Gestational Diabetes Mellitus in PregnancyNCT06957028
CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
A study testing Diabetes Treatment in people with Gestational Diabetes Mellitus in Pregnancy, run by Jaeb Center for Health Research at 10 sites in 2 countries.
Trial summary
The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are: (1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Diabetes Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 27 May 2025to 27 Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Maternal age of 18 years and older
- Singleton pregnancy
- Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening
- Although it is preferable that ultrasound results be available prior to enrollment, if ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available
- HbA1c <6.5% (48 mmol/mol) since onset of pregnancy
- If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility.
- No prior history of gestational diabetes mellitus (GDM)
- Able to read English or Spanish
Who cannot join
- Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound
- Planned termination of pregnancy or any indications of miscarriage
- Prior gastric bypass surgery
- Pregravid diabetes (type 1 or type 2)
- Unwillingness/inability to wear CGM sensor
- Unwillingness to attend routine antenatal obstetric appointments
Show all 15Show fewer
- Use of corticosteroids by a route that can produce hyperglycemia (e.g., oral, intravenous, intramuscular, intra-articular) during the 7 days prior to initiating CGM screening or during the CGM screening
- Topical and inhaled corticosteroids are acceptable
- Use of insulin during the pregnancy prior to enrollment
- Use of metformin within one week of the initiation of the blinded CGM sensor for screening or use of a GLP-1 or other weight-reduction medication that can affect glucose levels within 4 weeks of the initiation of the blinded CGM sensor for screening
- Deemed unable to participate for medical reasons identified by their physician
- Additional Criteria for RCT Eligibility
- Screening CGM meeting study criteria for hyperglycemia: 5% to <25% time >140 mg/dL
- Randomization by 16 week 6 days of pregnancy
- No participation in a separate intervention trial.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35173
Jennifer Bryant, 832-453-8402, jlbryant@uabmc.edu
Ashley Battarbee
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Stacey Ehrenberg, 216-618-7235, ehrenbs@ccf.org
Stacey Ehrenberg
- Recruiting
Emory University
Decatur, Georgia, 30033
Olivia Carter, olivia.carter2@emory.edu
Suchitra Chandrasekaran
- Recruiting
University of Miami
Miami, Florida, 33016
Stephanie Cardona, 305-585-5610, stephanie.cardona@miami.edu
Alfredo Rodriguez
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Shaziah Hassan, 212-241-5355, Shaziah.hassan@mssm.edu
Carol Levy
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Elizabeth Norton, 973-600-8830, elizabeth.norton@pennmedicine.upenn.edu
Celeste Durnwald
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Monica Rincon, 503-494-8748, rincon@ohsu.edu
Amy Valent
- Recruiting
IDC at Park Nicollet
Saint Louis Park, Minnesota, 55416
Shannon Krizka, (952) 993-3393, shannon.krizka@parknicollet.com
Anders Carlson
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, Leeds
Eleanor Scott, +44 7876 031952, E.M.Scott@leeds.ac.uk
Eleanor Scott
- Not yet recruiting
Norfolk and Norwich University Hospitals NHS
Norwich, Norwich
Helen Murphy, +44 1603 286286, Helen.Murphy@uea.ac.uk
Helen Murphy
About this study
The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are:
(1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.
Read the detailed description
Data from continuous glucose monitoring (CGM) in the Glucose Lowering group tracked over time, will be compared to data from blinded sensors in the Usual Care group approximately every 4 weeks.
- Pregnant women who do not have diabetes and have a single, uncomplicated pregnancy will be enrolled by 14 weeks and 6 days. They will start by wearing a hidden CGM sensor to check for high blood sugar.
- The blinded CGM sensor data will be evaluated to determine if the following criterion is met: 5% to <25% of values >140 mg/dL
- An initial assessment will be made after 5 days and for those not meeting the criterion, again after 10 days
- Participants meeting the CGM hyperglycemia criteria and the other study eligibility criteria will proceed to randomization, which must be performed by 16 weeks 6 days of gestation.
- Participants who do not meet the CGM hyperglycemia criteria will form an observational cohort, provided that HbA1c is <6.5% (48 mmol/mol)
- Being tested
- Diabetes Treatment, Usual Care Group
- Keywords
- GDM, CGM, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes TreatmentOther
Also called Continuous Glucose Monitoring
Management will include an unblinded CGM sensor worn 24/7, GDM specific nutrition information, training on using CGM in daily glucose management to achieve euglycemia (maximizing time 63-140 mg/dL [3.5-7.8 mmol/L]).
Visits (which could be telehealth) per usual obstetrical care for glycemia management (expected to be about every 4 weeks for most participants) and weekly glycemic management with review of CGM data by site and by central CGM Resource Center for flagged cases.
Participants not receiving glucose lowering medication by 24-28 weeks will undergo OGTT per usual obstetrical management and those with positive OGTT will be treated for GDM per usual clinic routine and continue to wear an unblinded CGM.
Usual Care GroupOther
Also called Blinded Continuous Glucose Monitoring
The control group will receive usual obstetrical care at the clinical center. A general pregnancy nutrition information handout will be provided to each participant and a blinded CGM sensor will be placed at routine obstetrical care visits and worn for 10-14 days each time throughout the pregnancy beginning between 18-22 weeks' gestation.
At 18-22 weeks, blinded CGM data will be reviewed to assess if participant has ≥25% time >140 mg/dL to determine if an early OGTT or glycemic management is required. Site clinicians will be unblinded to the masked CGM data for participants with CGM data ≥25% time >140 mg/dL and those participants may be treated as those with a positive OGTT.
An OGTT will be performed at ~24-28 weeks per the clinic's usual routine and those with positive OGTT will be treated for GDM per usual clinic routine. If real-time CGM is to be used, then unblinded study CGM sensors can be used instead of blinded sensors for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Glucose Lowering Group | Experimental | Not described Receives: Other: Diabetes Treatment |
| Usual Care Group (with periodic blinded CGM) | Active comparator | Not described Receives: Other: Usual Care Group |
| Observational | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of Pregnancy
Composite endpoint of (1) neonatal complications of large for gestational age (LGA), shoulder dystocia (including humeral or clavicular fracture), elevated bilirubin requiring phototherapy, or neonatal intensive care unit (NICU) admission; or (2) maternal hypertensive disorder of pregnancy (HDP) .
Measured: Baseline to 45 weeks
Secondary outcomes (1)
Composite of Neonatal Complications, Death, and Maternal Complications
- Composite of neonatal complications
- Individual maternal and neonatal complications
- Neonatal death
Measured: Baseline to 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start27 May 2025
- Primary completion27 Nov 2027 (estimated)
- Study completion27 Nov 2027 (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 in PregnancyStudies of the same condition, open and under way.
- 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, DexCom, Inc., Abbott
- Responsible party
- Sponsor
- Investigators
- Celeste Durnwald, MD, Study chair, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957028
- Sponsor's protocol ID
- IMAGINE
- Status last verified
- Dec 2025
- First submitted
- 2 Apr 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
- ClinicalTrials.gov ID
- NCT06957028
- Acronym / sponsor ID
- IMAGINE
- Keywords
- GDM, CGM, Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, DexCom, Inc., Abbott
- Study start
- 27 May 2025 (actual)
- Primary completion
- 27 Nov 2027 (estimated)
- Study completion
- 27 Nov 2027 (estimated)
- First posted
- 4 May 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 goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are:
(1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.
Detailed description
Data from continuous glucose monitoring (CGM) in the Glucose Lowering group tracked over time, will be compared to data from blinded sensors in the Usual Care group approximately every 4 weeks.
- Pregnant women who do not have diabetes and have a single, uncomplicated pregnancy will be enrolled by 14 weeks and 6 days. They will start by wearing a hidden CGM sensor to check for high blood sugar.
- The blinded CGM sensor data will be evaluated to determine if the following criterion is met: 5% to <25% of values >140 mg/dL
- An initial assessment will be made after 5 days and for those not meeting the criterion, again after 10 days
- Participants meeting the CGM hyperglycemia criteria and the other study eligibility criteria will proceed to randomization, which must be performed by 16 weeks 6 days of gestation.
- Participants who do not meet the CGM hyperglycemia criteria will form an observational cohort, provided that HbA1c is <6.5% (48 mmol/mol)
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucose Lowering Group | Experimental | Other: Diabetes Treatment |
| Usual Care Group (with periodic blinded CGM) | Active comparator | Other: Usual Care Group |
| Observational | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Maternal age of 18 years and older
- Singleton pregnancy
- Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening
- HbA1c <6.5% (48 mmol/mol) since onset of pregnancy
- No prior history of gestational diabetes mellitus (GDM)
Key exclusion criteria (15 listed)
- Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound
- Planned termination of pregnancy or any indications of miscarriage
- Prior gastric bypass surgery
- Pregravid diabetes (type 1 or type 2)
- Unwillingness/inability to wear CGM sensor
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 |
|---|---|---|
| Diabetes TreatmentAlso: Continuous Glucose MonitoringManagement will include an unblinded CGM sensor worn 24/7, GDM specific nutrition information, training on using CGM in daily glucose management to achieve euglycemia (maximizing time 63-140 mg/dL [3.5-7.8 mmol/L]). Visits (which could be telehealth) per usual obstetrical care for glycemia management (expected to be about every 4 weeks for most participants) and weekly glycemic management with review of CGM data by site and by central CGM Resource Center for flagged cases. Participants not receiving glucose lowering medication by 24-28 weeks will undergo OGTT per usual obstetrical management and those with positive OGTT will be treated for GDM per usual clinic routine and continue to wear an unblinded CGM. | Other | Glucose Lowering Group |
| Usual Care GroupAlso: Blinded Continuous Glucose MonitoringThe control group will receive usual obstetrical care at the clinical center. A general pregnancy nutrition information handout will be provided to each participant and a blinded CGM sensor will be placed at routine obstetrical care visits and worn for 10-14 days each time throughout the pregnancy beginning between 18-22 weeks' gestation. At 18-22 weeks, blinded CGM data will be reviewed to assess if participant has ≥25% time >140 mg/dL to determine if an early OGTT or glycemic management is required. Site clinicians will be unblinded to the masked CGM data for participants with CGM data ≥25% time >140 mg/dL and those participants may be treated as those with a positive OGTT. An OGTT will be performed at ~24-28 weeks per the clinic's usual routine and those with positive OGTT will be treated for GDM per usual clinic routine. If real-time CGM is to be used, then unblinded study CGM sensors can be used instead of blinded sensors for the duration of the study. | Other | Usual Care Group (with periodic blinded CGM) |
Primary outcome
Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of Pregnancy
Time frame: Baseline to 45 weeks
Composite endpoint of (1) neonatal complications of large for gestational age (LGA), shoulder dystocia (including humeral or clavicular fracture), elevated bilirubin requiring phototherapy, or neonatal intensive care unit (NICU) admission; or (2) maternal hypertensive disorder of pregnancy (HDP) .
1 secondary outcome
Composite of Neonatal Complications, Death, and Maternal Complications
Time frame: Baseline to 45 weeks
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 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Celeste Durnwald, MD study chair
University of Pennsylvania
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Treatment in people with Gestational Diabetes Mellitus in Pregnancy, run by Jaeb Center for Health Research at 10 sites in 2 countries.
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 8 inclusion and 15 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, United Kingdom. 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 Judy Sibayan, MPH, CCRP, Epidemiologist (813-975-8690, jsibayan@jaeb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of Pregnancy (time frame: Baseline to 45 weeks). 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 23 Dec 2025.