Closed loop systems and the artificial pancreas for type I diabetes mellitus (T1DM)
Scottish Health Technologies Group (SHTG)
SHTG Recommendations for NHSScotland
This recommendation applies to single hormone closed loop systems. No evidence was identified for artificial pancreas systems (multi-hormone closed loop systems) available on the UK market.
To minimise inequalities in accessing diabetes technologies, clinicians should pro-actively initiate meaningful discussions with all patients with type 1 diabetes about the suitability of a closed loop system for their individual circumstances.
Single hormone closed loop systems should be available to people with type 1 diabetes (paediatric and adult) who:
- under their current diabetes care plan, continue to have suboptimal glycaemic control, a high risk of severe hypoglycaemia, or impaired awareness of hypoglycaemia, or
- experience diabetes-related distress, measured using a validated tool, that adversely affects quality of life or their ability to manage diabetes, and which is likely to be improved by moving to a closed loop system.
People who can achieve the desired glycaemic targets using finger prick testing, flash glucose monitoring or continuous glucose monitoring plus multiple daily insulin injections, or flash glucose monitoring plus an insulin pump, should be supported to remain on their current diabetes care plan subject to their circumstances and quality of life. People who are currently using continuous glucose monitoring in combination with an insulin pump (non-integrated) should be offered a closed loop system, which may provide them with additional clinical benefits at lower costs.
In their discussions, people with type 1 diabetes and clinicians must consider the day-to-day requirements of managing closed loop systems, for example, responding to alerts or replacing sensors when required. Support on how to use the closed loop system effectively should be provided to everyone offered the technology.
The Scottish Care Information (SCI)-Diabetes database should be used to collect clinical and person- reported outcomes data from people with type 1 diabetes using closed loop systems. These data will be used to inform quality of care improvements and future advice for NHSScotland.
NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) advice.
How the Council reached the recommendation
- When formulating their recommendations, the Council took into account the published evidence, SHTG economic modelling, and the views of clinical experts and patients.
- The Council acknowledged that closed loop systems are a rapidly advancing technology, and that consequently some of the evidence reviewed may relate to devices that have been superseded. The Council felt it important that the published evidence, and outcomes data from the SCI-Diabetes database, should be reviewed regularly by SHTG to allow for updating of the recommendations on closed loop systems for NHSScotland.
- Particular note was made of current evidence being based on trials that recruited participants who had relatively well controlled type 1 diabetes. The Council recognised that the benefits of closed loop systems may be greater for people with less well controlled type 1 diabetes.
- The Council were advised by clinical experts that very few people in Scotland with type 1 diabetes currently receive a closed loop system through the NHS.
- The Council noted that costs and incremental cost-effectiveness ratios (ICERs) in the economic modelling could be lower in the future, particularly if lower device costs are negotiated between NHS National Procurement and device manufacturers.
- Clinical experts highlighted that glycaemic targets in the published literature were aligned with Scottish definitions. Time spent in glycaemic range has been internationally agreed to be time spent with glucose levels between 3.9 and 10.0 mmol/L. Optimal glycaemic control is defined in the Scottish Diabetes Improvement Plan as <58 mmol/mol (9.4 mmol/L) in adults and <48 mmol/mol (7.2 mmol/L) in children.
- The Council discussed the most appropriate way of defining and measuring diabetes-related distress. They agreed that validated tools should be used to provide information to facilitate discussions between clinicians and people with type 1 diabetes about whether using a closed loop system would be suitable for the individual. Appropriate tools for measuring diabetes-related distress in people with type 1 diabetes include the Problem Areas In Diabetes (PAID) scale and the Diabetes Distress Scale.
- The Council discussed the lack of clinical data comparing closed loop systems with flash glucose monitoring plus an insulin pump. As a consequence, any additional clinical benefit of closed loop systems for people currently using flash glucose monitoring and an insulin pump remains unclear.
- The Council discussed the value of educational programmes that help people with type 1 diabetes to use a closed loop system. These programmes should be designed for people with a range of educational and technological knowledge levels and should be accessible to people with English as a second language.
- Patient organisations highlighted the daily burden of managing type 1 diabetes and the impact this has on the lives of people with diabetes, with particular reference to effects on physical and mental health, including diabetes-related distress and quality of life.
- The Council recognised the mental health and wellbeing benefits of using closed loop systems, in addition to their physical health benefits, regardless of people’s previous levels of glycaemic control.
- The Council acknowledged that there are a growing number of people with type 1 diabetes who are using ‘do it yourself’ (DIY) closed loop systems. DIY closed loop systems are not regulated and are not covered in these SHTG Recommendations. Diabetes UK has developed a position statement on DIY closed loop systems which has been endorsed by the Royal College of Nursing.
- The Council noted the link between poor glycaemic control and subsequent development of diabetes-related complications, which in addition to the heavy burden placed on individuals with type 1 diabetes, carries a substantial treatment cost to NHSScotland.
- There is an ongoing trial of closed loop systems in NHS England that should provide useful data to inform an update of this review.
- The SCI-Diabetes database provides a fully integrated shared electronic record of population level data for all people with diabetes in Scotland. SCI-Diabetes should be used for the robust capture of national data to facilitate decision making and real world assessment of diabetes technologies across NHSScotland.
Date of publication: 28 January 2022