Continuous Glucose Monitoring to Detect Postpartum Dysglycemia in Patients With Gestational Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blinded Continuous Glucose Monitoring Device.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this study is to determine the ability of postpartum continuous glucose monitoring (CGM) for subjects with gestational diabetes (GDM) to predict dysglycemia on 4-12 week postpartum oral glucose tolerance test (OGTT).
Detailed description
Gestational diabetes (GDM) is glucose intolerance that develops during pregnancy. In the US, GDM affected 8.3% of pregnancies in 2021. Persistent glucose intolerance is present in up to 20% of women at post-partum follow up and subsequent risk for type 2 diabetes is significantly increased. All patients with GDM should undergo post-partum oral glucose tolerance test (OGTT) at 4-12 weeks to identify persistence glucose intolerance or overt diabetes. Detecting postpartum dysglycemia in people with GDM is a critical step for reducing long-term risk of type 2 diabetes and its associated complications. However, \<50% of people complete the postpartum OGTT due to barriers in transportation, finances, and childcare. Recent studies have examined the use of postpartum continuous glucose monitoring (CGM) and proposed CGM metrics to predict dysglycemia on postpartum OGTT in people with GDM. These findings should be validated in other cohorts to confirm broad applicability.
This pilot study aims to enroll subjects with GDM at the University of Chicago to wear a blinded CGM for 14 days postpartum (study intervention) and then complete a OGTT at 4-12 weeks postpartum (standard of care).
Interventions
- Device Blinded Continuous Glucose Monitoring Device
Subjects will be asked to wear blinded continuous glucose monitoring device for 14 days.
Primary outcome measures
- Determine the ability of continuous glucose monitoring to predict dysglycemia [Time frame: baseline to Day 70]
Eligibility criteria
Inclusion criteria
- Age greater than or equal to 18
- Completed pregnancy with delivery of a live born infant(s). Pregnancies with multiple gestations will be included
- No prior history of type 1 or type 2 diabetes
\* Patients with a history of gestational diabetes (GDM) in a prior pregnancy will be eligible for inclusion.
- GDM diagnosis by standard screening at 24-28 weeks
- 2 hour 75g oral glucose tolerance test (OGTT); one abnormal value required for diagnosis
- Fasting glucose 92
- 1 hour 180
- 2 hour 153
- 3 hour 100g OGTT - two abnormal values required for diagnosis
- Fasting glucose - 95
- 1 hour 180
- 2 hour 155
- 3 hour 140
There are no exclusion criteria for this study. Eligibility will be based on inclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- QuickStats: Percentage of Mothers with Gestational Diabetes,* by Maternal Age - National Vital Statistics System, United States, 2016 and 2021. MMWR Morb Mortal Wkly Rep. 2023 Jan 6;72(1):16. doi: 10.15585/mmwr.mm7201a4. No abstract available. PMID 36602935
- Kjos SL, Buchanan TA, Greenspoon JS, Montoro M, Bernstein GS, Mestman JH. Gestational diabetes mellitus: the prevalence of glucose intolerance and diabetes mellitus in the first two months post partum. Am J Obstet Gynecol. 1990 Jul;163(1 Pt 1):93-8. doi: 10.1016/s0002-9378(11)90676-0. PMID 2375376
- Catalano PM, Vargo KM, Bernstein IM, Amini SB. Incidence and risk factors associated with abnormal postpartum glucose tolerance in women with gestational diabetes. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):914-9. doi: 10.1016/0002-9378(91)90438-w. PMID 1951553
- American Diabetes Association Professional Practice Committee. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S306-S320. doi: 10.2337/dc25-S015. PMID 39651985
- Werner EF, Has P, Kanno L, Sullivan A, Clark MA. Barriers to Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2019 Jan;36(2):212-218. doi: 10.1055/s-0038-1667290. Epub 2018 Jul 30. PMID 30060291
- Cabrera C et al. Postpartum Dysglycemia Screening with Continuous Glucose Monitoring. Diabetes 2024;73(Supplement_1):1973-LB
Identifiers
NCT: NCT07034261 · IRB25-0910