Gestational Diabetes Mellitus (GDM)VALIDNCT06858787
Validating CGM for GDM
A study testing Continuous glucose monitor in people with Gestational Diabetes Mellitus (GDM), run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Continuous glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Oct 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-50
- Singleton pregnancy between 24-32 weeks gestational age
- Prenatal care and delivery at Mount Sinai Hospital
Who cannot join
- Multiple fetal gestation
- Preexisting diabetes
- Concurrent use of steroids
- Anomalous fetus
- Insufficient prenatal care (identified as missing half the recommended visits or establishing care after 20 weeks gestation)
- Unable to tolerate oral glucose test
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mount Sinai West
New York, New York, 10019
Shelly Thai, MD, 917-755-3033, shelly.thai2@mountsinai.org
Nicola F Tavella, MPH, CPH, 212-241-3888, nicola.tavella@mssm.edu
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Victoria Ly, MD, 212-241-5681, victoria.ly@mssm.edu
Nicola Tavella, MPH, 212-241-3888, nicola.tavella@mssm.edu
- Recruiting
Mount Sinai South Nassau
Oceanside, New York, 11572
Dina El Kady, MD
Dina El Kady, MD
About this study
Official title: The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study
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.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Continuous glucose monitor
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitorDevice
Device is a remote sensor applied to the upper extremity that continuously samples glucose of interstitial fluid and uploading results to a mobile application.
| Study group | Role | What they receive |
|---|---|---|
| Individuals receiving prenatal care at Mount Sinai Hospital | Experimental | Women receiving prenatal care at Mount Sinai Hospital to have 10-day application of continuous glucose monitor Receives: Device: Continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose from CGM
Blood glucose aggregate values from Dexcom G7 continuous glucose monitor (CGM)
Measured: 10 days from sensor application to completion of testing
Glucose Tolerance Test (GTT) values
1-hour GTT values and 3-hour GTT values
The glucose tolerance test is a lab test to check how the body moves sugar from the blood into tissues like muscle and fat. The test is used as standard of care to diagnose gestational diabetes.
Measured: 1 hour and 3 hours
Postpartum blood glucose
A blood sugar test measures the amount of a sugar called glucose in a sample of blood.
Measured: 4 hours after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start2 Oct 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Bianco, Icahn School of Medicine at Mount Sinai
- Investigators
- Angela Bianco, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858787
- Sponsor's protocol ID
- STUDY-25-00172
- Acronym
- VALID
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study
- ClinicalTrials.gov ID
- NCT06858787
- Acronym / sponsor ID
- VALID / STUDY-25-00172
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals receiving prenatal care at Mount Sinai Hospital | Experimental | Device: Continuous glucose monitorWomen receiving prenatal care at Mount Sinai Hospital to have 10-day application of continuous glucose monitor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18-50
- Singleton pregnancy between 24-32 weeks gestational age
- Prenatal care and delivery at Mount Sinai Hospital
Key exclusion criteria (6 listed)
- Multiple fetal gestation
- Preexisting diabetes
- Concurrent use of steroids
- Anomalous fetus
- Insufficient prenatal care (identified as missing half the recommended visits or establishing care after 20 weeks gestation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitorDevice is a remote sensor applied to the upper extremity that continuously samples glucose of interstitial fluid and uploading results to a mobile application. | Device | Individuals receiving prenatal care at Mount Sinai Hospital |
Primary outcome
Blood glucose from CGM
Time frame: 10 days from sensor application to completion of testing
Blood glucose aggregate values from Dexcom G7 continuous glucose monitor (CGM)
Glucose Tolerance Test (GTT) values
Time frame: 1 hour and 3 hours
1-hour GTT values and 3-hour GTT values The glucose tolerance test is a lab test to check how the body moves sugar from the blood into tissues like muscle and fat. The test is used as standard of care to diagnose gestational diabetes.
Postpartum blood glucose
Time frame: 4 hours after childbirth
A blood sugar test measures the amount of a sugar called glucose in a sample of blood.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes Mellitus (GDM)
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Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
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A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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The WAIT Trial: Waiting Versus Active Induction at Term in Women With A1 Gestational Diabetes Mellitus
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Recruiting
Effects Of Core Canister Training in Pregnant Women With History of Gestational Diabetes Mellitus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Bianco, MD principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitor in people with Gestational Diabetes Mellitus (GDM), run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola F Tavella, MPH (212-241-3888, nicola.tavella@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose from CGM (time frame: 10 days from sensor application to completion of testing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.