Active not recruitingNAINTERVENTIONAL

MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY)

The MyREMEDY study is checking if a special self-help app, MyDiaMate, can help adults with Type 1 diabetes feel better mentally. Living with Type 1 diabetes can be very demanding, leading to feelings like tiredness, constant worry about blood sugar, or eating issues. While many people face these challenges, not everyone gets professional help. This study aims to see if MyDiaMate can offer support. It's happening in the UK and other countries, comparing app users to those receiving their usual care. Participants will use the app or continue with their normal routine for a few months, filling out questionnaires along the way to see if MyDiaMate makes a positive difference to their mental health.

At a glance

Status

Active not recruiting

Phase

Sponsor

Maartje de Wit

Enrolment target

660

Start

03 Apr 2024

Estimated completion

01 Jan 2026

Type 1 Diabetes Diabetes Distress

What is this study about?

Living with Type 1 diabetes means constantly managing your condition, which can be a big burden. Because of this, many people with Type 1 diabetes experience mental health challenges. These might include feeling very tired, worrying a lot about blood sugar levels (especially dangerously low ones), or struggling with eating. Even if these feelings aren't severe enough to be called a 'disorder', they can still make life harder.

Often, people facing these issues don't get professional help. Sometimes, the problems aren't seen as serious enough for formal treatment, or some people prefer to try to manage things on their own, at their own pace. That's where MyDiaMate comes in. It's an app designed to offer individual support for these mental health challenges, aiming to make help easily accessible without many hurdles.

This study, called MyREMEDY, is looking into how well MyDiaMate works. We want to see if using the app can help reduce mental health problems for adults with Type 1 diabetes who feel distressed because of their condition. The study is taking place in several countries, including the UK, to get a broad understanding of its effects.

Key takeaways

This study looks at a self-help app (MyDiaMate) for mental health in Type 1 diabetes.
It aims to reduce distress and improve well-being in adults with Type 1 diabetes.
Participation lasts for 6 months, involving app use and questionnaires.
You'll need internet access and a smart device to take part.
The study takes place in the UK and other European countries.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and have been diagnosed with Type 1 diabetes at least six months ago. It's also important to have access to a smartphone, tablet, or computer and the internet for the whole study period.

Crucially, you would need to be experiencing some level of 'diabetes distress'. This means feeling worried or stressed about your diabetes, which will be checked during a quick phone call with the research team.

There are also some reasons why you might not be able to join. For example, if you've been diagnosed with a mental health condition and are currently getting psychological or psychiatric treatment, or have started new mental health medication in the last three months. You also can't join if you have severe reading or comprehension difficulties, or issues with your vision or hearing that really affect your daily life. If you've used MyDiaMate before (this mainly applies to people in the Netherlands), you wouldn't be able to join either.

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?
Have you had Type 1 diabetes for at least 6 months?
Do you have regular access to a smartphone/tablet/computer and the internet?
Do you feel distress, worry, or stress about your diabetes?
Have you not started new mental health medication or therapy in the last 3 months?
Can you read and use digital devices without major difficulty due to vision/hearing problems?

Answer every question to see your result.

What does participation involve?

If you're chosen for the study, you'll first complete some initial questionnaires to assess your current well-being. After that, you'll be randomly assigned to one of two groups: either you'll get access to the MyDiaMate app for three months, or you'll continue with your usual diabetes care as you normally would during that time.

Three months into the study, everyone will fill out another set of questionnaires. If you were in the group using MyDiaMate, you'll also be asked about your experiences with the app through surveys and possibly an interview. After this, everyone in the study will get access to MyDiaMate for the next three months, regardless of their initial group.

Finally, at the six-month mark, everyone will complete one last set of questionnaires. After that, the study will end for all participants, and access to the MyDiaMate app will stop. The total time you'll be involved in the study is six months.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as gaining access to MyDiaMate, which could help you manage distress related to your Type 1 diabetes. Even if you're in the group that initially receives usual care, you will get access to the app later in the study. However, there's no guarantee that MyDiaMate will be effective for everyone. There are very few major risks involved, but you might find the questionnaires time-consuming or you might feel some emotional discomfort when answering questions about your mental well-being. It is important to know that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

Forschungsinstitut Diabetes-Akademie Bad Mergentheim
Verified postcode
Bad Mergentheim, Germany
Amsterdam UMC
Verified postcode
Amsterdam, Netherlands
Universidad de Málaga
Verified postcode
Málaga, Spain
King's College London
Verified postcode
London, United Kingdom

Common questions

What is MyDiaMate?

MyDiaMate is a self-help app designed to support adults with Type 1 diabetes who are experiencing distress or mental health challenges related to their condition.

Why is this study important?

Many people with Type 1 diabetes experience stress and worry. This study aims to find out if MyDiaMate can effectively help people improve their mental well-being and cope better with their diabetes.

Will I definitely get to use the MyDiaMate app if I join?

If you join, you will be randomly assigned to either use the app for the first three months or continue with your usual care. However, everyone in the study will get access to MyDiaMate for the final three months of the study.

How long does the study last?

If you take part in the study, your involvement will last for a total of six months.

Do I need special equipment to join?

Yes, you'll need regular access to a smartphone, tablet, or computer and an internet connection for the entire duration of the study.