About Hybrid Closed Loop for T1D

This blog was reviewed and updated on 26 January 2024

NICE (National Institute for Health and Care Excellence) Guidelines were updated in December 2023 to include the use of hybrid closed loops (HCL) for type 1 diabetes management by the NHS in England.

This blog gives an overview of the criteria used to determine eligibility of HCL, and information about the rollout.

 

To support of the decisions around HCL and medtech, the NHS have published supporting information: Making a decision about managing Type 1 diabetes.

How will the NICE guidelines apply across the nations of the UK?

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• The below information relates to T1Ds under the NHS in England.
• For T1Ds in Wales a 5 year rollout is also expected, but details have not yet been given.
• For T1Ds in Northern Ireland, the guidelines have yet to be fully adopted and details are not yet available.
• It is understood that T1Ds in Scotland have access to hybrid closed loop systems under guidance published in 2022.

Who will be eligible under the NICE Guidelines?

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Hybrid Closed Loops - also referred to as an artificial pancreas - could benefit up to 150,000 type 1s with the rollout set to take place over the next 5 years.

The guidelines identify the following as being eligible for a hybrid closed loop under the NHS.

✅ All children aged 0-18 years with Type 1

✅  Pregnant Type 1s and those planning a pregnancy

Priority will also be given to those already with a pump.

For other adults, the criteria states that they must have tried to manage the condition with a CGM first, or suffer disabling hypoglycaemia and have a HbA1c greater than 7.5%. 

NICE define disabling hypos as "when hypoglycaemia occurs frequently or without warning, so the person is constantly anxious about having hypoglycaemic episodes".

What is a hybrid closed loop?

A hybrid closed loop system (HCL) - also referred to as an artificial pancreas or automated insulin delivery (AID) - is the use of a combination of medtech to adjust glucose levels through automated-means.

A T1D would use real-time glucose monitoring from a continuous glucose monitor (CGM) which links to a control algorithm (on an app, usually a smartphone) to direct insulin delivery through an insulin pump.

Users of HCL do not need to inject but still need to carb count to adjust insulin flow for meals.

How many T1Ds will benefit from hybrid closed loops?

It is thought that over 150,000 type 1s in England and Wales could benefit. This includes those under 18 years old - as priority, and pregnant women or those planning a pregnancy.

Note: there are currently approximately 290,000 individuals registered as having type 1 diabetes, although statistics suggest the number to be around 400,000, which is often quoted in the media and on academic papers.

 What are the advantages of Hybrid Closed Loop?

The potential benefits of using a HCL rather than solely MDI or MDI and sensor use include the following:

What options will be available when choosing a pump as part of a HCL?

Dependent on price to the NHS, all options (from a range of manufacturers) should be available to those meeting criteria (yet to be determined). Current pump users should be able to upgrade and users shouldn't be held back by having to use pumps that can't loop. 

Current usage of pumps by children is around 42-48%.

For adults, the uptake is around 10% - largely due to restrictive criteria and some ICS not following the Guidelines.

Which systems are approved for use by the NHS as Hybrid Closed Loop?

The following HCL have been licensed, however many more options are likely to be available if/when updated NICE Guidelines are approve and formally in place.

• CamAPS FX (on Android phone) with a Dana or mylife YpsoPump and Dexcom G6 CGM or Abbott Libre 3 CGM with YpsoPump. It is licenced for PWD age 1+

• Medtronic 670G with Guardian sensors. It is licenced for PWD age 7+

• Medtronic 780G with Guardian sensors. It is licenced for PWD age 7+

• Control IQ hybrid closed loop uses Tandem t:slim insulin pump and Dexcom CGM. It is licenced for PWD age 4+

Note, Omnipod 5 (a tubeless option) has not yet been approved for use in the UK.

What is the cost of Hybrid Closed Loop to the NHS?

Sources of information

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

Assessment Document by Warwick University, published October 2022

Diabetes UK

https://www.diabetes.org.uk/guide-to-diabetes/diabetes-technology/closed-loop-systems

JDRF