Image

Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

Recruiting
18-50 years
Female
Phase N/A

Powered by AI

Overview

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.

Description

Gestational diabetes (GDM) is associated with a significantly increased risk of type 2 diabetes, with 1/3 of individuals with GDM developing glucose intolerance in the first 3 years postpartum. The American Diabetes Association recommends a follow up oral glucose tolerance test (OGTT) 4-12 weeks after delivery for all patients with GDM, but rates of follow up screening are as low as 19%. OGTT presents many challenges to postpartum patients, including lengthy visits and the need to fast for at least 8 hours, that likely impact these follow up rates. There is also evidence that many individuals with normal OGTT develop dysglycemia within the first year postpartum, leading to concerns about the diagnostic yield of OGTT. Continuous glucose monitors (CGM) have revolutionized the care of type 1 and 2 diabetes, but its utility in GDM is poorly studied. There are many potential benefits of CGM as a possible GDM postpartum screening, including the ability to transmit data remotely and increased glycemic data, but the impact CGMs have on quality of life postpartum and if they would be acceptable screening methods for patients after delivery has yet to be studied. Our research aims to understand the acceptability and feasibility of CGM for detection of ongoing dysglycemia in the postpartum period in GDM. A sample of 20 postpartum individuals with a history of GDM will have CGMs placed at 6-8 weeks postpartum . Participants will have surveys after the CGM period about CGM impact on quality of life as well as complete a validated glucose monitoring satisfaction survey. They will then complete the standard of care OGTT at 10-12 weeks postpartum and be asked to compare their experience with CGM versus OGTT and which screening method they found preferable. Wear times and study dropout rates will be analyzed for intervention fidelity as a marker of feasibility. The investigators will begin to characterize postpartum glycemia by mean serum glucose, time in range (TIR) and coefficient of variation (CV) as measured by CGM. Glycemic data will be compared to a 12-week OGTT to determine relative sensitivity. This study could determine if CGM may provide a novel screening method for postpartum GDM that is acceptable to patients.

Eligibility

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 details
    Gestational Diabetes
    Hyperglycemia

NCT06184373

Ohio State University

31 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.