RecruitingInterventional

Hybrid closed loop insulin pump system for people with diabetes caused by chronic pancreatitis

This study explores a new kind of insulin pump system for individuals with diabetes resulting from chronic pancreatitis. This specific type of diabetes, sometimes called type 3c, can be tricky to manage due to pain, digestion issues, and unpredictable blood sugar changes. The advanced insulin pump system, which works with a glucose sensor to automatically adjust insulin, is widely used for type 1 diabetes but hasn't been studied much for this group. The research aims to find out if it's practical and acceptable to compare this new technology with standard insulin treatment for people with chronic pancreatitis-related diabetes. It also plans to understand participants' experiences using these devices and taking part in the study, hoping to inform future, larger research.

At a glance

Status

Recruiting

Sponsor

Newcastle upon Tyne Hospitals NHS Foundation Trust

Enrolment target

Start

01 Jun 2026

Estimated completion

31 Oct 2026

Diabetes, chronic pancreatitis

What is this study about?

People who have long-term inflammation of the pancreas, known as chronic pancreatitis, can develop a type of diabetes because their pancreas is damaged. This is sometimes called type 3c diabetes. For these individuals, managing blood sugar levels can be quite a challenge. This is because they might also experience pain, problems with digestion, and their blood sugar can change very unexpectedly. Current advice on how to treat this condition often comes from research on other types of diabetes, and there isn't much information yet on whether newer diabetes technologies are helpful for this specific group.

This study is looking at something called an 'advanced hybrid closed-loop insulin system.' Think of it as a smart insulin pump that works together with a sensor placed on the skin to continuously check blood sugar levels. Based on these readings, the pump then automatically adjusts the amount of background insulin delivered. These systems are commonly used by people with type 1 diabetes, but we don't know much about how well they work for individuals whose diabetes is caused by chronic pancreatitis. The main goal is to see if it's practical and acceptable to conduct a bigger study in the future that would compare this advanced pump system with the usual insulin treatments.

The research also wants to hear directly from participants about their experiences using these technologies. Their feedback will be very important in understanding whether these systems are easy to use, make a difference to their daily lives, and if they feel comfortable taking part in this type of study. Ultimately, this information will help researchers decide if a larger study is needed and how best to improve care for people living with both chronic pancreatitis and diabetes.

Key takeaways

This study evaluates an advanced insulin pump for diabetes linked to chronic pancreatitis.
It aims to see if this technology is practical and helpful for managing blood sugar.
Participants will either use the new pump system or continue standard care.
You'll share your experiences through visits, questionnaires, and potentially interviews.
Your involvement helps improve future care for people with this condition.

Who may be eligible?

This study is particularly looking for adults, aged 18 or over, who have both chronic pancreatitis and diabetes caused by their pancreatic condition. You should currently be using insulin, whether that's twice a day or multiple injections daily. It's also important that your blood sugar levels are currently higher than recommended, or you're experiencing troublesome low blood sugar episodes.

There are certain situations where you wouldn't be able to join. For instance, if you have type 1 or type 2 diabetes (rather than diabetes specifically from chronic pancreatitis), or if you've had pancreatic cancer, you wouldn't be suitable. Also, if you've had major surgery on your pancreas (apart from a specific procedure called a Frey’s procedure), or if you're already using an insulin pump, you wouldn't be eligible. Pregnant individuals or those with other significant medical conditions that could make taking part unsafe or difficult are also unable to participate.

Quick self-check

Are you 18 years or older?
Do you have chronic pancreatitis and diabetes caused by it?
Are you currently taking insulin (injections)?
Are your blood sugars often too high or do you have troublesome lows?
Have you NOT had pancreatic cancer or total pancreas removal surgery?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have an initial visit to gather some basic health information. After this, you'll be randomly placed into one of two groups. One group will use the advanced hybrid closed-loop insulin pump system, receiving training and support on how to use it. The other group will continue with their usual NHS diabetes care, which typically involves insulin injections and continuous glucose monitoring.

The study will last approximately 16 weeks in total, including a preparation period and 12 weeks during which you'll be actively involved. You'll have up to 10 study visits. Some of these will be in person at the Newcastle Diabetes Centre, and others can be done remotely, such as over the phone or by video call. These visits will involve support for managing your diabetes, checking your glucose data, answering questionnaires, and having routine blood tests. A small number of participants will also be asked if they'd like to do an interview to share their experiences in more detail. Your usual medical team will continue to look after you throughout the study.

Potential risks and benefits

Taking part could offer several potential benefits. You might receive extra support with managing your diabetes, and if you're in the group using the new technology, you'll get access to an advanced diabetes device. More importantly, your participation will help researchers learn more about this condition and could improve care for other people with chronic pancreatitis and diabetes in the future. The risks involved are generally similar to those you might experience with usual diabetes care. These can include blood sugar levels that are too low or too high, minor discomfort from blood tests or inserting the sensor, and possibly some skin irritation from the devices. Some questions in questionnaires or interviews might bring up difficult feelings, but you are always free to skip any questions or stop taking part at any time. It's important to remember that your regular healthcare team will continue to look after you throughout the study.

Locations (1)

The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, England

Common questions

What is chronic pancreatitis?

Chronic pancreatitis is a long-term condition where the pancreas becomes inflamed repeatedly, leading to damage over time.

What is type 3c diabetes?

This is a type of diabetes caused by damage to the pancreas, often due to conditions like chronic pancreatitis, which affects its ability to produce insulin.

What is a hybrid closed-loop insulin system?

It's a smart insulin pump that works with a glucose sensor to automatically adjust the amount of background insulin delivered, helping to manage blood sugar levels.

Where and when will the study take place?

The study will happen at the Newcastle Diabetes Centre. It's expected to start after necessary approvals, with each person taking part for about 16 weeks.

Who is funding this research?

The study is funded by the National Institute for Health and Care Research (NIHR) as part of a doctoral fellowship program.

How to find out more

Ayat Bashir

ayat.bashir@ncl.ac.uk - Official trial record

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