The National Institute for Health and Care Excellence (NICE), England’s cost-effectiveness watchdog, has finalized a draft guidance regarding hybrid closed-loop systems, concluding that the technology should be made broadly affordable and accessible to help people with Type 1 diabetes better manage the condition.
Closed-loop systems for diabetes management—often referred to as an artificial pancreas—combine an insulin pump and continuous glucose monitor, with the latter’s real-time blood sugar readings analyzed by an algorithm and transmitted to the pump to automatically tweak basal insulin dosages, eliminating the need for manual injections and constant monitoring of glucose levels. Hybrid versions of these systems do still require some input from users, however, whether to program bolus doses of insulin, report a mealtime carbohydrate count or alter other system settings.
In this month’s final draft guidance (PDF), NICE recommended that hybrid closed-loop technology be offered to all people with Type 1 diabetes who are having trouble controlling the condition using their existing devices.
Amid that glowing recommendation, the committee stressed that it holds true only if diabetes devicemakers “and NHS England agree [to] a cost-effective price for the systems on behalf of the relevant health bodies.” With the systems currently expected to cost nearly £5,684 ($6,900) per patient per year, NICE noted that companies will need to arrange discounts with the NHS to ensure the technology’s costs match up to its benefits.
NICE said that it has already devised a five-year rollout plan with the NHS to bring the technology to people with Type 1 diabetes. Hybrid closed-loop systems will be offered first to children, young people, existing insulin pump users and women who are pregnant or planning to become pregnant, after which they’ll be issued to adults who have an average HbA1c reading of at least 7.5%.
“Using hybrid closed loop systems will be a game changer for people with type 1 diabetes,” Jonathan Benger, NICE’s chief medical officer, said in a release. “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 well-being of patients, and save the NHS money in the long term."
Partha Kar, national specialty adviser for diabetes at NHS England, added that while the technology “might sound sci-fi-like,” it will indeed have a significant impact on diabetes care and 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.”
The draft guidance will remain open to appeals for three weeks before it’s locked in and published as a final guidance in December.
The NICE committee’s decision was hailed by several makers of the devices used in hybrid closed-loop systems.
Medtronic applauded the decision in a release of its own, in which it noted that its MiniMed 780G artificial pancreas system has proven in real-world studies to help users achieve an average time in the range of 72%, and nearly 80% for those who stick with the recommended settings.
Dexcom, meanwhile, called the recommendations a “historic victory.” The CGM maker cited its own U.K. survey data showing that 100% of people who have Type 1 diabetes and have used the technology said that it helped to reduce the burden of managing the condition. However, the survey also revealed a gap in the number of people actually taking advantage of the technology, as 45% of respondents said they don’t understand what a hybrid closed-loop system is or how it could help them.