Diabetes Technology Can Fail. That Is Why Safety, Transparency and Fair Access All Matter

Recent reporting by 60 Minutes, The Sydney Morning Herald and The Age, including the 60 Minutes investigation “Help That Harms”, raised legitimate concerns about medical-device safety. The accompanying article published by The Age and The Sydney Morning Herald provided important clinical context, including comments from leading diabetes experts about the benefits of modern diabetes technology. The television program, however, understandably focused much more heavily on distressing patient stories. That distinction matters because viewers and readers may leave with very different impressions. Australians deserve the fullest possible conversation about safety, regulation, risk and equitable access to beneficial diabetes technology.

Devices can fail. People deserve compassion, answers and action.

I have lived with Type 1 diabetes for 34 years. I remember managing it with injections and finger-prick checks alone. I now use continuous glucose monitoring (CGM) and automated insulin delivery (AID). I know both the benefits of this technology and the unease that comes when a device on which you depend does not behave as expected. This is not my first engagement with Nine on diabetes technology. I previously spoke to Nine News for a report broadcast in December 2025 about the benefits of technology and the need for fairer access.

The 60 Minutes program “Help That Harms” confronted viewers with distressing accounts of people harmed by medical devices. The program reported the experience of a woman who became paralysed following complications involving an implanted pain pump; a man who said he received excessive insulin during a clinical trial; and the family of a young driver who raised concerns about glucose alerts being muted through his vehicle’s Bluetooth system before a fatal crash. The precise contribution of the alert issue to the crash cannot be determined from the program alone, but the events described were distressing and the questions they raise are serious.

No number of adverse events should be dismissed as insignificant to the people and families affected. People harmed by medical devices deserve compassion, timely warnings, practical support, clear answers and transparent investigation.

The program also raised legitimate questions about how the Therapeutic Goods Administration assesses, approves and monitors medical devices in Australia. These are important questions that deserve proper public scrutiny, and they are not new within the diabetes community. The accompanying article by The Age also included important perspectives from endocrinologists and diabetes specialists who emphasised that continuous glucose monitors and automated insulin delivery systems remain life-changing technologies whose benefits overwhelmingly outweigh their limitations for many people living with Type 1 diabetes. That important context deserves recognition. My concern is that many people will remember the emotional impact of the television program more than the clinical context presented alongside it.

The broader picture is essential. Diabetes technology can be life-changing and, for many people, life-saving. It can also fail. People with diabetes deserve both fair access to beneficial technology and a regulatory system that responds quickly, transparently and compassionately when problems emerge. Safety, transparency and fair access must be pursued together.

Diabetes Australia has responded to the same reporting by emphasising that safety must come first, while also warning that public discussion focused only on risk may cause people to lose confidence in technologies that could improve their health. Its statement calls for rigorous regulation and monitoring, proper investigation of adverse events, balanced evidence-based information and individualised backup plans developed with healthcare professionals. Its concluding words provide a useful standard for this discussion: “Informed choice matters. Safety matters. Evidence matters.” In many respects, Diabetes Australia’s response closely reflects the balance found in The Age article. Both acknowledge genuine safety concerns while also recognising the substantial evidence supporting modern diabetes technology. That balance is essential because people living with diabetes should not be left believing these technologies are inherently unsafe simply because failures receive the greatest public attention.

Not all medical devices are the same

The 60 Minutes segment covered a range of devices: permanently implanted spinal pain pumps, externally worn insulin pumps, and continuous glucose monitors. The broad framing may lead viewers to conflate very different types of technology with very different risk profiles.

Unlike a surgically implanted device, an external Pod can generally be removed without surgery and managed through an established replacement or backup procedure. That does not make an insulin-delivery failure harmless. It means the devices have materially different designs, consequences and response pathways, distinctions that matter when evaluating risk.

Two separate Omnipod corrections in 2026

Two separate Omnipod corrections were issued in 2026, involving different defects, different lots and different geographical scope. It is important not to conflate them.

March 2026 — US correction (internal tubing): In March 2026, Insulet initiated a voluntary Medical Device Correction for specific lots of Omnipod 5 Pods in the United States, after identifying a manufacturing issue through ongoing product monitoring. The problem involved a possible small tear in the internal tubing that delivers insulin. If this occurred, insulin could leak inside the Pod rather than being fully infused into the body as intended. This correction concerned specified Omnipod 5 Pod lots distributed in the United States. It did not include Omnipod DASH. As of 17 April 2026, Insulet had reported 29 serious injuries and no deaths in connection with this issue. On 29 April 2026, the U.S. Food and Drug Administration confirmed that the action had been classified as a Class I recall, its most serious classification. Class I reflects the potential for serious consequences if an affected device is used; it does not mean every affected Pod failed or caused an injury.

May 2026 — Australian and international correction (external cannula): A separate correction was announced in Australia in May 2026. The Australian action affected specified lots of Omnipod 5 and Omnipod DASH Pods. The corresponding action in some other markets also covered certain legacy Omnipod System, sometimes called Eros, Pods. This defect involved a possible tear in the external cannula immediately above the skin, between the Pod and the point where the cannula enters the body. If this occurred, insulin could leak outside the Pod rather than being delivered into the body. As of 20 May 2026, Insulet had reported 24 serious adverse events globally in connection with this issue, including hospitalisation and diabetic ketoacidosis (DKA). No deaths and no serious adverse events in Australia had been reported at that date. On 2 July 2026, the FDA confirmed that the corresponding US action had been classified as a Class I recall. The Therapeutic Goods Administration was notified of the Australian action (recall reference RC-2026-RN-00389-1).

In both cases, the defects did not affect continuous glucose monitoring systems or CGM readings, though this does not remove the danger associated with interrupted insulin delivery. Insulet has stated that the causes have been identified and corrective actions implemented.

My personal experience of this issue was a very positive one. Insulet were quick to communicate directly, and addressed it with transparency, whereby I quickly checked my stash of Omnipod 5’s to confirm I was not impacted.

What the numbers can and cannot tell us

Medical-device surveillance relies on adverse-event reports. These reports are an essential early-warning system. They are not, by themselves, proof of causation.

An adverse-event report is a notification that an event occurred involving a device. It does not confirm that the device caused the event. It may include reports where the device was suspected but not confirmed, where other factors were involved, or where the event severity was reported differently by different sources. Public adverse-event databases may contain incomplete information, reports submitted at different stages of investigation and, in some circumstances, more than one report relating to the same underlying event. Conversely, some events may never be reported. These limitations prevent raw report counts from being treated as confirmed incidence rates. To interpret these reports responsibly, readers also need information such as the number of devices in use, the duration of exposure, the types and severity of the reported events, how possible duplicate reports were handled and whether a causal relationship was established.

When broad totals are quoted without showing the distribution of event types and severity, fundamentally different incidents may appear equivalent to readers. The TGA’s Database of Adverse Event Notifications (DAEN) itself states that “an assessment of the safety of a medical device cannot be made based on the information contained in the DAEN alone.”

Increased device use can result in more reports, but raw totals cannot show whether the underlying event rate has changed without reliable usage data. At the same time, under-reporting, delayed reporting and incomplete records mean the databases may not capture every incident. These limitations are precisely why reports must be investigated carefully rather than either sensationalised or dismissed.

For people who depend on these devices every hour of every day, stories of failure can trigger genuine fear and cause them to question technology they may have previously trusted.

Continuous glucose monitors and insulin pumps are different components

CGMs measure glucose, while insulin pumps deliver insulin. They may operate together as part of an automated insulin delivery system, but they remain separate components, often made by different manufacturers and subject to different failure modes. The two Omnipod corrections concerned insulin-delivery components and did not affect CGM readings. Identifying which component is involved is essential to interpreting a reported incident accurately.

Every technology should be judged against the alternative

Investigative journalism plays an important role in exposing failures in medical devices and regulation. But people living with Type 1 diabetes face a different question every day: compared with what?

The relevant comparison is not between diabetes technology and perfect safety. It is between diabetes technology and managing a complex, lifelong condition without that technology.

Readers should therefore ask two equally important questions:

• How many people have been harmed when diabetes technology failed?
• How many episodes of severe hypoglycaemia, diabetic ketoacidosis, hospital admissions and long-term complications have these same technologies helped prevent?

The first question was explored in detail by the investigation. The second is just as important. Together they provide the fuller picture that people with diabetes, their families and the wider community deserve.

Living with Type 1 diabetes without technology also carries risk

This is not said to diminish device-related injuries. It is said because the comparison people with Type 1 diabetes face every day is not between technology and zero risk. The relevant alternative differs between individuals. It may be multiple daily injections, a non-automated pump, intermittent finger-prick monitoring or another combination of available tools. None of these options are risk-free.

Before CGM, I checked my blood glucose by pricking my finger. I could miss a low overnight. I could eat a meal and guess the carbohydrate content incorrectly. All of those decisions carried real risk. Before insulin pumps, I injected myself manually, calculating every dose, every hour, every day. That mental load contributes to the diabetes distress and burnout experienced by many people living with the condition.

Technology is not perfect. It can also create new burdens, including alarm fatigue, interrupted sleep, connectivity problems, data overload, skin reactions and anxiety when devices fail. The experience is not universally positive. Some people decide that a particular device is not right for them, and that choice should also be respected. For many people, however, the overall effect is a meaningful reduction in risk and mental load. None of this means people should ignore device failures or accept lower safety standards. Quite the opposite. The goal should be continual improvement so that future generations benefit from technologies that are even safer, more reliable and easier to use. Better regulation and innovation should work together, not compete with one another.

For people who can access and use them, CGM and automated insulin delivery can improve overnight safety, reduce the number of relentless manual decisions, give families greater peace of mind, provide earlier warning of glucose changes, and support greater freedom in everyday life. These benefits are reflected in lived experience, peer-reviewed research and the 2024 Australian consensus statement on automated insulin delivery.

Automated insulin delivery systems remain hybrid systems. They require user input, active monitoring, training and contingency planning. They are not fully autonomous, infallible or a cure.

Access is a safety and equity issue

Australia subsidises continuous glucose monitoring through the National Diabetes Services Scheme for people with Type 1 diabetes. It also subsidises pump consumables. But it lacks a broad national affordability pathway for the pump hardware itself, particularly for adults. Pump hardware commonly costs between $7,000 and $10,000 and requires replacement every four years. Without subsidy, access depends on private health insurance or personal income. Ironically, the same technologies highlighted because they can occasionally fail remain financially out of reach for thousands of Australians who could benefit from them. Improving device safety and improving access are complementary goals. Australia should pursue both.

Although the pump-subsidy proposal discussed here focuses on people with Type 1 diabetes, access barriers also affect some people with Type 2 diabetes and other forms of diabetes who use insulin or could benefit from continuous glucose monitoring. Fair access policy should be guided by evidence, clinical need and lived burden, while recognising that the eligibility criteria and technology needs of different groups may not be identical.

The diabetes sector, including major Australian organisations, has published a manufacturer-neutral proposal to subsidise pump hardware for 38,000 priority Australians between 2027 and 2030. The immediate policy request is for the Australian Government to undertake a formal, time-bound assessment of that proposal, publish the assessment process and include people with lived experience in its consideration.

Access to diabetes technology should reflect clinical need and lived burden, not wealth, age, postcode or private health insurance. That is a safety argument as much as an equity one.

Read the full advocacy brief including economic modelling →

My own involvement with Nine News

In December 2025, I provided lived-experience input to a Nine News report about the benefits of modern diabetes technology and the case for fairer access. I explained how these tools can improve safety, reduce some of the relentless mental burden of Type 1 diabetes and give families greater peace of mind. I also argued that access should be based on clinical need, not income or private health insurance. I remain grateful that Nine gave those benefits and access barriers public attention.

My response is not intended as a criticism of investigative journalism or of the important work undertaken by The Age, The Sydney Morning Herald and 60 Minutes in examining medical-device safety. Public scrutiny is essential. Rather, it is an argument that discussions about diabetes technology should include both the risks when devices fail and the substantial evidence demonstrating the benefits these technologies provide when they work as intended.

People who report device failures should be listened to respectfully and should not be treated as opponents of diabetes technology. Their experiences are essential to making that technology safer for everyone.

What reasonable regulation looks like

People with diabetes and the broader community are entitled to expect:

• More proactive post-market surveillance capable of identifying and investigating emerging safety signals early.
• Faster safety communications when problems are identified, written in plain language that patients and families can act on.
• Accessible recall information that makes it simple to check whether your device is affected and what to do next.
• Clear public explanations of the evidence relied upon when higher-risk devices are approved, including any material limitations or reliance on overseas certification.
• Stronger human-factors and interoperability requirements so that critical medical alerts are not unintentionally suppressed by phones, vehicles or other connected systems.
• Meaningful consumer support when devices fail, including clear pathways for reporting problems and receiving replacements or alternative therapy.
• Transparent regulatory decisions that the public can understand and have confidence in.
• Routine publication of de-identified safety trends, including the number of devices in use or another suitable denominator where available, so reporting patterns can be interpreted responsibly.
• Meaningful involvement of people with diabetes in regulatory reviews, safety communications and diabetes-technology policy.

These are reasonable expectations. They are not inconsistent with supporting access to beneficial technology. They are, in fact, essential to it.

The lesson is not that we should fear diabetes technology. It is that we need safer technology, better regulation and fairer access together.

People harmed by medical devices deserve acknowledgement, answers and meaningful support. People living with diabetes deserve clear recall information, stronger post-market surveillance and confidence that reported problems will be investigated transparently. They also deserve fair access to technology that, when it works as intended, can reduce risk and make an extraordinarily demanding condition more manageable.

If you use diabetes technology, check current recall advice, maintain an agreed backup plan and report suspected problems. If you regulate, fund or report on these technologies, present both the harms that can result when devices fail and the harms created when beneficial technology is inaccessible.

Better regulation and fairer access are complementary goals. Every person harmed by a medical device deserves answers, accountability and better safeguards. Every person who could benefit from diabetes technology also deserves a fair opportunity to access it. Australia should not have to choose between safer technology and broader access. We should insist on both.

The recent investigation has started an important national conversation. My hope is that the next stage of that conversation focuses not only on how we make diabetes technology safer, but also on how we ensure that every Australian who could benefit from these life-changing technologies has a realistic opportunity to access them, regardless of their financial circumstances.