At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Diabetes Treatment (other), Usual Care Group (other)
- How long the study runs
- Study runs about 30 months (dates as stated)
- About the drug or intervention
- Diabetes Treatment — other: 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 \[3.5-7.8 mmol/L\]). · Usual Care Group — other: The control group will receive usual obstetrical care at the clinical center.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether continuous glucose monitoring (CGM) — a small sensor that checks blood sugar levels — can help detect and manage high blood sugar early in pregnancy. It focuses on people at risk of gestational diabetes mellitus (GDM), a type of diabetes that develops during pregnancy. The study is sponsored by the Jaeb Center for Health Research.
Who can take part
- Age 18 or older
- Pregnant with one baby (not twins or more)
- Less than 14 weeks and 6 days pregnant, based on an ultrasound scan, when screening starts
- HbA1c (a blood sugar test) below 6.5% (48 mmol/mol) since becoming pregnant
- No previous gestational diabetes in an earlier pregnancy
- Able to read English or Spanish
- To enter the main trial, the CGM screening must show blood sugar above 140 mg/dL for between 5% and under 25% of the time, and you must join by 16 weeks and 6 days of pregnancy
Who may not be able to
- Signs of abnormal development of the baby or placenta at the first routine pregnancy visit or scan
- Planning to end the pregnancy, or any signs of miscarriage
- Previous gastric bypass surgery
- Diabetes (type 1 or type 2) before pregnancy
- Unable or unwilling to wear a CGM sensor
- Unwilling to attend routine pregnancy appointments
- Use of steroid medicines that can raise blood sugar (such as tablets, injections into a vein, muscle or joint) in the 7 days before CGM screening or during it — creams and inhalers are allowed
- Use of insulin during this pregnancy before joining
- Use of metformin within one week before starting the CGM screening sensor, or a weight-loss medicine that affects blood sugar (such as a GLP-1) within 4 weeks before starting it
- A doctor decides you cannot take part for medical reasons
- Taking part in a separate intervention trial (this applies to the main trial stage)
What taking part involves
- • Wearing a blinded CGM sensor for screening — 'blinded' means you cannot see the readings during this stage
- • Not stated — ask the trial team about what happens after the screening stage
Time commitment: Taking part involves wearing a CGM sensor and attending your routine pregnancy appointments; the total study length is not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 6,000
- Started
- 2025-05-27
- Last checked
- 2025-12
Plain English Summary
What is this study?
- • Testing a new treatment for gestational diabetes mellitus in pregnancy
- • NA - 6,000 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with gestational diabetes mellitus in pregnancy
- • Female only
Where?
- • Leeds - Leeds Teaching Hospitals NHS Trust
- • Norwich - Norfolk and Norwich University Hospitals NHS
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
What the study is looking for
- ✓Inclusion Criteria
- ✓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
See the full criteria
Where Is This Study? (2 UK sites)
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Norfolk and Norwich University Hospitals NHS
Norwich, United Kingdom
How to Get in Touch
Judy Sibayan, MPH, CCRP, Epidemiologist
Sponsor contactCONTACT
Paige N Miller, BS
Sponsor contactCONTACT
