Utilisation, access and recommendations regarding technologies for people living with type 1 diabetes: consensus statement of the ADS/ADEA/APEG/ADIPS Working Group

Despite developments in diabetes care, people with type 1 diabetes still experience the debilitating impact of glycaemic fluctuations and a disproportionately high risk of vascular and pregnancy‐related complications.1,2,3,4,5,6 Therefore, the continued advancement of diabetes management technologies has a major role in the efforts to reduce the impact and economic cost of the disease on people with type 1 diabetes and on health care systems.

The high acquisition cost of diabetes management technologies remains a key barrier to equitable access for people living with type 1 diabetes.7,8,9 Despite government funding initiatives that improve access for some groups, diabetes management technologies appear to be underutilised overall. It was estimated in 2020 that about 21% of people with type 1 diabetes used insulin pumps across the lifespan in Australia (unpublished data). Furthermore, it was reported that 80% of pump users in Australia obtained their device via private health insurance and about twice as many pump users were living in areas of high socio‐economic status compared with low socio‐economic status areas.10,11 Comparable to utilisation data from other developed countries, the Australian National Diabetes Audit (ANDA) reported in 2019 that continuous glucose monitoring was used by 23% of adults and 62% of young people at participating centres across Australia.12,13

Through the National Diabetes Services Scheme (NDSS), the Australian Government commenced subsidisation of continuous glucose monitoring in April 2017 for people with type 1 diabetes under 21 years of age who meet the eligibility criteria.14 The Continuous Glucose Monitoring (CGM) Initiative was later extended to include some adults with type 1 diabetes, such as those with concessional status or people of Aboriginal or Torres Strait Islander origin, as well as to women who were planning a pregnancy, were pregnant or immediately after pregnancy (< 3 months).14 While these funding strategies assist some groups, they do not facilitate access to interstitial glucose sensors for the majority of adults without concessional status. Furthermore, access to insulin pump therapy in Australia remains almost entirely restricted to those with Gold or Silver tiers of private health insurance (hospital cover).15

In addition to ongoing advocacy for greater access to devices for people with type 1 diabetes, it is important to highlight the increasing workload that diabetes management technologies have on health care systems. Reports from current generation insulin pumps and continuous glucose monitoring/flash glucose monitoring provide large volumes of complex data but do not currently have specific Medicare Benefits Schedule item numbers to remunerate health care professionals for the significant amount of additional time required to interpret them or alter management. The degree of expertise required of health care professionals to manage these technologies also warrants further consideration of their scope of practice and credentialling as well as accreditation for service providers.

This consensus statement thus highlights the inequity of access and barriers to optimal implementation of technology, and provides consensus recommendations to improve health care for people living with type 1 diabetes in Australia. The full version of the consensus statement is available at https://diabetessociety.com.au/position-statements.asp.

Methods

Members of the Working Group comprised key stakeholders, including people with type 1 diabetes and representatives of multiple national bodies involved in the management of diabetes — the Australian Diabetes Society (ADS), the Australian Diabetes Educators Association (ADEA), the Australasian Paediatric Endocrine Group (APEG) and the Australasian Diabetes in Pregnancy Society (ADIPS) (Supporting Information). Meetings over 2019–2021 and collaborative drafting processes led to consensus recommendations based on expert opinion and therefore have very low certainty of evidence according to the GRADE framework. It is expected that the consensus statement will be read in conjunction with the Australian living evidence guidelines in diabetes for continually updated evidence‐based recommendations regarding the comparative efficacy of technologies.16

Diabetes management technologies and consensus recommendations for use

Insulin delivery

Management of type 1 diabetes requires basal insulin as well as intermittent rapid‐acting insulin boluses for meals and correction of hyperglycaemia. Continuous subcutaneous insulin infusion is an alternative to multiple daily injections and comprises a portable, battery‐operated device that pumps insulin to the subcutaneous tissue via an infusion set (or tubeless system for patch pumps).17 Comprehensive discussions regarding continuous subcutaneous insulin infusion therapy and the different available pumps are important because these devices require additional education, accurate carbohydrate counting, and the capacity to manage reasonably complex troubleshooting for the device and data‐uploading processes.18,19 The consensus recommendations for insulin pump therapy are presented in Box 1.

Glucose monitoring

People living with type 1 diabetes must regularly monitor glucose levels to make self‐management decisions. Self‐monitoring of capillary blood glucose requires multiple finger prick checks at discrete time points before and after meals and activity.7 Interstitial glucose monitoring technologies continue to evolve, with different sensors currently able to provide one to two weeks of real‐time or intermittently scanned (ie, flash glucose monitoring) continuous glucose measurements before requiring replacement.20

Current evidence suggests that the proportion of time using interstitial glucose monitoring correlates with the degree of glycaemic benefit.7,21,22,23 Furthermore, the interpretation of reports from interstitial glucose monitoring requires detailed discussions between health care professionals and people living with type 1 diabetes to correlate multiple potential contributing factors with observed glucose levels and tailored advice regarding insulin, diet and other lifestyle measures. Box 2 shows the consensus recommendations for the use of technologies for glucose monitoring.

Technology for insulin dose advice

Optimal education for people with type 1 diabetes is comprehensive and needs to be tailored to the individual’s age and learning level, involving carers as required. Individualised education should include carbohydrate counting as well as training for insulin dose adjustment according to current glucose levels, previous insulin doses, diet, and physical activity.24 The most commonly used technologies for insulin dose advice include insulin pumps with built‐in calculators, free‐standing insulin dose advisors, and applications for smart devices. Applications for smart devices offer a portable solution within a device that does not carry the perceived stigma that may exist for some medical devices.25 However, not all applications have been assessed or approved by professional or regulatory bodies and therefore require more cautious consideration.26 The consensus recommendations regarding insulin dose advisors are described in Box 3.

Integrated insulin pumps and continuous glucose monitoring systems

Insulin pumps may be integrated with continuous glucose monitoring systems to facilitate varying levels of automation for insulin delivery. In some systems, basal insulin delivery is suspended when a low glucose threshold is reached or predicted to be reached in the near future to reduce the burden of hypoglycaemia.27,28 Hybrid closed‐loop systems have been developed more recently and appear to provide the best potential for glycaemic outcomes due to the dual capabilities of increasing basal insulin delivery to mitigate hyperglycaemia and decreasing basal insulin delivery to reduce the burden of hypoglycaemia.29,30,31,32,33,34,35,36

Limitations of integrated insulin pumps and continuous glucose monitoring include financial cost, sensor failures, capillary calibration checks, being attached to multiple devices, the need for manual boluses, and potential alarm fatigue.37,38,39 In addition, commercially available hybrid closed‐loop systems are not recommended for use in pregnancy or young children.39,40

At the time of writing, the only available hybrid closed‐loop system in Australia was the MiniMed 670G (Medtronic).40 Supporting their use, hybrid closed‐loop systems have recently been reported as relatively cost‐effective compared with multiple daily injections with capillary glucose testing among adults in the Australian context.41 Box 4 outlines the consensus recommendations for the use of integrated insulin pump and continuous glucose monitoring systems.

“Do‐it‐yourself” technology and regulatory issues

The Working Group does not endorse the use of any technology unless approved by the Therapeutic Goods Administration and used according to the manufacturers’ instructions. However, all clinicians should be aware of unapproved devices or systems and be able to discuss the functionality and risks of using them.

Inequity of access to diabetes management technologies

Insulin pumps

The Australian Government’s Insulin Pump Program is administered by the Juvenile Diabetes Research Foundation and provides a means‐tested subsidy for the cost of an insulin pump.8,11 However, the program is restricted to a proportion of people with type 1 diabetes under the age of 18 years (~220 per year following the 2018–19 Budget) who meet the eligibility criteria.11

Among the adult population and young people without subsidised access, insulin pumps require private health insurance; alternatively, individuals may completely self‐fund ($6994–$8574 per device).42 The highest tier private health insurance policies (Gold with hospital cover) will reimburse for insulin pumps on an unrestricted basis, and some funds may also choose to provide insulin pumps with lower tiers of cover.43 However, apart from Gold tier policies, the Working Group is only aware of a limited number of Silver and Bronze policies that offer insulin pumps as additional clinical categories.

Restricted compassionate access pathways for insulin pumps also highlight the limitations of current funding systems, are not usually widely advertised, and may further disadvantage patients in rural and remote areas without access to tertiary centres or health care professionals familiar with these access pathways.

Glucose monitoring

In Australia, continuous glucose monitoring is broadly subsidised for young people under 21 years of age and is fully subsidised for children aged under 10 years.44 However, not all interstitial glucose sensors are indicated for use in all age groups or conditions. The eligibility criteria for young people between 11 and 21 years of age are outlined on the NDSS website.44

• children and young people with conditions very similar to type 1 diabetes, such as cystic fibrosis‐related diabetes and neonatal diabetes, who require insulin;
• women with type 1 diabetes who are actively planning a pregnancy (< 12 months), pregnant, or immediately after pregnancy (< 3 months); and
• people with type 1 diabetes over 21 years of age with concessional status or of Aboriginal or Torres Strait Islander origin and who have a high clinical need to access continuous glucose monitoring products.

The CGM Initiative was further extended from March 2020 to include flash glucose monitoring. Eligibility criteria were also expanded to adults over 21 years of age with concessional status or of Aboriginal or Torres Strait Islander origin without the requirement of “high clinical need”.45

While the CGM Initiative greatly assists some groups, it does not facilitate equitable access to interstitial glucose sensors, as most adults do not have concessional status. Furthermore, the CGM Initiative will negatively affect young people who do not retain concessional status once they reach 21 years of age and thus lose access to a vital self‐management tool.

Technology for insulin dose advice

People with type 1 diabetes who are registered with the NDSS in Australia may acquire glucose meters with insulin dose advisor functionality without cost through health care professionals or other manufacturer‐specific pathways.46

Health care systems and barriers

The 2011 national evidence‐based clinical care guidelines provide extensive insights into holistic care for people with type 1 diabetes.24 However, the continually evolving landscape of management technologies requires further attention.

Comprehensive guidelines are also needed regarding the scope of practice for health care professionals as well as which health care professionals and services should be involved in commencing and monitoring diabetes management technologies across primary care, private practice (ie, private medical specialists and diabetes educators), and tertiary care settings. The extensive framework provided by the Australian National Adult Insulin Pump Therapy Working Group in 2013 remains relevant,47 and the consensus statement Working Group intends to integrate updated technologies and broaden the scope across the lifespan and across the range of health care services. The approach to scope and scale of expertise for rural and regional areas also requires particular attention. The ideal would be to ensure experienced and ongoing health care professional oversight for all people with type 1 diabetes using diabetes management technology.

Consensus statement recommendations for technology use and implementation

Commencing diabetes management technologies

The Working Group believes that all people with type 1 diabetes should have equitable access to all technologies that assist in the optimal management of their condition, improve quality of life, and reduce the burden of self‐management.

The Working Group also recommends establishing suitability criteria to determine which individuals with type 1 diabetes would derive particular benefit from diabetes management technologies. Rather than focusing on strict glycaemic thresholds to guide clinical or funding decisions, the Working Group emphasises that optimal glycaemic improvements are derived when people with type 1 diabetes actively engage with the device and health care professionals. The essential criteria for commencing technology and the criteria indicating that intensified therapy with technology may be of particular benefit are outlined in Box 5.

Continuing diabetes management technologies

Due to limited resources, the Working Group proposed that there should also be criteria for continued use of diabetes management technologies. This has particular applicability in instances where the government is subsidising devices or related consumables, and provides an implementation framework for subsidisation of other technologies in the future.

The Working Group proposed that the focus of these criteria be on supporting all people living with type 1 diabetes while also recognising that diabetes management technology may not be necessary or appropriate for everybody. When there is concern about the ability or willingness of an individual living with type 1 diabetes to continue using diabetes management technology, a thorough assessment should consider contributing factors. Multidisciplinary efforts should also be made to support and assist people with type 1 diabetes to engage with diabetes management technology and to individualise care to address concerns such as burnout, self‐image, expectations, and other factors. In addition, the inclusion of individualised diabetes management goals is a recognition of the broad spectrum of benefits potentially offered by technology rather than the focus being limited to the achievement of strict glycaemic targets. Individualised goals may relate to quality of life, fear of hypoglycaemia, participation in healthy behaviour, and improved glycaemia among others. These individualised goals may also change following commencement of technologies.

Rather than applying punitive threshold criteria for the cessation of diabetes management technology, individualised management goals should allow the consideration of observed benefits and disadvantages to direct the most appropriate management strategy. The individual with type 1 diabetes should then be supported by their health care professionals to address any barriers to effective implementation of technology, choose a more suitable technology, or have a break from technology if appropriate. Health care professionals should also update people with type 1 diabetes who have chosen to have a break from technology of any subsequent systems or new technologies that are developed and that may overcome previous barriers to effective implementation. The essential criteria for continuing technology are presented in Box 5.

Strategic issues raised as part of the implementation framework in Australia

The overarching focus for the Working Group was the need for access to diabetes management technologies as well as a strategic implementation framework. Specific advocacy steps and collaborations within the Australian health care system are outlined in Box 6.

Conclusion

The Working Group believes that all people with type 1 diabetes should have equitable access to the most effective management systems, including technology, where clinically appropriate, regardless of age, concessional status or level of private health insurance cover. This Australian consensus statement provides a unified implementation framework to ensure optimal utilisation of diabetes management technologies with international relevance. In addition to ongoing advocacy for greater access, the proposed implementation framework highlights the need for accreditation, credentialling and technology‐specific funding initiatives for health care professionals to support the management of people with type 1 diabetes using technologies that generate large volumes of complex data. The Working Group also outlines the need for ongoing appraisal of implementation strategies, safety reporting, and funding initiatives to ensure sustainable health care and optimal outcomes for all people living with type 1 diabetes.