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CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

Sponsor: Jaeb Center for Health Research

NCT ID: NCT06957028

View on ClinicalTrials.gov ↗

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)

Gestational Diabetes Mellitus in Pregnancy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

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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
Inclusion Criteria 1. Maternal age of 18 years and older 2. Singleton pregnancy 3. 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 4. 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. 5. No prior history of gestational diabetes mellitus (GDM) 6. Able to read English or Spanish Exclusion Criteria 1. Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound 2. Planned termination of pregnancy or any indications of miscarriage 3. Prior gastric bypass surgery 4. Pregravid diabetes (type 1 or type 2) 5. Unwillingness/inability to wear CGM sensor 6. Unwillingness to attend routine antenatal obstetric appointments 7. 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 8. Use of insulin during the pregnancy prior to enrollment 9. 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 10. Deemed unable to participate for medical reasons identified by their physician Additional Criteria for RCT Eligibility 1. Screening CGM meeting study criteria for hyperglycemia: 5% to \<25% time \>140 mg/dL 2. Randomization by 16 week 6 days of pregnancy 3. No participation in a separate intervention trial.

Where Is This Study? (2 UK sites)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Eleanor ScottPrincipal Investigator

Norfolk and Norwich University Hospitals NHS

Norwich, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Helen MurphyPrincipal Investigator

How to Get in Touch

Judy Sibayan, MPH, CCRP, Epidemiologist

Sponsor contact

CONTACT

813-975-8690 jsibayan@jaeb.org

Paige N Miller, BS

Sponsor contact

CONTACT

813-975-8690 pmiller@jaeb.org
Data sourced from ClinicalTrials.gov · Last verified: 2025-12