Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

NCT06184373 | Recruiting DMC FDA Device

• 1 other identifier: 2023H0066
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.

Conditions

Gestational Diabetes; Hyperglycemia

Outcome Measures

Primary Outcomes (2)

• Acceptability of CGM

  As determined by survey

  15 weeks from enrollment

• Comparative experience of OGTT and CGM

  As determined by survey

  15 weeks from enrollment

Secondary Outcomes (3)

• Prevalence and characteristics of dysglycemia in GDM postpartum

  15 weeks from enrollment

• Lifestyle changes survey

  15 weeks from enrollment

• Medical care

  15 weeks from enrollment

Other Outcomes (1)

• Infant outcomes

  birth outcomes only

Study Arms (1)

Participants

Participants will be recruited at 6-8 weeks postpartum; at that appointment, CGMs will be placed. After wearing the CGM, participants will fill out surveys regarding their experience. At 10-12 weeks postpartum, they will complete the standard of care OGTT as well as complete an interview regarding their experience. At 12 months postpartum, they will complete a blood test to check their hemoglobin A1c.

Device: Continuous glucose monitor; Diagnostic Test: Oral Glucose Tolerance Test; Diagnostic Test: Hemoglobin A1c

Interventions

Continuous glucose monitor DEVICE

CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum.

Also known as: CGM

Participants

Oral Glucose Tolerance Test DIAGNOSTIC_TEST

At 10-12 weeks postpartum, participants will complete an oral glucose tolerance test, which involves drinking a glucose substance and having glucose levels measured a maximum of 3 times.

Participants

Hemoglobin A1c DIAGNOSTIC_TEST

At 11-14 months postpartum, participants will be asked to have their blood drawn to check their hemoglobin A1c to look for signs of developed insulin resistance

Participants

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We anticipate enrolling a total of 20 participants with a recent pregnancy affected by GDM

You may qualify if:

• Women with a viable singleton intrauterine pregnancy
• Able to understand the study, and having understood, provide written informed consent in English
• Recent pregnancy affected by gestational diabetes

You may not qualify if:

• Pregestational Diabetes (Type I or Type II)
• Continued use of diabetes medications (including metformin and insulin) immediately after delivery
• Preterm delivery (\< 37 weeks gestation)
• Twin or higher order gestation
• No access to a smartphone
• Unable or unwilling to wear CGM or return for follow up at postpartum mother-infant dyad clinic
• Participation in this trial in a prior pregnancy
• History of skin allergy to adhesive products or CGM

Sponsors & Collaborators

• Ohio State University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Hyperglycemia

Interventions

Glucose Tolerance Test

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Central Study Contacts

Rachel Gordon, MD, MPH

CONTACT

614-293-7980; rachel.gordon@osumc.edu

Seuli Brill, MD

CONTACT

614-293-7980; seuli.brill@osumc.edu

Study Design

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

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: June 6, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)