An artificial pancreas is being trialled for people with type 2 diabetes who also need kidney dialysis, it was revealed yesterday.
Tests led by the University of Cambridge and Inselspital, University Hospital of Bern, Switzerland, show the device can help patients manage their blood sugar levels safely and effectively and can also reduce the risk of low blood sugar levels.
It builds on work completed by a team at the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust, which developed an artificial pancreas that aimed to replace insulin injections for patients with type 1 diabetes.
In Nature Medicine, this team confirms this fully closed loop system, which functions automatically, can support patients living with both type 2 diabetes and kidney failure.
It is a small, portable medical device that carries out the function of a healthy pancreas, using digital technology to automate insulin delivery, is worn externally 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, while the glucose sensor measures the patient’s blood sugar levels and sends these back to the smartphone to make further adjustments.
The study recruited 26 patients who needed dialysis between October 2019 and November 2020, half of whom were randomised to receive the artificial pancreas first, while the remaining 13 received standard insulin therapy first.
The research team compared how long patients spent in the target blood sugar range – 5.6 to 10.0mmol/L – over 20 days.
Efficacy
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 – equating to about 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 at 10.1 compared to 11.6 mmol/L, and the artificial pancreas reduced the amount of time patients spent with potentially dangerously low blood sugar levels.
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 more than 60% by the 20th day.
Nine out of ten (92%) patients reported spending less time managing their diabetes with the artificial pancreas than during the control period, and 87% reported being less worried about their blood sugar levels when using it.
Other benefits of included fewer finger-prick blood sugar checks, less time managing their diabetes and improved peace of mind and reassurance.
Study leader Dr Charlotte Boughton, from the Wellcome-MRC Institute of Metabolic Science at the University of Cambridge, 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.
“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 now trialling the artificial pancreas for outpatient use in people with type 2 diabetes who do not need dialysis and is also exploring the system in complex medical situations such as perioperative care.
Dr Lia Bally, who co-led the study in Bern, added: “The artificial pancreas has the potential to become a key feature of integrated personalised care for people with complex medical needs.”
Boughton CK, Tripyla A, Hartnell S et al. Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomised crossover trial. Nat Med 4 August 2021
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