Recommendations for NHSScotland
SHTG Council Considerations
Evidence Overview
Background
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.
When formulating their recommendations, the Council took into account the published evidence, SHTG economic modelling, and the views of clinical experts and patients.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. The Council discussed the most appropriate way of defining and measuring diabetesrelated 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. There is an ongoing trial of closed loop systems in NHS England that should provide useful data to inform an update of this review.
15. 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.
1. Trials comparing closed loop systems with usual care generally have small sample sizes and evaluate interventions over short time periods with a study population of people with well controlled type 1 diabetes who have lived with the condition for many years. The closed loop systems used in trials have often been superseded by more advanced versions. Meta-analyses show high levels of statistical heterogeneity based on these trials.
2. A network meta-analysis of 14 trials (n=1,043) in adults with type 1 diabetes found that the mean percentage time in normal glycaemic range was significantly greater with closed loop systems compared with other diabetes technologies, including continuous glucose monitoring plus insulin pump therapy. A meta-analysis of 12 trials (n=344) that compared closed loop systems with sensor-augmented pump therapy reached similar conclusions.
3. A meta-analysis of 19 studies (n=364) compared closed loop systems with continuous subcutaneous insulin infusion in adolescents and children with type 1 diabetes. There was a statistically significant difference in mean percentage time in normal glycaemic range that favoured closed loop systems: 11.97%, 95% confidence interval (CI) 5.54% to 18.40%, p=0.0003.
4. A meta-analysis of 41 trials (n=1,042) comparing closed loop systems with continuous subcutaneous insulin infusion or sensor-augmented pump therapy, in people of any age with type 1 diabetes, found a statistically significant improvement in weighted mean percentage time in normal glycaemic range in the closed loop group compared with the control group: 9.62%, 95% CI 7.54% to 11.70%, p<0.001. A subgroup analysis was consistent with the overall meta-analysis for comparisons of an artificial pancreas (a dual hormone closed loop system) with continuous subcutaneous insulin infusion or sensor-augmented pump therapy.
5. The meta-analyses described in key points 3 and 4 found corresponding statistically significant reductions in the mean percentage time spent in hypoglycaemia and hyperglycaemia with closed loop systems.
6. The results of 13 randomised controlled trials (RCTs), published after the most recent meta-analysis, are consistent with the findings reported in the secondary literature. Two of the trials tested closed loop systems in people with a moderate-to-high risk of hypoglycaemia or suboptimal glycaemic control.
7. Clinical safety outcomes, such as severe hypoglycaemia or diabetic ketoacidosis, were rarely reported in the secondary literature. As a result there is uncertainty around the frequency of these outcomes with closed loop systems compared with other diabetes management options.
8. Device-associated safety concerns related to either technical difficulties affecting components within the closed loop system or human factors. The main safety issues reported with closed loop systems were about loss of connectivity between component devices often owing to the devices being too far apart.
9. In the published literature on patient experiences and views of closed loop systems, people with type 1 diabetes described how closed loop systems improved their glycaemic control, gave them increased flexibility around eating and exercise, and provided ‘time off’ from managing their diabetes. People also described a burden of treatment associated with this technology such as the need to respond to frequent alarms, replace sensors and deal with technical problems. Some people expressed concerns about the trustworthiness of closed loop systems or found the systems challenging to use when exercising.
10. An audit of services in England and Wales for children and young people with type 1 diabetes found that continuous glucose monitors and insulin pumps were significantly more likely to be used by children and young people with diabetes who live in the most affluent areas and are of white ethnicity.
11. The patient organisation Insulin Pump Awareness Group (iPAG) Scotland identified inequalities in access to closed loop systems in Scotland created by the current requirement for people to self-fund the use of these systems. This is a cost that many from lower income areas cannot afford.
12. Three patient organisations (iPAG Scotland, Juvenile Diabetes Research Foundation (JDRF), and Diabetes Scotland) outlined the substantial impact the condition has on those living with type 1 diabetes and all strongly supported access to closed loop systems in Scotland.
- Managing type 1 diabetes is a daily burden that has a major impact on the daily lives of people with diabetes, their families and carers.
- The adverse effects of managing type 1 diabetes are both physical and mental and include diabetes-related distress and reduced quality of life.
- There are currently financial barriers to accessing closed loop systems because of the requirement to self-fund and barriers to education about diabetes and the role of closed loop systems.
- Equal access to closed loop systems across NHSScotland is highly desirable for people with type 1 diabetes.
13. Two studies reporting interviews with healthcare professionals in NHS England identified the importance of defining priority groups and ensuring consistency of access to closed loop systems in clinical practice.
14. SHTG adapted an economic model comparing closed loop systems with continuous glucose monitoring plus multiple daily injections, flash glucose monitoring plus multiple daily injections, continuous subcutaneous insulin infusion pumps plus continuous glucose monitoring, and finger prick testing plus multiple daily injections. Based on the available clinical evidence in people with well controlled type 1 diabetes:
- closed loop systems were associated with the highest costs and quality adjusted life years in a Scottish adult population with type 1 diabetes (except in the comparison with continuous glucose monitoring plus continuous subcutaneous insulin infusion, where associated closed loop system costs were lower)
- base case results showed that closed loop systems are cost-effective compared with continuous subcutaneous insulin infusion plus continuous glucose monitoring (non-integrated)
- base case results showed that closed loop systems are unlikely to be cost[1]effective compared with flash or continuous glucose monitoring plus multiple daily injections. The results are sensitive to baseline HbA1c, technology costs and effects on hypoglycaemia. The model does not capture day-to-day quality of life improvements associated with the use of closed loop systems, and
- the costs associated with closed loop systems (device and consumables cost) should be considered in the context of the reduction in the costs of managing long-term complications of type 1 diabetes.
What were we asked to look at?
We were asked to examine the evidence on using closed loop systems and the artificial pancreas for the management of type 1 diabetes. We were asked to consider the cost-effectiveness of these technologies compared with current diabetes management options, and to consider clinical effectiveness, safety and patient aspects.
Why is this important?
Access to technologies to support people with managing diabetes is a key priority of the Scottish Government’s Diabetes Improvement Plan. The 2019 Scottish diabetes survey found that there were 33,452 people living with type 1 diabetes in Scotland. Living with type 1 diabetes is associated with a significant physical and mental health burden caused by the demands of managing the condition every day and worrying about future complications. Poorly controlled diabetes is associated with complications such as leg, toe or foot amputation, nephropathy, neuropathy and retinopathy resulting in sight loss. People with type 1 diabetes are also at increased risk of cardiovascular disease and premature mortality. Approximately 80% of the £10 billion annual spending on diabetes in the UK is used to fund the treatment of complications. Rapidly advancing diabetes technologies, such as closed loop systems and the artificial pancreas, have the potential to transform the lives of people living with type 1 diabetes. Demand for these technologies is increasing, with many people with type 1 diabetes anticipated to benefit from an artificial pancreas or closed loop system in the future.
