Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Pan-European proof-of-concept study comparing Decentralised Clinical Trial (DCT) and hybrid approaches to conventional clinical trial approaches in patients with Type 2 diabetes mellitus treated with Toujeo®

This study is for people in Europe who have Type 2 diabetes and are currently using Toujeo insulin. It's looking at different ways to carry out clinical trials. Researchers want to compare traditional methods, where you might visit a clinic often, with newer, more flexible approaches that use technology like apps or online tools. The main goal is to see if these new methods make it easier for people to join and stay in studies, and if they collect information just as well. They'll also be checking how well people stick to their insulin and how their blood sugar levels change. This is a "Phase IV" study, which means the medicine (Toujeo) is already approved and the study is gathering more information about its real-world use and how to run studies efficiently.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

University Medical Center Utrecht

Enrolment target

500

Start

02 Nov 2022

Type 2 diabetes mellitus (T2DM)

What is this study about?

This study is focused on people who have Type 2 diabetes and are currently taking Toujeo insulin. The main idea behind this research is to find better ways to run clinical trials. Currently, many trials require frequent visits to a clinic, which can be difficult for some people. This study is testing out more modern approaches, sometimes called "Decentralised Clinical Trials" (DCTs), which might involve using smartphone apps, wearable devices, or online communication to collect information and interact with study participants.

The researchers want to compare these new, more flexible methods with the traditional way of running trials. They'll be looking at things like how quickly people can join the study, how many people complete the study, and if these new methods help a wider range of people from different backgrounds take part. They also want to see if the new methods make it easier and quicker to record any side effects that might happen.

Beyond just looking at how trials are run, the study will also gather important health information. They'll be checking how well people with Type 2 diabetes stick to their daily insulin injections and how their blood sugar control changes over time. This includes looking at a measure called HbA1c, which gives an average of blood sugar levels over several months, and also fasting blood sugar levels. This is a 'Phase IV' study, which means Toujeo is already a well-established medication, and this research helps us understand more about its use in everyday life and how to make future studies even better for patients.

Key takeaways

This study is comparing new ways to run clinical trials to improve patient experience.
It's for adults with Type 2 diabetes who are already using Toujeo insulin.
The study explores if technology can make participating in trials easier and more convenient.
Participation lasts about 6 months and involves ongoing monitoring of your diabetes.
Your blood sugar control and how you use your insulin will be tracked.
You can stop participating at any time if you change your mind.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old. There's no upper age limit, meaning older adults can also take part.

This study is for both men and women.

The most important health requirement is that you must have Type 2 diabetes and already be receiving treatment with Toujeo insulin.

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?
Are you currently being treated with Toujeo insulin?
Are you willing to participate for about 6 months?
Are you able to provide information either through clinic visits or potentially using an electronic diary/app?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the exact details of your involvement will depend on which group you are in (the traditional trial group or one of the newer, more flexible trial groups). However, generally, you would be involved for a total duration of 24 weeks (about 6 months).

You would continue to take your Toujeo insulin as prescribed. You might be asked to record information daily using an electronic diary (eDiary), which could be an app on a smartphone or another digital device. This would include details about your insulin injections and any side effects you experience.

The study would involve regular assessments, which might be done through clinic visits for the traditional group, or potentially through virtual check-ups and remote data collection for the more flexible groups. These assessments would involve checking your blood sugar levels (like HbA1c and fasting blood sugar). All participants can choose to leave the study at any time.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to our understanding of how to make clinical trials more patient-friendly and accessible in the future, which could improve healthcare for everyone. You would also receive close monitoring of your diabetes and insulin use throughout the study period. As Toujeo is an approved medication, you won't be taking an unknown drug; the focus is on how the trial is run. Potential risks are generally low, as you would continue your established diabetes treatment. However, as with any medication, side effects can occur, and these would be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (5)

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

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Unverified
Denmark
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Unverified
Italy
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Unverified
Spain
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Unverified
Poland
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Unverified
Germany

Common questions

What is the main purpose of this study?

The main purpose is to compare different ways of running clinical trials, especially for people with Type 2 diabetes, to see if newer, more flexible methods work well.

Is Toujeo a new medication being tested?

No, Toujeo is already a well-known and approved insulin for Type 2 diabetes. This study isn't testing the medication itself, but rather how we gather information about its use in real-world settings.

How long would I be in the study if I participate?

If you join, your participation would last for about 24 weeks, which is roughly 6 months.

What do 'decentralised' and 'hybrid' trials mean?

These terms refer to trials that use technology (like apps or online tools) to make it easier for you to take part from home, potentially reducing the need for many clinic visits.

Will my regular diabetes care change if I join?

You would continue to use Toujeo as prescribed. The study would involve additional monitoring and data collection, but your fundamental diabetes management should remain under your doctor's guidance.