RecruitingNAINTERVENTIONAL

CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

This research is testing a new way to pick up high blood sugar in pregnant women very early on. They're using a device called a Continuous Glucose Monitor (CGM), which is a small patch worn on the skin that constantly checks sugar levels. The main goal is to see if finding and managing these higher sugar levels sooner can reduce potential problems for the baby, such as being born too large or needing special care, and for the mother, like developing high blood pressure during pregnancy. Participants will wear a hidden CGM initially, and if certain sugar level changes are found, they might be invited to join the main part of the study, where some will get extra support to manage their sugar, while others receive standard care.

At a glance

Status

Recruiting

Phase

Sponsor

Jaeb Center for Health Research

Enrolment target

6,000

Start

27 May 2025

Estimated completion

27 Nov 2027

Gestational Diabetes Mellitus in Pregnancy

What is this study about?

This study, called "CGM for Early Detection and Management of Hyperglycemia in Pregnancy," is all about finding and managing high blood sugar levels in pregnant women as early as possible. 'Hyperglycemia' just means having high sugar in your blood. The researchers want to see if using a Continuous Glucose Monitor (CGM) – a small device that sticks to your skin and measures your sugar levels around the clock – can help spot these changes much earlier than usual.

The main idea is that if high blood sugar is found and dealt with sooner, it might prevent potential health issues that can sometimes arise during pregnancy. For the baby, this could mean avoiding problems like growing too big (which can make birth more difficult), having shoulder injuries, needing light treatment for yellow skin (jaundice), or requiring a stay in intensive care. For the mum, the study hopes to see if early detection can lower the chance of developing high blood pressure during her pregnancy.

Participants who join will first wear a hidden CGM. If this shows signs of higher sugar levels, they might then be invited to the next stage of the study. Here, some women will receive extra guidance and support to manage their sugar levels with the help of their CGM readings, while others will continue with regular pregnancy care. Researchers will then compare how both groups fare to understand the benefits of early CGM use.

Key takeaways

This study uses a small skin patch (CGM) to find high blood sugar early in pregnancy.
The goal is to prevent problems for mum and baby, like babies being too big or mum getting high blood pressure.
Participation involves wearing a hidden CGM first, possibly followed by extra blood sugar management support.
It's for women pregnant with one baby, under 15 weeks, and without existing diabetes.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and pregnant with only one baby. You should be in the early stages of pregnancy, up to 14 weeks and 6 days, and an ultrasound should confirm your baby's age. It's important that you don't already have diabetes (Type 1 or Type 2) or a history of diabetes in a previous pregnancy, and your recent blood sugar test (HbA1c) should be normal.

You also need to be able to read English or Spanish. You can't join if there are any known problems with the baby's development, if you're planning to end the pregnancy, or if you've had certain stomach surgeries in the past. It's also not suitable if you're already taking specific medications like insulin or certain steroids, or if you've recently used some diabetes or weight-loss drugs.

Additionally, you must be happy to wear the CGM sensor and attend all your regular antenatal appointments. Your doctor will also need to agree that you are well enough to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you pregnant with only one baby, and less than 15 weeks pregnant?
Have you never had diabetes (Type 1, Type 2, or during a previous pregnancy)?
Are you able to read English or Spanish?
Are you willing to wear a small sensor patch (CGM) and attend your regular pregnancy appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first wear a hidden Continuous Glucose Monitor (CGM) sensor for a short period, starting by 14 weeks and 6 days of pregnancy. This sensor will quietly check your blood sugar levels. After about 5 to 10 days, if your hidden CGM shows specific signs of higher-than-normal blood sugar, and you meet all the other study requirements, you might then be invited to the next stage of the study. This decision needs to be made by 16 weeks and 6 days of pregnancy.

In this next stage, you'd be randomly assigned to either receive extra support based on your CGM readings to manage your blood sugar, or to continue with your usual pregnancy care. Those who don't show the specific higher sugar levels will still be followed as an 'observational group' if their long-term blood sugar levels (HbA1c) are okay. The study will involve regular check-ups and the use of the CGM, and the researchers will compare your health and your baby's health to understand the benefits of early blood sugar monitoring. The total duration of your involvement would be throughout your pregnancy and includes tracking your baby's health outcomes after birth.

Potential risks and benefits

Taking part in this study could potentially help you understand and manage your blood sugar levels earlier in pregnancy, which might lead to better health for both you and your baby. However, there are also some potential inconveniences, like having to wear the CGM sensor and attend study appointments. As with any medical study, there's a small chance of unexpected side effects from the devices or interventions. You are always in control, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
University of Miami
Verified postcode
Miami, United States· Recruiting
Emory University
Verified postcode
Decatur, United States· Recruiting
IDC at Park Nicollet
Verified postcode
Saint Louis Park, United States· Recruiting
Icahn School of Medicine at Mount Sinai
Verified postcode
New York, United States· Recruiting
Cleveland Clinic
Verified postcode
Cleveland, United States· Recruiting
Oregon Health & Science University
Verified postcode
Portland, United States· Recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
Leeds Teaching Hospitals NHS Trust
Verified postcode
Leeds, United Kingdom· Not yet recruiting
Norfolk and Norwich University Hospitals NHS
Verified postcode
Norwich, United Kingdom· Not yet recruiting

Common questions

What is a CGM?

A CGM (Continuous Glucose Monitor) is a small patch you wear on your skin that automatically checks your blood sugar levels, day and night, without needing finger pricks.

Why is early detection of high blood sugar important in pregnancy?

Catching high blood sugar early can help your medical team provide support sooner, which might reduce potential health issues for you and your baby down the line.

Will my care change if I join the study?

If you meet certain sugar level criteria and are in the main part of the study, some participants will receive extra support to manage their sugar, while others will continue with their usual care.

What happens if I don't meet the blood sugar criteria?

If your sugar levels are within normal limits during the initial screening, you might still be part of an 'observational group' where your health will be followed, but you won't be involved in the treatment comparison part of the study.

Is the CGM painful to wear?

The CGM sensor is generally small and designed to be comfortable. Most people find it easy to wear and almost forget it's there.

How to find out more

Judy Sibayan, MPH, CCRP, Epidemiologist

jsibayan@jaeb.org 813-975-8690 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.