On December 19th 2023, the National Institute for Health and Care Excellence (NICE) shared the final guidance 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 have been recommended for.
The information 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.
NICE guidance can also be formally adopted in Northern Ireland and there is work underway to start that process. Scotland already has guidance for hybrid closed-loop systems which was published in 2022 and plans to continue to implement this guidance are being made there separately.
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?
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.
NICE have 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 is expected to begin in early 2024, as more detailed plans are developed by local health systems on how to do this, guided by a national strategy. From what we know of the national strategy developed by NHS England so far, priority will 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 people who already use insulin pumps where it could be easier to transition over to hybrid closed-loop with less intensive training requirements.
There would also be ongoing support to develop the specialist workforce and equip more services to deliver the tech to more people as the rollout progresses.
NHS England plan to 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 will sit on.
It is likely it will take up to a few years for some people who are eligible to be offered hybrid closed-loop. More details will be set out in implementation plans being developed by the NHS.
The England-wide implementation strategy will further outline a suggested approach for how local areas can plan their rollout, and we will share more information about this when it is available.
There will also be a focus on how groups of people are prioritised in the oversight group which will be set up to monitor the roll out, ensuring a national approach to guard against inequities in access.
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 additional recruitment and training required to establish a diabetes workforce sufficiently trained to manage a rollout of this scale.
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 sensible to initially target available resources to 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.
We anticipate that plans will be 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, we expect 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.
To support the rollout, NHS England have committed to providing initial mobilisation funding to each Integrated Care Board (ICB) in England to support them developing their local plans in early 2024.
They will also provide funding to reimburse 75% of ICB's estimated costs for hybrid closed-loop, based on regular reporting of local data. 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 ring-fenced funding and look forward to working with NHS England and others over the coming years to make this guidance a reality.
The recommendations in this appraisal apply to hybrid closed-loop systems as a whole and not particular models. As part of the implementation plan, a national framework of available systems on the NHS which meet cost-effective price set by NICE during appraisal is being developed.
This is still being finalised and we will share more details when they are available. The framework is also being designed so that it can be adapted over time to keep up with changes in the tech as systems develop and new ones are launched.