Continuous Glucose Monitoring to Detect Postpartum Dysglycemia in Patients With Gestational Diabetes

NCT07034261 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB25-0910
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Gestational Diabetes

Keywords

CGM Device

Outcome Measures

Primary Outcomes (1)

• Determine the ability of continuous glucose monitoring to predict dysglycemia

  Assess the validity of the continuous glucose monitoring metrics (percentage) proposed by Cabrera et al. (percent time \>180 of \>4%)

  baseline to Day 70

Study Arms (1)

Blinded Continuous Glucose Monitoring Device

EXPERIMENTAL

Subjects will wear a blinded continuous glucose monitoring device.

Device: Blinded Continuous Glucose Monitoring Device

Interventions

Blinded Continuous Glucose Monitoring Device DEVICE

Subjects will be asked to wear blinded continuous glucose monitoring device for 14 days.

Blinded Continuous Glucose Monitoring Device

Eligibility Criteria

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

You may qualify if:

• 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
• GDM diagnosis by standard screening at 24-28 weeks
• hour 75g oral glucose tolerance test (OGTT); one abnormal value required for diagnosis
• Fasting glucose 92
• hour 180
• hour 153
• hour 100g OGTT - two abnormal values required for diagnosis
• Fasting glucose - 95
• hour 180
• hour 155
• hour 140

Sponsors & Collaborators

• University of Chicago: lead

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Cabrera C et al. Postpartum Dysglycemia Screening with Continuous Glucose Monitoring. Diabetes 2024;73(Supplement_1):1973-LB

  BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Laura Dickens, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Dickens, MD

CONTACT

773-795-0460; ldickens1@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share