People with advanced type 2 diabetes may soon be offered an artificial pancreas, research suggests.
The disease develops when the body builds up resistance to insulin. As a result, more of the blood sugar-lowering hormone needs to be produced to keep a patient's glucose at a safe level. When the pancreas – which produces insulin – cannot make enough, symptoms of type 2 diabetes emerge.
Patients often rely on insulin injections to keep their blood sugar levels down, helping to prevent complications like heart disease, blindness and even limb amputations.
Scientists from the University of Cambridge have now raised hopes of an artificial pancreas for type 2 diabetes patients who rely on dialysis, a common complication once the disease has become advanced.
When put to the test, the artificial organ kept patients' blood sugar levels within a target range for more of the day than standard insulin therapy alone, while also giving the user more "peace of mind".
Although it is unclear when the device – worn outside of the body – may be available, the scientists are testing its potential in type 2 diabetes patients who do not rely on dialysis.
"Patients living with type 2 diabetes and kidney failure are a particularly vulnerable group and managing their condition can be a challenge," said lead author Dr Charlotte Boughton.
"There's a real unmet need for new approaches to help them manage their condition safely and effectively."
Diabetes is behind just under a third (30%) of kidney failure cases in the UK. This occurs when the organs stop working, prompting a patient to rely on dialysis – the removal of waste products and excess fluid from the blood.
Kidney failure cases are set to rise as diabetes becomes more prevalent. More than 4.9 million people live with diabetes in the UK, of whom around nine in 10 (90%) have type 2. A rise in obesity and sedentary lifestyles are expected to make the condition increasingly widespread.
As well as many type 2 diabetes patients relying on dialysis, kidney failure worsens the risk the individual will develop abnormally high or low blood sugar levels, which can trigger dizziness, falls or even a coma.
Kidney failure aside, type 2 diabetes can be difficult to manage due to often complex insulin dosing regimens.
The Cambridge scientists' artificial pancreas is a small portable device that acts as the healthy organ, controlling a patient's blood glucose levels via digital technology.
The device is made up of a glucose sensor, computer algorithm and insulin pump.
Software in a user's smartphone sends a signal to the pump, adjusting the amount of insulin the patient receives. The glucose sensor also measures the person's blood sugar levels, sending these recordings back to the smartphone.
Putting the device to the test, the scientists analysed 26 type 2 diabetes patients who required dialysis.
Thirteen of the patients used the artificial pancreas, followed by standard insulin therapy, while the remaining 13 participants just had the latter treatment.
The scientists compared the amount of time the participants' blood sugar levels stayed in the target range, 5.6 millimoles (mmol)/L to 10 mmol/L, over 20 days.
Results – published in the journal Nature – reveal the patients with the artificial pancreas spent more than half (53%) of their time in the target range, compared to just over a third (38%) in the control group. This equated to around 3.5 "extra" hours a day in the target range.
A patient's average blood sugar levels were also lower with the artificial pancreas – 10.1 mmol/L versus 11.6 mmol/L – and they spent less time with dangerously low levels, known as "hypos".
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The artificial pancreas also became more effective over the study period, as the device's algorithm adapted. On day one, the patient's blood sugar levels were in the target range for 36% of the time, rising to 60% by day 12.
Patient satisfaction was also good, with more than nine in 10 (92%) saying they spent less time managing their diabetes and 87% being less worried about their blood sugar levels.
"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," said co-author Professor Roman Hovorka.
"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."
An artificial pancreas is in development for type 1 diabetes, when the pancreas produces too little or no insulin. This version is "a fully closed loop system", where a patient "tells" the artificial organ they are about to eat, allowing their insulin to be adjusted.
In the Cambridge device, the artificial pancreas functions automatically.
"Now 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," said Dr Boughton.
The scientists are testing the device's potential among type 2 diabetes patients who do not require dialysis.
Co-lead author Dr Lia Bally concluded: "The artificial pancreas has the potential to become a key feature of integrated personalised care for people with complex medical needs."
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