The National Institute for Health and Care Excellence (NICE) shared the final guidance in 2023 which recommends hybrid closed-loop systems for certain people living with type 1 diabetes in England and Wales.
You can read the full details here of who hybrid closed-loop systems are recommended for.
And on April 2nd 2024, NHS England announced that the rollout of these systems is now starting in England.
The information in the guide below is relevant for people in England, as it is based on the information we have about plans to implement the guidance there. NHS Wales have similarly agreed a five-year period to roll out hybrid closed loop following the appraisal, and we await further details of this.
The NICE guidance has also been adopted in Northern Ireland and there is work underway to plan the implementation process.
Scotland has guidance for hybrid closed-loop systems which was published in 2022 and the Scottish Government has recently funded plans to accelerate implementation, including funding a dedicated innovation team to support roll out. 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.
In this guide:
- Does this mean some people with type 1 diabetes won’t be able to access hybrid closed-loop under the current recommendations?
- What plans are being made to implement this guidance now it has been published?
- How long may I have to wait to be offered hybrid closed-loop, even if I’m eligible?
- What is the reason for phasing the rollout over a five-year implementation period in this way?
- Will every diabetes team in the country have to offer this immediately?
- Is there any funding being made available for the rollout?
- What hybrid-closed loop systems can people get on the NHS under the guidance?
- What about people with other types of diabetes?
Yes, these recommendations don’t include everyone with type 1 diabetes and there are additional criteria adults over 18 years old who aren’t pregnant or planning to become pregnant will have to meet before being offered the tech.
They should already be using at least one of either an insulin pump, CGM or Flash and have a HbA1c above 58 mmol/mol (7.5%) or experience disabling hypos. Disabling hypos are defined by NICE as “when hypoglycaemia occurs frequently or without warning, so the person is constantly anxious about having hypoglycaemic episodes”.
We estimate that the current recommendations would apply to over half of people with type 1 diabetes in England, and there is further opportunity to review the guidance in the years following publication.
Our ambition is for everyone who can benefit from this technology to be able to access it and over time we intend to continue to push for this by building our understanding and evidence base to support expansion of the recommendations.
What plans are being made to implement this guidance now it has been published?
NICE agreed to a request from NHS England to allow a phased five-year implementation of this appraisal, to guide the rollout and assist in delivering the tech in a way that provides access to people who could benefit from it most first.
This started in April 2024, and plans have been developed by local health systems for this guided by a national strategy. This plan recommends priority should initially be given to children and young people under 18 years old and people who are pregnant or planning to become pregnant – where the need to optimise care is often highest - and other adults who already use insulin pumps where it could be easier to move over to hybrid closed-loop with less intensive training requirements. However, there will be some differences in the approaches local areas take.
There will also be ongoing support to develop skills within the workforce and equip more services to deliver the tech to more people as the rollout progresses.
NHS England has also set up an oversight group to monitor the progress of the implementation and ensure the necessary steps are being taken to offer hybrid closed-loop to as many people as possible safely and effectively, which Diabetes UK sits on.
How long may I have to wait to be offered hybrid closed-loop, even if I’m eligible?
The rollout is planned to happen over five years so some people who are eligible will have to wait longer to be offered hybrid closed-loop technology.
The England-wide implementation strategy outlines a suggested approach for how local areas can plan their rollout, which prioritises children and young people in the early stages.
Diabetes teams will offer the technology during routine appointments, so people should wait to have a discussion about moving on to hybrid closed loop until then.
There will also be a focus on how groups of people are prioritised in the oversight group which will has been set up to monitor the roll out, ensuring a national approach to guard against inequities in access.
What is the reason for phasing the rollout over a five-year implementation period in this way?
In normal circumstances the NHS would have to implement technical appraisal recommendations within three months, but there currently isn’t the clinical capacity to do this – with recruitment and training required to establish a well-trained workforce to manage the rollout.
As healthcare teams would be unable to offer hybrid closed-loop to everyone eligible straight away, steps need to be taken to start the rollout whilst allowing for more time to recruit to diabetes teams and equip them with skills to help people to use the tech effectively.
Doing so will also help tackle health inequalities, which is another important part of the strategy. An unplanned rollout which does not address these foundational issues around staff capacity and variation in what services can offer would have a greater risk of making gaps in access to tech worse. This is why we supported the request from NHS England to create a longer implementation period.
Though this may be disappointing for some people who have to wait longer to access the technology despite being eligible under the new guidance, we think it is a sensible compromise to initially target some groups with greatest need as capabilities for a wider rollout are being built up.
It is also key that these decisions are made based on best available evidence and communicated clearly, so plans around how the rollout will be phased should be transparent and supported by data.
We believe people with diabetes should be able to get the tech they are eligible for and have been making that call through our Tech Can’t Wait campaign and other activities. But we need to make sure this is done in a safe, sustainable and fair way.
Will every diabetes team in the country have to offer this immediately?
Plans have been made to offer hybrid closed-loop as widely as possible over time but some diabetes teams are more experienced and equipped to manage this change than others at the moment, so some will need time to be upskilled and be in a position to offer the technology themselves.
In the meantime, there will be collaboration between teams to enable them to support each other so people in all areas of the country are able to access hybrid closed-loop from the start of the rollout, as broader changes are made to equip more teams to offer it directly.
Is there any funding being made available for the rollout?
To support the rollout, NHS England provide initial mobilisation funding to each Integrated Care Board (ICB) in England to support them developing their local plans in early 2024.
They have also committed to funding to reimburse 75% of ICB's estimated costs for hybrid closed-loop, based on regular reporting of local data on people taking up the technology during the rollout. Both the mobilisation funding and reimbursement will also be ring-fenced to ensure it's used to drive forward this work.
As technical appraisals like this are not automatically provided with funding, this is a key factor in successfully implementing the guidance.
We have reiterated the importance of ensuring the implementation plan is backed by funding, including making the case to government with the help of thousands of our supporters in our Diabetes Tech Can’t Wait campaign.
We welcome the positive commitment to provide dedicated funding and look forward to working with NHS England and others over the coming years to make this guidance a reality.
What hybrid closed-loop systems can people get on the NHS under the guidance?
The recommendations in this appraisal apply to hybrid closed-loop systems as a whole and not particular models. As part of the implementation plan, NHSE have been negotiating with the manufacturers to agree on which systems which meet cost-effective price set by NICE during appraisal is being developed.
More details about which hybrid closed loop systems will be available are expected soon, which will set out the devices people with diabetes are able to access under the NICE guidance.
What about people with other types of diabetes?
The scope of the NICE appraisal of hybrid closed loop was for type 1 diabetes, and the implementation plan in England is focused on offering it to people with type 1.
When deciding the recommendations, NICE considered the benefits to other groups who need to regularly administer insulin, such as those with type 3c diabetes, and recognised there are likely benefits similar for people with type 1 but they were unable to make recommendations at this stage due to a lack of research evidence.
We support research on technology to understand it’s impact for different groups of people in different settings. For example, earlier this year a world-first trial testing the use of closed loop systems for people with type 2 diabetes who use insulin reported increased time-in-range compared to injections, which helps to build our knowledge of how it can be used safely and effectively in this cohort.
There is potential for people with other types of diabetes to be considered for the tech as more evidence becomes available and systems evolve, but this will take more time.
If you don’t have type 1 diabetes but think you may benefit from closed loop you can discuss it with their healthcare team at your next appointment, but access would be considered on a case-by-case basis rather than under this guidance and implementation plan.
