Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06184373
Status
Recruiting
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Conditions

  • Gestational Diabetes
  • Hyperglycemia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Continuous glucose monitor — DEVICE
    CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum.
  • 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.
  • 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

Study Details

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.

Key Dates

Start date
Jun 6, 2025
Status verified
Jan 2026
Primary completion
May 30, 2026
Completion
May 30, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Acceptability of CGM [ Time Frame: 15 weeks from enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Medical CenterColumbusOhio43210
Rece Foss
[email protected]
614-293-8000

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By research site
Ohio State University Medical Center· Columbus, OH

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