UPDATE, 19 DECEMBER, 2023: NICE has published the final guidance and the appraisal has concluded, with plans now being agreed to begin rolling out the tech in 2024
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.
NICE have published 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 to become pregnant.
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 has guidance for hybrid closed-loop systems which was published in 2022 and plans to implement this are being made there separately. In Scotland, they are recommended for people with type 1 diabetes who are struggling to manage their blood sugars, are at a high risk of hypos, have impaired hypo awareness, or are experiencing diabetes-related distress.
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) so they can “talk” to each other. This is done by a computer algorithm that can calculate the amount of insulin someone needs based on blood sugar readings so the pump can automatically give accurate and timely doses.
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.
What happens next?
As part of the NICE appraisal, the NHS in England and Wales have agreed to develop plans to offer hybrid closed-loop to eligible people in a phased programme over a period of five years.
Plans are still being finalised for this but the rollout is expected to begin early next year in England, as local health systems make plans to offer it to eligible people in their area.
NHS England are also developing a national strategy to guide the rollout, with the aim that the tech can be offered to as many people as possible and a focus on improving outcomes for those with the greatest unmet need first and reducing health inequalities in access.
For further information on what funding will be made available to support the rollout and which hybrid closed loop systems will be available under the guidance, please check our Frequently Asked Questions page which we will keep updated with the latest news.
“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 have made for the 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.
