1 Recommendations

Access to hybrid closed loop systems will be through a 5‑year phased roll out in line with NHS England's implementation plan. For enquiries about cost-effective pricing, contact Leigh.Carr@supplychain.nhs.uk.

1.1

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 1 of the following:

continuous subcutaneous insulin infusion (CSII)
real-time continuous glucose monitoring
intermittently scanned continuous glucose monitoring.

HCL systems are only recommended if they are procured at a cost-effective price agreed by the companies and NHS England, and implemented following NHS England's implementation plan.

1.2

HCL systems are recommended as an option for managing blood glucose levels in type 1 diabetes for children and young people. HCL systems are only recommended if they are procured at a cost-effective price agreed by the companies and NHS England, and implemented following NHS England's implementation plan.

1.3

HCL systems are recommended as an option for managing blood glucose levels in type 1 diabetes for women, trans men and non-binary people who are pregnant or planning to become pregnant. HCL systems are only recommended if they are procured at a cost-effective price agreed by the companies and NHS England, and implemented following NHS England's implementation plan.

1.4

Only use HCL systems with the support of a trained multidisciplinary team experienced in CSII and continuous glucose monitoring in type 1 diabetes.

1.5

Only use HCL systems if the person or their carer:

is able to use them, and
is offered approved face-to-face or digital structured education programmes, or
is competent in insulin dosing and adjustments.

1.6

These recommendations are not intended to affect use of HCL systems that was 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 this means in practice

HCL systems must be funded in the NHS in England for the condition and populations in the recommendations, if they are considered the most suitable option for managing blood glucose levels. HCL systems must be funded in England within 5 years of final publication of this guidance.

There is enough evidence to show that HCL systems provide benefits and value for money, so they can be used routinely across the NHS in these populations.

The choice of components or system is based on a person's preference and whether the system has the appropriate licence for use. Whether HCL systems are licensed for use in pregnancy or in children or young people may differ.

NICE has produced tools and resources to support the implementation of this guidance.

Why the committee made these recommendations

Standard care for type 1 diabetes involves regularly measuring blood glucose levels by self-monitoring (blood testing) or by using a continuous glucose monitor (real-time or intermittently scanned). Blood glucose levels are managed with multiple daily insulin injections or by using a pump to inject insulin under the skin (CSII). The aim of treatment is to decrease blood glucose levels and keep them within a healthy range.

Continuously managing blood glucose levels is a substantial mental burden for people with type 1 diabetes and their families or carers. HCL systems deliver insulin automatically using a calculation based on continuous glucose measurements. The systems do not need as much input from the person, but manual insulin dosing is still needed sometimes, for example, around mealtimes. So, they may reduce the mental burden and improve people's quality of life.

Clinical trial and real-world evidence shows that HCL systems are more effective than standard care at maintaining blood glucose levels within a healthy range.

There is uncertainty in the economic model, so the systems need to be procured at a cost-effective price agreed by the companies who manufacture HCL systems and NHS England. This will mean the HCL systems are likely to be cost effective for adults who have an HbA1c level of 58 mmol/mol (7.5%) or more, or have disabling hypoglycaemia (when hypoglycaemia occurs frequently or without warning, so the person is constantly anxious about having hypoglycaemic episodes). So, HCL systems are recommended for these people. HCL systems are likely to be more cost effective for children and young people than adults, so they are also recommended for children and young people irrespective of their HbA1c level. And because blood glucose levels are harder to manage in pregnancy, they are also recommended for women, trans men and non-binary people with type 1 diabetes who are pregnant or planning to become pregnant.