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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women diagnosed with gestational diabetes | Pregnant individuals who have been diagnosed with gestational diabetes during the current pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freestyle Libre 2 | Device | Participants will wear a continuous glucose monitoring device, the Freestyle Libre 2, for two weeks following delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-14 days postpartum; 4-6 months postpartum |
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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People who are currently pregnant and have been diagnosed with gestational diabetes during the current pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Yamamoto, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N1N4 | Canada | ||
| University of Manitoba |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18463375 | Background | 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. | |
| 27703026 | Background |
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| Freestyle Libre 2 | Device | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 4-6 months to 5 years postpartum |
| Winnipeg |
| Manitoba |
| R3E3P4 |
| Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5T3L9 | Canada |
| Universite Laval | Québec | Quebec | G1V4G2 | Canada |
| Sellers 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. |
| 30208453 | Background | Lowe 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. |
| 18984776 | Background | Ferrara 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. |
| 24567578 | Background | McGovern 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. |
| 28506815 | Background | Butalia 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. |
| 29650105 | Background | Diabetes 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. |
| 1951534 | Background | Neiger 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. |
| 20105163 | Background | Meltzer 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. |
| 40738649 | Derived | Sigurdson 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. |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011236 | Prediabetic State |
| D011248 | Pregnancy Complications |
| D003924 | Diabetes Mellitus, Type 2 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D009750 | Nutritional and Metabolic Diseases |
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