RecruitingNAINTERVENTIONAL

Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM

This research study is looking at a new digital tool called covivio. It’s designed to help adults living with type 2 diabetes deal with the emotional difficulties that can come with their condition. We know that living with diabetes can sometimes feel overwhelming, and this study wants to see if covivio can make a positive difference. Two hundred and fifty people with type 2 diabetes will join the study. Some will get access to covivio along with their usual care, while others will just continue with their usual care. Researchers will then compare how both groups feel emotionally and how well they manage their blood sugar levels after six months. The aim is to find effective ways to support people with type 2 diabetes beyond just physical health.

At a glance

Status

Recruiting

Phase

Sponsor

Gaia AG

Enrolment target

250

Start

09 Oct 2024

Estimated completion

09 Apr 2026

Glucose Metabolism Disorders (Including Diabetes Mellitus)Metabolic Disease Endocrine System Diseases Diabetes Mellitus, Type 2

What is this study about?

Living with type 2 diabetes can sometimes be tough, not just physically but emotionally too. Many people find themselves feeling stressed, worried, or down because of their condition. This research study is looking into a new digital tool called covivio that might help with these feelings. It's an online program designed to support people in managing the emotional side of diabetes. The study wants to find out if using covivio, alongside your regular diabetes care, can make a difference in how you feel and how well you manage your diabetes.

To do this, 250 adults who have type 2 diabetes and are feeling some emotional stress related to it will be invited to take part. Half of these participants will use covivio in addition to their usual diabetes care, while the other half will continue with their usual care only. This setup allows the researchers to fairly compare how each group is doing and see if covivio has a real impact.

Over six months, the study will check in with participants to see how their emotional well-being is changing and how their blood sugar levels are being managed. They'll also look at other things like how well people are managing their diabetes day-to-day, their body weight, and their general quality of life. The findings from this study could help improve the support available for people living with type 2 diabetes in the future.

Key takeaways

This study evaluates a digital tool (covivio) for emotional stress in type 2 diabetes.
It aims to see if covivio helps with mood and blood sugar management.
250 adults with type 2 diabetes and some emotional distress will participate.
Participants will either use covivio plus usual care, or just usual care.
The study lasts for six months and involves questionnaires and blood sugar monitoring.
Findings could improve emotional support for people with type 2 diabetes.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with type 2 diabetes by a doctor. To join, you should also be experiencing some emotional distress related to your diabetes, which will be checked using a special questionnaire. You'll need to be able to understand and speak German and agree to take part.

There are some reasons why you might not be able to join. These include if you have type 1 diabetes, or if you've recently changed your diabetes medication or other treatments (like bariatric surgery or talking therapies) or plan to change them in the next six months. If you're already using a continuous glucose monitor (CGM) as part of your regular diabetes care, or if there were problems getting enough information from a CGM at the start of the study, you also wouldn't be able to take part.

The study also requires you to have a smartphone that can work with a CGM device, as these will be used to track blood sugar levels for some parts of the study.

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 been diagnosed with type 2 diabetes?
Are you experiencing some emotional stress related to your diabetes?
Do you speak and understand German?
Do you have a smartphone that can work with a blood sugar monitor?
Have you *not* recently changed or planned to change your diabetes medication or other major treatments (like surgery or talking therapy)?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for six months. At the start, you'll have an initial visit where researchers will check your eligibility, and you'll complete some questionnaires to assess your emotional well-being related to diabetes. You'll also wear a continuous glucose monitor (CGM) for about a week to measure your blood sugar levels.

After this initial check, you would be randomly placed into one of two groups. One group will get access to the digital tool called covivio in addition to your usual diabetes care. The other group will continue with only their usual diabetes care. Your doctor will still be in charge of your regular diabetes treatment, and you should continue to follow their advice.

Throughout the six months, you will likely be asked to complete further questionnaires and wear the CGM again at different points to see if there have been any changes in your emotional well-being and blood sugar management. You won't need to make any changes to your medication unless your own doctor recommends it. The total duration of active participation and monitoring will be six months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that if you're in the group using covivio, you might find it helps to reduce any emotional stress you feel because of your diabetes. Even if you're in the group receiving only usual care, your information will help researchers better understand how to support people with type 2 diabetes. We don't expect many risks from this study, as covivio is a digital tool and wouldn't interfere with your medical treatment. However, some people might find completing questionnaires or wearing the blood sugar monitor a bit inconvenient. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

GAIA AG
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is covivio?

Covivio is a digital tool, like an online program, designed to help people manage the emotional challenges of living with type 2 diabetes.

Will I have to change my diabetes medication?

No, you will continue with your usual diabetes medication and care as prescribed by your doctor. The study won't ask you to change your medication.

How long will the study last for me?

If you join, your participation in the study will last for six months.

What is a continuous glucose monitor (CGM)?

A CGM is a small device you wear that measures your blood sugar levels throughout the day and night without needing to prick your finger as often.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. It won't affect your regular medical care.

How to find out more

Gitta A Jacob, PhD

gitta.jacob@gaia-group.com +49 40 349930-374 Official trial record

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