Continuous glucose monitoring to find high blood sugar early in pregnancy
Tests continuous glucose monitoring for gestational diabetes in pregnant women, starting early in pregnancy.
Key facts
- Who runs it
- Jaeb Center for Health Research
- Where
- Birmingham, Cleveland, Decatur, Miami, New York, Philadelphia, Portland, and Saint Louis Park, United StatesSee the 8 sitesAlso in 1 other country, 2 sites
- Trial code
- Registry title
- CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
- Status
- Recruiting
- People taking part
- 6,000 people, planned
- Started
- 27 May 2025
- Expected to end
- 27 Nov 2027
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Diabetes Treatment
- Usual Care Group
- Record updated
- 23 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 or older who are early in a pregnancy with one baby and have never had gestational diabetes. A glucose sensor (CGM) checks for high blood sugar.
- Age
- 18 years and older
- Sex
- Female (pregnant women)
- Disease stage
- Pregnancy with one baby, up to 14 weeks 6 days as measured by ultrasound. To be randomized, the sensor must show 5% to <25% of time above 140 mg/dL, by 16 weeks 6 days.
- Earlier treatment
- No insulin during this pregnancy before joining. No metformin within one week, and no GLP-1 or other weight-loss medicine within 4 weeks, before the screening sensor. No corticosteroids by mouth, vein, muscle or joint in the 7 days before or during screening; creams and inhalers are allowed.
- Biomarker or test result
- HbA1c <6.5% (48 mmol/mol) since the start of pregnancy.
Main reasons for not taking part
- Diabetes (type 1 or type 2) before pregnancy
- Earlier gestational diabetes
- Signs of abnormal development of the baby or placenta, or signs of miscarriage or planned termination
- Earlier gastric bypass surgery
- Not willing or able to wear the CGM sensor or attend routine pregnancy visits
This trial only enrols pregnant participants. The registry sentence this rests on: 2. Singleton pregnancy
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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 take part
- Prior gastric bypass surgery
- 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
- Pregravid diabetes (type 1 or type 2)
- 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
- Screening CGM meeting study criteria for hyperglycemia: 5% to <25% time >140 mg/dL
- 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
- Unwillingness/inability to wear CGM sensor
- Unwillingness to attend routine antenatal obstetric appointments
- Deemed unable to participate for medical reasons identified by their physician; Additional Criteria for RCT Eligibility
- Randomization by 16 week 6 days of pregnancy
- No participation in a separate intervention trial
Where in United States
Also in 1 other country, 2 sites
- University of Alabama at BirminghamBirmingham, United StatesContact: Jennifer BryantTaking people
- Cleveland ClinicCleveland, United StatesContact: Stacey EhrenbergTaking people
- Emory UniversityDecatur, United StatesContact: Olivia CarterTaking people
- University of MiamiMiami, United StatesContact: Stephanie CardonaTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesContact: Shaziah HassanTaking people
- University of PennsylvaniaPhiladelphia, United StatesContact: Elizabeth NortonTaking people
- Oregon Health Science UniversityPortland, United StatesContact: Monica RinconTaking people
- IDC at Park NicolletSaint Louis Park, United StatesContact: Shannon KrizkaTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
(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.
The 3 groups in the trial
- Glucose Lowering GroupTreatment being tested
Treatment: Diabetes Treatment
- Usual Care Group (with periodic blinded CGM)Existing treatment, for comparison
Treatment: Usual Care Group
- ObservationalNo study treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
- Plain-language title
- Continuous glucose monitoring to find high blood sugar early in pregnancyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 23 December 2025