More than 150,000 adults and children with type 1 diabetes in England and Wales are to be offered an artificial pancreas on the NHS, which experts are hailing as a “gamechanger” that will “save lives and heartbreak”.
The groundbreaking device, also called a hybrid closed-loop system, uses a hi-tech algorithm to determine the amount of insulin that should be administered and reads blood sugar levels to keep them steady. A world-first trial on the NHSshowed it was more effective at managing diabetes than current devices and required far less input from patients.
Final draft guidance from the National Institute for Healtha nd Care Excellence (Nice) recommends that people in England and Wales should benefit from the wearable device if their diabetes is not adequately controlled by their current pump or glucose monitor. The decision to give the go-ahead for widespread use of the artificial pancreas was announced on Tuesday at Nice’s annual conference in Manchester by Dr Sam Roberts, its chief executive.
There are about 290,000 people living with type 1 diabetes in England and Wales. More than half of them will now become eligible because their diabetes is not controlled with their current device.
The artificial pancreas has been found to be better at keeping blood sugar levels within a healthy range, cutting the risk of people suffering complications from diabetes. It works via a continuous glucose monitor sensor attached to the body which transmits data to a body-worn insulin pump.
This pump then calculates how much insulin is needed and delivers the precise amount to the body. Hybrid closed-loop systems mean people do not need to rely on finger-prick blood tests or injecting insulin to control their blood sugar levels.
Living with type 1 diabetes can be relentless, health experts say, and requires intense management 24 hours a day. Hundreds of individual treatment decisions must be made around the clock as extreme blood glucose highs and lows can be fatal. By automating what is currently a manual process, the artificial pancreas could lift the relentless burden and risk of burnout.
Nice said it had agreed with NHS England that
• all children and young people,
• women who are pregnant or
• planning a pregnancy, and
• people who already have an insulin pump will be first to be offered a hybrid closed-loop system as part of a five-year rollout plan.
The technology will then be rolled out to those
• adults with an average HbA1c reading of 7.5% 58 mmol/mol mmol/mol or more and
• those who suffer abnormally low blood sugar levels.
Nice guidelines recommend people should aim for an HbA1c level of 6.5% 45 mmol/mol or lower.
“Using hybrid closed-loop systems will be a gamechanger for people with type 1 diabetes. By ensuring their blood glucose levels are within the recommended range, people are less likely to have complications such as disabling hypoglycaemia, strokes and heart attacks, which lead to costly NHS care.
“This technology will improve the health and wellbeing of patients, and save the NHS money in the long term.”
Nice said that, due to the need for extra staff alongside specialist training for patients and staff, it had accepted a request from NHS England for a rollout over five years.
Karen Addington, the chief executive of JDRF UK, a type 1 diabetes charity, hailed the announcement, saying it would transform the lives of children and adults.
- “Hybrid closed-loop defines a new era for medicine,” she said.
- “It’s a beautiful algorithm, which will save lives and heartbreak, as well as in the long term saving NHS the cost of cardiovascular and retinal surgery, kidney dialysis and transplantation.”
She added: “Today’s announcement makes Great Britain the first country in the world to make hybrid closed-loop widely available, as England and Wales follow the lead of Scotland, who approved the use of HCL earlier in 2022.”
Colette Marshall, the chief executive of Diabetes UK, said the artificial pancreas had the potential “to transform the lives of many people with type 1 diabetes”, improving both health and quality of life.
Yasmin Hopkins, who took part in trials of the artificial pancreas, said: “From day one it was amazing. Before the closed-loop system, I would experience a lot of highs, which I’d then overcorrect, go low and eat a lot of sugar. All of that has been eradicated.
“This technology gives me the freedom to get on with my life and live without fear of what might happen in a few hours, days or years.”
NICE made its recommendation after reviewing clinical-effectiveness evidence that showed HCL systems are likely to improve blood glucose control in Type 1 diabetes. The evidence came from both randomized trials and real-world studies in the English healthcare system. Based on the data, NICE concluded HCL devices are likely most cost-effective in children, pregnancy and people with high blood glucose.."
PRESS RELEASE NICE UK
An independent NICE committee has recommended people whose diabetes is not controlled with their current device despite best possible management with an insulin pump, or real-time or intermittently scanned continuous glucose monitoring, are offered a hybrid closed loop system.
Hybrid closed loop systems comprise a continuous glucose monitor sensor attached to the body. This transmits data to a body-worn insulin pump. It calculates how much insulin needs to be automatically delivered into the body to keep blood glucose levels within a healthy range.
People can use these systems to continue normal activities without the need for regular finger prick testing or injecting themselves with insulin to control their blood sugar levels. Keeping blood sugar levels under tight control greatly reduces the risk of complications such as blindness and amputations.
Clinical trial and real-world evidence show that hybrid closed loop systems are more effective than standard care at maintaining blood glucose levels within a healthy range. Evidence suggests that the systems appear to be more effective for people with higher long-term average blood glucose levels.
NICE has agreed with NHS England that all children and young people, women who are pregnant or planning a pregnancy, and those people who already have an insulin pump will be first to be offered a hybrid closed loop system as part of a 5-year roll-out plan.
The technology will also be issued to those adults with an average HbA1c reading of 7.5% or more. NICE guidelines recommend people should aim for an HbA1c level of 6.5% or lower. Adults who suffer disabling hypoglycaemia, defined as an abnormally low level of glucose the blood, despite best possible management will also be offered the technology.
According to the National Diabetes Audit 2021-22 for England and Wales here are 270,935 people in England and 16,090 people in Wales living with type 1 diabetes.
Professor Jonathan Benger, chief medical officer at NICE, said: “With around ten percent of the entire NHS budget being spent on diabetes, it is important for NICE to focus on what matters most by ensuring the best value for money technologies are available to healthcare professionals and patients.
“Using hybrid closed loop systems will be a game changer for people with type 1 diabetes. By ensuring their blood glucose levels are within the recommended range, people are less likely to have complications such as disabling hypoglycaemia, strokes and heart attacks, which lead to costly NHS care. This technology will improve the health and wellbeing of patients, and save the NHS money in the long term.
“It has been a team effort to get this appraisal to a successful conclusion. I would like to pay tribute to the hard work of the NICE staff, the independent committee, and our colleagues at NHS England and in industry to ensure people with type 1 diabetes will benefit from this life-changing technology.”
England’s integrated care boards, which are overseen by NHS England on a regional basis, would usually implement NICE recommendations within 90 days of the publication of final guidance.
However with the need for trusts to employ extra staff to complete the roll out – alongside specialist training for both patients and staff – NICE has accepted a funding variation request from NHS England which will see the technology rolled out over a five-year period.
Colette Marshall, chief executive of Diabetes UK, said:“We’re excited to welcome these recommendations which broaden access to the technology for key groups including children and young people, recognising our comments to the consultation earlier this year …
“However, funding to roll out this technology to the people that need it is of paramount importance and we re-iterate the campaign call we made last month for Government and the NHS to agree this.
“We’ll also be working with the NHS to help ensure that everyone who could benefit from this technology has access to it as soon as possible in the phased rollout that has been agreed to achieve this.”
Professor Partha Kar, national specialty adviser for diabetes at NHS England, said:“This is amazing news for people living with type 1 diabetes and this announcement can be made possible thanks to the hard work of the NHS, once again trialling and testing the best and latest innovations for the benefit of our patients.
“This tech might sound sci-fi like but it will have a dramatic impact on the quality of people’s lives, not to mention outcomes – it is as close to the holy grail of a fully automated system as science can provide at the moment, where people with type 1 diabetes can get on with their lives without worrying about glucose levels or medication.”
In type 1 diabetes, a person’s blood glucose level becomes too high (hyperglycaemia) because there is no, or very little, production of insulin by the pancreas. Blood glucose levels can only be regulated by giving insulin to prevent hyperglycaemia. If type 1 diabetes is not well controlled, people are at increased risk of long-term complications including blindness, amputations and kidney problems.
Consultees and commentators can appeal the committee’s decision during the next three weeks. Final guidance is expected to publish in December 2023.
Final draft for recommendations 26 pages pdf free
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