RecruitingNAINTERVENTIONAL

Hybrid Closed-Loop Insulin Delivery After Pancreatectomy

This study is for people who have diabetes after having surgery to remove their pancreas (pancreatectomy). This type of diabetes can be tricky to manage, making it hard to live a full life because blood sugar levels can change a lot. The study wants to see if a system that automatically delivers insulin, called a 'hybrid closed-loop' system (specifically, the MiniMed 780G pump and Simplera sensor), can make blood sugar control easier and improve quality of life. This system is already used for Type 1 diabetes, and early research suggests it might help people with diabetes after pancreas surgery too. The study will compare how well participants manage their blood sugar using this new system versus their usual diabetes treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Sud Francilien

Enrolment target

Start

19 May 2026

Estimated completion

19 Nov 2027

Pancreatectomy Total Pancreatectomy Partial Pancreatectomy

What is this study about?

This study is investigating a new way to help people manage their diabetes after they've had an operation to remove all or part of their pancreas. This surgery, called a pancreatectomy, can sometimes lead to a type of diabetes that's particularly challenging to control, mostly because blood sugar levels can be very up and down. This can impact someone's daily life and overall well-being.

The researchers want to see if a special type of insulin pump system, called a 'hybrid closed-loop' system, can make a difference. This system works by automatically giving you insulin based on your blood sugar readings from a continuous glucose sensor. These systems are already widely used and helpful for people with Type 1 diabetes. Early studies have hinted that they might also be very beneficial for people with diabetes after pancreas surgery, helping to keep blood sugar more stable.

Currently, there isn't a lot of strong evidence to show how well the commercially available systems work for this specific group of people. This study aims to provide that important evidence, which could help more people get access to this technology if it proves effective. The system being tested combines the MiniMed 780G insulin pump with the Simplera glucose sensor.

Key takeaways

This study tests a smart insulin pump and sensor system for diabetes after pancreas surgery.
It aims to improve blood sugar control and quality of life.
The system uses continuous glucose monitoring to automatically adjust insulin.
Participation involves using the new system for 3 months and then your usual treatment (with a sensor) for 3 months.
It's for adults (18+) with specific diabetes requirements after a pancreatectomy.
The findings could help more people access this technology in the future.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must have had a total or partial pancreatectomy (surgery to remove part or all of your pancreas), and as a result, have diabetes that requires insulin and is confirmed by a specific blood test (your C-peptide level will be checked). Your daily insulin dose should be between 6 and 250 units, and you should be covered by a French social security plan, as this study is taking place in France.

There are also some reasons why you might not be able to join. For example, if you have severe eye problems from diabetes that aren't stable, or if you're already using an advanced insulin pump system that pauses before low blood sugar. You also can't be pregnant or planning to become pregnant in the next six months, or be planning chemotherapy in the next six months.

Other reasons for not being able to join include if you're receiving tube feeding, have a life expectancy of less than a year, have certain memory or mental health conditions that would make managing the automatic insulin system difficult, or if you're currently in another research study. The study also cannot include anyone who is imprisoned or under legal guardianship, or if there are any specific health warnings for using the MiniMed 780 - Simplera system.

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 had surgery to remove part or all of your pancreas?
Do you have diabetes that requires insulin?
Are you NOT pregnant and not planning to be in the next 6 months?
Are you currently covered by French social security?
Are you able and willing to give your written consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will use a hybrid closed-loop system for three months. This system is made up of the MiniMed 780G insulin pump and the Simplera glucose sensor. After this period, or possibly before, you will spend three months using your usual diabetes treatment, but you will also wear the Simplera sensor to keep track of your blood sugar levels. The study will compare your blood sugar control during the three months using the new system with the three months using your usual treatment.

The MiniMed 780G pump is an external device that delivers insulin through a tiny tube you place under your skin, usually in your tummy, bottom, thighs, or upper arms. You’ll be shown how to insert this yourself. The Simplera system is a small, all-in-one sensor that you'll place under the skin on the back of your upper arm using a special device. This sensor continuously monitors your blood sugar. Throughout the study, you'll have regular check-ups with the study team to monitor your health and how you're getting on with the devices.

Potential risks and benefits

Taking part in this study could potentially help you manage your blood sugar levels more effectively, which might improve your overall health and how you feel day-to-day. You’ll also get close monitoring from the study team. However, there are potential risks, such as skin irritation from the sensor or pump insertion site, or the usual risks associated with insulin use like low blood sugar (hypoglycaemia) or high blood sugar (hyperglycaemia), although the system aims to reduce these. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Centre Hospitalier Sud Francilien
Verified postcode
Corbeil-Essonnes, France· Recruiting
Hôpital Bichat (APHP)
Verified postcode
Paris, France· Not yet recruiting

Common questions

What is a 'hybrid closed-loop' system?

It's a smart system that combines an insulin pump with a continuous glucose sensor. It automatically adjusts your insulin delivery based on your blood sugar readings.

What is a pancreatectomy?

It's a surgery where part or all of your pancreas is removed. This can sometimes cause diabetes because the pancreas makes insulin.

Will I have to pay for the devices?

The study description doesn't mention costs to participants, but typically, study-related devices and care are provided as part of the research.

How long will I be in the study?

The main part of the study involves two three-month periods, one with the new system and one with your usual treatment, plus follow-up visits.

Can I still take part if I'm pregnant?

Unfortunately, no. The study cannot include anyone who is pregnant or planning a pregnancy within the next six months.

How to find out more

Coralie AMADOU, MD

coralie.amadou@chsf.fr 1 61 69 33 87 Official trial record

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