NICE approve Hybrid closed loop systems for managing blood glucose levels in Type 1 diabetes
Access to hybrid closed loop systems will be through a 5-year phased roll out in line with NHS England’s and NHS Wales’ implementation plans.
In all cases where Hybrid closed loop systems are recommended, this is only if they are procured at a cost-effective price agreed by the companies and NHS England, and implemented following NHS England’s and NHS Wales’ implementation plans.
Recommendations
- Adults with Type 1 diabetes – Hybrid closed loop (HCL) 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 one of the following:
(i) continuous subcutaneous insulin infusion (CSII),
(ii) real-time continuous glucose monitoring,
(iii) intermittently scanned continuous glucose monitoring. - Children and young people – HCL systems are recommended as an option for managing blood glucose levels in Type 1 diabetes for children and young people.
- Women, trans men and non-binary, people who are pregnant or planning pregnancy –
HCL systems are recommended as an option for managing blood glucose levels in Type 1 diabetes in these groups of people. - HCL systems should only be used with the support of a trained multidisciplinary team experienced in CSII and continuous glucose monitoring in Type 1 Diabetes.
- Only use HCL systems if the person or their carer: (i) is able to use them, and (ii) is offered approved face-to-face or digital structured education programmes, and (iii) is competent
in insulin dosing and adjustments.
These recommendations are not intended to affect use of HCL systems that were started in the NHS before this guidance was published. People using HCL systems outside these recommendations may continue until they and their NHS clinician consider it appropriate to stop. For children and young people, this decision should be made jointly by them, their clinician and their parents or carers.
What is the Hybrid closed loop system?
Hybrid closed loop (HCL) systems use a mathematical algorithm to deliver insulin automatically in response to continuously monitored interstitial fluid glucose levels (fluid in the cells, not blood).
They use a combination of real-time glucose monitoring from a continuous glucose monitor (CGM) device and a control algorithm to direct insulin delivery through CSII.
Different HCL systems are available, and some are built by combining interoperable components from different companies.
A large number of combinations of components are available to the NHS, so HCL systems are considered as a class of technologies rather than individual components or systems. Expert advice received by NICE suggested that in practice, minimal differences in outcomes would be expected between systems if used as intended.
The choice of components or system is based on a person’s preference and whether the system has the appropriate licence for use.
At the time of the NICE recommendations, the following systems and interoperable components were available:
SmartGuard control algorithm (Medtronic) with Guardian 4 CGM sensor (Medtronic) and MiniMed 780G insulin pump (Medtronic).
These components are not available for use with components from other companies.
ControlIQ control algorithm (Tandem Diabetes Care/Air Liquide) with Dexcom G6 CGM sensor (Dexcom) and t:slim X2 insulin pump (Tandem Diabetes Care/Air Liquide).
CamAPS FX control algorithm (CamDiab) with Dexcom G6 CGM sensor (Dexcom) and either:
(i) DANA insulin pump (Advanced
Therapeutics UK Ltd)
(ii) mylife YpsoPump (Ypsomed)
(iii) other systems are available.
