PharmaSens' All-In-One Tubeless Insulin Pump & CGM

A new era of insulin delivery is on board with Niia, an innovative tubeless insulin pump under development by PharmaSens. The Swiss diabetes tech company is working on a lineup of three devices, including the world’s first all-in-one insulin pump and CGM system - a huge simplification for people with diabetes. I got to see two prototypes of this all-in-one device and it’s got me excited for what’s in store. First, let’s take a closer look at the Niia Essential, the first pump planned for release.

PharmaSens’ three iterations of Niia tubeless insulin pumps

The Niia Essential, PharmaSens' first insulin pump, is awaiting FDA 510(k) clearance and is designed to replace insulin pens for people who need basal and bolus insulin delivery. Unlike the Omnipod 5 or Tandem t:slim X2, this first pump does not yet integrate with a CGM or have closed-loop capabilities. The pump is tubeless and compact, with a 3mL insulin capacity, allowing for an extended wear time that PharmaSens hopes will last 3-7 days. 

The Niia pumps are semi-reusable. The electronic cover has a two-year lifespan, and the disposable patches and vial holders are replaced with each new infusion set. While bolus dosing is done directly from the pump, Bluetooth connectivity enables users to adjust settings and create treatment profiles via an app. 

@diabe_tech

An insulin pump and CGM all-in-one could is coming! #t1d #diabetes

A new device category: CGM & insulin pump all-in-one 

PharmaSens plans to expand its lineup with a second pump, the Niia Advanced, which will add external CGM connectivity with sensors like Dexcom or Libre. Its third pump, Niia Signature, promises a groundbreaking all-in-one insulin pump and CGM system. This would mean less room for error and more space in our cabinets and suitcases for anything other than diabetes supplies!

An all-in-one device would also mean users wouldn’t need to worry about loss of connection when swimming! Bluetooth does not work under water and this is how our phones  and diabetes devices connect to one another. On my current system, Omnipod + Dexcom G7, whenever I go under water, I lose connection for long periods of time. Niia Signature would not rely on Bluetooth for its CGM to speak with the pump – so cool!

At EASD in March, PharmaSens showed me two prototypes of the pump with varying CGM integrations. The prototypes were created in collaboration with a start up in Oregon called Pacific Diabetes Technology (PDT). 

The first prototype takes a two-strand approach, with separate cannula and sensor filaments. By separating the insulin infusion and CGM sensor, this design minimizes the risk of one component interfering with each other. This could be particularly useful in ensuring accurate glucose readings while insulin is being delivered.

The second prototype combines the two by encasing the steel cannula with an outer CGM sensor. The "sensor blanket" surrounding the steel needle is an interesting design choice, and while it might look more compact, it still faces the challenge of ensuring accurate sensor readings when insulin is delivered in the area. PDT put this interaction to the test. 

Its clinical studies indicate that insulin infusion can cause a temporary inaccuracy in CGM readings (for about 10-15 minutes) when boluses are 10 units or larger. Algorithms would need to account for these fluctuations in order for a device like this to provide automated insulin delivery.

So far, the testing of these pumps has placed the electronics for the CGM on the outside of the pump. One of the most critical next steps for PharmaSense is integrating the CGM electronics within the pump. 

PharmaSens may have the hardware down, but we all know that an integrated insulin pump is only as good as its algorithm. And an algorithm doesn’t currently exist. PharmaSens is actively looking for others to help develop the software and algorithm to power its system. It’s clear the road ahead will be a mix of hardware innovation and software development, but the potential for an integrated insulin delivery and glucose monitoring system is within reach – and I’m beyond excited about it!

The future of tubeless insulin pumps and combined tech

Whether PharmaSens’ all-in-one Niia sees the light of day or not – I expect it to push innovation and competition within the space. Perhaps Tandem will try to integrate a sensor in its upcoming tubeless pump, Sigi. Or, maybe Omnipod will update its pump to match Niia’s 3mL insulin capacity. Medtronic has already made clear it is working on a combined CGM and infusion set and it’s possible other pump companies are moving in that direction as well.

The big question – when will Niia come to market?

PharmaSens has made significant progress in bringing the Niia pumps to market. In November 2023, the company received the ISO 13485 certification, which is an internationally recognized standard for medical devices. This certification validates PharmaSens’ commitment to quality and compliance with regulatory standards. Following this, they submitted the Niia Essential for FDA approval in January 2024, and the device is currently under review.

The company is also preparing for a market launch and has engaged in trade sale discussions to ensure a successful market entry once FDA clearance is granted. CEO Marcel Both has stated that PharmaSens is committed to transforming diabetes care with its innovative technology, and they are ready to move forward quickly once they receive approval. I got the chance to sit and talk with the CEO and Head of Business Development on my podcast. Check it out below.

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