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

NCT04972955 | Active Not Recruiting

• 1 other identifier: REB20-1660
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Gestational Diabetes; Prediabetes; Complicating Pregnancy; Type 2 Diabetes; Pregnancy Related; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

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.

  4-6 months postpartum

• Acceptability of CGM based on an acceptability questionnaires after device return and after final testing.

  15-17 days postpartum; 4-6 months postpartum

• Dyslipidemia at time of postpartum bloodwork.

  4-6 months postpartum

• Glycemic variability reflected by coefficients of variation and standard deviations of blood glucose data.

  1-14 days postpartum; 4-6 months postpartum

• Cardiometabolic and related health outcomes diagnosed by regular healthcare team.

  1, 2 and 5 years postpartum

Study Arms (1)

Pregnant women diagnosed with gestational diabetes

Pregnant individuals who have been diagnosed with gestational diabetes during the current pregnancy

Device: Freestyle Libre 2

Interventions

Freestyle Libre 2 DEVICE

Participants will wear a continuous glucose monitoring device, the Freestyle Libre 2, for two weeks following delivery.

Pregnant women diagnosed with gestational diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (4)

University of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3E3P4, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T3L9, Canada

Location

Universite Laval

Québec, Quebec, G1V4G2, Canada

Location

Related Publications (10)

• 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.

  PMID: 18463375 BACKGROUND

• 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.

  PMID: 27703026 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.

  PMID: 30208453 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.

  PMID: 18984776 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.

  PMID: 24567578 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.

  PMID: 28506815 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.

  PMID: 29650105 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.

  PMID: 1951534 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.

  PMID: 20105163 BACKGROUND

• 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.

  PMID: 40738649 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Prediabetic State; Pregnancy Complications; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Nutritional and Metabolic Diseases

Study Officials

• Jennifer Yamamoto, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 22, 2021
• Study Start: July 4, 2023
• Primary Completion: July 25, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)