NICE backs 'artifical pancreas' tech for type 1 diabetics

An independent NICE committee has recommended that thousands of people with type 1 diabetes who can’t control the condition with current glucose monitoring and insulin pump devices should be offered new hybrid closed-loop (HCL) systems.

The final draft guidance has been hailed by patient representative organisations, which estimate it could result in up to 150,000 children and adults with type 1 diabetes becoming eligible for the HCL systems – sometimes called 'artificial pancreas' technology – provided that funding is made available to roll out the technology.

HCLs consist of a continuous glucose monitor (CGM) worn on the body that transmits data to a wearable insulin pump and uses an algorithm to calculate how much insulin should be administered to keep blood glucose levels under control.

Patients who use the systems can get on with their lives without the need for regular finger prick testing or injecting themselves with insulin. The systems can also vary insulin delivery if blood glucose starts to go too low or too high, such as after vigorous exercise or during sleep.

The new guidance concludes that the systems should be made available to patients in England and Wales if their diabetes is not adequately controlled by their current pump or glucose monitor, including real-time and intermittent CGM sensors.

The technology will also be issued to adults with an average HbA1c reading of 7.5% or more, i.e., above the upper target threshold of 6,5%, and those who suffer disabling low blood sugar levels (hypoglycaemia).

NICE said it has agreed with NHS England that all children and young people, women who are pregnant or planning a pregnancy, and those people who already have an insulin pump will be first to be offered a hybrid closed-loop system as part of a five-year roll-out plan.

However, the guidance emphasises that there is “uncertainty” in the cost-effectiveness data for HCLs, and the companies that manufacture the components used in them – which include Medtronic, Dexcom, Tandem Diabetes Care/Air Liquide, CamDiab, Advanced Therapeutics UK, and Ypsomed – will have to reach agreements with NHS England on “a lower price” for the systems. The analysis used in the guidance estimates an average annual cost of £5,684 at present.

“By ensuring their blood glucose levels are within the recommended range, people are less likely to have complications such as disabling hypoglycaemia, strokes, and heart attacks, which lead to costly NHS care,” commented Professor Jonathan Benger, NICE’s chief medical officer.

“This technology will improve the health and wellbeing of patients, and save the NHS money in the long term,” he added.

The are currently around 290,00 people living with type 1 diabetes in England and Wales, so the systems could be an option for more than half of them. NICE’s decision follows a pilot study of HCLs in 1,000 patients that got underway in 2021 at around 25 specialist centres across England.

Welcoming the decision, Colette Marshall, chief executive of Diabetes UK, said: “Funding to roll out this technology to the people that need it is of paramount importance and we re-iterate the campaign call we made last month for government and the NHS to agree this.”

She added that her organisation will 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.”

The Juvenile Diabetes Research Foundation (JDRF), meanwhile, called the announcement the biggest treatment breakthrough for type 1 diabetes since the discovery of insulin.

JDRF UK CEO Karen Addington said it “makes Great Britain the first country in the world to make hybrid closed loop widely available, as England and Wales follow the lead of Scotland, who approved the use of HCL earlier in 2022.”

She added: “We know the world is watching right now and we hope that today’s announcement spurs other countries to follow.”