Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

Gestational Diabetes Clinical Trial

— ENGAGED  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06184373
• Other study ID #: 2023H0066
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Hyperglycemia

Intervention

Device:
• Dexcom G6/G7 CGM
CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum.

Diagnostic Test:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant outcomes	in-hospital medical record review	birth outcomes only
Primary	Acceptability of CGM	As determined by survey	15 weeks from enrollment
Primary	Comparative experience of OGTT and CGM	As determined by survey	15 weeks from enrollment
Secondary	Prevalence and characteristics of dysglycemia in GDM postpartum	As determined by survey	15 weeks from enrollment
Secondary	Lifestyle changes survey	Breastfeeding practices, changes in diet and physical activity	15 weeks from enrollment
Secondary	Medical care	Number of doctor's visits (both for participant and their infant), prescribed medications	15 weeks from enrollment