Gestational DiabetesNCT07332416
Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening
A study testing Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott in people with Gestational Diabetes, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The oral glucose tolerance test (OGTT) is the standard of care in the postpartum period to screen patients with gestational diabetes mellitus (GDM) for persistent dysglycemia. However, most patients find it burdensome and dread having to do it. 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 monitoring for 14 days using the Freestyle LibrePro by Abbott
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2026to Jan 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
- 12-16 weeks postpartum
- Gestational diabetes Mellitus (GDM) diagnosis in most recent pregnancy
- Oral Glucose Tolerance Test (OGTT) order placed in the medical record
Who cannot join
- Pre-gestational diabetes
- Non-English language
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
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The oral glucose tolerance test (OGTT) is the standard of care in the postpartum period to screen patients with gestational diabetes mellitus (GDM) for persistent dysglycemia. However, most patients find it burdensome and dread having to do it. Adherence rates are low (18-61%), impeding initiation of follow-up care to improve diabetes-related outcomes in subsequent pregnancies and long-term.
Read the detailed description
Continuous glucose monitoring (CGM) is an appealing alternative to the OGTT because it is a low-burden, fully remote, comprehensive assessment of glycemic status. Emerging data suggest that CGM is superior to the OGTT in identifying persistent dysglycemia at 2-5 months postpartum, and preferable to the OGTT among women willing to complete both assessments in the context of a research study. This study proposes a feasibility study of postpartum CGM among patients who do not complete the standard postpartum OGTT. The study will offer CGM in a telehealth (fully remote) context to determine if it can increase adherence to postpartum glycemic screening in real-world settings. This study will (a) evaluate uptake of CGM screening, (b) characterize patients who complete CGM, complete the OGTT, or do not complete screening, and (c) monitor initiation of follow-up care after abnormal results.
- Conditions
- Gestational Diabetes
- Being tested
- Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott
- Keywords
- Continuous glucose monitoring, Postpartum glucose screening, Dysglycemia
- 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 monitoring for 14 days using the Freestyle LibrePro by AbbottOther
Postpartum CGM
| Study group | Role | What they receive |
|---|---|---|
| Postpartum CGM | Active comparator | Postpartum continuous glucose monitoring Receives: Other: Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott |
| Postpartum OGTT | No intervention | Postpartum oral glucose tolerance test |
| No screening | No intervention | No postpartum glucose screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Glucose Monitor (CGM) uptake - Percentage of CGM-eligible patients
Percentage of CGM-eligible patients that return a used CGM sensor
Measured: 20 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start6 Jul 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 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 Wake Forest University Health SciencesThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medstar Health Research Institute, University of North Carolina, Chapel Hill, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Katherine A Sauder, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332416
- Sponsor's protocol ID
- IRB00143138
- Other IDs
- P30DK124723
- Status last verified
- May 2026
- First submitted
- 8 Jan 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data will be published from this pilot study; individual patient level data will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening
- ClinicalTrials.gov ID
- NCT07332416
- Acronym / sponsor ID
- IRB00143138
- Conditions
- Gestational Diabetes
- Keywords
- Continuous glucose monitoring, Postpartum glucose screening, Dysglycemia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Medstar Health Research Institute, University of North Carolina, Chapel Hill, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 12 Jan 2026 (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 oral glucose tolerance test (OGTT) is the standard of care in the postpartum period to screen patients with gestational diabetes mellitus (GDM) for persistent dysglycemia. However, most patients find it burdensome and dread having to do it. Adherence rates are low (18-61%), impeding initiation of follow-up care to improve diabetes-related outcomes in subsequent pregnancies and long-term.
Detailed description
Continuous glucose monitoring (CGM) is an appealing alternative to the OGTT because it is a low-burden, fully remote, comprehensive assessment of glycemic status. Emerging data suggest that CGM is superior to the OGTT in identifying persistent dysglycemia at 2-5 months postpartum, and preferable to the OGTT among women willing to complete both assessments in the context of a research study. This study proposes a feasibility study of postpartum CGM among patients who do not complete the standard postpartum OGTT. The study will offer CGM in a telehealth (fully remote) context to determine if it can increase adherence to postpartum glycemic screening in real-world settings. This study will (a) evaluate uptake of CGM screening, (b) characterize patients who complete CGM, complete the OGTT, or do not complete screening, and (c) monitor initiation of follow-up care after abnormal results.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Postpartum CGM | Active comparator | Other: Continuous glucose monitoring for 14 days using the Freestyle LibrePro by AbbottPostpartum continuous glucose monitoring |
| Postpartum OGTT | No intervention | –Postpartum oral glucose tolerance test |
| No screening | No intervention | –No postpartum glucose screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 12-16 weeks postpartum
- Gestational diabetes Mellitus (GDM) diagnosis in most recent pregnancy
- Oral Glucose Tolerance Test (OGTT) order placed in the medical record
Key exclusion criteria (2 listed)
- Pre-gestational diabetes
- Non-English language
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 monitoring for 14 days using the Freestyle LibrePro by AbbottPostpartum CGM | Other | Postpartum CGM |
Primary outcome
Continuous Glucose Monitor (CGM) uptake - Percentage of CGM-eligible patients
Time frame: 20 weeks postpartum
Percentage of CGM-eligible patients that return a used CGM sensor
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 10 Jul 2026.
- Individual participant dataSharing planned: No. Aggregate data will be published from this pilot study; individual patient level data will be kept confidential.
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
Katherine A Sauder, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott in people with Gestational Diabetes, run by Wake Forest University Health Sciences 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 2 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: enrolling by invitation, as of the sponsor's last update on 10 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?
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?
Continuous Glucose Monitor (CGM) uptake - Percentage of CGM-eligible patients (time frame: 20 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 10 Jul 2026.