Aidex: A Game Changer or a Gamble? A Closer Look at South Africa's New CGM (Revised article)
By: Kirsten de Klerk, Co-founder SA Diabetes Advocacy
Most people living with diabetes in South Africa have heard about Continuous Glucose Monitoring (CGM) and how life-changing these devices can be. However, they still come at a great expense and are inaccessible to most people in South Africa. We continue the fight with private healthcare funders, the public healthcare system and device manufacturers to make sensor technology more accessible to South Africans with diabetes.
New Continuous Glucose Monitor enters the market
In the last few years, the global leading manufacturers of these devices have launched their products in South Africa, namely Dexcom, FreeStyle Libre and Medtronic. A new device called Aidex has just entered the market and some diabetes community members are excited by the low cost of the device.
We would like to revise our previous statement with the following information:
In our article that was published on our website on 30 October 2023, we stated that the AiDEX sensor was removed from the NHS prescription tariff. We have since been in communication with the AiDEX distributors in South Africa, Homemed, who have confirmed that AiDEX is currently available on the NHS’s prescription tariff in the UK. We have revised the article below as part of our ongoing commitment to our community to provide the most current data in a fair and balanced manner to make sure that anyone testing out new technologies is equipped with all the information they need to make an informed choice when it comes to diabetes technology.
Global diabetes community feedback on Aidex
Unfortunately in the global diabetes space, there has been an overwhelming sense that the accuracy is not up to expected standards. In fact, the reported overall MARD (mean absolute relative difference) was 21.9%, which is worse than Dexcom and Medtronic sensors from more than 15 years ago.
Dawn Adams, a diabetes advocate from Northern Ireland, shares that in her country, the Aidex CGM was added to the list of glucose sensors available on the NHS in the summer of 2022. At a Diabetes Network meeting, of which Dawn Adams is a lived experience member, she asked the lead Clinical Consultant for Diabetes Technology why the Aidex was being made available when there were significant concerns in the T1D community about its accuracy. Dawn also referred those present at the meeting to a campaign about CGM accuracy by John Pemberton, a Paediatric Diabetes Dietitian who also lives with Type 1 diabetes.
Diabetes research feedback on Aidex
FIND, the global alliance for diagnostics that aims to ensure equitable access to reliable diagnosis around the world, has similar concerns. They are currently engaging in research to generate supporting evidence for the use of CGMs across low- and middle-income countries (LMICs). This is part of their Access to CGMs for Equity in Diabetes management (ACCEDE) project.
I had a discussion with Beatrice Vetter from FIND, who explained the conclusion to not include Aidex as a contender in the project. Based on their findings, the MARD was obtained in a misleading way. The trials of the Aidex CGM mostly included people living with Type 2 diabetes who are not insulin dependent, whose glucose levels are not as volatile as a person living with Type 1 diabetes.
Commentary from Homemed, AiDEX Distributors in South Africa
The AiDEX Distributors in South Africa, Homemed, have commented that there is some critique on the methodology used in FIND’s publication. The AiDEX company sponsored study showed a vastly different MARD of 9.08% within a population of 11.3% Type 1 and 88.7% of people living with Type 2 diabetes on insulin.
From a research perspective, Homemed confirm that it would have been scientifically invaluable to include all potentially available devices to critically assess the efficacy and safety of the devices for their clients living with diabetes in South Africa. Homemed states that this data would arm our healthcare providers with robust evidence, rather than hearsay.
Conclusion
While we welcome new and cheaper alternatives to Continuous Glucose Monitoring in South Africa, we are equally concerned about the accuracy of certain products coming into the market. An inaccurate sensor can mean the difference between treating a hypo and needing emergency attention.
Every person living with diabetes has the right to use any medication and technology that they feel is right for them. However, we would like to share our concerns and make sure that anyone that is testing out new technologies is equipped with all the information they need to make an informed choice when it comes to diabetes technology.
If you’re interested in finding out more about Aidex accuracy, here are some further articles to read:
Investigating the accuracy and safety data behind CGM devices in the UK
Performance Assessment of Three Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes
Why Aidex shouldn’t be on a Formulary. Anywhere. | Diabettech - Diabetes and Technology
Pemberton et al. CGM accuracy: Contrasting CE marking with the governmental controls of the USA (FDA) and Australia (TGA): A narrative review. Diabetes Obes Metab. 2023;25:916–939, Dec 2022. (https://dagensdiabetes.se/index.php/alla-senaste-nyheter/4018-cgm-accuracy-a-review-diab-obesitas-metab)
Linong Ji et al. Multicenter Evaluation Study Comparing a New Factory-Calibrated Real-Time Continuous Glucose Monitoring System to Existing Flash Glucose Monitoring System. Journal of Diabetes Science and Technology 1–6, 2021 (https://glucorxaidex.com/wp-content/uploads/2022/05/clinical-study.pdf)
Community feedback on the AiDEX CGM device:
“Fantastic product and local rep was extremely helpful. I've used freestyle libres and dexcoms previously. Did everything like Dexcom. Used 6 Aidex so far.” - Chris Macdonald
“I am waiting for my new Aidex sensors to arrive. Overall I had a great experience. And the accuracy which I compared to my machine was on point..for me personally I think it is worth a second try…” - Lesinda Smi
“Freely available is nice, lately people want to see how food effects there blood sugar. If you buy it voluntary and it fail or whatever I guess that is a calculated risk you take. Then with our experience with both Dexcom G6 and Libre 3, none of these cgm's are flawless, in fact I do more finger pricks then before we start using a cgm. Why I am keep paying for cgm's is the ability to see TRENDS. I can see blood sugar is trending up, I can see blood sugar is trending down and pay attention. So I don't think it is all just bad. If a blood sugar trends or spikes for ex to finger prick 6.5 and sensor is reading 8.9....the beauty is that I can take action in time to prevent the 8.5. If desperate one finds a strategy to make a cgm works for you. We know we can't make decision based on the cgm reading alone, we need to verify first.” - Emily Steyn
