Active not recruitingNAINTERVENTIONAL

The FreeStyle Libre Enabled Reduction of A1c Through Effective Eating and Exercise Study

This study, called LIBERATE, is for people with Type 2 diabetes aged 18 and over, particularly those whose blood sugar (A1c) is 8.0% or higher. It explores how using wearable technology, like the FreeStyle Libre (a glucose monitor) and a FitBit (a fitness tracker), can help individuals improve their diets and exercise habits. Participants will join online group classes for six months to learn more about managing their condition. The study aims to make it easier for people to understand their body's responses to food and activity, helping them make better choices. The knowledge gained from this study could help develop new tools and programs for diabetes care centres across Canada.

At a glance

Status

Active not recruiting

Phase

Sponsor

Western University, Canada

Enrolment target

184

Start

26 Sep 2022

Estimated completion

01 Oct 2025

Diabetes Mellitus, Type 2

What is this study about?

This study, called LIBERATE, is looking into how people with Type 2 diabetes can get better control over their blood sugar levels. If you have Type 2 diabetes, you know that keeping your blood sugar in a healthy range is really important for your long-term health. This study wants to see if using certain smart devices and attending online classes can make a big difference.

Participants will use a FreeStyle Libre, which is a small sensor you wear that continuously checks your glucose (sugar) levels without needing finger pricks. They'll also wear a FitBit, which tracks your activity throughout the day. The idea is that seeing how your body reacts to different foods and exercises in real-time can help you make healthier choices. You'll also join online group classes where you'll learn about healthy eating and exercise from specialists, which can be a great way to get support and new ideas.

The study is happening in two different places in Ontario, Canada, and will involve about 184 people. The main goal is to find out if this approach can lower a person’s A1c, which is a blood test that shows your average blood sugar over the past few months. What they learn from this study will help create helpful guides and programs for other diabetes clinics to use in the future, potentially helping many more people manage their diabetes better.

Key takeaways

Learn to better manage Type 2 diabetes with technology.
Improve blood sugar control (A1c) through diet and exercise.
Receive personalised support and online group education.
Use a FreeStyle Libre sensor and a FitBit device.
Contribute to creating better diabetes care programs for the future.

Who may be eligible?

To be considered for this study, you need to have Type 2 diabetes and be at least 18 years old. Importantly, your average blood sugar level (A1c) should be 8.0% or higher. You should also be new to using flash glucose monitors like the FreeStyle Libre, but keen to try this technology.

You'll need to have access to a smartphone that's compatible with the devices used in the study (specific iPhone or Android models are listed), an email address, and a reliable internet connection for the online classes. It’s also essential that your doctor has confirmed you are healthy enough to participate in exercise.

You wouldn't be able to join if you struggle with technology, have a language barrier or a severe mental health condition that would make group participation difficult, or if you are pregnant. Also, if you have any serious, untreated health problems like foot ulcers, unstable heart conditions, or uncontrolled high blood pressure, or if you've had a recent major health event (like a heart attack or stroke) in the last three months, you wouldn't be eligible. Lastly, if you can't commit to the full six-month program due to upcoming surgery or moving, you wouldn't be able to join.

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.

Do I have Type 2 diabetes and am I 18 or older?
Is my A1c (average blood sugar) 8.0% or higher?
Am I new to continuous glucose monitors but interested in trying one?
Do I own a compatible smartphone, have an email, and internet access?
Has my doctor said it's okay for me to exercise?
Can I commit to a 6-month online program without major health or relocation issues?

Answer every question to see your result.

What does participation involve?

If you join the LIBERATE study, you'll first have a phone call with the research team to make sure you're a good fit and understand what's involved. Before starting the classes, you'll attend an orientation, likely online, to learn about the technology you'll be using. You'll then begin recording two weeks of your usual blood sugar and step counts using the FreeStyle Libre and a FitBit.

The main part of the study involves attending five online group classes every two weeks, followed by three additional online classes once a month. These sessions are about an hour long and will teach you about healthy eating and exercise, with support from the FreeStyle Libre data. You'll wear the FreeStyle Libre for the first three months, and you can choose to continue wearing it for the last three months. The FitBit will be worn for the entire six months. You'll also have the option to get personalised exercise plans from the team. You can communicate with the study team (exercise specialist, doctor, or dietitian) weekly by email if you have questions between classes. The total duration of active participation in the program will be six months. There is no specific mention of changes in medication, but the study focuses on lifestyle interventions.

Potential risks and benefits

Taking part in this study could offer several benefits, such as gaining a better understanding of how your body responds to food and exercise, leading to improved blood sugar control and healthier habits. You'll receive structured education and support from healthcare professionals, and you'll get to use advanced wearable technology. There are minimal risks associated with using the wearable devices, mainly skin irritation from the FreeStyle Libre sensor or discomfort from wearing the FitBit. Exercise prescriptions will be tailored to your fitness level, and you'll need physician clearance to exercise to ensure your safety. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

St. Joseph's Family Medical and Dental Centre
Verified postcode
London, Canada

Common questions

What is A1c and why is it important?

A1c is a blood test that shows your average blood sugar levels over the past 2-3 months. Keeping your A1c in a healthy range is crucial for managing diabetes and preventing long-term complications.

What devices will I use in this study?

You'll use a FreeStyle Libre, which monitors your blood sugar continuously, and a FitBit Inspire 2, which tracks your physical activity and steps.

How often are the classes and how long do they last?

There will be five classes every two weeks, followed by three classes once a month. Each class is about one hour long and will be held online.

Will I have support between classes?

Yes, you can communicate weekly with the study team (exercise specialist, doctor, or dietitian) via email if you have questions or need support.

What happens after the 6 months?

After the six months, the study data will be used to help create a 'toolkit' of resources for other diabetes clinics to use, potentially helping many more people.