Glucose monitors sold as wellness gadgets put diabetics at risk, say experts

Medical specialists are warning that the booming CGM market lacks proper regulation, leaving patients vulnerable to devices that may not have been rigorously tested.

Kirsten de Klerk, co-founder of SA Diabetes Advocacy (Sada), said: “We have seen CGMs being promoted in the wellness world to track how food and lifestyle impact people’s glucose levels. But for people living with diabetes, they are more than just a tool to optimise their health, they are essential for survival. So they need to be accurate.”

Unlike traditional blood glucose meters, which must meet ISO standards, there are no formal accuracy standards for CGMs in South Africa.

“Many people assume that if a CGM is available on the market, it must be accurate, but that is not always true,” said Cathy Haldane, head of the non-communicable disease programme at the Foundation for Innovative New Diagnostics (Find).

“Not all CGM are tested in ways that reflect real-life use, especially for people who use insulin and experience fast-changing glucose level,” added Haldane.

For some families, the consequences have been severe.

Chantal dos Santos’ young son landed in ICU with diabetic ketoacidosis in January last year after their CGM consistently gave false readings. “When we raised our concerns with the distributors, we were made to feel as if the fault lay with us, not the device. That’s terrifying,” said Dos Santos.

Doctors say they rely on CGMs to make real-time decisions about insulin doses, but accuracy is non-negotiable.

“If a CGM isn’t reliable, it puts lives at risk,” said Dr Michelle Carrihill, a paediatric endocrinologist at Red Cross Children’s Hospital.

In response, Sada, Find, the Institute for Diabetes Technology and the Society for Endocrinology, Metabolism and Diabetes of South Africa are developing a new CGM accuracy checklist to help people with diabetes, healthcare providers and medical funders assess whether a CGM suitable for use, especially among those with insulin-dependent diabetes.

“While the checklist does not replace regulatory standards, it helps to fill the gap, providing interim guidance grounded in the best available evidence and developed with technical experts and the diabetes community,” said the experts.

Advocates stress that while more affordable CGMs are entering the market, affordability can never come at the expense of quality and safety.

“Some CGM devices have not been extensively tested, especially on people living with diabetes who are insulin dependent, so it’s impossible to tell if these devices are truly effective,” said De Klerk.

Experts say South Africa should adopt stricter standards similar to those used internationally. Until then, patients are being forced to question the very tools meant to save their lives.

Medical technology has the power to improve lives but only when it’s safe, reliable and tested correctly. In the case of CGMs, accuracy is not just a technical detail, it is a life-saving requirement.

“As the global regulatory landscape evolves, tools like the checklist help ensure that people have access to the best available information, even in the absence of binding international standards,” Haldane said.

TimesLIVE

Issued on TimesLIVE by Mmatumelo Lebjane | https://www.timeslive.co.za/lifestyle/2025-08-19-tl-6-am-glucose-monitors-sold-as-wellness-gadgets-put-diabetics-at-risk-say-experts/