RecruitingNAINTERVENTIONAL

RT-CGM in Young Adults at Risk of DKA

This study is for young adults, aged 18-25, living with type 1 diabetes who find it hard to keep their blood sugar levels in check or have been in hospital because of very high blood sugar. We're testing a device called real-time continuous glucose monitoring (RT-CGM), like the Dexcom G6. This device continuously checks your sugar levels through a small sensor on your skin and sends the information to your phone, even alerting you if levels are too high or low. We want to see if using this technology for six months helps improve overall blood sugar control (measured by HbA1c) and reduces the need for hospital stays. This is a small pilot study to help us plan a bigger one in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

03 Sep 2020

Estimated completion

30 Jun 2022

Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Disease Autoimmune Diseases Endocrine System Diseases

What is this study about?

This study is looking into how a special type of blood sugar monitoring called real-time continuous glucose monitoring (RT-CGM) can help young adults with type 1 diabetes. You might know these devices by names like Dexcom G6. They work differently from finger-prick tests because they constantly measure your sugar levels through a small sensor placed on your skin. This information is then sent wirelessly to your smartphone or a special handheld device, showing you your sugar levels all the time and even setting off alarms if your levels get too high or too low. We believe this technology could be really helpful for managing diabetes.

We're especially interested in how young people, aged 18 to 25, find these devices to use. We want to know if using RT-CGM for six months helps them better control their diabetes. This includes seeing if their average blood sugar levels (measured by a test called HbA1c) improve and if they need to go to hospital less often because of very high blood sugar. Many young adults struggle with keeping their blood sugar stable, so finding new tools to help is very important.

This is a pilot study, which means it's a smaller first step. The information we gather will help us understand if RT-CGM is beneficial for this age group and if it makes sense to do a much larger study in the future. By taking part, you could be helping to shape how diabetes is managed for young people in the years to come.

Key takeaways

Study for young adults (18-25) with type 1 diabetes.
Investigates benefits of continuous glucose monitoring (RT-CGM).
Aims to improve blood sugar control and reduce hospital visits.
Participation involves 12 months, including 6 months with RT-CGM.
Involves interviews, questionnaires, and blood tests.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for young adults between 18 and 25 years old who have been living with type 1 diabetes for at least a year. You should be using insulin injections multiple times a day or an insulin pump.

We are particularly interested if you have found it difficult to keep your blood sugar levels in control (your doctor will know if your HbA1c is above 75 mmol/mol or 9%), or if you've been admitted to hospital at least once in the last year because your blood sugar was dangerously high.

It's important that you haven't used a real-time continuous glucose monitor (RT-CGM) like the Dexcom G6 before, except maybe for a very short time if a doctor used it for diagnosis or checking. However, if you've used other types of glucose monitors that aren't 'real-time' – for example, flash glucose monitors – that's perfectly fine.

Quick self-check

Are you between 18 and 25 years old?
Have you had type 1 diabetes for more than a year?
Do you use insulin injections or an insulin pump?
Is your HbA1c usually high (above 75 mmol/mol or 9%), or have you been in hospital for very high blood sugar in the last year?
Have you not regularly used a real-time continuous glucose monitor (RT-CGM) before?
Are you not pregnant, planning to be, or breastfeeding, and do not have certain serious medical conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you'll be part of it for 12 months. At the very beginning, you’ll have an interview with a diabetes psychologist and complete some questionnaires. You’ll also have a blood test to check your HbA1c.

For the first six months, you'll either use the RT-CGM device (like the Dexcom G6) or you’ll continue your usual finger-prick blood sugar checks. After these six months, you'll switch, so if you had the finger-prick checks, you'll then use the RT-CGM device for the next six months, and vice versa. During the time you're using the RT-CGM, you can choose to share your blood sugar data with the research team, and they will help you understand it and adjust your treatment if needed. You will have another interview with the psychologist, complete questionnaires, and have an HbA1c blood test after 6 months and again after 12 months.

At the very end of the 12 months, all participants will be invited to a group discussion to share their experiences and help us understand what worked well or not so well. Overall, it means attending some appointments for interviews and blood tests, and actively monitoring your blood sugar, either with the new device or your usual method, for a total of 12 months.

Potential risks and benefits

Taking part in this study could offer you the benefit of learning more about your blood sugar patterns with the help of a RT-CGM device, which might lead to better control of your diabetes. The research team will support you in understanding your data. While the RT-CGM device is generally safe, some people might experience mild skin irritation where the sensor is placed. There are no other significant risks expected beyond those usually associated with managing diabetes and having blood tests. Remember, you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Imperial College Clinical Research Facility
London, United Kingdom· Recruiting

Common questions

What is RT-CGM?

RT-CGM stands for real-time continuous glucose monitoring. It's a small device that checks your sugar levels constantly throughout the day and night through a sensor on your skin, sending the information to your phone.

Will I get to keep the Dexcom G6?

Participants will use the Dexcom G6 for a period of six months during the study. The study focuses on evaluating its impact during this period.

Do I have to do finger-prick tests if I'm using RT-CGM?

The RT-CGM largely replaces the need for routine finger-prick tests. You might still need to do them sometimes, for example, to double-check a reading if it doesn't match how you feel.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months. It's a good way to see how well your diabetes is being managed over time.

What if I get pregnant during the study?

If you become pregnant or plan to become pregnant, you would no longer be able to continue in the study for safety reasons.

How to find out more

Shivani Misra

s.misra@nhs.net 02075946136 Official trial record

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