Continuous Glucose Monitoring for Gestational Diabetes

KA
Overseen ByKatherine A Sauder, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if continuous glucose monitoring (CGM) after pregnancy offers a better method for checking blood sugar in those who had gestational diabetes, a type of diabetes that develops during pregnancy. Typically, the oral glucose tolerance test (OGTT) is used, but many find it inconvenient. The trial compares CGM with the standard OGTT and no screening at all. This research could improve follow-up care and future health outcomes for mothers. Ideal participants are 12-16 weeks postpartum and had gestational diabetes in their most recent pregnancy. As an unphased trial, this study allows participants to contribute to research that could enhance postpartum care and health monitoring.

What prior data suggests that continuous glucose monitoring is safe for postpartum women?

Research shows that continuous glucose monitoring (CGM) safely and effectively tracks blood sugar levels. Studies have found that CGM is easier to use than traditional methods and provides more detailed glucose information. This can improve gestational diabetes management and prevent related health issues.

In past studies, pregnant patients using CGM received consistent glucose readings, indicating it is well-tolerated. Although some experts note that more data is still being collected, CGM is generally considered safe for managing glucose levels. Significant reports of serious side effects have not emerged, making it a promising option for those who find other tests difficult.12345

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring (CGM) for gestational diabetes because it offers real-time insights into blood sugar levels, allowing for more precise and timely adjustments to diet and lifestyle. Unlike standard options like the oral glucose tolerance test (OGTT), which provides only a snapshot of glucose levels at a single point in time, CGM tracks glucose levels continuously, offering a comprehensive picture of how levels fluctuate throughout the day. This continuous data can help expectant mothers manage their health more effectively and may improve outcomes for both mother and baby.

What evidence suggests that continuous glucose monitoring is effective for gestational diabetes?

Research has shown that continuous glucose monitoring (CGM) can benefit women with gestational diabetes. Studies have found that CGM keeps blood sugar levels in the target range more often than traditional methods. It also reduces the risk of having larger-than-normal babies, a common concern with gestational diabetes. Additionally, CGM helps detect high blood sugar levels and reduces nighttime low blood sugar episodes. In this trial, one group will use postpartum CGM to manage blood sugar levels after pregnancy. While more research is needed for some groups, these early findings suggest CGM could effectively manage blood sugar levels postpartum.12678

Who Is on the Research Team?

KA

Katherine A Sauder, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for women who are 12-16 weeks postpartum and were diagnosed with gestational diabetes during their most recent pregnancy. They must have an order for an Oral Glucose Tolerance Test in their medical record. Women with pre-gestational diabetes or those who do not speak English cannot participate.

Inclusion Criteria

12-16 weeks postpartum
Gestational diabetes Mellitus (GDM) diagnosis in most recent pregnancy
Oral Glucose Tolerance Test (OGTT) order placed in the medical record

Exclusion Criteria

Pre-gestational diabetes
I do not speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postpartum CGM

Participants use continuous glucose monitoring to assess glycemic status postpartum

20 weeks
Fully remote

Follow-up

Participants are monitored for initiation of follow-up care after abnormal results

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous Glucose Monitoring

Trial Overview

The study is testing the use of a continuous glucose monitoring device, Freestyle LibrePro by Abbott, over a period of 14 days to screen for abnormal blood sugar levels after giving birth in women who had gestational diabetes.

How Is the Trial Designed?

3

Treatment groups

Active Control

Group I: Postpartum CGMActive Control1 Intervention
Group II: Postpartum OGTTActive Control1 Intervention
Group III: No screeningActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Medstar Health Research Institute

Collaborator

Trials
202
Recruited
187,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

University of North Carolina, Chapel Hill

Collaborator

Trials
1,588
Recruited
4,364,000+

Citations

Continuous Glucose Monitoring for Diabetes Management ...

The ADA has concluded that data are insufficient to recommend CGM for all pregnant individuals with T2D or GDM, and that the decision to use CGM ...

Real-Time Continuous Glucose Monitoring in Pregnancies ...

We demonstrated a significantly higher %TIR using real-time CGM compared with CBG glucose monitoring among pregnant people with GDM. Studies are ...

Glycaemic control and pregnancy outcomes with real-time ...

rt-CGM use in women with gestational diabetes reduced LGA births, without differences in serious adverse events. The higher-than-expected ...

Continuous glucose monitoring in early gestational diabetes ...

We also found that CGM in pregnant women with GDM may be more effective in detecting hyperglycaemia and reducing nocturnal hypoglycaemia.

Evidence for improved glucose metrics and perinatal ...

Evidence for improved glucose metrics and perinatal outcomes with continuous glucose monitoring compared to self-monitoring in diabetes during pregnancy.

Expert Perspectives on Evolving Evidence on CGM Use in ...

Continuous glucose monitoring (CGM) is a method of assessing and monitoring glucose levels that provide real-time data for glucose management.

Continuous glucose monitoring in gestational diabetes ...

Compared with SMBG, CGM is easier for performing and providing more comprehensive glucose data to improve the management of GDM and prevent associated adverse ...

Glucose levels measured with continuous ...

Mean glucose levels and time 63–120 mg/dL (3.5–6.7 mmol/L) remained nearly stable throughout pregnancy and values above 140 mg/dL (7.8 mmol/L) were rare.