New 'artificial pancreas' technology is set to change the lives of people unable to manage their type 1 diabetes, provided a cost-effective price is agreed, said the National Institute for Health and Care Excellence (NICE) today.
For a while now, people with type 1 diabetes - along with the help of family, friends, and some healthcare professionals - have used existing and open source technology to create 'DIY' hybrid closed-loop, or 'artificial pancreas', systems.
The independent NICE committee has now recommended the use of official hybrid closed loop systems – that continually monitor blood glucose and automatically adjust the amount of insulin given through a pump - for managing blood glucose levels in type 1 diabetes.
These systems can eliminate finger prick tests and prevent life-threatening hypoglycaemic and hyperglycaemia attacks. NHS England had previously pointed out that figures show a 5-year-old child diagnosed with type 1 diabetes faces up to "23,000 insulin injections and 52,000 finger prick blood tests" by the time they are 18 years old.
The hybrid closed loop system comprises a continuous glucose monitor sensor attached to the body, which transmits data to a body-worn insulin pump. This uses the data to run a mathematical calculation to work out how much insulin needs to be delivered into the body to keep blood glucose levels within a healthy range.
Professor Partha Kar OBE, national specialty advisor for diabetes at NHS England, previously explained that the device "picks up your glucose levels, sends the reading across to the delivery system – aka the pump – and then the system kicks in to assess how much insulin is needed". He enthused that it is not very far away from the "holy grail" of a fully automated system, where people with type 1 diabetes can "get on with their lives without worrying about glucose levels or medication".
More Effective Than Standard Care
In the new draft guidance – which applies only to England and Wales, where it is estimated that approximately 278,000 people are living with type 1 diabetes – NICE said that around 105,000 people in England are set to be offered the technology, which will allow a person with type 1 diabetes to go about their day-to-day life without having to monitor if their blood glucose levels are too high or too low.
Clinical trial and real-world evidence has shown that hybrid closed loop systems are "more effective than standard care" at maintaining blood glucose levels within a healthy range, NICE emphasised.
Mark Chapman, interim director of medical technology at NICE, highlighted that some people living with type 1 diabetes "struggle to manage their condition", even though they are doing "everything asked of them by their diabetes team".
He emphasised that this technology, which has been described as a step towards an artificial pancreas, is the "best intervention" to help people control their diabetes, barring a cure.
Benefits Go Beyond Blood Glucose Levels
NICE highlighted that continuously managing blood glucose levels is a substantial mental load for people with type 1 diabetes, and for their families or carers, which "can be exhausting, affect people's mood and frequently leads to burn out". The hybrid closed loop systems do not need as much input from the person so may "reduce the mental load and improve people’s quality of life", said NICE. In addition, managing glucose levels is a "lot of work" and can affect home life, sleep, education, training, and work.
For parents of children with diabetes, since children are "less able to recognise the symptoms of hypoglycaemia and hyperglycaemia", this is a "constant worry" for parents when they are apart from their children.
NHS England said that in addition to the physical benefits, using the 'artificial pancreas' can also help relieve some of the mental burden on people with type 1 diabetes, and their carers, who otherwise must remain "constantly vigilant" to blood sugar levels.
The NICE committee concluded that managing type 1 diabetes is a "substantial mental burden" on people with diabetes and their families, and that automated technologies such as hybrid closed loop systems can "reduce some of the burden, and improve quality of life" for people, their families, and carers.
NICE also highlighted inequality issues related to family background and socioeconomic status, and that the automation offered by hybrid closed loop systems could help reduce some of the inequalities for people who find it difficult to maintain healthy blood glucose levels because of a language barrier, a lower level of education, or a learning disability, for example.
Cost-Effective Price Required
NICE has recommended the technology for those who are unable to control their condition despite using an insulin pump, or real-time or intermittently scanned continuous glucose monitoring, if their long-term average blood glucose levels are indicating they are at risk of long-term complications, that is, an average HbA1c reading of 8.0% or more – NICE guidelines recommend an HbA1c target level of 6.5% or lower to minimise the risk of long-term complications from diabetes.
People who are pregnant or planning a pregnancy are also eligible for the technology, because blood glucose levels are "harder to manage during this time", said NICE.
However, the draft recommendations also require NHS England to agree a cost-effective price for the systems on behalf of relevant health bodies. At present an average annual cost for the technology is £5,744, which is higher than what NICE considers a cost-effective use of NHS resources.
"At a time when the number of people with diabetes is rising, we have to focus on what matters most to people who use NHS services by balancing recommending the best care with value for money," explained Mark Chapman.
"Our committee has reviewed the real-world data generated by the NHS and evidence generated by randomised controlled trials which show there are clear benefits of recommending the technology’s use. We look forward to working with NHS England and industry to ensure a cost-effective price can be reached which is fair to taxpayers," he said.
NICE emphasised that the recommendations were not intended to affect use of hybrid closed loop systems that were started in the NHS before the new guidance was published. People using hybrid closed loop systems outside these recommendations may continue until they and their NHS clinician consider it appropriate to stop. For children and young people, this decision should be made jointly by them, their clinician and their parents or carers, NICE said.
Chris Askew OBE, chief executive of Diabetes UK, recently commented that this technology has the potential to "transform" the lives of people with type 1 diabetes, improving both their quality of life and clinical outcomes.
"The technology has been proven to give the best control for managing type 1 diabetes," said Professor Kar, who expressed hope that it should "make things like amputations, blindness, and kidney problems possibly a thing of the past".
The consultation runs until Tuesday 31 January 2023.