\u201cIt nearly killed me,\u201d Cummins says of the device, which delivered insulin under the skin and is an alternative to injections. \u201cI was the worst I had ever been. I couldn\u2019t walk or talk for more than two hours.\u201d<\/p>\n
In the past decade, diabetes treatment \u2013 which long required finger-prick testing and insulin injections \u2013 has been revolutionised by automated insulin pumps such as the Omnipod and continuous glucose monitors (CGMs)<\/a>, which provide real-time glucose data on a patient\u2019s smartphone.<\/p>\n<\/p>\n \u201cThey have been life-changing,\u201d said Dr Ashley Ng, head of education and professional standards at the Australian Diabetes Educators Association. High-quality evidence<\/a> shows CGMs and insulin pumps<\/a> cut complications and improve blood-sugar control.<\/p>\n The rollout has also been accompanied by a dramatic increase in the number of adverse event reports linked to the devices.<\/p>\n The Therapeutic Goods Administration tracks these problems in a public database but does not release that data in aggregate, making it impossible for consumers to know which devices are linked to the most reports.<\/p>\n An investigation by this masthead<\/a> and 60 Minutes used automated website scrapers to crack open that database, extracting about 81,000 publicly available reports to reveal that diabetes management devices make up seven of the 10 devices with the most adverse-event reports submitted to the TGA since 2024.<\/p>\n They also hold five of the top 10 spots for reports of injury or death since 2024. The results highlight the tension between advancing technology and the adequacy of warnings and regulation.<\/p>\n<\/p>\n Many of the complaints focus on the devices\u2019 accuracy, alarm failures or difficulty connecting to readers or smartphones.<\/p>\n The TGA notes that an adverse event report, which can be submitted by a patient, health professional or any other member of the public, does not mean the device caused the event. Nor can such a report be used in isolation to assess the safety of a medical device.<\/p>\n Still, diabetes experts are concerned the TGA has eased the regulatory requirements for monitors, allowing a new generation of less-accurate devices to be sold here.<\/p>\n US regulators have also warned American patients that Bluetooth connections from smartphones or car stereos can mute crucial blood sugar alarms \u2013 a warning that Australian regulators did not pass on.<\/p>\n A Victorian coronial inquest<\/a> is investigating five deaths resulting from a high-profile car crash possibly linked to a CGM that failed to raise an alarm because of a Bluetooth issue.<\/p>\n Widely used in Australia<\/p>\n The Omnipod 5 insulin pump, which is partially subsidised by the federal government, is associated with 429 adverse-event reports, including 330 injuries, 283 cases of hyperglycaemia and six cases of diabetic ketoacidosis \u2013 a life-threatening complication typically requiring treatment in intensive care.<\/p>\n<\/p>\n Hundreds of deaths related to insulin pumps have been reported<\/a> in the US. Just before this story was published, some batches of the Omnipod 5 were recalled<\/a> in Australia over an insulin leaking issue associated with 24 serious events.<\/p>\n The five government-subsidised glucose monitors from Dexcom, Abbott and MiniMed are linked to 687 adverse-event reports, including 215 injuries and one death.<\/p>\n The device manufacturers pointed to the large number of Australians now using their technology to explain the number of incidents. More than 107,000 Australians are approved for monitor subsidy, the TGA said, and more than 146,000 people for insulin pumps.<\/p>\n The devices include warnings about smartphones or Bluetooth connections muting alarms, and instructions for patients to check their glucose levels with a finger-prick test if they suspect the reading is inaccurate.<\/p>\n \u201cOmnipod is supported by extensive clinical evidence and real-world experience across geographies demonstrating its safety, effectiveness and quality-of-life benefits for people with diabetes,\u201d a spokeswoman for the device\u2019s manufacturer, Insulet, said.<\/p>\n<\/p>\n Associate Professor Neale Cohen, director of clinical services at the Baker Heart and Diabetes Institute, is one of several leading experts who told this masthead all mainstream CGMs were reliable and accurate.<\/p>\n Professor David O\u2019Neal, director and founder of the Diabetes Technology Research Group at the University of Melbourne, said while the monitors were \u201cnot necessarily as accurate as some finger-prick meter, as a rule they are accurate enough, so that one can use them on their own without using a glucose meter to confirm the reading.\u201d<\/p>\n Insulet asked O\u2019Neal to speak to this masthead but has no commercial relationship with the academic.<\/p>\n In interviews with this masthead, many people with diabetes recounted highly inaccurate CGM measurements compared to finger-prick tests. Those concerns have also shown up repeatedly<\/a> in academic<\/a> surveys and systematic reviews<\/a>.<\/p>\n \u201cThey are deadly,\u201d says Yvette Petrie, who uses a CGM connected to an automatic insulin pump to manage her type 1 diabetes. \u201cIt was an absolute nightmare. When it was reading high \u2013 but I was only 13 mils, minimal \u2013 it was still dosing insulin. It could have overdosed me. I have told Dexcom a few times they are going to kill someone.\u201d<\/p>\n Bec Ritchie, a diabetes educator, registered nurse and founder of SEE Diabetes, which offers support and education for people with type 1 diabetes, said reports of inaccuracy \u201cdo not surprise me\u201d.<\/p>\n \u201cI have had many a client who has had significant issues and injuries from these devices,\u201d she said. \u201cThe key thing that I see most from clients is inaccuracy. And inaccuracy, when they are connected up to insulin pumps that are automatically delivering insulin, it can very easily over or under-insulin people and cause hypo or hyperglycemia, which is quite a risk.\u201d<\/p>\n \u2018It can be deadly\u2019<\/p>\n Tye Cummins, who struggled with the Omnipod pump, also ran into issues with Dexcom\u2019s G6 monitor. In 2024, a year after having his Omnipod pump removed, his Dexcom monitoring device showed that his sugars were elevated, even though he didn\u2019t have the telltale signs of thirst and lethargy. The 50-year-old injected himself with insulin to lower his glucose levels.<\/p>\n Something didn\u2019t feel right, so he decided to check his glucose using an old-school finger-prick test. He placed the drop of blood on a test strip and found his blood glucose was now dangerously low.<\/p>\n This meant the reading on the Dexcom G6 monitoring device had been wildly inaccurate. He had now lowered his glucose to such a level that he was at risk of seizures, coma or death.<\/p>\n \u201cIf this had happened when I was going to bed, I may have never woken up,\u201d the Geelong man said.<\/p>\n Cummins complained to the manufacturer, and said it told him the inaccuracy was probably caused by something he had done, such as taking painkillers.<\/p>\n \u201cYou put a fair bit of faith in these companies and devices,\u201d he said. \u201cThe advancements in diabetes are so good, but it is only easier until something goes wrong. Then it can be deadly, and that\u2019s my worry.\u201d<\/p>\n Amy Wright used Dexcom\u2019s G6 continuous glucose monitor for years without incident, before switching to the newer G7. \u201cIt\u2019s inaccurate, it disconnects. It is dangerous,\u201d she said.<\/p>\n<\/p>\n \u201cThe numbers were way out. I had the G6 on at the same time. There was a massive difference. And the G7 kept cutting out all the time. It kept saying it wasn\u2019t in range, even though my phone was next to me.\u201d Wright has started a petition<\/a> calling for Dexcom to stop phasing out the G6.<\/p>\n \u201cAn inaccurate CGM can lead to death. It can make your pump overdose you. If it\u2019s reading 12, but you\u2019re actually six, it might overdose you, and you end up with a hypo.\u201d<\/p>\n The accuracy of Dexcom\u2019s new G7, which won government subsidy in March 2025, is a major flashpoint among people with diabetes.<\/p>\n In that month, US regulators sent Dexcom a letter warning it was relying on data from the G6 to determine the G7\u2019s accuracy \u2013 and the G7 was using a new, unapproved component in sensors that internal Dexcom testing showed to be less accurate. The Food and Drug Administration\u2019s warning letter noted \u201csignificant variation in the clinical performance of sensors\u201d.<\/p>\n<\/p>\n \u201cThe larger inaccuracies in (the new) sensors cause higher risks for users who rely on the sensors to dose insulin or make other diabetes treatment decisions,\u201d it said.<\/p>\n That has caused consternation here.<\/p>\n \u201cI am definitely worried about that,\u201d said Dr Ng, from the Australian Diabetes Educators Association. \u201cIf I had the choice, I wouldn\u2019t go with the G7.\u201d<\/p>\n In a statement, Dexcom said it was working closely with US regulators to address the issues identified and had made \u201cmeaningful progress toward resolution\u201d. It noted US regulators had not demanded a recall of the G7.<\/p>\n \u201cThere is a large body of clinical evidence that demonstrates the use of Dexcom CGM leads to improved glycaemic control compared to the use of finger sticks,\u201d the company said. \u201cDexcom G7 has been recognised globally for its contributions to diabetes care.\u201d<\/p>\n The TGA issued a product correction last year for users of Dexcom\u2019s G6 receiver, warning it might fail to alert for high or low blood glucose or signal loss.<\/p>\n Some batches of another monitor, Abbott\u2019s FreeStyle Libre 3, which won access to an Australian government subsidy in December, were recalled by US regulators last year<\/a> due to sensor inaccuracies that caused 860 serious injuries and seven deaths.<\/p>\n The company said Australian customers were not affected by the issue. Its US parent said it had resolved<\/a> the problem and continued to produce the sensors.<\/p>\n How technology and warnings fail<\/p>\n Many modern CGMs can link to a smartphone to display real-time blood glucose levels and alarms. This combination of a life-saving medical device with a frequently updated smartphone has introduced a new weakness to the system.<\/p>\n The TGA and Dexcom have issued six product corrections for its app since 2025, for delays or failures to update glucose levels, alarms not going off and silent loss of connection.<\/p>\n Abbott\u2019s FreeStyle app had a similar issue in 2023, after a software update caused some Android phones to silently lose connection to their sensors, according to a TGA alert.<\/p>\n Antonia Watson, 40, from Melbourne, has had \u201cheaps and heaps\u201d of connection issues between her phone and FreeStyle Libre 2. \u201cIf I leave my phone on charge in the kitchen and walk 10 metres to the laundry, I have to come back and manually reconnect it. And if you put your phone on silent, you don\u2019t get the alarms.\u201d<\/p>\n And when the sensor worked, it was frequently inaccurate. \u201cHow many people are out there who are treating themselves for lows and highs that don\u2019t exist, and are sickening themselves in the process?\u201d<\/p>\n This link between CGMs and smartphones is also at the centre of a major coronial investigation.<\/p>\n In November 2023, William Swale suffered a severe low-blood-sugar attack and crashed his BMW into families dining in the beer garden outside the Royal Daylesford Hotel in Daylesford, Victoria, killing five people.<\/p>\n Swale was initially charged over the deaths, but a magistrate <\/a>struck out those charges in 2024 after finding his actions had been involuntary.<\/p>\n Swale, who has type 1 diabetes, wore an Abbott FreeStyle Libre 2 CGM on the day of the crash. It sent 10 low-blood-sugar alarms in the hour leading up to the crash, but Swale told the Coroners Court he never heard them<\/a>.<\/p>\n Following the fatal crash, Swale\u2019s doctor pointed him to a 2025 warning from US medical regulators<\/a> that connecting a phone linked to a CGM to a car Bluetooth can mute blood sugar alarms.<\/p>\n Australia\u2019s TGA has never passed on the American warning about car Bluetooth to patients in this country using CGMs, the regulator confirmed.<\/p>\n After police turned off his car at the crash scene, disabling the Bluetooth connection, they were able to hear the alarm beeping from his phone, Swale told the coroner.<\/p>\n Neither Swale nor his doctor knew about the issue before the crash.<\/p>\n \u201cI don\u2019t much know that anyone was aware that this failure of alarms was an issue,\u201d Swale\u2019s doctor, Matthew Cohen, told the coroner. \u201cWe\u2019re relying on low glucose alarms, and we weren\u2019t aware that these could be muted.\u201d <\/p>\n<\/p>\n Speaking generally to this masthead, Cohen described CGMs as \u201clife-changing, amazing pieces of equipment\u201d.<\/p>\n \u201cThe main issue people complain of is, like any technology, they occasionally fail. You can get a faulty batch, some that don\u2019t work. We tell people they are not 100 per cent accurate,\u201d he said. \u201cIt is better than a finger prick. But you can get false lows and false highs. None of these things are perfect, but they are so useful. The benefits are so overwhelming.\u201d<\/p>\n Related Article In a statement, the TGA defended not passing on the US regulator\u2019s warning about Bluetooth devices potentially muting CGM alarms.<\/p>\n The regulator said it \u201cpublishes device\u2011specific or general safety information about medical devices on its website where appropriate\u201d, and that was \u201cinformed by safety signals and any trends, including numbers of adverse event reports received from both overseas and the Australian market\u201d.<\/p>\n Yet the TGA has received some safety signals.<\/p>\n On December 23, 2024, a year after Swale\u2019s crash, the Australian regulator received an adverse-event report about a person potentially injured by a CGM: \u201cHypoglycaemia episode with no alarm due to Bluetooth issue\u201d. The device was the FreeStyle Libre 2, the same one Swale used.<\/p>\n And the regulator has received more than a dozen adverse-event reports about faulty connections between CGMs and smartphones, including a FreeStyle 2 patient who could not get glucose readings on their phone, leaving them unable to treat themselves. They \u201cexperienced a seizure and loss of consciousness\u201d.<\/p>\n In a statement, the manufacturer, Abbott, said the \u201cconnectivity of Libre sensors with smartphones may sometimes be impacted due to automatic operating system updates on smartphones.<\/p>\n \u201cWe recommend Libre users disable automatic operating system updates on any smartphone and wait to update to a new operating system until Libre mobile app compatibility is confirmed.\u201d<\/p>\n<\/p>\n It remains for the coroner to decide whether the CGM-Bluetooth issue played a role in the crash.<\/p>\n Endocrinologist Professor John Carter told the coroner Swale was probably aware he was hypoglycaemic in the lead-up to the crash, as he tried to buy food, but was turned away.<\/p>\n And if a CGM regularly alerts about high or low blood sugar, many patients can grow frustrated and turn it off or tweak the alarm level lower.<\/p>\n Professor Richard O\u2019Brien, dean of medicine at the University of Melbourne, told the coroner: \u201cI have many patients who have switched off their low-glucose alarm entirely because of frequent annoying alerts.\u201d<\/p>\n Continuous glucose monitors are most accurate when glucose levels are stable, and least accurate when they are changing quickly. But people with diabetes are prone to rapidly fluctuating glucose levels.<\/p>\n \u201cIt is crucial to subject CGM systems to those rapid glucose fluctuations during testing,\u201d said Dr Manuel Eichenlaub, a researcher at the Institute for Diabetes Technology in Germany.<\/p>\n \u201cUnfortunately, most manufacturers do not share this view and actively try to avoid rapid glucose changes during testing. This is because CGM accuracy tends to deteriorate during rapid glucose changes, which would worsen their claimed accuracy.\u201d<\/p>\n Eichenlaub published a paper last year<\/a> testing CGMs from Dexcom, Abbott and MiniMed in patients whose blood glucose was rapidly changing \u2013 the first evaluation not funded by the manufacturers.<\/p>\n He compared the devices to a gold-standard test for blood glucose, known as YSI, and two other commercial tests.<\/p>\n All three devices performed worse than in their key clinical trials.<\/p>\n \u201cThe [MiniMed] device shows systematically lower readings than the other two, and can absolutely have clinical consequences,\u201d said Eichenlaub. \u201cHowever, I should stress that CGM systems by established manufacturers \u2013 mainly Abbott\/Libre and Dexcom \u2013 are safe and have been a blessing for people living with diabetes.\u201d<\/p>\n MiniMed said Eichenlaub\u2019s claim was \u201cwithout merit\u201d, arguing the YSI data was similar across all three devices tested. \u201cMiniMed has complete confidence in the evidence built across 280+ independent, clinical and real-world studies across the globe, demonstrating consistent glycaemic outcomes in comparable patient populations.\u201d<\/p>\n Amid this complicated backdrop, the TGA in 2024 moved to lower the regulatory classification of CGMs from high to medium-risk devices.<\/p>\n New sensors, new concerns<\/p>\n Some diabetes experts are watching with alarm as new sensors with varying scientific evidence reach the market.<\/p>\n \u201cThere are many, many more coming onto the market that are really not reliable,\u201d said Associate Professor Neale Cohen, director of clinical services at the Baker Heart and Diabetes Institute. \u201cYou can get approval for these gadgets from the TGA, but it does not mean they are accurate.\u201d<\/p>\n![\"Tye](\"https:\/\/www.newsbeep.com\/au\/wp-content\/uploads\/2026\/07\/27874a20a1527433f60c133d13398c11b5a1c158.jpeg\")
Tye Cummins praises the advances in diabetes care, but worries about the consequences when devices malfunction.Jason South<\/p>\n![\"William](\"https:\/\/www.newsbeep.com\/au\/wp-content\/uploads\/2026\/07\/565d9f8edce4ba819963d69c5e2ebfa1241d630f.jpeg\")
William Swale (front), the Daylesford crash driver.Jason South<\/p>\n![\"Vicki](\"https:\/\/www.newsbeep.com\/au\/wp-content\/uploads\/2026\/07\/f64e6a9d9158430c3ffe1c2358f212e562410910330ae5adc226b079d45e7ed3.gif\")
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