RecruitingOBSERVATIONAL

Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes

This study aims to understand how well a treatment called 'closed-loop therapy' (often called an artificial pancreas system) works for people living with unstable Type 1 diabetes. This type of diabetes makes it very difficult to keep blood sugar levels steady, leading to serious highs and lows. Researchers want to see if the artificial pancreas system could be a good option for people who would otherwise consider an islet transplant. They will be looking at how well the artificial pancreas helps manage blood sugar over 12 months in patients who have been referred to a specialist centre. The goal is to help doctors decide the best treatment path for each individual.

At a glance

Status

Recruiting

Sponsor

University Hospital, Grenoble

Enrolment target

Start

04 Jun 2025

Estimated completion

30 Jun 2031

Type 1 Diabetes (T1D)

What is this study about?

Living with Type 1 diabetes can be challenging, especially for those whose blood sugar levels vary wildly, leading to unpredictable highs and dangerous lows. This is often called 'unstable diabetes'. For some, managing these fluctuations becomes very difficult, even with the best care, and it can significantly affect their daily life and health. Doctors are always looking for better ways to help these patients.

This study is designed to look closely at a modern treatment called 'closed-loop therapy'. You might hear it called an 'artificial pancreas' because it uses a sensor to check blood sugar levels and an insulin pump to deliver the right amount of insulin automatically. Researchers want to see how effective this system is over a year for people with very unstable Type 1 diabetes who are already considering another advanced treatment called islet transplantation.

The main idea is to understand if closed-loop therapy can really help stabilise blood sugar and improve quality of life for these patients. By carefully observing how well the system works for a group of people, the study hopes to provide valuable information that will help doctors and patients make informed decisions about the best course of treatment in the future.

Key takeaways

This study investigates 'artificial pancreas' systems for unstable Type 1 diabetes.
It aims to understand if this system is a good alternative to islet transplantation.
Participation involves using a closed-loop system and being monitored for 12 months.
The study focuses on adults whose blood sugar is difficult to manage.
It helps doctors decide the best advanced treatment options for patients.

Who may be eligible?

This study is looking for adults (aged 18 or over) living with Type 1 diabetes. A main requirement is that your blood sugar levels are very unstable and difficult to control, even though you've been working with a specialist team for over a year to manage it optimally. This means you might experience frequent or severe low blood sugar episodes (hypoglycaemia) that require help from someone else, or even cause unconsciousness or seizures. You might also have high blood sugar leading to problems like ketoacidosis.

To be considered, your blood sugar variability needs to be significant, as measured by certain medical tests. This high variability must have been persistent for more than a year despite receiving excellent care, including using insulin pumps and glucose sensors, and learning how to manage your diabetes effectively with a healthcare team.

You would not be able to join this study if you've already had a closed-loop system installed. Also, if you've had a kidney transplant, or if there are other specific medical or legal reasons that prevent you from taking part in research studies, you would not be eligible. Finally, if you do not meet the standard medical requirements for an islet transplant, you would also be excluded.

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 1 diabetes that is very difficult to control, with unpredictable highs and lows, even with specialist care?
Have you experienced severe low blood sugar (hypoglycaemia) that needed help from someone else, or caused serious effects (like losing consciousness) in the last year?
Are you NOT currently using a closed-loop (artificial pancreas) system?
Have you NOT had a kidney transplant?
Are you eligible for islet transplantation based on standard medical criteria?

Answer every question to see your result.

What does participation involve?

The study aims to observe your health and how well the closed-loop system works for you over a 12-month period. You would be seen by a specialist team, who would manage your diabetes and help you use the closed-loop system. We don't have specific details on the number of clinic visits or assessments, but it's likely you would have regular check-ups to monitor your blood sugar levels, general health, and how you are adapting to the closed-loop therapy. There would be no extra medication beyond your usual diabetes treatment and the closed-loop system itself. The total duration of active observation in the study is 12 months.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of better blood sugar control and an improved quality of life if the closed-loop system helps manage your unstable diabetes more effectively. However, it's important to remember that all medical treatments carry some risks, and using a new system might require adjustments and careful monitoring. The exact risks of closed-loop therapy would be fully explained by the study team. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

HCL - Edouard Herriot Hospital
Verified postcode
Lyon, France· Recruiting
Hospices Civils de Lyon - Lyon Sud
Verified postcode
Pierre-Bénite, France· Recruiting
Strasbourg Civil Hospital
Verified postcode
Strasbourg, France· Recruiting
Grenoble University Hospital
Verified postcode
La Tronche, France· Recruiting
Montpellier University Hospital - Lapeyronnie Hospital
Verified postcode
Montpellier, France· Recruiting
Toulouse University Hospital - Hôpital Rangueil
Verified postcode
Toulouse, France· Recruiting
APH Paris - LARIBOISIERE Hospital
Verified postcode
Paris, France· Not yet recruiting

Common questions

What is 'closed-loop therapy'?

It's a system that links a continuous glucose monitor (CGM) to an insulin pump, automatically adjusting insulin delivery based on your blood sugar levels, much like an 'artificial pancreas'.

What does 'unstable Type 1 diabetes' mean?

It means your blood sugar levels are very difficult to keep steady, leading to frequent and unpredictable highs and dangerous lows, despite good care.

Will I get an islet transplant if I join this study?

No, this study is comparing closed-loop therapy to islet transplantation. You would not receive an islet transplant as part of this particular study.

How long will I be in the study?

The study will observe your progress for 12 months.

Can I stop participating if I want to?

Yes, you can leave the study at any time without it affecting your medical care.

How to find out more

Myriam HADDOUCHE

mhaddouche@chu-grenoble.fr +33476765509 Official trial record

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