Gestational DiabetesNCT05714761
Postpartum Continuous Glucose Monitoring (CGM) Study
A study testing Dexcom glucose sensor in people with Gestational Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Dexcom glucose sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2023to 8 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- include diagnosis of gestational diabetes during a current or recent pregnancy
- age 18 or older.
Who cannot join
- include known pregestational diabetes,
- known skin adhesive allergy which would prevent subject from wearing a CGM,
- chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Postpartum Dysglycemia Screening With Continuous Glucose Monitoring
This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent \& screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).
- Conditions
- Gestational Diabetes
- Being tested
- Dexcom glucose sensor
- Keywords
- gestational diabetes, oral glucose tolerance test, glucose sensor
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom glucose sensorDevice
Use of a Dexcom G6 Pro
| Study group | Role | What they receive |
|---|---|---|
| Postpartum glucose sensor | Other | Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test. Receives: Device: Dexcom glucose sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least 72 Hours of CGM Data Downloaded.
Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.
Measured: Postpartum days 10-20
Secondary outcomes (6)
Specificity
Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the number and proportion of people who test negative among all those who actually do not have that disease. A higher specificity in a test indicates it is better at correctly identifying individuals with the condition.
Specificity for Time in Range 70-180 mg/dL of <96% for abnormal OGTT is reported.
Measured: up to 12 weeks postpartum
Sensitivity
Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the number of people who test positive among all those who actually have the disease. A higher sensitivity in a test indicates it is better at correctly identifying those who have the condition and not missing cases.
Sensitivity for Time in Range 70-180 mg/dL of <96% for abnormal OGTT is reported.
Measured: up to 12 weeks postpartum
Positive Predictive Value (PPV)
PPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease.
Positive predictive value (PPV) of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported.
Measured: up to 12 weeks postpartum
Positive Likelihood Ratio (PLR)
PLR for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. PLR compares the likelihood of a positive test result in people with a disease to the likelihood in people without the disease and is used to help determine how likely a disease is present if a test is positive. The higher the PRL, the stronger the evidence that a positive test result supports the presence of the condition.
PLR of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported.
Measured: up to 12 weeks postpartum
Negative Predictive Value (NPV)
NPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease.
NPV of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported.
Measured: up to 12 weeks postpartum
Negative Likelihood Ratio (NLR)
NLR estimates how likely a patient is to not have a disease after a negative test. The lower the NRL, the stronger the evidence that a negative test result supports the absence of the condition.
NLR of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported.
Measured: up to 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start16 Feb 2023
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gestational DiabetesStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Grenye O'Malley, Icahn School of Medicine at Mount Sinai
- Investigators
- Grenye O'Malley, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714761
- Sponsor's protocol ID
- STUDY-20-02062
- Status last verified
- Mar 2025
- First submitted
- 27 Jan 2023
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Aggregate data will be reported
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Dysglycemia Screening With Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT05714761
- Acronym / sponsor ID
- STUDY-20-02062
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, oral glucose tolerance test, glucose sensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent \& screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum glucose sensor | Other | Device: Dexcom glucose sensorWill wear glucose sensor for 10 days postpartum and at time of glucose tolerance test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- include diagnosis of gestational diabetes during a current or recent pregnancy
- age 18 or older.
Key exclusion criteria (3 listed)
- include known pregestational diabetes,
- known skin adhesive allergy which would prevent subject from wearing a CGM,
- chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.
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 |
|---|---|---|
| Dexcom glucose sensorUse of a Dexcom G6 Pro | Device | Postpartum glucose sensor |
Primary outcome
Number of Participants With at Least 72 Hours of CGM Data Downloaded.
Time frame: Postpartum days 10-20
Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.
6 secondary outcomes
Specificity
Time frame: up to 12 weeks postpartum
Sensitivity
Time frame: up to 12 weeks postpartum
Positive Predictive Value (PPV)
Time frame: up to 12 weeks postpartum
Positive Likelihood Ratio (PLR)
Time frame: up to 12 weeks postpartum
Negative Predictive Value (NPV)
Time frame: up to 12 weeks postpartum
Negative Likelihood Ratio (NLR)
Time frame: up to 12 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Aggregate data will be reported
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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. This study is not recruiting at the moment.
Grenye O'Malley, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom glucose sensor in people with Gestational Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With at Least 72 Hours of CGM Data Downloaded. (time frame: Postpartum days 10-20). 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 20 Mar 2025.