Technology aims to improve quality of life for people with cystic fibrosis-related diabetes

A Welsh health board is taking part in a UK-wide research study which has enabled people with cystic fibrosis and diabetes to access closed-loop insulin systems, which help improve their blood sugar management and quality of life.

Cystic fibrosis (CF) is a genetic condition which causes mucus to build up in the lungs and other organs. This mucus often causes damage to the pancreas, and can eventually lead to the pancreas not producing insulin properly, leading to CF-related diabetes (CFD). This is the most common non-respiratory complication of CF, developed by up to one-third of people with the condition.

CF has a significant impact on people’s day-to-day life, necessitating a daily regime of medication and physiotherapy to help keep airways clear. For people with CFD, this burden is increased, as they must also check their blood glucose levels and inject themselves with insulin multiple times a day.

Closed-loop systems can make this easier, by reading blood glucose levels and delivering insulin automatically. They comprise of a continuous glucose monitor (CGM), a small sensor that sits under the skin and constantly tracks glucose levels, connected using Bluetooth technology to an insulin pump, an electronic device programmed to release insulin through the day and night.

An in-built algorithm reads the sugar levels reported by the CGM and calculates how much insulin the pump needs to deliver to keep the patient’s blood sugar levels in target range. Patients can use a smartphone app to easily access their data and control insulin administration themselves.

Using a closed-loop system reduces the amount of finger prick blood tests and insulin injections needed. The amount of insulin given is calculated more precisely, helping keep blood sugar levels more stable. They can also help prevent blood sugar levels going too low (hypoglycaemia, or hypos) or too high (hyperglycaemia), sounding an alarm and suspending or increasing doses.

While closed-loop systems are licensed for people with type 1 diabetes, the CL4P-CF study is the first randomised control trial to look at their benefits for patients with CFD. The trial is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC), with contributions from Health and Care Research Wales.

‘Constantly worried’

Andrew Hale, 45, from Pontypool, took part in the study at Cardiff and Vale University Health Board. Andrew said: “I’ve had CF all my life. It hasn’t held me back, but it has made me more cautious. I’ve always got to think about the risk of catching an infection.

“I was diagnosed with diabetes in my thirties and found that much more challenging. It was warm and I’d been working in the garden, but nothing would quench my thirst. I drank almost everything in the fridge but nothing helped. When I saw my consultant, he sent me straight to the diabetes clinic to learn how to inject.

“With CF, when I get a chest infection, I can have treatment to clear it and then go on with my life, putting it to the back of my mind. Diabetes is constant. It felt surreal, the responsibility of injecting myself. I had to understand the impact of my diet on my blood sugar levels, remember how to finger prick test. I really struggled to keep my blood sugar under control and as a single dad with two young girls, I was constantly worried about having a hypo. I didn’t want to be a burden to them but it just felt like an impossible challenge.”

When he first heard about the study, Andrew felt nervous at the thought of using diabetes technology. “I had been offered a pump before but I was apprehensive to hand my diabetes care to a little machine. I also felt self-conscious at the thought of wearing something constantly. But I thought it might give me more freedom, and I really understand the importance of taking part in research like this to help move things forward. The study was randomised, so I thought I’d go for it and leave it up to fate.”

Andrew was randomised to the closed-loop insulin pump and soon noticed an impact on his mental health as well as his physical health.

“Within a few months my blood sugar levels were in range 90% of the time. It took a huge weight off my mind. I wasn’t so worried, for myself or for my kids having to know how to help me if I had a hypo. The girls know what the alarms from the app on my phone mean. I can go out for a meal and instead of feeling self-conscious going to the toilets to inject myself, I wear my pump with pride.”

“Research like this is so important to help understand these conditions and what really makes a difference to patients. I would recommend this technology to anyone with CFD. The way it has simplified things and reduced my anxiety has been huge – for me and my family.”

Principal Investigator, Dr Dawn Lau, said: “Diabetes technology has taken leaps and bounds forwards in recent years, enabling insulin pumps and CGMs to mimic the role of a healthy pancreas. Closed loop systems are widely used among people with type 1 diabetes and have been proven to improve their blood glucose management and quality of life, but no randomised control trial in the UK has evaluated these benefits for people with CFD until now.

“While results of the study are still being evaluated, we believe these systems have benefited our patients, substantially improving their average blood glucose levels compared to standard care.

“CFD patients are currently waiting up to two years for referrals for closed-loop systems. We hope this study’s results may provide compelling evidence to discussions around licensing this technology for CFD and bringing the benefits to more patients like Andrew in the future.”