An independent NICE committee has recommended people whose diabetes is not controlled with their current device despite best possible management with an insulin pump, or real-time or intermittently scanned continuous glucose monitoring, are offered a hybrid closed loop system.
Hybrid closed loop systems comprise a continuous glucose monitor sensor attached to the body. This transmits data to a body-worn insulin pump. It calculates how much insulin needs to be automatically delivered into the body to keep blood glucose levels within a healthy range.
People can use these systems to continue normal activities without the need for regular finger prick testing or injecting themselves with insulin to control their blood sugar levels. Keeping blood sugar levels under tight control greatly reduces the risk of complications such as blindness and amputations.
Clinical trial and real-world evidence show that hybrid closed loop systems are more effective than standard care at maintaining blood glucose levels within a healthy range. Evidence suggests that the systems appear to be more effective for people with higher long-term average blood glucose levels.
NICE 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 5-year roll-out plan.
The technology will also be issued to those adults with an average HbA1c reading of 7.5% or more. NICE guidelines recommend people should aim for an HbA1c level of 6.5% or lower. Adults who suffer disabling hypoglycaemia, defined as an abnormally low level of glucose the blood, despite best possible management will also be offered the technology.
According to the National Diabetes Audit 2021-22 for England and Wales there are 270,935 people in England and 16,090 people in Wales living with type 1 diabetes.
Professor Jonathan Benger, chief medical officer at NICE, said: “With around ten percent of the entire NHS budget being spent on diabetes, it is important for NICE to focus on what matters most by ensuring the best value for money technologies are available to healthcare professionals and patients.
“Using hybrid closed loop systems will be a game changer for people with type 1 diabetes. 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. This technology will improve the health and wellbeing of patients, and save the NHS money in the long term.
“It has been a team effort to get this appraisal to a successful conclusion. I would like to pay tribute to the hard work of the NICE staff, the independent committee, and our colleagues at NHS England and in industry to ensure people with type 1 diabetes will benefit from this life-changing technology.”
England’s integrated care boards, which are overseen by NHS England on a regional basis, would usually implement NICE recommendations within 90 days of the publication of final guidance.
However with the need for trusts to employ extra staff to complete the roll out – alongside specialist training for both patients and staff – NICE has accepted a funding variation request from NHS England which will see the technology rolled out over a five-year period.
Colette Marshall, chief executive of Diabetes UK, said: “We’re excited to welcome these recommendations which broaden access to the technology for key groups including children and young people, recognising our comments to the consultation earlier this year …
“However, 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.
“We’ll also 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.”
Professor Partha Kar, national specialty adviser for diabetes at NHS England, said: “This is amazing news for people living with type 1 diabetes and this announcement can be made possible thanks to the hard work of the NHS, once again trialling and testing the best and latest innovations for the benefit of our patients.
“This tech might sound sci-fi like but it will have a dramatic impact on the quality of people’s lives, not to mention outcomes – it is as close to the holy grail of a fully automated system as science can provide at the moment, where people with type 1 diabetes can get on with their lives without worrying about glucose levels or medication.”
In type 1 diabetes, a person’s blood glucose level becomes too high (hyperglycaemia) because there is no, or very little, production of insulin by the pancreas. Blood glucose levels can only be regulated by giving insulin to prevent hyperglycaemia. If type 1 diabetes is not well controlled, people are at increased risk of long-term complications including blindness, amputations and kidney problems.
Consultees and commentators can appeal the committee’s decision during the next three weeks. Final guidance is expected to publish in December 2023.