Gestational DiabetesNCT07034261
Continuous Glucose Monitoring to Detect Postpartum Dysglycemia in Patients With Gestational Diabetes
A study testing Blinded Continuous Glucose Monitoring Device in people with Gestational Diabetes, run by University of Chicago.
Trial summary
The aim of this study is to determine the ability of postpartum continuous glucose monitoring (CGM) for subjects with gestational diabetes (GDM) to predict dysglycemia on 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?
- Blinded Continuous Glucose Monitoring Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18
- Completed pregnancy with delivery of a live born infant(s). Pregnancies with multiple gestations will be included
- No prior history of type 1 or type 2 diabetes
- Patients with a history of gestational diabetes (GDM) in a prior pregnancy will be eligible for inclusion.
- GDM diagnosis by standard screening at 24-28 weeks
- 2 hour 75g oral glucose tolerance test (OGTT); one abnormal value required for diagnosis
Show all 15Show fewer
- Fasting glucose 92
- 1 hour 180
- 2 hour 153
- 3 hour 100g OGTT - two abnormal values required for diagnosis
- Fasting glucose - 95
- 1 hour 180
- 2 hour 155
- 3 hour 140
- There are no exclusion criteria for this study. Eligibility will be based on inclusion criteria.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to determine the ability of postpartum continuous glucose monitoring (CGM) for subjects with gestational diabetes (GDM) to predict dysglycemia on 4-12 week postpartum oral glucose tolerance test (OGTT).
Read the detailed description
Gestational diabetes (GDM) is glucose intolerance that develops during pregnancy. In the US, GDM affected 8.3% of pregnancies in 2021. Persistent glucose intolerance is present in up to 20% of women at post-partum follow up and subsequent risk for type 2 diabetes is significantly increased. All patients with GDM should undergo post-partum oral glucose tolerance test (OGTT) at 4-12 weeks to identify persistence glucose intolerance or overt diabetes. Detecting postpartum dysglycemia in people with GDM is a critical step for reducing long-term risk of type 2 diabetes and its associated complications. However, <50% of people complete the postpartum OGTT due to barriers in transportation, finances, and childcare. Recent studies have examined the use of postpartum continuous glucose monitoring (CGM) and proposed CGM metrics to predict dysglycemia on postpartum OGTT in people with GDM. These findings should be validated in other cohorts to confirm broad applicability.
This pilot study aims to enroll subjects with GDM at the University of Chicago to wear a blinded CGM for 14 days postpartum (study intervention) and then complete a OGTT at 4-12 weeks postpartum (standard of care).
- Conditions
- Gestational Diabetes
- Being tested
- Blinded Continuous Glucose Monitoring Device
- Keywords
- CGM Device
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded Continuous Glucose Monitoring DeviceDevice
Subjects will be asked to wear blinded continuous glucose monitoring device for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Blinded Continuous Glucose Monitoring Device | Experimental | Subjects will wear a blinded continuous glucose monitoring device. Receives: Device: Blinded Continuous Glucose Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the ability of continuous glucose monitoring to predict dysglycemia
Assess the validity of the continuous glucose monitoring metrics (percentage) proposed by Cabrera et al. (percent time >180 of >4%)
Measured: baseline to Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Dickens, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034261
- Sponsor's protocol ID
- IRB25-0910
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
QuickStats: Percentage of Mothers with Gestational Diabetes,* by Maternal Age - National Vital Statistics System, United States, 2016 and 2021. MMWR Morb Mortal Wkly Rep. 2023 Jan 6;72(1):16. doi: 10.15585/mmwr.mm7201a4. No abstract available.
PubMed 36602935Kjos SL, Buchanan TA, Greenspoon JS, Montoro M, Bernstein GS, Mestman JH. Gestational diabetes mellitus: the prevalence of glucose intolerance and diabetes mellitus in the first two months post partum. Am J Obstet Gynecol. 1990 Jul;163(1 Pt 1):93-8. doi: 10.1016/s0002-9378(11)90676-0.
PubMed 2375376Catalano PM, Vargo KM, Bernstein IM, Amini SB. Incidence and risk factors associated with abnormal postpartum glucose tolerance in women with gestational diabetes. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):914-9. doi: 10.1016/0002-9378(91)90438-w.
PubMed 1951553American Diabetes Association Professional Practice Committee. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S306-S320. doi: 10.2337/dc25-S015.
PubMed 39651985Werner EF, Has P, Kanno L, Sullivan A, Clark MA. Barriers to Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2019 Jan;36(2):212-218. doi: 10.1055/s-0038-1667290. Epub 2018 Jul 30.
PubMed 30060291Cabrera C et al. Postpartum Dysglycemia Screening with Continuous Glucose Monitoring. Diabetes 2024;73(Supplement_1):1973-LB
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring to Detect Postpartum Dysglycemia in Patients With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT07034261
- Acronym / sponsor ID
- IRB25-0910
- Conditions
- Gestational Diabetes
- Keywords
- CGM Device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Jun 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.
The aim of this study is to determine the ability of postpartum continuous glucose monitoring (CGM) for subjects with gestational diabetes (GDM) to predict dysglycemia on 4-12 week postpartum oral glucose tolerance test (OGTT).
Detailed description
Gestational diabetes (GDM) is glucose intolerance that develops during pregnancy. In the US, GDM affected 8.3% of pregnancies in 2021. Persistent glucose intolerance is present in up to 20% of women at post-partum follow up and subsequent risk for type 2 diabetes is significantly increased. All patients with GDM should undergo post-partum oral glucose tolerance test (OGTT) at 4-12 weeks to identify persistence glucose intolerance or overt diabetes. Detecting postpartum dysglycemia in people with GDM is a critical step for reducing long-term risk of type 2 diabetes and its associated complications. However, <50% of people complete the postpartum OGTT due to barriers in transportation, finances, and childcare. Recent studies have examined the use of postpartum continuous glucose monitoring (CGM) and proposed CGM metrics to predict dysglycemia on postpartum OGTT in people with GDM. These findings should be validated in other cohorts to confirm broad applicability.
This pilot study aims to enroll subjects with GDM at the University of Chicago to wear a blinded CGM for 14 days postpartum (study intervention) and then complete a OGTT at 4-12 weeks postpartum (standard of care).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinded Continuous Glucose Monitoring Device | Experimental | Device: Blinded Continuous Glucose Monitoring DeviceSubjects will wear a blinded continuous glucose monitoring device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age greater than or equal to 18
- Completed pregnancy with delivery of a live born infant(s). Pregnancies with multiple gestations will be included
- No prior history of type 1 or type 2 diabetes
- GDM diagnosis by standard screening at 24-28 weeks
- There are no exclusion criteria for this study. Eligibility will be based on inclusion criteria.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blinded Continuous Glucose Monitoring DeviceSubjects will be asked to wear blinded continuous glucose monitoring device for 14 days. | Device | Blinded Continuous Glucose Monitoring Device |
Primary outcome
Determine the ability of continuous glucose monitoring to predict dysglycemia
Time frame: baseline to Day 70
Assess the validity of the continuous glucose monitoring metrics (percentage) proposed by Cabrera et al. (percent time >180 of >4%)
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 11 Jun 2026.
- Background: PubMed 36602935QuickStats: Percentage of Mothers with Gestational Diabetes,* by Maternal Age - National Vital Statistics System, United States, 2016 and 2021. MMWR Morb Mortal Wkly Rep. 2023 Jan 6;72(1):16. doi: 10.15585/mmwr.mm7201a4. No abstract available.
- Background: PubMed 2375376Kjos SL, Buchanan TA, Greenspoon JS, Montoro M, Bernstein GS, Mestman JH. Gestational diabetes mellitus: the prevalence of glucose intolerance and diabetes mellitus in the first two months post partum. Am J Obstet Gynecol. 1990 Jul;163(1 Pt 1):93-8. doi: 10.1016/s0002-9378(11)90676-0.
- Background: PubMed 1951553Catalano PM, Vargo KM, Bernstein IM, Amini SB. Incidence and risk factors associated with abnormal postpartum glucose tolerance in women with gestational diabetes. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):914-9. doi: 10.1016/0002-9378(91)90438-w.
- Background: PubMed 39651985American Diabetes Association Professional Practice Committee. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S306-S320. doi: 10.2337/dc25-S015.
- Background: PubMed 30060291Werner EF, Has P, Kanno L, Sullivan A, Clark MA. Barriers to Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2019 Jan;36(2):212-218. doi: 10.1055/s-0038-1667290. Epub 2018 Jul 30.
- BackgroundCabrera C et al. Postpartum Dysglycemia Screening with Continuous Glucose Monitoring. Diabetes 2024;73(Supplement_1):1973-LB
- Individual participant dataSharing planned: No
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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.
Laura Dickens, MD principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Blinded Continuous Glucose Monitoring Device in people with Gestational Diabetes, run by University of Chicago.
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 15 inclusion and 0 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Laura Dickens, MD (773-795-0460, ldickens1@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the ability of continuous glucose monitoring to predict dysglycemia (time frame: baseline to Day 70). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07034261, which also lists 6 linked publications.
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 11 Jun 2026.