Hybrid closed loop equity and access

Diabetes Professional Care (DPC) 2023 saw over 100 lectures covering the most critical topics within diabetes care delivered by some of the leading voices in the sector. One such lecture was on closed loop equity and access, co-presented by Sufyan Hussain, Consultant in Diabetes, Endocrinology and General Medicine at Guy’s and St Thomas’ Hospital, and Matthew Heppel, Advanced Clinical Diabetes and Endocrinology Pharmacist at Hull University Teaching Hospital.??

With the final NICE appraisal recommendations on hybrid closed loop systems published at the end of last year, Sufyan and Matthew’s presentation looking at the practicalities of rolling out this new technology on the NHS and how to ensure equitable access was extremely topical. “The relationship between equity and access was a key feature in the development of NICE’s technical appraisal (TA), but there’s still a lot more work to be done in this regard,” states Sufyan.??

For those unfamiliar with the workings of a hybrid closed loop (HCL) system, Sufyan provides a succinct explanation. “Hybrid closed loops are devices which rely on an insulin pump delivering insulin and a continuous glucose monitor linked together by an algorithm which determines how much insulin to give and adjust the insulin in the background. It’s a hybrid system because it still relies on manual input. The manual input particularly occurs around the time of meals for entering carbs and insulin, but also when announcing things such as exercise. With type 1 diabetes being an intensive 24/7 condition, this form of automation really helps reduce the burden but can also improve outcomes for type 1 diabetes.”?

Although hybrid closed loops are no doubt a huge step forward in diabetes technology, ensuring equitable access to this new technology is no mean feat. Sufyan uses the example of regular glucose pumps to illustrate the “inverse care law” according to which the distribution of high-cost treatment is not always done in a uniform and consistent manner. “One of the key challenges when delivering higher cost treatment within the NHS is the geographical variation and postcode lottery. Deprivation and ethnicity are key determinants. The least deprived have higher access to pumps and the most deprived have lower access to pumps. Ethnicity data is hard to dissect, but if you’re white, you’re more likely as a ratio to be on a pump versus other ethnicities.”?

Currently, the NICE TA recommends hybrid closed loops for:??

• Any adult living with type 1 diabetes with a HbA1c of 7.5% or higher??
• Children and young people under the age of 18 living with type 1 diabetes?
• Those living with type 1 diabetes who are pregnant or planning a pregnancy??

Sufyan notes that these criteria represent a significant widening of the goalposts when compared with NICE’s 2008 technical appraisal for insulin pumps. “You may be wondering why we can’t give it to somebody with a HbA1c of 7% who is working really hard? Well unfortunately, there is going to be a cost-effectiveness aspect and a quality of life gained aspect that we have to show to make it equitable for a publicly funded treatment, and that’s what we have available right now. And I think that is still a big achievement given where we were 15 or 20 years ago.”??

Once published, most TAs have a 3-month period over which they should be implemented. However, due to the cost and complexity of implementing hybrid closed loops, in August 2023 NHS England granted a 5-year extension for the roll-out.??

As part of a phased implementation strategy, some priority groups have been designated who will receive first access to hybrid closed loops. Sufyan notes that, “when the Covid vaccine came out, we had some priority categories because we knew that we couldn’t give it to everyone at the same time so there had to be a queueing system. So similarly with the hybrid closed loop, there was this rationale that we have to think about who gets it first in which phase and then move upwards.”?

While there may still be scope for this to change in the future, as it currently stands the priority groups for hybrid closed loops are:??

• Children (0 to 12 years)?
• Young people (13 to 19 years)??
• People who are pregnant or planning a pregnancy??
• Adults who already use pumps who want to transition to a HCL system (over time this will be extended to people who want to start using a pump for the first time)?

While the priority groups have no doubt been designed with the intention of providing hybrid closed loops to those who most need it, Sufyan points out that these four groups don’t take into consideration individual circumstances, leaving some individuals who could massively benefit from a hybrid closed loop system without priority access. “If you already have a pump, you are less likely to be from a deprived population and more likely to be white. So this priority classification already amplifies inequities out there and certainly disadvantages those who are older. We hope to be able to get this list removed and then be able to base our priorities on local needs and adjust this in an appropriate manner, and that’s a work in progress at the moment.”?

While the prospect of introducing hybrid closed loop systems on the NHS is undoubtedly exciting, Matthew points out that there are a number of challenges associated with their implementation, the most obvious of which is money. “I don’t think anyone is living in a dream world where there are endless amounts of money. The financial climate of the NHS is probably the worst that any of us have ever known. The difficulty that we have with this is that the savings are downstream. So while we might get some benefits initially with things like quality of life and reduced stress for patients, actually we’re not going to see the reduced admissions and amputations for some time. And so we’ve got an upfront spend and a downstream save which, financially, the ICBs aren’t in a great position to support. This is why we’re needing to look at a phased implementation so that ultimately the initial phase will fund your next.”??

Another obvious pitfall that Matthew identifies when thinking about implementing hybrid closed loops are workforce challenges. “Starting someone on a hybrid closed loop is a highly specialist task. So how are we going to adequately resource the manpower that needs to be there to do this? In the long run these tools will help us to reduce the time we need in clinics, but in the short term there is a hump that we need to get over because it requires a lot of time onboarding, carrying out reviews, and dealing with issues before that situation arises.”?

When it comes to the time needed for onboarding, Sufyan adds that, “some individuals may not be suitable for group starts. We have had experiences where the complexity of the case requires one-to-one initiation. And when it comes to equity and access, these are the individuals who often don’t have the best digital literacy or health literacy, and that’s why it takes time and effort, and we need time in our services to do that.”??

Overall, while the NICE TA on hybrid closed loops systems is a huge step forwards in improving access and making HCLs a standard of care for individuals with type 1 diabetes, there are still challenges surrounding its implementation around funding, workforce capacity and achieving equitable distribution and minimising geographical variation to ensure uniform outcomes for all.?

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