An artificial pancreas, managed with an app, has been trialled for the first time in people with Type 2 diabetes requiring kidney dialysis.
Researchers from the University of Cambridge and Inselspital (University Hospital of Bern), Switzerland, have demonstrated that the artificial pancreas device can help patients safely and effectively manage their blood sugar levels and reduce the risk of low blood sugars.
Diabetes is the most common cause of kidney failure. As the number of people living with Type 2 diabetes increases, so too does the number of people that require dialysis or a kidney transplant. Managing diabetes in patients with kidney failure is challenging for both patients and healthcare professionals and many aspects of their care are poorly understood, including targets for blood sugar levels and treatments.
A team at the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust has previously developed an artificial pancreas designed to replace the need for insulin injections for patients living with Type 1 diabetes. In this new research, the team, in collaboration with researchers at Bern University Hospital and University of Bern, Switzerland, has demonstrated the efficacy of the device for supporting patients with both Type 2 diabetes and kidney failure.
The study has been published in Nature Medicine.
Automatic functioning
Unlike the artificial pancreas being used to manage Type 1 diabetes, this version is a fully closed loop system. Patients with Type 1 diabetes must tell their artificial pancreas that they are about to eat to allow adjustment of insulin, but this new version enables the device to function entirely automatically.
Dr Charlotte Boughton from the Wellcome-MRC Institute of Metabolic Science at the University of Cambridge, who led the study, said: “Patients living with Type 2 diabetes and kidney failure are a particularly vulnerable group and managing their condition – trying to prevent potentially dangerous highs or lows of blood sugar levels – can be a challenge. There’s a real unmet need for new approaches to help them manage their condition safely and effectively.”
Portable device activated by smartphone app
The artificial pancreas is a small, portable medical device designed to carry out the function of a healthy pancreas in controlling blood glucose levels, using digital technology to automate insulin delivery. The system is worn externally on the body and is made up of three functional components: a glucose sensor, a computer algorithm to calculate the insulin dose, and an insulin pump. Software in the user’s smartphone sends a signal to an insulin pump to adjust the level of insulin the patient receives. The glucose sensor measures the patient’s blood sugar levels and sends these back to the smartphone to enable it to make further adjustments.
For the research, the team recruited 26 patients requiring dialysis between October 2019 and November 2020. As a randomised selection, half of the participants were chosen to receive the artificial pancreas first whilst the other half received standard insulin therapy first. The researchers compared how long patients spent in the target blood sugar range (5.6 to 10.0mmol/L) over a 20-day period as outpatients.
Patients using the artificial pancreas spent, on average, 53% of their time in the target range, compared to 38% when they used the control treatment. This equated to around 3.5 additional hours every day spent in the target range, compared with the control therapy. Mean blood sugar levels were lower with the artificial pancreas (10.1 vs. 11.6 mmol/L) and the device reduced the amount of time patients spent with potentially dangerously low blood sugar levels, known as ‘hypos’.
The efficacy of the artificial pancreas improved considerably over the study period as the algorithm adapted, and the time spent in the target blood sugar range increased from 36% on day one to over 60% by the twentieth day. This finding highlights the importance of using an adaptive algorithm, which can adjust in response to an individual’s changing insulin requirements over time.
When asked about their experiences of using the artificial pancreas, all of those who responded said they would recommend it to others. Nine out of ten reported that they spent less time managing their diabetes with the artificial pancreas than during the control period, and similar numbers (87%) were less worried about their blood sugar levels when using it.
Other benefits of the artificial pancreas reported by study participants included less need for finger-prick blood sugar checks, less time required to manage their diabetes resulting in more personal time and freedom, and improved peace of mind and reassurance. Downsides included discomfort wearing the insulin pump and carrying the smartphone.
Senior author Professor Roman Hovorka, also from the Wellcome-MRC Institute of Metabolic Science, said: “Not only did the artificial pancreas increase the amount of time patients spent within the target range for the blood sugar levels, it also gave the users peace of mind. They were able to spend less time having to focus on managing their condition and worrying about their blood sugar levels, and more time getting on with their lives.”
Dr Boughton added: “Now that we’ve shown the artificial pancreas works in one of the more difficult-to-treat groups of patients, we believe it could prove useful in the wider population of people living with Type 2 diabetes.”
The team is currently trialling the artificial pancreas for outpatient use in people living with Type 2 diabetes who do not need dialysis and exploring the system in complex medical situations such as perioperative care.
Dr Lia Bally, who co-led the study in Bern, said: “The artificial pancreas has the potential to become a key feature of integrated personalised care for people with complex medical needs.”
