Draft NICE guidance outlining access to closed-loop insulin delivery systems increases access for both adults and children in England with type 1 diabetes, but could lead to patients deliberately worsening their diabetes control in order to access the technology, a leading diabetologist has warned.

Mr Newland-Jones, consultant pharmacist in diabetes and endocrinology and the clinical director of the diabetes and endocrine service at University Hospitals Southampton NHS Foundation Trust, said that the closed-loop technology was the future of diabetes management, but that access to the treatment currently varies across the country.

And under new draft NICE guidance, only patients with sub-optimal glucose control will be able to access closed-loop systems due to the high cost of the technology.

What is closed-loop technology?

The NICE guidance, which was published last week for consultation, recommends that hybrid closed loop systems, a step closer to an artificial pancreas, be recommended to people struggling to optimally manage their type 1 diabetes – but only if a lower price can be agreed for the technology.

Currently, most people with type 1 diabetes use multiple daily injections of insulin, although some that meet existing NICE guidance use a continuous subcutaneous insulin pump. The majority can either be managed manually with the patient working out how much insulin they need to administer, or a system that connects to a glucose monitor that can make suggestions about how much insulin is needed.

A closed-loop system involves a continuous glucose monitor linked to an insulin pump delivering both a background dose of insulin and insulin at mealtimes.  The technology allows algorithms to automatically adjust the background insulin as it learns patterns of insulin requirement and can automatically deliver multiple ‘micro-boluses’ of insulin at mealtimes to match carbohydrate intake and keep glucose levels within a set range.

The system greatly reduces the risk of low glucose levels as it can automatically stop insulin delivery if it detects glucose levels are falling – decreasing the risk of experiencing hypoglycaemia overnight, for example.

Who will be eligible for it?

The new NICE draft guidance brings together guidance for insulin pumps and glucose monitoring systems, which Mr Newland-Jones said that he hoped would increase access to the technology as practice becomes more aligned across England.

However, he warned that the cost of the technology could prevent the guidance from being implemented in some areas, continuing the ‘postcode lottery’ in access.

At present an average annual cost for the technology is £5,744, which is higher than what NICE considers a cost-effective use of NHS resources.

Mr Newland-Jones also said that he hoped that the final wording of the guidance would be flexible enough to allow patients with glucose levels within the target range to access the technology, and recognises the HbA1c “bar” NICE have suggested for access is lower than in its existing guidance for insulin pumps without a closed loop system which will inevitably increase access to the technology.

The draft NICE guidance suggests that hybrid closed loop systems should be recommended as an option in people with type 1 diabetes who are having difficulty managing their condition and have an average HbA1c of around 64 mmol/mol (8.0%) or more.

They must also already have optimal management with at least one of continuous subcutaneous insulin infusion, real-time continuous glucose monitoring or intermittently scanned continuous glucose monitoring.

The recommendations would also apply to patients with type 1 diabetes who are pregnant or planning a pregnancy.

‘I inherently don't like the idea of saying well, actually you're too well controlled for this technology. It just seems slightly bizarre to me. And I wonder whether a lot of the feedback certainly from patient groups I've already seen on this is going to be along those lines, which is: why can't we have access to this?’ Mr Newland-Jones commented.

‘It comes down to cost efficacy, where a reduction in HbA1c can be associated with a reduction in complication rates, therefore making it more cost effective to the NHS to offer access. If you can’t lower your HbA1c any more, then it ends up being primarily a quality of life marker, which is harder to put a cost on.’

Use of the technology can reduce the mental load for people with the condition (or their families or carers) and improve quality of life, the NICE committee found.

Mr Newland-Jones warned that there was a risk that patients might deliberately worsen their diabetes control in order to be able to access the technology.

‘It has the possibility of people needing to play the system, which seems ridiculous. I hope that it doesn't come down to that,’ he said.

Mark Chapman, interim director of medical technology at NICE, said: ‘Some people living with type 1 diabetes struggle to manage their condition, even though they are doing everything asked of them by their diabetes team. This technology is the best intervention to help them control their diabetes, barring a cure.

‘At a time when the number of people with diabetes is rising, we have to focus on what matters most to people who use NHS services by balancing recommending the best care with value for money.’

Professor Partha Kar, national specialty advisor for diabetes at NHS England, commented: ‘This technology has been proven to give the best control for managing type 1 diabetes and should make things like amputations, blindness, and kidney problems possibly a thing of the past.

‘We have seen fantastic results from the real-world trials which have taken place and thank you to NICE for their review of the evidence and subsequent conclusions. The quality of life this technology gives to those using it is huge.

‘We look forward to working with industry colleagues to help ensure this technology can be made available to those who need it.’

The NICE consultation on the draft guidance will be open until 31 January, after which it may be amended before the final guidelines are published.

‘It’s the future’: Philip Newland-Jones on why all healthcare professionals should understand diabetes technology

There is huge variation in access to insulin pump technology for those with type 1 diabetes across England. In some centres, less than 5% of patients use insulin pumps, while in others, more than 50% have access to the technology.

A greater percentage of children are using the technology but given the huge benefits we see in clinical markers there is a drive nationally to move closer to 30-50% of the type 1 diabetes population using it, which would be in line with other European countries and the USA.

We now have the technology for computer algorithms to adjust both background ‘basal’ insulin and micro dose mealtime ‘bolus’ insulin, but in the future we may even use dual hormones of insulin and glucagon within one pump to control highs and lows.

And as technology becomes more advanced its uptake will increase. Paediatric services are driving uptake forwards, with those patients then progressing into adult services.

While not all type 1 services manage patients on insulin pumps, eventually, we need to get to a place where all type 1 services are able to do insulin pumps.

As the technology becomes more commonplace, it will be important for all healthcare professionals, including pharmacists working in community pharmacy or general practice, to understand the technology and the principles behind it.

While an insulin pump wouldn’t interact with other medications a patient was taking any more so than someone taking multiple daily injections, it would be very good for people with diabetes if their regular pharmacist knows more about their health condition and the technology they’re using and will only instil confidence in them as a source for information.

There are plenty of free resources out there for people to be able to research themselves and do some CPD on it because it is the future so it's we should all be prepared for it.

And patients really like being able to talk to a healthcare professional who understands what they're on.

DTN UK, part of the Association of the British Clinical Diabetologists (ABCD), hosts videos about continuous glucose monitoring and insulin pumps, with more general materials for patients or those looking for an introduction, and materials for healthcare professionals for those working with diabetes patients, for example as part of their work in general practice.