A landmark announcement by the National Institute of Health Care and Excellence (NICE) outlines details of who will be offered hybrid closed-loop technology in England and Wales and how it will be rolled out over the coming years.
NICE have today announced details of the outcome of their appraisal for hybrid closed-loop systems – recommending that over the next five years hundreds of thousands of people living with type 1 diabetes should be offered this next-generation technology to help them manage their condition.
Who has hybrid closed-loop been recommended for?
Under the new recommendations, hybrid closed-loop has been recommended for adults living with type 1 diabetes who have an HbA1c of 58 mmol/mol (7.5%) or higher, or have disabling hypoglycaemia, despite best possible management with at least one of the following:
- Continuous subcutaneous insulin infusion (CSII) (i.e. an insulin pump)
- Real-time continuous glucose monitoring (CGM)
- Intermittently scanned continuous glucose monitoring (Flash)
Hybrid closed-loop has also been recommended for:
- Children and young people (under 18 years old) living with type 1 diabetes
- People living with type 1 diabetes who are pregnant or planning a pregnancy.
The guidance goes on to say that hybrid closed-loop systems should only be used with the support of a trained multidisciplinary team experienced in insulin pumps and continuous glucose monitoring in type 1 diabetes.
It also says that eligible people and their carers should be able to use them safely and either be offered an approved structured education programme or know how to manage insulin dosing and adjustments.
These recommendations are wider than the draft recommendations NICE shared in January – with advice to offer the tech to all children and young people, a reduction in the HbA1c criteria and more flexibility in providing the skills people need to use the technology.
This was something that we and many others called for during the consultation, to offer hybrid closed-loop to as many people as possible and reduce the impact of inequalities, so it is very welcome to see this reflected in the final guidance.
Where does this guidance apply?
Guidance for NICE technical appraisals applies to England and Wales but can also be formally adopted in Northern Ireland, with work underway to start that process. Scotland already has guidance for hybrid closed-loop systems and will continue to implement this.
What are hybrid closed-loop systems?
Sometimes known as an ‘artificial pancreas’ – hybrid closed-loop systems work by linking insulin pumps and continuous glucose monitors (CGM) with a computer algorithm that can calculate the amount of insulin someone needs based on blood sugar readings.
This allows the system to do some of the work to help manage blood sugar levels. Manual input is still needed to alert the system when eating or doing exercise.
There’s lots of evidence to show that the technology can help people with type 1 diabetes to improve their blood sugar levels, have less hypos and make self-managing the condition easier.
NICE is responsible for assessing medicines and medical technologies to see if they are beneficial and cost effective for use in the NHS in England and Wales. We’ve been working with NICE and its evaluation of hybrid closed-loop from its early stages.
We’ve also supported NHS England in their pilot rollout of the technology, which produced valuable real-world data that fed into NICE’s evaluation.
Choice of systems
This appraisal is intended to assess hybrid closed-loop systems as a whole and not individual systems so can apply to various approved devices. The final appraisal document says that these recommendations above only apply to hybrid closed-loop systems which meet a cost-effective price agreed by NICE.
The NHS have been negotiating with manufacturers of closed-loop systems to agree which ones will be available nationally under this agreement and we are awaiting the outcome of these discussions.
Funding to be decided
With the help of over 2,000 of our campaigners we, alongside others, have called for additional funding to be provided to support the rollout, in order to ensure that there are resources available to upskill and recruit the workforce needed to offer hybrid closed-loop widely across the country.
This is to support the NHS to offer hybrid-closed loop systems fairly and sustainably, as though the guidance in technical appraisals is mandatory they don’t automatically come with additional funding, which can be a real barrier to health systems following the recommendations.
We reiterate that this funding will be vital to avoiding the geographical variation that has happened in the rollout of earlier technology like insulin pumps, and overcoming the inequalities to access many have experienced.
What happens next?
These recommendations are the result of a three-year process which involved extensive consultation with stakeholders and a national real-world pilot of the tech to assess its benefits.
The final appraisal document will be subject to appeals and challenges until 28th November, and when this is concluded the final guidance will be prepared for publication. This is expected to published in December 2023 and at this stage we will know which hybrid closed-loop systems will be available under this guidance and what funding arrangements have been made to support the implementation strategy.
The tech itself has been backed by decades of Diabetes UK-funded research, starting in the 1970s when we funded the UK’s first ever ‘artificial pancreas’. We’ve been investing in research to improve the technology and build the evidence we need to widen access to it ever since.
But NICE’s recommendations are just the beginning of the journey. This guidance means that hybrid closed-loop will be offered to many more people with type 1 diabetes and position the UK as a world leader in offering this tech over the next few years.
This will require significant changes to the way specialist diabetes services are delivered and, in order to manage workforce pressures and ensure people are supported to use the tech confidently and safely, a phased five-year implementation plan has been developed to guide the roll-out.
Managing the rollout in this way is designed to help the NHS deliver the tech in a way that offers the greatest benefit to people with the greatest unmet need.
As part of this plan, priority will initially be given to children and young people under 18 and women who are pregnant or planning a pregnancy – where the need to optimise care is often highest - and existing pump users interested in upgrading, as capacity to offer it to more people is developed . Further information on prioritization will also be developed as part of wider engagement that we will be involved in.
This means that not everyone eligible will be able to get it straightaway, but should enable the rollout to be managed to ensure fairness and adapt to local circumstances.
The implementation will also be subject to regular monitoring through an oversight group set up by NHS England. Diabetes UK will sit on this group which will scrutinise audit and other data and reports to ensure that access and uptake of the technology are fair and not driving inequalities.
Colette Marshall, chief executive of Diabetes UK, said:
“Hybrid closed-loop technology has the potential to transform the lives of many people with type 1 diabetes, improving both health and quality of life. 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.
“This is a breakthrough, and we’re incredibly proud of Diabetes UK’s legacy of research in this field, which dates back to the 1970s. It is exciting to be in a position where these life-changing systems are being rolled out on the NHS in England and Wales.
“However, funding to rollout 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.”
Our research made it possible
We've supported research to develop this technology since the beginning.
We bought the UK’s first artificial pancreas device in 1977. Our researchers used it to help stabilise blood sugar levels for people with type 1 diabetes during surgery and childbirth.
Since then, we've carried on backing research to improve this technology. We've built evidence of its life-changing impact and we’ve looked for ways to make sure it can benefit as many people as possible.
In 2007, we supported a world-first trial testing the technology outside of a hospital setting for the first time. We then funded research that showed the artificial pancreas could help women with type 1 diabetes better manage their blood glucose levels during pregnancy. And, most importantly, it could help more women to have safer births and healthy babies.
And we funded one of the first trials of the artificial pancreas with people with type 2 diabetes. The results, in 2018, showed that the device could transform the care some people with type 2 diabetes receive while in hospital.
Diabetes Tech Can’t Wait
In order for most adults to be considered for hybrid closed-loop, they will need to already be using a CGM or insulin pump. This means it’s even more important everyone can access whatever diabetes tech they’re eligible for now.
Visit www.diabetes.org.uk/tech-cant-wait and type in your postcode to find out how you can continue to support the campaign where you live.