Thousands of people with type 1 diabetes could be offered
wearable technology to help them manage their condition following
the publication of final draft guidance by NICE.
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.
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 two weeks. Final guidance is expected to publish
in December 2023.
ENDS
About the recommendations
- Hybrid closed loop systems are recommended as an option for
managing blood glucose levels in type 1 diabetes 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.
- Hybrid closed loop systems are recommended as an option for
managing blood glucose levels in type 1 diabetes for children and
young people.
- Hybrid closed loop systems are recommended as an option for
managing blood glucose levels in type 1 diabetes for people who
are pregnant or planning a pregnancy.
About the final draft guidance
- The final draft guidance will be available at www.nice.org.uk/ from
16.00 GMT on Tuesday 7 November 2023.
- Embargoed copies of the guidance can be downloaded here
(Please right click and copy hyperlink into your web browser if
the direct link does not work).
- NICE multiple technology appraisal guidance applies to
England and Wales.
- NHS England will roll out the technology within five years.
The Welsh government has indicated that it will also roll out the
technology over the next five years.