Published: 19 December 2023
Thousands of people with type 1 diabetes could be offered wearable technology to help manage their condition.
New evidence shows that hybrid closed loop systems are more effective than standard care for keeping blood glucose levels within a healthy range. It suggests that the systems appear to be better for people with higher long-term average blood glucose levels.
New guidance has been announced by an independent NICE committee. It follows a review of clinical trial and real-world evidence, funded by the NIHR. The research, carried out by the University of Warwick, was evaluated by Warwick Medical School.
Effective management
In type 1 diabetes, the body can’t make and release insulin to help control blood sugar levels. The hybrid closed loop system works by releasing insulin when the body needs it. There are 270,935 people in England and 16,090 people in Wales living with type 1 diabetes. These figures come from the National Diabetes Audit 2021-22 for England and Wales.
The recommendations are for people whose diabetes can't be managed effectively by insulin pump. They also cover those who are unable to manage their condition with real-time or intermittently scanned continuous glucose monitoring.
These individuals will be recommended to wear the hybrid closed loop system. It comprises 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. It measures the amount needed to keep blood glucose levels within a healthy range.
Dr Lena al-Khudairy, who led the University of Warwick’s review said: “This device will make a significant difference to the lives of many in the UK living with Type 1 diabetes. By offering an independent academic evaluation of all the evidence, Warwick Evidence is proud to have contributed to the recommendations for this life-changing technology.”
Reducing the risk of long-term complications
People can use these systems to continue normal activities. This means regular finger prick testing or insulin injections to control blood sugar levels are not necessary. Keeping blood sugar levels under tight control reduces the risk of long-term complications. These can include blindness, amputations and kidney problems.
In type 1 diabetes, a person’s blood glucose level becomes too high (hyperglycaemia). This is 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.
NICE and NHS England have agreed the following groups will be offered the technology first:
- all children and young people
- women who are pregnant or planning a pregnancy
- those people who already have an insulin pump
The technology will also be issued to those adults with an average blood sugar (HbA1c) reading of 7.5% or more. NICE guidelines recommend people should aim for a level of 6.5% or lower. Adults who suffer disabling hypoglycaemia, defined as an abnormally low level of glucose, despite best possible management, will also be offered the technology.
Professor Jonathan Benger, chief medical officer at NICE, said: “With around 10% 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.”
Five-year roll-out
England’s integrated care boards are overseen by NHS England on a regional basis. They 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. This will see the technology rolled out over a 5-year period.
Read the published guidance here https://www.nice.org.uk/guidance/indevelopment/gid-ta10845.
For more information on this NIHR-funded Technology Assessment Review, please visit our Funding and Awards website.