RecruitingOBSERVATIONAL

Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System

Patient.info is helping to explain a new study for people with Type 1 diabetes, aged 7 to 75. Researchers are testing a new device called the Medtrum Hybrid Closed Loop (HCL) system. This system acts like an 'artificial pancreas' to automatically deliver insulin. The study wants to see how safe and effective this HCL system is when people use it at home. They will compare it to using an insulin pump in the usual 'manual' way. The main goal is to find out if the HCL system helps people spend more time with their blood sugar levels in the healthy range (between 4 and 10 mmol/L). Participants will also answer questionnaires about their diabetes management and quality of life.

At a glance

Status

Recruiting

Sponsor

Medtrum France

Enrolment target

160

Start

15 Apr 2024

Estimated completion

01 Dec 2025

Type 1 Diabetes

What is this study about?

This study is looking at a new way to manage Type 1 diabetes called the Medtrum Hybrid Closed Loop (HCL) system. Think of it as a step closer to an 'artificial pancreas'. This system combines an insulin pump with a continuous glucose monitor (which tracks your sugar levels all the time) and smart software. The software uses the information from the glucose monitor to decide how much insulin you need and automatically delivers it through the pump.

The main aim of this research is to see if this new automatic system is better at keeping blood sugar levels stable within the target range compared to using an insulin pump where you have to adjust the insulin yourself. Researchers also want to make sure the system is safe for people to use in their everyday lives at home. They're also checking how well a feature called 'meal announcement' works, which helps the system prepare for rises in blood sugar after eating.

Finding better ways to manage Type 1 diabetes is really important because keeping blood sugar levels steady can help prevent complications in the long run and improve daily life. This study could help more people with Type 1 diabetes benefit from advanced technology to make day-to-day management easier and more effective.

Key takeaways

A new 'artificial pancreas' system for Type 1 diabetes is being tested.
The study aims to see if it improves blood sugar control at home.
It's open to people with Type 1 diabetes aged 7 to 75.
Participants will use either the new system or a standard insulin pump.
Questionnaires will gather feedback on quality of life and treatment satisfaction.

Who may be eligible?

To join this study, you need to have Type 1 diabetes and be between 7 and 75 years old. You should be taking at least 10 units of insulin each day and weigh more than 22 kg. It's important that you, or your parents/guardians if you're a child, are able to accurately count carbohydrates in your food.

While you don't need to be currently using an insulin pump, you should either be an experienced pump user or regularly take multiple insulin injections. Your current diabetes management shouldn't be fully meeting your blood sugar targets. For instance, your HbA1c (a measure of average blood sugar over a few months) might be between 7% and 12%, or you might not be spending enough time in your target glucose range.

There are also reasons why you might not be able to join. For example, if you're pregnant or breastfeeding, have certain skin conditions that react badly to tapes or metals, or if you're not able to do finger-prick blood sugar tests when needed. If you have unstable eye problems related to diabetes (retinopathy), or if you use certain other diabetes medications (like GLP-1 agonists), you would likely not be eligible. The research team will go through all these details with you to see if the study is a good fit.

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.

Do you have Type 1 diabetes and are you between 7 and 75 years old?
Do you take at least 10 units of insulin daily?
Are you, or your guardian, good at counting carbohydrates?
Are your current blood sugar targets not quite being met?
Are you able to use study devices and follow instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first receive training on how to use the Medtrum A8 TouchCare® Insulin Management system. Then, by chance, you will be placed into one of two groups: one group will use the insulin pump in the standard 'manual' way (called the Open Loop group), and the other will use the new automated 'closed-loop' system (the Closed Loop group). This random assignment ensures a fair comparison.

During the study, you'll be asked to complete several questionnaires. These will help researchers understand your fears around low blood sugar, how your diabetes affects your quality of life, and how satisfied you are with your treatment. The main part of the study will involve collecting data on your blood sugar levels through your continuous glucose monitor. Researchers will specifically compare how much time you spend within the target blood sugar range during the last 12 weeks of the study, depending on which group you were in. The study involves using the system at home.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as gaining access to a new diabetes management technology and potentially achieving more stable blood sugar levels. Your health will be closely monitored, and you'll receive dedicated training and support. However, as with any medical device or treatment, there are potential risks, such as skin irritation from the pump or sensor, or the possibility of blood sugar levels going too low or too high. You might also find the questionnaires time-consuming. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

CHU Angers
Verified postcode
Angers, France· Not yet recruiting
CHU Besançon
Verified postcode
Besançon, France· Not yet recruiting
CHU Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
CHU Caen
Verified postcode
Caen, France· Not yet recruiting
Centre Hospitalier Sud-Francilien
Verified postcode
Corbeil-Essonnes, France· Recruiting
Centre Hospitalier de Gonesse
Verified postcode
Gonesse, France· Recruiting
Centre Hospitalier Saint-Louis
Verified postcode
La Rochelle, France· Not yet recruiting
Hôpital Hôtel-Dieu
Verified postcode
Le Creusot, France· Recruiting
Hospices Civils de Lyon
Verified postcode
Lyon, France· Not yet recruiting
Hôpital Européen
Verified postcode
Marseille, France· Not yet recruiting
Hôpital La Timone
Verified postcode
Marseille, France· Not yet recruiting
CHU Montpellier
Verified postcode
Montpellier, France· Not yet recruiting

Common questions

What is a 'Hybrid Closed Loop' system?

It's an advanced insulin pump system that automatically adjusts insulin delivery based on your sugar levels, acting a bit like an artificial pancreas.

What is the 'target glucose range' they refer to?

This is the healthy blood sugar zone they want to keep your levels in, usually between 4 and 10 mmol/L (or 70-180 mg/dL as mentioned in the study).

Will I have to pay to participate?

No, you will not have to pay to take part in the study. All study-related devices and support are provided.

How long will I be in the study?

The study involves collecting data over a period that measures your blood sugar control for at least 12 weeks, but the total duration could be longer to allow for training and setup.

What does 'meal announcement' mean?

This is a feature where you tell the system when you're about to eat, helping it to deliver insulin more effectively to manage the sugar from your meal.

How to find out more

Mélanie MARMOUNIER

melanie.marmounier@medtrum.fr 0620591224 Official trial record

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