An artificial pancreas developed at the University of Cambridge has been successfully trialled by patients living with type 2 diabetes.
The device doubled the amount of time patients were in the target range for glucose compared to those on standard treatment and halved the time spent they experienced high glucose levels.
Researchers at the Wellcome-MRC Institute of Metabolic Science combined an off-the-shelf glucose monitor and insulin pump with an app they had developed, known as CamAPS HX, which is run by an algorithm that predicts how much insulin is required to maintain glucose levels in the target range.
They have previously shown that an artificial pancreas run by a similar algorithm can work for patients living with type 1 diabetes, from very young children through to adults. They have also previously successfully trialled the device in patients with type 2 diabetes requiring kidney dialysis.
The new study, reported in Nature Medicine, reports the first trial of the device in a wider population living with type 2 diabetes – those not requiring kidney dialysis.
They have now submitted the device for regulatory approval with a view to making it commercially available for outpatients with type 2 diabetes.
Unlike the device used in the type 1 diabetes trial, which requires users to tell their artificial pancreas that they are about to eat to allow adjustment of insulin, this version features a fully closed loop system, meaning it can be left to function entirely automatically.
Patients using it spent 66 per cent of their time within the target range – compared to those 32 per cent for those not using the device.
And while those taking the control therapy spent 67 per cent of their time with high glucose levels – which raises the risk of serious complications – those using the artificial pancreas spent 33 per cent in this range.
Dr Charlotte Boughton, from the institute, who co-led the study, said: “Many people with type 2 diabetes struggle to manage their blood sugar levels using the currently available treatments, such as insulin injections. The artificial pancreas can provide a safe and effective approach to help them, and the technology is simple to use and can be implemented safely at home.”
Dr Aideen Daly, also from the institute, said: “One of the barriers to widespread use of insulin therapy has been concern over the risk of severe ‘hypos’ – dangerously low blood sugar levels. But we found that no patients on our trial experienced these and patients spent very little time with blood sugar levels lower than the target levels.”
Participants said they were happy to have their glucose levels controlled automatically, with 89 per cent spending less time managing their diabetes overall.
Eliminating the need for injections or fingerprick testing, and increased confidence in managing blood glucose were reported as key benefits.
Downsides included increased anxiety about the risk of hypoglycaemia – which the researchers suggest could reflect increased awareness and monitoring of glucose levels – plus practical annoyances with wearing of devices.
The team plan a much larger multicentre study to build on their findings. About 415 million people worldwide are believed to be living with type 2 diabetes. In the UK, 4.9 million people have diabetes, of whom 90 per cent have type 2, costing the NHS £10bn a year.
The research was supported by the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre.