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

Type 2 Diabetes Clinical Trial

— PREDISPOSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972955
• Other study ID #: REB20-1660
• Status: Recruiting
• Start date: July 4, 2023
• Est. completion date: February 1, 2028

Study information

• Verified date: December 2023
• Source: University of Manitoba
• Contact: Jennifer Yamamoto, MD
• Phone: (204) 789-3697
• Email: jennifer.yamamoto[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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/m2, yes/no (<27 weeks gestation BMI of =25 kg/m2 or =27 weeks gestation predicted BMI of = 25 kg/m2 using (current weight in kg - 10kg)/height in meters2)

• Planned in-hospital delivery

• Able to provide informed consent

• Willingness to use the study device and complete assessments

• Have access to email in order to complete participant questionnaire through REDCap

Exclusion Criteria:

• Non-gestational diabetes (i.e. pre-existing diabetes)

• 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.)

• On medications which may interfere with the Freestyle Libre 2 accuracy (for example Vitamin C >1000mg/day)

• Unable to speak and understand French or English

• Unable to consent or declined informed consent

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Endocrine System Diseases
• Gestational Diabetes
• Glucose Intolerance
• Glucose Metabolism Disorders
• Metabolic Disease
• Metabolic Diseases
• Prediabetes; Complicating Pregnancy
• Prediabetic State
• Pregnancy Complications
• Pregnancy Related
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Universite Laval	Quebec City	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View Citation

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. Erratum In: Can J Diabetes. 2018 Jun;42(3):337. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New diagnosis of maternal diabetes or prediabetes based on 75g OGTT	Maternal diabetes defined as fasting plasma glucose = 7.0mmol/L or 2-hour plasma glucose of = 11.1 mmol/L and maternal prediabetes defined as fasting plasma glucose 6.1-6.9 mmol/L or 2-hour plasma glucose of 7.8-11.0 mmol/L. Both are defined by the Diabetes Canada 2018 Clinical Practice Guidelines.	4-6 months postpartum
Secondary	New diagnosis of maternal diabetes or prediabetes based on postpartum HbA1c	Diabetes is defined as HbA1c = 6.5% and prediabetes is defined as HbA1c 6.0-6.4%.	4-6 months postpartum
Secondary	Acceptability of testing using the device based on an acceptability questionnaire	The Acceptability Questionnaire for the Freestyle Libre 2 Postpartum will be completed at two points throughout the study. Scores can range between 7 and 60, with a higher score indicating a worse outcome.	15-17 days postpartum; 4-6 months postpartum
Secondary	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.	Delivery to 2 weeks postpartum
Secondary	New diagnosis of dysglycemia and additional health outcomes	Information on new pre-diabetes, type 2 diabetes, and overt diabetes diagnoses and additional health outcomes will be obtained through administrative provincial databases and chart review.	1, 2 and 5 years postpartum
Secondary	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