RecruitingNot ApplicableInterventional

Characterisation of sensor accuracy performance for Continuous Glucose Monitoring (CGM) systems

This study aims to understand how accurately different continuous glucose monitoring (CGM) systems measure blood sugar levels for people living with diabetes in the UK. If you are 18 or older and have Type 1 or Type 2 diabetes, you might be able to take part. Researchers want to see how these CE-marked CGM devices perform during everyday life. You would wear up to three sensors for up to 31 days and do four finger-prick blood tests daily. Your involvement could help improve our understanding of these important devices and give you the chance to try out CGM technology. There are small risks, like skin irritation or minor pain from finger-prick tests, but your safety is important.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

Abbott Diabetes Care Ltd.

Enrolment target

4,500

Start

19 May 2025

Estimated completion

01 Apr 2035

Diabetes mellitus

What is this study about?

Imagine being able to keep a closer eye on your blood sugar levels throughout the day without lots of finger-prick tests. That's what Continuous Glucose Monitoring (CGM) systems aim to do. This study is all about checking how well different CGM systems, which have already been approved for use (they have a 'CE-mark'), actually work.

Researchers want to see if the readings from these sensors are accurate and reliable in real-world settings. They'll be comparing the sensor readings against traditional finger-prick blood tests. The information gathered will help us better understand how these devices perform and could lead to improvements or more widespread use, ultimately benefiting many people with diabetes.

By taking part, you'd be helping scientists gather vital information that could shape the future of diabetes management. This knowledge can help doctors and patients make more informed choices about which devices might be best for managing blood sugar levels effectively.

Key takeaways

Study examines accuracy of existing continuous glucose monitors (CGM).
Open to adults (18+) with Type 1 or Type 2 diabetes.
Involves wearing up to three sensors for up to 31 days.
Requires daily finger-prick blood tests (at least four times).
Small risks include skin irritation or minor pain from tests.
Participation helps improve understanding of diabetes technology.

Who may be eligible?

This study is looking for adults aged 18 or over who have either Type 1 or Type 2 diabetes. You'll need to be able to read and understand English, and be comfortable with doing regular finger-prick blood tests – at least four every day during the study period.

There are some reasons why you might not be able to join. For example, if you are pregnant or planning to become pregnant during the study, or if you have a known allergy to medical sticky tape. You also can't take part if you have certain skin conditions where the sensor would be placed, or if you have a pacemaker or other similar electronic device in your body.

It's important that you're not currently involved in another medical study that could affect your blood sugar levels. The research team will also make sure that taking part won't put your health at risk, so they'll check for any other medical conditions that might make it unsuitable for you.

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?
Do you have Type 1 or Type 2 diabetes?
Are you willing and able to do at least four finger-prick blood tests daily?
Can you read and understand English well?
Do you have any pacemakers or similar electronic implants?
Are you pregnant or planning to be during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be asked to wear up to three different continuous glucose monitoring (CGM) sensors at the same time. Each sensor will be worn for a period of up to 31 days, depending on how long each specific sensor is designed to last. During this time, you'll go about your normal daily activities.

It's important that you also continue to use your usual way of checking your blood sugar levels. In addition, you'll need to do at least four finger-prick blood tests every day – typically before meals and at bedtime. These finger-prick results will be compared against the sensor readings to see how accurate the sensors are. You'll be asked to provide a minimum of 4 and up to 12 finger-prick samples each day. The study is expected to run from June 2024 to April 2035.

Potential risks and benefits

Taking part in this study could offer you the chance to gain experience with CGM devices and help improve our understanding of how well they work for people with diabetes. This knowledge could ultimately benefit many others in the future. There are some small risks involved, such as minor skin irritation where the sensors are attached, which could include redness, swelling, rash, itching, bruising, pain, or a slight risk of infection. Similarly, finger-prick tests, while common, might cause a little pain, bruising, or a very small risk of infection or feeling faint. You are free to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (2)

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

MAC Clinical Research Glasgow
City only
Glasgow, United Kingdom
MAC Clinical Research Barnsley
City only
Barnsley, United Kingdom

Common questions

What is a 'CE-marked' CGM system?

A 'CE-marked' device means it meets European safety, health, and environmental protection requirements, so it's approved for sale and use in the UK.

Do I need to stop taking my usual diabetes medicine?

No, you will keep using your current method of glucose monitoring and any diabetes medication as normal throughout the study.

Where in the UK is this study taking place?

The study is being run from two sites in the UK: MAC Clinical Research in Glasgow and MAC Clinical Research in Barnsley.

How long will I need to be in the study for?

You will wear the sensors for up to 31 days in total. The overall study is expected to run until April 2035, but your personal involvement is for a shorter period.

Who is paying for this research?

This study is funded by Abbott Diabetes Care Ltd, a company that makes diabetes products.

How to find out more

Pamela Reid

pamela.reid@abbott.com +44 1993 863024 Official trial record

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