378(91)90418-q.
PubMed 1951534Meltzer SJ, Snyder J, Penrod JR, Nudi M, Morin L. Gestational diabetes mellitus screening and diagnosis: a prospective randomised controlled trial comparing costs of one-step and two-step methods. BJOG. 2010 Mar;117(4):407-15. doi: 10.1111/j.1471-0528.2009.02475.x. Epub 2010 Jan 26.
PubMed 20105163Sigurdson SM, Bernier KJ, Donovan LE, Feig DS, Lemieux P, Pylypjuk C, Shen GX, Jiang D, Nerenberg K, Chrisp MM, Katz PM, Benham JL, Yamamoto JM. Predicting dysglycaemia in individuals with gestational diabetes immediately postpartum using continuous glucose monitoring (PREDISPOSE) in a multicentre prospective cohort study in Canada: a study protocol. BMJ Open. 2025 Jul 30;15(7):e103771. doi: 10.1136/bmjopen-2025-103771.
PubMed 40738649
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT04972955
- Acronym / sponsor ID
- PREDISPOSE / REB20-1660
- Conditions
- Gestational Diabetes, Prediabetes; Complicating Pregnancy, Type 2 Diabetes, Pregnancy Related, Glucose Metabolism Disorders, Metabolic Disease
- Keywords
- Gestational Diabetes, Pregnancy, Prediabetes, Prospective Cohort Study, Type 2 Diabetes, CGM, Continuous Glucose Monitoring, Flash Glucose Monitoring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women diagnosed with gestational diabetes | – | Device: Freestyle Libre 2Pregnant individuals who have been diagnosed with gestational diabetes during the current pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who are currently pregnant and have been diagnosed with gestational diabetes during the current pregnancy
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freestyle Libre 2Participants will wear a continuous glucose monitoring device, the Freestyle Libre 2, for two weeks following delivery. | Device | Pregnant women diagnosed with gestational diabetes |
| Freestyle Libre 2Participants 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. | Device | Pregnant women diagnosed with gestational diabetes |
Primary outcome
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.
6 secondary outcomes
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
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
Dyslipidemia at time of postpartum bloodwork.
Time frame: 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
Cardiometabolic and related health outcomes diagnosed by regular healthcare team.
Time frame: 1, 2 and 5 years postpartum
Cost component analysis of CGM vs. 75g OGTT.
Time frame: 4-6 months to 5 years postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 18463375HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Background: PubMed 27703026Sellers EA, Dean HJ, Shafer LA, Martens PJ, Phillips-Beck W, Heaman M, Prior HJ, Dart AB, McGavock J, Morris M, Torshizi AA, Ludwig S, Shen GX. Exposure to Gestational Diabetes Mellitus: Impact on the Development of Early-Onset Type 2 Diabetes in Canadian First Nations and Non-First Nations Offspring. Diabetes Care. 2016 Dec;39(12):2240-2246. doi: 10.2337/dc16-1148. Epub 2016 Oct 4.
- Background: PubMed 30208453Lowe WL Jr, Scholtens DM, Lowe LP, Kuang A, Nodzenski M, Talbot O, Catalano PM, Linder B, Brickman WJ, Clayton P, Deerochanawong C, Hamilton J, Josefson JL, Lashley M, Lawrence JM, Lebenthal Y, Ma R, Maresh M, McCance D, Tam WH, Sacks DA, Dyer AR, Metzger BE; HAPO Follow-up Study Cooperative Research Group. Association of Gestational Diabetes With Maternal Disorders of Glucose Metabolism and Childhood Adiposity. JAMA. 2018 Sep 11;320(10):1005-1016. doi: 10.1001/jama.2018.11628.
- Background: PubMed 18984776Ferrara A, Peng T, Kim C. Trends in postpartum diabetes screening and subsequent diabetes and impaired fasting glucose among women with histories of gestational diabetes mellitus: A report from the Translating Research Into Action for Diabetes (TRIAD) Study. Diabetes Care. 2009 Feb;32(2):269-74. doi: 10.2337/dc08-1184. Epub 2008 Nov 4.
- Background: PubMed 24567578McGovern A, Butler L, Jones S, van Vlymen J, Sadek K, Munro N, Carr H, de Lusignan S. Diabetes screening after gestational diabetes in England: a quantitative retrospective cohort study. Br J Gen Pract. 2014 Jan;64(618):e17-23. doi: 10.3399/bjgp14X676410.
- Background: PubMed 28506815Butalia S, Donovan L, Savu A, Johnson J, Edwards A, Kaul P. Postpartum Diabetes Testing Rates after Gestational Diabetes Mellitus in Canadian Women: A Population-Based Study. Can J Diabetes. 2017 Dec;41(6):613-620. doi: 10.1016/j.jcjd.2016.12.013. Epub 2017 May 12.
- Background: PubMed 29650105Diabetes Canada Clinical Practice Guidelines Expert Committee; Feig DS, Berger H, Donovan L, Godbout A, Kader T, Keely E, Sanghera R. Diabetes and Pregnancy. Can J Diabetes. 2018 Apr;42 Suppl 1:S255-S282. doi: 10.1016/j.jcjd.2017.10.038. No abstract available.
- Background: PubMed 1951534Neiger R, Coustan DR. The role of repeat glucose tolerance tests in the diagnosis of gestational diabetes. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):787-90. doi: 10.1016/0002-9378(91)90418-q.
- Background: PubMed 20105163Meltzer SJ, Snyder J, Penrod JR, Nudi M, Morin L. Gestational diabetes mellitus screening and diagnosis: a prospective randomised controlled trial comparing costs of one-step and two-step methods. BJOG. 2010 Mar;117(4):407-15. doi: 10.1111/j.1471-0528.2009.02475.x. Epub 2010 Jan 26.
- Derived from this study: PubMed 40738649Sigurdson SM, Bernier KJ, Donovan LE, Feig DS, Lemieux P, Pylypjuk C, Shen GX, Jiang D, Nerenberg K, Chrisp MM, Katz PM, Benham JL, Yamamoto JM. Predicting dysglycaemia in individuals with gestational diabetes immediately postpartum using continuous glucose monitoring (PREDISPOSE) in a multicentre prospective cohort study in Canada: a study protocol. BMJ Open. 2025 Jul 30;15(7):e103771. doi: 10.1136/bmjopen-2025-103771.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Yamamoto, MD principal investigator
University of Manitoba
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Prediabetes; Complicating Pregnancy, run by University of Manitoba at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic accuracy of CGM as a screening test for postpartum dysglycemia. (time frame: 1-14 days postpartum; 4-6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972955, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.