RecruitingPhase IVInterventional

Initiation and management of DExcom continuous glucose monitoring in primary care in people living with type 2 diabetes on insulin

This study is about people with type 2 diabetes who use insulin in the UK and Ireland. It's investigating the Dexcom ONE+ Continuous Glucose Monitoring (CGM) system in everyday GP clinics. Currently, many people check their blood sugar by pricking their finger, but CGM offers a way to get continuous readings. The study wants to find out if using this system helps people control their blood sugar better, if patients and healthcare staff like using it, and if it can be easily used within current healthcare practices. It will help understand if this technology can improve diabetes care in the future. The study is for adults aged 18 and over who have had type 2 diabetes for at least three months, are on insulin, and mostly get their diabetes care from their GP.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

Dexcom (United States)

Enrolment target

232

Start

12 Mar 2026

Estimated completion

31 Jan 2027

Type 2 Diabetes Mellitus

What is this study about?

If you live with type 2 diabetes and use insulin, you know how important it is to keep your blood sugar levels in a healthy range. This helps prevent serious health problems later on, like heart disease, kidney issues, and eye problems. Many people currently check their blood sugar by pricking their finger, but there's a newer technology called Continuous Glucose Monitoring (CGM). CGM systems use a small sensor worn on your body to constantly measure your blood sugar, giving you a more complete picture throughout the day and night.

This study, called "DExcom," is looking at a specific CGM system called Dexcom ONE+. This system is already approved for use in the UK. The main goal is to see how well it works in regular GP surgeries across the UK and Republic of Ireland. Doctors and researchers want to understand if using the Dexcom ONE+ helps people with type 2 diabetes manage their blood sugar more effectively. They also want to see if patients find it easy and helpful to use, and if healthcare professionals can easily fit it into their daily practice without causing disruptions.

Ultimately, this research aims to improve diabetes care. By understanding how CGM systems work in real-world GP settings, the study hopes to gather important information that could lead to better ways for people with type 2 diabetes to manage their condition and live healthier lives. Your participation could help make a difference for many others in the future.

Key takeaways

Study evaluating new glucose monitoring system (Dexcom ONE+) in GP practices.
Aimed at people with type 2 diabetes on insulin.
Duration of participation is approximately 24 weeks.
May help improve future diabetes care, but no direct personal benefit.
Risks are generally low, mostly minor skin irritation.
Participation is voluntary, you can withdraw at any time.

Who may be eligible?

This study is looking for adult volunteers aged 18 or older. To join, you need to have been diagnosed with type 2 diabetes for at least three months, and you should currently be using insulin. While some specialist care is fine, most of your diabetes care should be handled by your local GP practice.

Another important requirement is that your recent blood test for average blood sugar (called HbA1c) needs to be 64 mmol/mol or higher. Also, for the past three months, your diabetes medications, including insulin, should have been fairly stable, meaning no big changes in dose or type of medication. You'll also need to be able to safely use the CGM system and follow the study instructions.

Unfortunately, if you are planning to become pregnant, you cannot take part. If you are a woman who could become pregnant, you'll need a negative pregnancy test at the start of the study. The study team will make sure you understand all the requirements before you decide to participate.

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 2 diabetes and have been on insulin for at least 3 months?
Does your GP manage most of your diabetes care?
Is your recent HbA1c blood test result 64 mmol/mol or higher?
Have your diabetes medications (including insulin) been fairly stable for the last 3 months?
Are you not planning to become pregnant during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement will last for about 24 weeks, which is roughly six months. At the very beginning, you'll have an in-person visit where the study team will check if you meet all the requirements. You'll first wear a special sensor for about 10 days that collects your glucose information, but you won't be able to see the readings during this initial period.

After these first 10 days, you'll then switch to a different CGM system that allows you to see your glucose levels in real-time. You'll use this system for the rest of the 24 weeks, replacing the sensors approximately every 10 days. Throughout the study, you'll be asked to fill out several short questionnaires about your diabetes care, your general health, and how you feel day-to-day when using the device.

Some participants might also be asked to have a brief interview about their experiences with the CGM system. These interviews can be done remotely or in person and will be recorded and kept private. Finally, you will have a small amount of blood taken for routine tests during the study. You can always reach out to the study doctor or local team if you have any questions or concerns.

Potential risks and benefits

There might not be any direct benefit to you personally from taking part in this study. However, your involvement is very valuable as it will help researchers understand how CGM systems work in everyday GP settings. This knowledge could lead to better diabetes care for many people in the future. Remember, taking part is completely your choice, and you can withdraw from the study at any time without it affecting your medical care. The risks of participating are generally low. The Dexcom ONE+ CGM system is an approved device in the UK. You might experience some minor issues where the sensor is worn, such as mild discomfort, redness, swelling, irritation, itching, bleeding, or a slight risk of infection. Blood tests might cause a little discomfort or bruising. Your personal information will be protected very carefully in line with UK privacy laws, but there's always a very small risk when handling data.

Locations (6)

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

Northenden Group Practice
Unverified
Manchester, England
Hockley Farm Medical Practice
Unverified
Leicester, England
Manchester Integrative Medical Practice
Unverified
Manchester, England
Preston Hill Surgery
Unverified
Harrow, England
Ashton Medical Group LTD
Unverified
Lancashire, England
Shipley Medical Practice
Unverified
Shipley, England

Common questions

What is Continuous Glucose Monitoring (CGM)?

CGM is a system that uses a small sensor to constantly measure your blood sugar levels throughout the day and night, giving you a continuous picture of your glucose.

Will I get to see my blood sugar readings during the study?

Yes, after an initial 10-day period where the sensor readings are hidden, you will use a system that lets you see your glucose levels in real time for 24 weeks.

Where is this study taking place?

The study is being carried out in GP practices across the United Kingdom and the Republic of Ireland.

Who is paying for this study?

The study is funded by Dexcom, Inc., a company that makes medical devices.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it will not affect the medical care you receive.

How to find out more

Trivart Shetty

trivart.shetty@dexcom.com +44 01858 200 0200 Official trial record

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