Thousands of people in England and Wales with type 1 diabetes could be offered wearable technology to help them manage their blood glucose levels following publication of final draft guidance by the National Institute for Health and Care Excellence (NICE).
An appraisal committee recommended that 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 — should be offered hybrid closed loop (HCL) systems.
The systems were suitable for adults who have an HbA1c of 58 mmol/mol (7.5%) or more, or have disabling hypoglycaemia, despite best possible management with at least 1 of the following:
- continuous subcutaneous insulin infusion (CSII)
- real-time continuous glucose monitoring
- intermittently scanned continuous glucose monitoring
They are also recommended as an option for managing blood glucose levels in type 1 diabetes for children and young people, and for people who are pregnant or planning a pregnancy.
Around 8% of people with diabetes have type 1, which equates to approximately 400,000 people in the UK, including around 29,000 children, according to figures from the charity Diabetes UK.
Body-worn Insulin Pump
HCL systems comprise a continuous glucose monitor sensor attached to the body. This transmits data to a body-worn insulin pump, and a mathematical algorithm calculates the amount of insulin to be delivered. People who use HCL systems can continue with their normal activities, without the need for regular finger prick testing or injecting themselves with insulin to control their blood sugar levels.
According to NICE, clinical trials and real-world evidence showed that these systems are more effective than standard care at maintaining blood glucose levels within a healthy range. Evidence also suggested that the systems appear to be more effective for people with higher long-term average blood glucose levels.
However, NICE has stipulated that HCL is recommended only if manufacturers and NHS England agree a cost-effective price for the systems on behalf of the relevant health bodies.
Rollout to Be Staged Over 5 Years
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, NICE said it recognised that the roll out of HCL systems would require trusts to employ extra staff and implement specialist training. For that reason, NICE had agreed with NHS England to roll out the technology over a 5-year period, with children and young people, women who are pregnant or planning a pregnancy, and those people who already have an insulin pump to be offered a HCL system.
Eventually, people who wanted to start using a pump for the first time would be given the opportunity to do so, NICE said.
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."
He predicted that HCL systems could prove to 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," Professor Benger added.
Asked to comment for Medscape News UK, Colette Marshall, chief executive of Diabetes UK, said, "Hybrid closed-loop technology has the potential to transform the lives of many people with type 1 diabetes, improving both health and quality of life."
The charity stressed that the necessary funding to roll out the technology would be of "paramount importance".
Final guidance is expected to be published in December 2023.