RecruitingNAINTERVENTIONAL

Liom Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM)

Researchers are investigating a new device called Liom Clinical Demo 2.0. This device aims to measure blood sugar levels continuously and without needing to prick your skin, which could make managing diabetes much easier. The study is open to both men and women with either type 1 or type 2 diabetes who are between 18 and 65 years old. To take part, you must have had diabetes for at least a year and be currently using insulin or other specified diabetes medications. The study will be done in stages, with groups of participants helping to test and improve the device over time. The goal is to see how well this new technology works in real-world settings.

At a glance

Status

Recruiting

Phase

Sponsor

Liom Health AG

Enrolment target

Start

23 Feb 2024

Estimated completion

31 Jul 2025

Type 1 Diabetes Type2diabetes

What is this study about?

This study is about a brand-new device called the Liom Clinical Demo 2.0, which scientists hope will make managing diabetes much simpler. Currently, many people with diabetes need to regularly prick their finger or wear a small sensor under their skin to check their blood sugar levels. This new device is designed to measure blood sugar without needing any needles or skin punctures – it's completely non-invasive.

The researchers want to see how well this new technology works for people with type 1 and type 2 diabetes. They'll be carefully testing it and using computer learning to make it better as the study goes along. Being able to check blood sugar levels easily and continuously without skin pricks could be a big step forward for managing diabetes, helping people stay healthier and feel more in control of their condition.

The study will involve several small groups of volunteers. After each group participates, the researchers will review the results and make improvements to the device and the way it works. This step-by-step process helps ensure that the final device is as accurate and user-friendly as possible.

Key takeaways

New device for blood sugar monitoring without skin pricks.
For adults (18-65) with type 1 or type 2 diabetes.
Must be on insulin or other specific diabetes medicines.
Helps develop future diabetes management tools.
You can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 to 65 who have been diagnosed with type 1 or type 2 diabetes for at least one year. You must also be currently using insulin or other specific diabetes medications to manage your condition.

However, some people won't be able to join the study. For example, if you're allergic to any of the materials in the Liom Clinical Demo 2.0 device, or if you have any skin problems, injuries, or tattoos on your wrists where the device might be worn.

Additionally, if you have any history of significant heart problems like a heart attack, stroke, or certain irregular heartbeats, you would not be able to participate for your safety.

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 between 18 and 65 years old?
Do you have type 1 or type 2 diabetes (diagnosed for at least one year)?
Are you currently using insulin or other diabetes medications?
Do you have any significant heart problems or serious skin conditions on your wrists?
Are you allergic to anything that might be in medical devices?

Answer every question to see your result.

What does participation involve?

This study is designed to be a 'clinical demonstration,' meaning you'd be helping to test a new device. It's a single-centre study, so you would likely need to attend appointments at one specific location. The study involves different groups of people, and the researchers might make adjustments to the device after each group participates. You will be using the Liom Clinical Demo 2.0 device, which is a key part of the study. The exact total time you'd be involved isn't specified, but it would involve using the device and likely attending follow-up visits.

Potential risks and benefits

A potential benefit of joining this study is helping to develop a new, non-invasive way to monitor blood sugar, which could greatly improve diabetes management in the future. You would also receive close monitoring related to the study. Potential risks are generally low, but might include a reaction to any materials in the device if you have unknown sensitivities, though allergies are screened for. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Profil for Stoffwechselforschung GmbH
Verified postcode
Neuss, Germany· Recruiting

Common questions

What is a 'non-invasive' device?

A non-invasive device means it doesn't break your skin or go inside your body, like a blood test or a sensor that's put under your skin. This device would measure blood sugar from the outside, like on your wrist.

Who is running this study?

This study is being conducted by researchers aiming to test and improve a new device for diabetes management.

Will I get paid to be in the study?

The information provided does not state whether participants will receive payment. This is a good question to ask the study team.

Do I have to stop my current diabetes medication if I join?

No, you will continue with your current diabetes treatment, including insulin or other medications. The study is testing the new device alongside your usual care.

What if I decide I don't want to be in the study anymore?

You are free to leave the study at any point, for any reason, without having to explain why, and it will not affect your usual medical care.

How to find out more

Banu Eyueboglu Seitz, PhD

bes@liom.com 0041 41 552 00 59 Official trial record

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