Recruiting

Glucose Monitoring

Sponsor:

Ohio State University

Code:

NCT06184373

Conditions

Gestational Diabetes

Hyperglycemia

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Continuous glucose monitor

Oral Glucose Tolerance Test

Hemoglobin A1c

Study Details

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

Study ID

NCT06184373

Start date

Jun 6, 2025

Status verified date

Jan, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Continuous glucose monitor

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

Oral Glucose Tolerance 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.

Hemoglobin A1c

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

Primary outcome measure

  • Acceptability of CGM [ Time Frame: 15 weeks from enrollment ]
  • Comparative experience of OGTT and CGM [ Time Frame: 15 weeks from enrollment ]

Central Contacts and Locations

Central contacts

Rachel Gordon, MD, MPH

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

Seuli Brill, MD

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

Locations

Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Rece Foss

614-293-8000rece.foss@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-01-22.