Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes

1 Recommendations

1.1 Hybrid closed loop systems are recommended as an option for managing blood glucose levels in type 1 diabetes for people who are having difficulty managing their condition and have an average HbA1c of around 64 mmol/mol (8.0%) or more, despite optimal management with at least 1 of the following:

Hybrid closed loops systems are only recommended if the companies and NHS England agree a cost-effective price for the systems on behalf of the relevant health bodies (see section 2).

1.2 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. Hybrid closed loops systems are only recommended if the companies and NHS England agree a cost-effective price for the systems on behalf of the relevant health bodies (see section 2).

1.3 Only use hybrid closed loop systems with the support of a trained multidisciplinary team experienced in continuous subcutaneous insulin infusion and continuous glucose monitoring in type 1 diabetes.

1.4 Only use hybrid closed loop systems if the person or their carer:

1.5 These recommendations are not intended to affect use of hybrid closed loop systems that was started in the NHS before this guidance was published. People using hybrid closed loop 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.

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 (continuous subcutaneous insulin infusion). 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 load for people with type 1 diabetes (and their families or carers). Hybrid closed loop systems automatically deliver insulin 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 load and improve people's quality of life.

Clinical trial and real-world evidence shows 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 (HbA1c) levels. But they are also effective for people with average HbA1c levels (the UK average HbA1c for people using a pump is around 64 mmol/mol [8.0%]).

So, to ensure wider access, hybrid closed loop systems are recommended for managing blood glucose levels in type 1 diabetes for people who are having difficulty managing their condition, and have an HbA1c level of around 64 mmol/mol (8.0%) or more. And because blood glucose levels are harder to manage in pregnancy, they are also recommended for people with type 1 diabetes who are pregnant or planning a pregnancy. But because there is some uncertainty in the economic model, they are only recommended if the companies and NHS England agree a cost-effective price for the systems.