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Omnipod 6 update: New trial results reveal Insulet's much bigger ambition

  • 6 min read

Insulet's latest Omnipod 6 announcements go beyond a smarter insulin pump. New clinical data and fresh insights into fully closed-loop technology reveal how the company hopes to reduce the daily burden of living with diabetes while raising important questions about automation, data and control.

When we first reported on Omnipod 6 earlier this year, Insulet had outlined its plans for a smarter next-generation insulin pump. Since then, the company has unveiled its first pivotal clinical trial results, shared more detail about how Omnipod 6 differs from Omnipod 5 and, perhaps most significantly, revealed just how ambitious its long-term vision for automated insulin delivery has become.

This article updates our previous Omnipod 6 coverage with the latest announcements from the American Diabetes Association (ADA) Scientific Sessions 2026 and Insulet's recent discussions about the future of automated insulin delivery ie. fully closed-loop technology.

If you missed our earlier coverage, you can read our original article on Insulet's plans for Omnipod 6 before catching up with the latest developments.

The first major Omnipod 6 trial results are now available

The biggest development since our previous article came during the ADA Scientific Sessions 2026, where Insulet presented results from its pivotal STRIVE study.

According to the company, Omnipod 6 met its primary safety and effectiveness endpoints in people with both type 1 diabetes and insulin-treated type 2 diabetes.

The updated algorithm was able to deliver up to 50 per cent more automated insulin when appropriate, allowing the system to respond more effectively to sustained high glucose levels while maintaining a reassuring safety profile. Insulet reported no increase in severe hypoglycaemia or diabetic ketoacidosis during the study.

Although the full peer-reviewed results are still to come, these are the strongest clinical data released so far and mark an important step towards regulatory approval.

Omnipod 6 is becoming clearer

When Omnipod 6 was first announced, Insulet described it as an evolution of Omnipod 5 rather than a completely new insulin pump.

Since then, we've learned considerably more about what that means in practice.

The company says Omnipod 6 will feature a more adaptive algorithm capable of learning each person's insulin requirements more quickly, allowing it to respond better to prolonged periods of high glucose with less need for manual intervention.

Insulet has also indicated that suitable users may be able to select a lower glucose target of around 5.6 mmol/L (100 mg/dL), compared with the current minimum target available on Omnipod 5.

Importantly, most users are unlikely to notice major changes to the Pod itself. The biggest advances are taking place in the software controlling insulin delivery rather than the hardware worn on the body.

Omnipod already works with FreeStyle Libre in the UK

For many people in the UK, the future described by Insulet has already begun.

The current Omnipod 5 system is available as a hybrid closed-loop (HCL) system that integrates with the FreeStyle Libre 2 Plus sensor, allowing the pump to automatically adjust basal insulin every five minutes based on glucose readings. It is also compatible with the Dexcom G7, giving people and diabetes teams a choice of CGM. 

In a hybrid closed-loop system, users still need to count carbohydrates and deliver meal boluses themselves. The automated algorithm takes care of background insulin, increasing, decreasing or temporarily pausing delivery to help keep glucose levels within range.

That makes Insulet's vision for Omnipod 6 particularly interesting. Rather than introducing hybrid closed-loop therapy for the first time, the company is focused on making that automation smarter and, ultimately, moving towards a future where far fewer manual decisions are required.

The real story isn't Omnipod 6

Perhaps the most interesting announcement this summer wasn't Omnipod 6 itself.

Instead, company executives spent much of their time discussing what comes next.

Speaking to the publication MedTech Dive, Insulet's Chief Medical Officer, Dr Trang Ly, described a future where automated insulin delivery goes well beyond today's hybrid closed-loop systems.

Current systems still rely on users entering carbohydrates before meals or delivering meal boluses manually. While insulin delivery is partly automated, people remain responsible for many of the daily decisions involved in diabetes management.

Insulet wants to change that.

What does fully closed-loop actually mean?

Dr Ly explained that the company's long-term ambition is a system that requires virtually no input from the person wearing it.

Instead of asking users to count carbohydrates, announce meals or programme insulin settings when starting pump therapy, future systems would use continuous glucose monitor (CGM) data to learn each person's insulin needs automatically.

The aim is to remove:

  • carbohydrate counting
  • meal announcements
  • manual bolus calculations
  • complex initial pump programming.

Rather than configuring detailed settings at the start, users would begin with the same basic starting point while the algorithm quickly adapts to their individual insulin requirements.

If successful, that could significantly reduce one of the biggest barriers preventing wider adoption of insulin pump therapy, particularly among people with type 2 diabetes.

Encouraging early results

Alongside Omnipod 6, Insulet also presented further data from its investigational fully closed-loop programme.

The latest EVOLUTION 3 feasibility study found adults with insulin-treated type 2 diabetes increased their average time in range from 51 per cent to 64 per cent while using the fully automated system.

Participants achieved these improvements without needing to count carbohydrates or deliver meal boluses themselves.

Researchers also reported lower average glucose levels without significant weight gain, supporting the larger EVOLVE pivotal study now underway.

What hasn't changed

While the evidence has moved forward considerably, the overall timeline remains broadly the same.

Omnipod 6 is still expected to launch during 2027, subject to regulatory approval.

Insulet's fully closed-loop system remains in clinical development and is currently targeting a launch around 2028, assuming ongoing studies continue to produce positive results.

A changing philosophy in diabetes technology

The developments around Omnipod 6 also highlight something bigger than a single product launch.

For decades, diabetes technology has largely focused on giving people more information. Blood glucose meters showed a glucose reading. CGMs added trends and alerts. Hybrid closed-loop systems began adjusting background insulin while still relying on people to make many of the important treatment decisions.

Insulet's vision points towards a different philosophy.

Rather than simply helping people make better decisions, the next generation of systems aims to remove many of those decisions altogether.

That represents one of the biggest shifts in diabetes technology since continuous glucose monitoring became mainstream.

Is reducing diabetes decisions always a good thing?

One of the biggest themes to emerge from this year's announcements isn't simply that insulin pumps are becoming smarter. It's that manufacturers increasingly want them to make decisions on our behalf.

For anyone living with diabetes, that raises an important question.

Living with diabetes means making hundreds of decisions every day, from calculating insulin doses and correcting highs to thinking about meals, exercise, illness and everyday routines. Reducing that mental workload has the potential to improve quality of life as much as glucose control itself.

But there is another side to the debate. As algorithms become more capable, how much control are we really comfortable handing over?

The potential benefits and concerns

Potential benefits Questions and concerns
Less decision fatigue. Reducing the constant mental effort of diabetes management could help lower stress and burnout. Will people lose confidence? If technology makes more decisions, will users feel less able to manage diabetes if technology isn't available?
Better overnight management. Algorithms never sleep and can respond continuously while users rest. Can algorithms understand real life? Exercise, illness, stress, alcohol and unusual meals don't always follow predictable patterns.
Improved accessibility. Simpler systems could make insulin pump therapy less intimidating for people who currently avoid it. Will users trust the system? Handing over meal decisions may feel uncomfortable for people who have managed diabetes themselves for decades.
More consistent glucose control. Automated systems may react faster than people can, particularly during busy days. What happens when something goes wrong? Sensors can fail, infusion sites can block and technology occasionally makes mistakes. Users still need the skills to recognise when intervention is needed.
Potentially better quality of life. Spending less time thinking about diabetes may free people to focus on everything else. Who is really in control? As automation increases, responsibility becomes less clear when decisions are made by software rather than people.

Beyond pumps: the next battle may be ecosystems

As insulin delivery becomes increasingly driven by software and algorithms, competition may shift from who makes the best pump to who builds the best ecosystem.

CGMs, insulin pumps, smartphone apps, cloud platforms and artificial intelligence are becoming increasingly interconnected. The algorithm is only one part of the experience. The data flowing into it, the devices that can connect to it and the choices available to users may become just as important.

That makes questions about interoperability, data ownership and user choice more relevant than ever. If future diabetes management depends on connected ecosystems, people living with diabetes should have confidence that they remain in control of both their treatment and the data that powers it.

We've explored that wider issue in It's our data. Yet medtech wants to own this too.

Editor's comment

The most interesting thing about this summer's announcements isn't simply that Omnipod 6 will be a smarter insulin pump. It's that they reveal where diabetes technology appears to be heading.

For years, innovation has centred on helping people make better decisions. The next phase appears to focus on reducing the number of decisions people need to make at all.

That could transform daily life for many people living with diabetes, particularly if it helps reduce decision fatigue without compromising safety.

But, perhaps the most successful automated systems of the future won't be those that make the most decisions - they'll be the ones that quietly reduce the burden while ensuring people remain informed, confident and ultimately in control of their own diabetes. I hope so!

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