An artificial pancreas which helps Type 2 diabetes patients manage their blood sugar levels has been created by Cambridge scientists. The announcement comes just days after the NHS gave the green light to using a different artificial pancreas for Type 1 diabetes sufferers.
Researchers say the latest device, powered by an algorithm, doubled the amount of time during which patients' blood sugar levels were on target. It also halved the time they spent with blood sugar that was too high.
The device, which was created by University of Cambridge scientists, combines an off-the-shelf glucose monitor and insulin pump with an app developed by the team, known as CamAPS HX. The app predicts how much insulin is needed to keep blood glucose at healthy levels.
Earlier studies have found an artificial pancreas run on a similar algorithm works in patients with type one diabetes, including very young children as well as adults. They have also successfully tried out their creation in patients who need kidney dialysis.
Unlike the earlier devices, this new one runs completely automatically and patients do not need to tell their artificial pancreas when they are about to eat. For the study, the researchers recruited 26 patients from the Wolfson Diabetes and Endocrine Clinic at Addenbrooke’s Hospital in Cambridge and a local group of GP surgeries.
Patients were randomly assigned to two groups. The first group tried the artificial pancreas for eight weeks and then switched to the standard therapy of multiple daily insulin injections while the second group began on standard therapy and then switched to the artificial pancreas after eight weeks.
The team used several measures to assess the effectiveness of the artificial pancreas. The first was the proportion of time that patients spent with their glucose levels within a target range of between 3.9 and 10 millimoles per litre, the standard measure of glucose levels in blood.
Patients using the artificial pancreas spent two thirds (66 per cent) of their time with their glucose levels within target range, double that for the control group (32 per cent). In contrast, patients taking the standard therapy spent 67 per cent of their time with high glucose levels, which halved to 33 per cent when they used the artificial pancreas.
Average glucose levels fell from 12.6 millimoles per litre when taking the control therapy to 9.2 millimoles per litre when they used the artificial pancreas. The app also reduced levels of a molecule known as glycated haemoglobin in patients.
Glycated haemoglobin develops when haemoglobin, a protein within red blood cells that carries oxygen throughout the body, joins with glucose in the blood and becomes ‘glycated’. By measuring it, doctors are able to get an overall picture of what a person's average blood sugar levels have been over a period of weeks or months.
For people with diabetes, the higher the glycated haemoglobin levels, the greater the risk of developing diabetes-related complications. After the control therapy, average levels of glycated haemoglobin were 8.7 per cent but this fell to 7.3 per cent while using the artificial pancreas.
No patients experienced dangerously-low blood sugar levels, known as hypoglycaemia, during the study period. One patient was admitted to hospital while using the artificial pancreas due to an abscess at the site of the pump needle.
Participants said they were happy to have their blood sugar managed in this way and nine out of ten of them (89 per cent) reported spending less time overall managing their condition. Users liked the fact they no longer needed to jab themselves and made them more confident in managing their blood sugar.
Downsides were increased anxiety about developing hyperglycaemia, which the team say may reflect greater awareness and monitoring of blood sugar levels, and practical annoyances with wearing devices.
The study’s co-lead author Dr Charlotte Boughton 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.”
Study author Dr Aideen Daly added: “One of the barriers to widespread use of insulin therapy has been concern over the risk of severe ‘hypos’ – dangerously low blood sugar levels. 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.”
More than 4.9 million Brits have diabetes, of whom 90 per cent have type two diabetes, which is estimated to cost the NHS £10bn per year. Globally around 415 million people suffer from the condition which costs around £551 billion (US$67 billion) in health spending.
Type two diabetes causes levels of glucose – blood sugar – to become too high. Ordinarily, blood sugar levels are controlled by the release of insulin, but in patients with type two diabetes insulin production is disrupted.
This can cause serious problems including eye, kidney and nerve damage as well as heart disease. The disease is usually managed through a combination of lifestyle changes such as a better diet and more exercise and medication, with the aim of keeping glucose levels low.
The team now plan to carry out a much larger study to build on their findings and have submitted the device for regulatory approval in the hope it will become commercially available for patients. The findings were published in the journal Nature Medicine.
