PREDISPOSE: Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Flash Glucose Monitoring
Study Details
Study Description
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 flash glucose monitoring immediately postpartum to estimate the risk of maternal dysglycemia postpartum.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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 women 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. Third, when including the direct medical costs, transportation costs, and the indirect time costs, it is estimated that the 75g OGTT costs $108/woman screened. 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. Flash 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) that is placed by a research assistant and removed by the participant. 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. Flash glucose monitoring gives a detailed picture of glycemic excursions throughout the day including both fasting and postprandial states.
There are currently no studies examining the use of flash glucose monitoring postpartum. Furthermore, no studies have examined flash glucose monitoring's potential role in diagnosis of maternal dysglycemia. There is an unmet need to improve postpartum screening for women with gestational diabetes so that high risk women do not miss the opportunity for early treatment. To address this, the investigators will perform a study examining the use of flash 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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Pregnant women diagnosed with gestational diabetes Pregnant women who have been diagnosed with gestational diabetes during the current pregnancy |
Device: Freestyle Libre 2
Participants will wear a flash glucose monitoring device, the Freestyle Libre 2, for two weeks following delivery.
|
Outcome Measures
Primary Outcome Measures
- New diagnosis of maternal diabetes based on 75g OGTT [4-6 months postpartum]
Maternal diabetes defined as fasting plasma glucose ≥ 7.0mmol/L or 2-hour plasma glucose of ≥ 11.1 mmol/L
- New diagnosis of maternal prediabetes based on 75g OGTT [4-6 months postpartum]
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
Secondary Outcome Measures
- New diagnosis of maternal diabetes based on postpartum HbA1c [4-6 months postpartum]
Diabetes is defined as HbA1c ≥ 6.5%
- New diagnosis of maternal prediabetes based on postpartum HbA1c [4-6 months postpartum]
Prediabetes is defined as HbA1c 6.0-6.4%
- Acceptability of testing using the device based on an acceptability questionnaire [15-17 days postpartum; 4-6 months postpartum]
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.
- Glycemic variability reflected by coefficients of variation and standard deviations of blood glucose data [Delivery to 2 weeks postpartum]
Blood glucose data will be collected using the Freestyle Libre 2 flash glucose monitoring system
- New diagnosis of type 2 diabetes [1, 2 and 5 years postpartum]
Information on new type 2 diabetes diagnoses will be obtained through administrative provincial databases
- Cost component analysis of CGM vs. 75g OGTT [4-6 months to 5 years postpartum]
Costs of assessing blood glucose via CGM versus lab-derived OGTT results will be compared.
Eligibility Criteria
Criteria
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)
-
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)
-
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Calgary
Investigators
- Principal Investigator: Jennifer Yamamoto, MD, University of Calgary
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Erratum in: Can J Diabetes. 2018 Jun;42(3):337.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Epub 2016 Oct 4.
- REB20-1660