Gestational DiabetesNCT07174245
Pregnancy and Postpartum CGM in GDM
An observational study of Gestational Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Gestational diabetes (GDM) is one of the most common complications of pregnancy, and up to one third of women with GDM will have abnormal blood sugars after their pregnancy. To screen for abnormal blood sugars, standard of care is a 4-12 week postpartum oral glucose tolerance test (OGTT). 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?
- continuous glucose monitor
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 1 Jul 2027
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosis of gestational diabetes during current pregnancy, age 18 or older, and prescribed Dexcom G7
Who may be able to join
- Diagnosis of gestational diabetes during current pregnancy
- age 18 or older
- prescribed Dexcom G7
Who cannot join
- Pregestational diabetes
- known skin adhesive allergy which inhibits ongoing use of CGM
- chronic oral steroid use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sarah Rancic, 212-241-5355, sarah.rancic@mssm.edu
Grenye O'Malley
About this study
Official title: Pregnancy and Postpartum Continuous Glucose Monitoring in Gestational Diabetes
Gestational diabetes (GDM) is one of the most common complications of pregnancy, and up to one third of women with GDM will have abnormal blood sugars after their pregnancy. To screen for abnormal blood sugars, standard of care is a 4-12 week postpartum oral glucose tolerance test (OGTT). However only 17-60% of women actually have this test performed. This study is to assess continuous glucose monitor data from the third trimester and up to 14 days postpartum to find predictors of postpartum OGTT results.
Read the detailed description
Those with GDM in current pregnancy using a Dexcom Continuous Glucose Monitoring (CGM) are eligible for enrollment. Participants use their CGM as usual during pregnancy and wear one sensor postpartum. They have their standard of care OGTT performed at around 6 weeks. They then complete a remote questionnaire after OGTT.
- Conditions
- Gestational Diabetes
- Being tested
- continuous glucose monitor
- Keywords
- gestational diabetes, continuous glucose monitor, glucose sensor, oral glucose tolerance test
- 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
Also called CGM
All participants who wear CGM
| Study group | Role | What they receive |
|---|---|---|
| Participants with Gestational diabetes GDM | All participants who wear CGM and have their postpartum OGTT Receives: Device: continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of postpartum TIR <96%
Sensitivity of postpartum time in range (TIR) <96% to predict dysglycemia on OGTT. Range 70-180 mg/dL.
Sensitivity determined by true positives of TIR <96% and abnormal OGTT and false negatives would be TIR <96% with normal OGTT.
Measured: up to 12 weeks postpartum
Secondary outcomes (2)
Specificity of postpartum TIR <96%
Specificity of postpartum TIR <96% to predict dysglycemia on OGTT
Specificity calculated by true negatives are TIR not <96% and normal OGTT and false positive are TIR <96% but normal OGTT results.
Measured: up to 12 weeks postpartum
Experience survey questionnaire
6 items in non validated questionnaire to be administered remotely. first 5 questions rated on a 5 point likert scale. question 6 asks participant to choose preference between glucose sensor or oral glucose tolerance test.
Each question evaluated on its own scored 1 (Strongly disagree) to 5 (Strongly Agree). The questions are not summed.
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 posted15 Sep 2025
- Study start5 Aug 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- 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
- NCT07174245
- Sponsor's protocol ID
- STUDY-25-00534
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Identifying dates
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and Postpartum Continuous Glucose Monitoring in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT07174245
- Acronym / sponsor ID
- STUDY-25-00534
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, continuous glucose monitor, glucose sensor, oral glucose tolerance test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 15 Sep 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.
Gestational diabetes (GDM) is one of the most common complications of pregnancy, and up to one third of women with GDM will have abnormal blood sugars after their pregnancy. To screen for abnormal blood sugars, standard of care is a 4-12 week postpartum oral glucose tolerance test (OGTT). However only 17-60% of women actually have this test performed. This study is to assess continuous glucose monitor data from the third trimester and up to 14 days postpartum to find predictors of postpartum OGTT results.
Detailed description
Those with GDM in current pregnancy using a Dexcom Continuous Glucose Monitoring (CGM) are eligible for enrollment. Participants use their CGM as usual during pregnancy and wear one sensor postpartum. They have their standard of care OGTT performed at around 6 weeks. They then complete a remote questionnaire after OGTT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Gestational diabetes GDM | – | Device: continuous glucose monitorAll participants who wear CGM and have their postpartum OGTT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of gestational diabetes during current pregnancy, age 18 or older, and prescribed Dexcom G7
Key inclusion criteria (3 listed)
- Diagnosis of gestational diabetes during current pregnancy
- age 18 or older
- prescribed Dexcom G7
Key exclusion criteria (3 listed)
- Pregestational diabetes
- known skin adhesive allergy which inhibits ongoing use of CGM
- chronic oral steroid use.
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 monitorAlso: CGMAll participants who wear CGM | Device | Participants with Gestational diabetes GDM |
Primary outcome
Sensitivity of postpartum TIR <96%
Time frame: up to 12 weeks postpartum
Sensitivity of postpartum time in range (TIR) <96% to predict dysglycemia on OGTT. Range 70-180 mg/dL. Sensitivity determined by true positives of TIR <96% and abnormal OGTT and false negatives would be TIR <96% with normal OGTT.
2 secondary outcomes
Specificity of postpartum TIR <96%
Time frame: up to 12 weeks postpartum
Experience survey questionnaire
Time frame: up to 12 weeks postpartum
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 8 Jul 2026.
- Individual participant dataSharing planned: No. Identifying dates
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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.
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?
An observational study of 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 3 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. 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?
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 Sarah Rancic (212-241-5355, sarah.rancic@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of postpartum TIR <96% (time frame: up to 12 weeks postpartum). 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 8 Jul 2026.