Continuous Glucose Monitor for Gestational Diabetes
(VALID Trial)
Trial Summary
What is the purpose of this trial?
This is a prospective pilot study to assess the validity of using a continuous glucose monitor (CGM) in diagnosing gestational diabetes mellitus (GDM). Pregnant individuals between the ages of 18-50 years old receiving prenatal care at Mount Sinai Hospital (e..g, E-Level clinic and Faculty Practice Associates) will be enrolled. Potential participants will be approached during their prenatal care appointments. Participants will complete an informed consent form for the study during their standard-of-care prenatal appointments at our institution.
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 data supports the effectiveness of the treatment Continuous Glucose Monitor for Gestational Diabetes?
Continuous glucose monitoring (CGM) is shown to help pregnant women with diabetes manage their blood sugar levels better, which can lead to improved outcomes for both mother and baby. It provides continuous information about blood sugar changes, helping women make lifestyle adjustments and manage their condition more effectively.12345
Is continuous glucose monitoring safe for use in humans?
How does the continuous glucose monitor treatment differ from other treatments for gestational diabetes?
The continuous glucose monitor (CGM) offers a less invasive and more consistent way to track blood sugar levels compared to traditional self-monitoring methods, which can be burdensome. It provides real-time or intermittently scanned data, potentially improving blood sugar control and reducing complications during pregnancy.127910
Research Team
Angela Bianco, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
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
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
Treatment Details
Interventions
- Continuous Glucose Monitor
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor