Gestational DiabetesENGAGEDNCT06184373
Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot
An observational study of Gestational Diabetes and Hyperglycemia, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Hyperglycemia
- What is being tested?
- Continuous glucose monitor, Oral Glucose Tolerance Test and Hemoglobin A1c
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to 30 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: We anticipate enrolling a total of 20 participants with a recent pregnancy affected by GDM
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University Medical Center
Columbus, Ohio, 43210
Rece Foss, 614-293-8000, rece.foss@osumc.edu
About this study
Official title: Early Investigation of Glucose Monitoring After Gestational Diabetes (ENGAGED): Utility and Acceptability of Continuous Glucose Monitoring in the Early Postpartum Period After Gestational Diabetes Mellitus
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.
Read the detailed 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.
- Conditions
- Gestational Diabetes, Hyperglycemia
- Being tested
- Continuous glucose monitor, Oral Glucose Tolerance Test, Hemoglobin A1c
- Medical subject headings
- Diabetes, Gestational, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitorDevice
Also called CGM
CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum.
Oral Glucose Tolerance TestDiagnostic 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 A1cDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous glucose monitor; Diagnostic Test: Oral Glucose Tolerance Test; Diagnostic Test: Hemoglobin A1c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of CGM
As determined by survey
Measured: 15 weeks from enrollment
Comparative experience of OGTT and CGM
As determined by survey
Measured: 15 weeks from enrollment
Secondary outcomes (3)
Prevalence and characteristics of dysglycemia in GDM postpartum
As determined by survey
Measured: 15 weeks from enrollment
Lifestyle changes survey
Breastfeeding practices, changes in diet and physical activity
Measured: 15 weeks from enrollment
Medical care
Number of doctor's visits (both for participant and their infant), prescribed medications
Measured: 15 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start6 Jun 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Rachel D'Amico, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184373
- Sponsor's protocol ID
- 2023H0066
- Acronym
- ENGAGED
- Status last verified
- Jul 2026
- First submitted
- 14 Dec 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided