Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

Study Overview
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Brief Summary
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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. We will ask postpartum women to use CGM intermittently for 12 weeks and answer surveys about quality of life while wearing the CGM. We will collect data on blood glucose trends for future studies if participants find CGM use acceptable. We hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.

Detailed Description
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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 15 pregnant individuals with GDM and 5 pregnant individuals without GDM will be recruited and have CGMs placed intermittently at regularly scheduled pediatric visits for the first 12 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 12 weeks 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. We will begin to characterize postpartum glycemia by mean serum glucose, time in range (TIR) and coefficient of variation (CV) as measured by CGM and trended throughout the first 12 weeks postpartum. These results will be compared between women with GDM and women without GDM to determine if there are noteworthy differences that may suggest time periods for future study. Glycemic data will also 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 both acceptable to patients and scientifically valid.

Official Title
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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

Conditions
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Gestational Diabetes, Hyperglycemia

Intervention / Treatment
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* Device: Dexcom G7 CGM
* Diagnostic Test: Oral Glucose Tolerance Test
* Diagnostic Test: Hemoglobin A1c


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with a viable singleton intrauterine pregnancy Able to understand the study, and having understood, provide written informed consent in English Agreeable to following up at OSU mother-infant dyad clinic postpartum 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Participants will be recruited during pregnancy, with the first device placed at 37 weeks pregnant. After that, CGMs will be placed at regularly scheduled infant follow up visits for a total of 5 CGM periods. After wearing the CGM, participants will fill out surveys regarding their experience. At 12 weeks postpartum, they will complete the standard of care OGTT as well as complete an interview regarding their experience | Device: Dexcom G7 CGM<br>* CGMs will be worn intermittently for a maximum of 10 days per period for a total of 5 periods<br>Diagnostic Test: Oral Glucose Tolerance Test<br>* At 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.<br>Diagnostic Test: Hemoglobin A1c<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of CGM | As determined by survey | 15 weeks from enrollment | 
| Comparative experience of OGTT and CGM | As determined by survey | 15 weeks from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and characteristics of dysglycemia in GDM postpartum | As determined by survey | 15 weeks from enrollment | 
| Lifestyle changes survey | Breastfeeding practices, changes in diet and physical activity | 15 weeks from enrollment | 
| Medical care | Number of doctor's visits (both for participant and their infant), prescribed medications | 15 weeks from enrollment |