Affordable CGM for Australia

The federal government of Australia is conducting a survey to determine whether continuous glucose monitoring devices (CGM) should be subsidised under the National Diabetes Supply Scheme (NDSS). The following research and outcomes data shows that yes, CGM should be made affordable for all people living with type 1 diabetes as an urgent priority.

Using CGM with an automated insulin delivery (AID) device has had an enormous positive impact on my life.

Artificial pancreas/AID systems are entering the Australian marketplace and have been used by members of the DIY community for over three years. They require CGM. This is the biggest development since insulin in 1922. But there is no use having it if people can’t afford it. Unfortunately the cost of CGM in Australia is currently prohibitive for most people.

South Korea, which has a similar health system to ours, commenced a 70% CGM subsidy for all with type 1 diabetes in January 2019.

This 17 minute ABC Science Show podcast (I’m interviewed with Jim Matheson and Tien-Ming Hing) highlights the urgency very well and explains the health outcomes that are possible IF people can afford CGM

Current situation using blood glucose test strips alone

Australia’s peak diabetes medical body, The Australian Diabetes Society, has set a HbA1c target of less than 7 (NGSP) as the glycaemic goal for people with type 1 diabetes because it is believed to give people the best chance of a healthy, long life. This is currently being achieved by less than 21% of adults with type 1 diabetes (Foster et al, 2019). The major limiting factor in achieving this target HbA1c is hypoglycemia. As discussed in the DCCT trials, achieving target HbA1c using currently subsidised methods only for blood glucose control leads to a 300% increase in hypoglycemia and one in five with type 1 diabetes now have hypoglycaemic unawareness which can be life-threatening.

It is recognised by leading medical practitioners and researchers that the desire for hypoglycemia avoidance contributes to the higher than recommended HbA1c outcomes (Choudhary & Amiel, 2018).

As described in research outcomes below, CGM use alone reduces the incidence of hypoglycaemia and improves HbA1c. When CGM is used in combination with AID ‘artificial pancreas’ systems, HbA1c and hypoglycemia are further reduced (Braune et al, 2019),  there is a reduction in glycaemic variability, which has also been linked with a reduction in diabetes complications (Hirsch, 2015), and there are major improvements in quality of life including sleep, mood, well-being and energy levels (Hng & Burren, 2018; Crabtree et al, 2019).

This is a major breakthrough. It is difficult to convey to someone without type 1 diabetes just how significant the impact of these psychological, social, and quality of life improvements can be. Many people using these systems describe them as life-changing.

Automated insulin delivery outcome studies

DIY systems

Over 1440 people around the world are currently using DIY automated delivery systems which means there is over 13,700,000+ hours of user experience and data to draw conclusions from.

Real-world use of open source artificial pancreas systems (Lewis, D & Leibrand, 2016) is the first study on DIYAPS systems. 16 people contributed their data.

• median HbA1c dropped from 7.1% to 6.2%
• median percent time in range (3.9-10 mmol/L) increased from 58% to 81%
• All but one respondent reported improvement in sleep and 56% reported a large improvement (this has mental health & productivity implications)

In 2018 three more DIY outcomes studies (US, Korea, Italy) showed similar results. Visualisations of the impact can be found here.

Numerous trials of commercial AID systems are underway and published positive results are available.

Cost effectiveness

Continuous glucose monitoring: A consensus conference of the American Association of Clinical Endocrinologists and American College of endocrinology (Fonseca et al 2016)

CGM improves glycemic control, reduces hypoglycemia, and may reduce overall costs of diabetes management. Expanding CGM coverage and utilization is likely to improve the health outcomes of people with diabetes.

Cost-effectiveness of continuous glucose monitoring and intensive insulin therapy for type 1 diabetes (McQueen, 2011)

“CGM may also provide a cost-effective means of lowering A1c in the general population. It is important for individuals with type 1 diabetes to have affordable access to and education about this technology”.

Cost savings

Subsidising CGM is an investment up front to save money on:

• hospital ‘sick day’ admissions
• admission for severe hypoglycaemia
• Avoidance of Royal Flying Doctor trips to major centres in DKA for rural patients
• Prevention of losing drivers licences due to severe DKA (maintenance of independence/livelihood/survival in rural areas)
• cost to the Australian healthcare system of treating complications
  • retinopathy – specialist treatment, laser surgery, anti-VEGF agents;
  • kidney disease – specialist treatment, pharmaceuticals, dialysis, kidney transplants;
  • cardiovascular – specialist treatment, pharmaceuticals, surgery, prostheses;
  • feet – antibiotics, specialist limb care, prostheses, amputation.
• Reduction in mental health costs associated with type 1 diabetes distress and depression
• cost of disability payments
• economic impact of early retirement and productivity losses due to complications, hypoglycaemia and sick days

Cost offsets

Currently blood glucose (BG) test strips are subsidised on the NDSS. People using CGM require significantly fewer strips and therefore receive less subsidy. Once newer CGM sensors become available in Australia (eg Dexcom G6) there will be only minimal need for BG test strips for those using CGM.  Patients should be able to use their allocated subsidy for CGM.

CGM use reduces hypoglycaemia

Many with type 1 diabetes lose hypoglycaemic awareness over the years so cannot even detect hypoglycaemia in the midst of it. They need outside help to recover from the hypoglycemia and if it is not received the situation becomes life-threatening. According to researchers, between twenty and forty percent of people with type 1 diabetes experience hypoglycemia unawareness. Since it is repeat hypoglycemia that causes hypoglycaemic unawareness to develop, it stands to reason that CGM use is prophylactic. CGM use reduces the likelihood of developing hypoglycaemic unawareness in the first place. This, in addition to the quality of life, wellbeing and productivity improvements with CGM, is why it is crucial that we subsidise all people with type 1 diabetes, not just a sub group.

As Pratik Choudhary and Stephanie Ariel point out in Diabetologia (2018), ‘hypoglycaemia and the fear it causes make a significant contribution to the higher than desired glucose results seen in national audits and registries.’

More CGM and hypoglycemia research

Real-time continuous glucose monitoring significantly reduces severe hypoglycemia in hypoglycemia-unaware patients with type 1 diabetes. (Choudhary et al, 2013).

Hypoglycemia is the limiting factor to excellent glycemic control in insulin-treated subjects. Intensification of glycemic control was associated with a 300 % increase in the rate of hypoglycemia in the Diabetes Control and Complications Trial. CGM use revealed an alarming rate of daytime and nocturnal episodes of hypoglycemia in patients with type 1 diabetes (Awoniyi et al, 2013).

The studies I have listed in this article are just the tip of the iceberg.

The bottom line is, people with type 1 diabetes have been advised by the medical establishment, since the DCCT trials in 1993, that if they are to remain healthy they need to maintain tight blood glucose levels. Less than 21% of people with type 1 diabetes are able to do this with the tools currently subsidised in Australia. The use of CGM and AID systems means that these glycemic targets are finally achievable, but only if people can access and afford them.

If the government decides against making CGM affordable for all through the NDSS, it really is time to change glycemic reporting to reflect, that no, patient glycemic control is not ‘poor’ or ‘suboptimal’ but, in fact, as has always been the case, people with diabetes are doing the best they can with the blunt tools they have under difficult circumstances.

But why not follow in the footsteps of other countries and fund the thing that works?

As Tim Street puts it in his brilliant article Are we living in the past? Good reasons why achieving the NICE Target Hba1C with the available NHS tools is tough.

“How much is one, pain and complication free, life really worth?”

This is the economic and ethical dilemma for the Australian government. To make your voice heard on the matter, please take a few minutes to fill out this government survey which runs until 25 August 2019 to ensure a healthy future for all with type 1 diabetes in Australia.

References

Public Consultation on Diabetes Products Subsidised under the National Diabetes Services Scheme (NDSS) Deadline 25 August 2019. Available at: https://consultations.health.gov.au/pharmaceutical-access-branch/ndss/

Patton, Mary Anne. “One year of DIY looping after 38 years of type 1 diabetes.” Australian Diabetes Educator, vol. 22, no. 2, 2019.

Diabetes Control and Complications Trial Research Group. “The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus.” New England journal of medicine 329.14 (1993): 977-986.

“DIY ‘loopers’ take diabetes into their own hands”, ABC Science Show podcast, 22 June 2019, available at: https://radio.abc.net.au/programitem/pgL78oXkkV

Patton, Mary Anne. “We Are Not Waiting for Access and affordability” Available at: https://myartificialpancreas.net/2018/11/

Australian Diabetes Society Position Statement: Individualization of HbA1c Targets for Adults with Diabetes Mellitus, Available at: https://diabetessociety.com.au/downloads/positionstatements/HbA1ctargets.pdf

Foster, Nicole C., et al. “State of type 1 diabetes management and outcomes from the T1D Exchange in 2016–2018.” Diabetes technology & therapeutics 21.2 (2019): 66-72.

Ryan, E. & Kwon, J. “When You Don’t Know You’re Low – Hypoglycemia Unawareness 101”
Diatribe article, Available at: https://diatribe.org/hypoglycemia-unawareness-101

Choudhary, Pratik, and Stephanie A. Amiel. “Hypoglycaemia in type 1 diabetes: technological treatments, their limitations and the place of psychology.” Diabetologia 61.4 (2018): 761-769.

Braune, Katarina, et al. “Real-World Use of Do-It-Yourself Artificial Pancreas Systems in Children and Adolescents With Type 1 Diabetes: Online Survey and Analysis of Self-Reported Clinical Outcomes.” JMIR mHealth and uHealth 7.7 (2019): e14087.

Hirsch, Irl B. “Glycemic variability and diabetes complications: does it matter? Of course it does!.” Diabetes care 38.8 (2015): 1610-1614.

Hng, Tien‐Ming, and David Burren. “Appearance of Do‐It‐Yourself closed‐loop systems to manage type 1 diabetes.” Internal medicine journal 48.11 (2018): 1400-1404.

Crabtree, Thomas SJ, Alasdair McLay, and Emma G. Wilmot. “DIY artificial pancreas systems: here to stay?.” Practical Diabetes 36.2 (2019): 63-68.

Lewis, Dana, Scott Leibrand, and OpenAPS Community. “Real-world use of open source artificial pancreas systems.” Journal of diabetes science and technology 10.6 (2016): 1411.

Lewis, Dana M., Richard S. Swain, and Thomas W. Donner. “Improvements in A1C and time-in-range in DIY closed-loop (OpenAPS) users.” (2018): 352-OR.

Choi, Soo Bong, Eun Shil Hong, and Yun Hee Noh. “Open artificial pancreas system reduced hypoglycemia and improved glycemic control in patients with type 1 diabetes.” (2018).

Provenzano, Vincenzo, et al. “Closing the loop with OpenAPS in people with type 1 diabetes—experience from Italy.” (2018): 993-P.

OpenAPS Outcomes. Available at: https://openaps.org/outcomes/

Bourdreaux, T. “Exciting trial results for Tandem’s Control-IQ hybrid closed loop system” (2019) Available at: https://beyondtype1.org/control-iq-study-results/

Fonseca, Vivian A., et al. “Continuous glucose monitoring: a consensus conference of the American Association of Clinical Endocrinologists and American College of Endocrinology.” Endocrine Practice 22.8 (2016): 1008-1021.

McQueen, R. Brett, et al. “Cost-effectiveness of continuous glucose monitoring and intensive insulin therapy for type 1 diabetes.” Cost effectiveness and resource allocation 9.1 (2011): 13.

P. Choudhary, P., de Portu, S., Delbaere, A., Lyon, J. & Pickup, J. “A modelling study of the budget impact of improved glycaemic control in adults with Type 1 diabetes in the UK.” Diabetic Medicine 36.1 (2019).

Martín-Timón, Iciar, and Francisco Javier del Cañizo-Gómez. “Mechanisms of hypoglycemia unawareness and implications in diabetic patients.” World journal of diabetes 6.7 (2015): 912.

Choudhary, Pratik, et al. “Real-time continuous glucose monitoring significantly reduces severe hypoglycemia in hypoglycemia-unaware patients with type 1 diabetes.” Diabetes Care 36.12 (2013): 4160-4162.

Awoniyi, Omodele, Rabia Rehman, and Samuel Dagogo-Jack. “Hypoglycemia in patients with type 1 diabetes: epidemiology, pathogenesis, and prevention.” Current diabetes reports 13.5 (2013): 669-678.

Street, T. “Are we living in the past: Why achieving the NICE target HbA1c with the available tools is tough, Diabettech, Available at: https://www.diabettech.com/uncategorized/are-we-living-in-the-past-good-reasons-why-achieving-the-nice-target-hba1c-with-the-available-tools-is-tough/