Continuous Glucose Monitor for Gestational Diabetes
(VALID Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method for diagnosing gestational diabetes, a type of diabetes that can develop during pregnancy. Researchers aim to determine if a continuous glucose monitor, a device that tracks blood sugar levels, aids in early detection. They seek pregnant individuals between 24 and 32 weeks who receive prenatal care at Mount Sinai Hospital. This trial may suit those not already diagnosed with diabetes and carrying one baby. Participants will wear the monitor for 10 days to gather the necessary data. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance early diagnosis methods for gestational diabetes.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it excludes those using steroids. It's best to discuss your specific medications with the trial team.
What prior data suggests that this continuous glucose monitor is safe for diagnosing gestational diabetes?
Research has shown that using a continuous glucose monitor (CGM) is safe during pregnancy. In one study, pregnant women with diabetes who used a CGM experienced better health outcomes compared to those using traditional finger-prick tests. Another study found the CGM safe for pregnant women with gestational diabetes. These studies reported no major safety issues. Overall, the CGM is generally well-tolerated and helps manage blood sugar levels more effectively during pregnancy.12345
Why are researchers excited about this trial?
Researchers are excited about using continuous glucose monitors (CGMs) for managing gestational diabetes because they offer a real-time, dynamic way to track blood sugar levels. Unlike traditional methods that rely on periodic finger-prick tests, CGMs provide continuous data, helping to catch fluctuations that might otherwise go unnoticed. This technology allows for more precise and timely adjustments to diet and insulin therapy, potentially leading to better outcomes for both mother and baby. Additionally, CGMs can enhance the convenience and comfort for pregnant women by reducing the need for frequent manual tests.
What evidence suggests that using a continuous glucose monitor is effective for diagnosing gestational diabetes?
Studies have shown that continuous glucose monitors (CGM) effectively manage gestational diabetes. These devices stabilize blood sugar levels by providing real-time information. Research indicates that CGM use keeps blood sugar levels within the target range more frequently. Additionally, CGM detects high blood sugar and reduces low blood sugar at night better than traditional finger-prick tests. Evidence also suggests that CGM users experience better pregnancy outcomes, such as healthier babies and fewer complications for the mother. Overall, CGM offers a promising method for effectively managing gestational diabetes.12678
Who Is on the Research Team?
Angela Bianco, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
This clinical trial is for pregnant individuals aged 18-50 receiving prenatal care at Mount Sinai Hospital. They are being considered for participation during their standard prenatal appointments and must consent to the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants have a 10-day application of a continuous glucose monitor (CGM) to assess blood glucose levels
Follow-up
Participants are monitored for blood glucose levels postpartum and through glucose tolerance tests
What Are the Treatments Tested in This Trial?
Interventions
- Continuous Glucose Monitor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor