Active not recruitingOBSERVATIONAL

Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Continuous Glucose Monitoring

If you had diabetes during pregnancy (gestational diabetes), this study wants to see if a small, stick-on sensor called a Freestyle Libre 2 can help predict your risk of developing diabetes again after your baby is born. Millions of women get gestational diabetes, and many go on to develop type 2 diabetes later, but current follow-up tests are often missed. This study hopes to find an easier and more accurate way to keep an eye on blood sugar levels in the weeks after childbirth, helping doctors identify those who might need extra support sooner. It's for women aged 18 and over who've had gestational diabetes.

At a glance

Status

Active not recruiting

Sponsor

University of Manitoba

Enrolment target

240

Start

04 Jul 2023

Estimated completion

01 Dec 2030

Gestational Diabetes Prediabetes; Complicating Pregnancy Type 2 Diabetes Pregnancy Related Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases

What is this study about?

Gestational diabetes is a type of diabetes that develops during pregnancy. It's quite common, affecting many pregnant women. While it usually goes away after the baby is born, it significantly increases a woman's chance of developing type 2 diabetes or a condition called 'pre-diabetes' later in life. In fact, about half of women who've had gestational diabetes will develop one of these conditions within ten years, so it's really important to keep an eye on things.

Currently, the recommended way to check for this after pregnancy is with a blood test called an Oral Glucose Tolerance Test (OGTT). However, many women don't get this test. It can be a bit inconvenient, as it involves drinking a sugary drink and having a couple of blood samples taken over two hours. This study wants to explore a new way to check blood sugar levels that might be much easier and more helpful.

This study will use a device called a Freestyle Libre 2, which is a small sensor you wear on your skin. It gently reads your blood sugar levels throughout the day and night without needing pinpricks, giving a much fuller picture than a single blood test. Researchers hope to see if using this sensor in the weeks after childbirth can accurately predict a woman's risk of developing future diabetes, making it easier for them and their doctors to manage their health going forward.

Key takeaways

This study explores a new, easier way to check diabetes risk after pregnancy.
It's for women who've had gestational diabetes.
You'll wear a stick-on sensor (Freestyle Libre 2) for a few weeks after birth.
The aim is to help doctors predict future diabetes risk more effectively.
It could lead to better follow-up care for new mums.

Who may be eligible?

This study is looking for pregnant women aged 18 and older who have been diagnosed with gestational diabetes. You might be eligible if your doctor diagnosed your gestational diabetes using standard guidelines, or if you had a slightly elevated HbA1c test result during pregnancy.

To be considered, you should also have had certain factors during your pregnancy, such as a high fasting blood sugar at diagnosis, needing insulin or metformin to manage your diabetes, or having a higher Body Mass Index (BMI). You must be planning to have your baby in a hospital and be happy to use the study device and complete some questionnaires after childbirth. You'll also need access to email to take part in the study.

You would not be able to participate if you already had type 1 or type 2 diabetes before or during your pregnancy. Other reasons for not being able to join include needing an X-ray, MRI, or CT scan within three weeks after your baby is born, having certain medical implants like a pacemaker, or taking medicines that could affect your blood sugar readings or interfere with the sensor's accuracy (like high-dose Vitamin C). You also need to be able to understand and speak either French or English.

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 or older?
Were you diagnosed with gestational diabetes during this pregnancy?
Are you planning to give birth in a hospital?
Do you have email access for questionnaires?
Are you not currently on certain medications that could interfere with the sensor?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be asked to wear a small sensor called a Freestyle Libre 2, typically for a few weeks, starting soon after your baby is born. This sensor will continuously measure your blood sugar levels. You'll also be asked to fill out some questionnaires through email. There are no specific visits beyond your delivery, but you'll need to be willing to use the device as instructed and answer questions about your health and experiences. The total duration of your active involvement will be in the weeks immediately following childbirth.

Potential risks and benefits

Participating in this study might offer you the benefit of better understanding your blood sugar levels soon after delivery. It could also help researchers find new, easier ways to predict future diabetes risks for women like you. Any risks are generally low; wearing the sensor is usually comfortable, but some people might experience minor skin irritation. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

University of Calgary
Verified postcode
Calgary, Canada
University of Manitoba
Verified postcode
Winnipeg, Canada
Mount Sinai Hospital
Verified postcode
Toronto, Canada
Universite Laval
Verified postcode
Québec, Canada

Common questions

What is gestational diabetes?

It's a type of diabetes that can develop during pregnancy and usually goes away after the baby is born, but it can increase the risk of developing diabetes later in life.

What is the Freestyle Libre 2?

It's a small sensor you wear on your arm that continuously checks your blood sugar levels without needing finger-prick tests.

Will I need to take any medicine for this study?

No, this study is about monitoring your blood sugar, not about giving you new medicines.

How long will I wear the sensor?

You will wear the sensor for a specific period immediately after your baby is born, as advised by the study team.

Will I get to see my blood sugar readings?

The study will collect your data, and typically, you would not have direct access to your real-time personalised data for clinical decision-making. The information helps the researchers.