Current automated insulin delivery platforms — like those offered by Insulet, Tandem Diabetes Care, Medtronic, Beta Bionics and Sequel Med Tech — link separate devices. The pump itself is either tubeless and placed on the body, or worn on clothing with tubing delivering insulin to the body. They communicate with a CGM worn elsewhere on the body — typically the arm or the torso.
In the case of PharmaSens and SiBionics, all-in-one really means all-in-one. Combining pump and CGM into one device, the companies hope to bring a differentiated offering to the diabetes community.
Last week, the two companies announced plans to develop the next-generation Niia Signature insulin patch pump. The all-in-one wearable device would integrate insulin delivery from Switzerland-based PharmaSens and glucose sensing from China-based SiBionics into a single, compact automated patch pump system.
The companies have worked fast, starting in November, to try and get the pump system moving. Speaking to Drug Delivery Business News at the American Diabetes Association’s 85th Scientific Sessions in Chicago, PharmaSens CEO Marcel Both and SiBionics Chief Strategy Officer Patrick Nowlin explained the aim of the two companies in providing this new technology to the diabetes community.
“We worked fast. That’s what this collaboration needs to be,” said Both. “Because we want to be the first. We are going to be the first with an all-in-one device in the market.”
What is the pump?
PharmaSens develops the Niia Essential insulin patch pump system. The basal-bolus patch pump aimed to combine the ease of an insulin pen with the advantages of a sophisticated pump. The company submitted the pump to the FDA at the end of 2023 but elected to withdraw that submission as it advances the new Niia Signature pump.
The waterproof pump features one reusable component and a disposable component. PharmaSens’ pump cover holds a user interface with an LED display, buzzer and buttons on one side. On the internal side, it features a battery, a drive and the electronics necessary to operate the pump.
Niia Signature then has a disposable sterile device that holds a 3 mL insulin reservoir. It takes both vials and prefilled cartridges through a reusable filling aid and a single-use transfer needle. Both said it’s the same process you’d use for a syringe. The device uses a fixed needle behind needle guards — it doesn’t shoot the needle into the subcutaneous tissue.
Once filled, it attaches to the pump cover and primes for approximately 50 seconds. Once primed, it’s ready for placement on the body with an adhesive. The user presses three buttons at once to bring back the needle guard and allow the fixed needle to enter the body.
With the SiBionics sensor included in the device, the two needles — one for glucose measurement, the other for insulin delivery — sit right next to each other.
What is the CGM
SiBionics’ current market CGM offering is the GS3 CGM. The company unveiled its CE-marked GS3 earlier this year. It touts the ultra-compact device as the world’s thinnest CGM at the size of a small coin.
GS3 features an ultra-compact design and three-second activation. With a thickness of just 2.9 mm, China-based SiBionics compares its size to that of a small coin. It also weighs just 1.5 grams, which the company says makes it “almost unnoticeable when worn.”
That also made it useful for the purpose of fitting it within the PharmaSens pump.
Nowlin explained that the all-in-one pump uses a slightly modified version of the GS3, but one that required no change in size. The only modification came in the form of membrane technologies to reduce interference between the adjacent needles.
“What we’ve had to modify is literally the coating on this teeny, tiny little sensor,” Nowlin said. “You have to use a very different chemistry on that sensor for it to be able to prevent all of the interference. It’s how it allows the glucose to get in but other molecules don’t get in.”
Both explained that PharmaSens tested CGM technology from a number of different companies, but SiBionics stood out in terms of its CGMs recovery ability after coming into contact with the insulin delivered by the pump when compared to other options.
“Obviously being located [next to the insulin needle], you’re going to have interference,” Nowlin said. “With the testing that PharmaSens did, I think what it really made them decide to go with us is the recovery. It’s almost 100% recovery in the function of the CGM after being inundated with the insulin at extremely high levels.”
What comes next for PharmaSens and SiBionics
At the moment, PharmaSens is producing its Niia pump to continuously test and improve the quality as it works on the integration. It already has features like Bluetooth connectivity and remote control available with the existing pump.
The company remains without an automated insulin delivery (AID) algorithm at the moment, but that should be taken care of soon. Both said the companies are in contact with four different potential partners for algorithms and should decide in the coming weeks.
He added that the company envisions bringing the all-in-one device to the U.S. But, first, the company intends to seek CE mark for its remote-controlled pump, making it the second brought to Europe. Then, PharmaSens and SiBionics plan to bring the automated pump to the U.S.
“The next step is now,” Both said. “We are going to connect this system here with a smartphone so we have remote control and additional features. Then, we integrate the sensor technology. … We will have not only the sensor technology but the algorithm and the electronics as well. So, we’ll have a complete AID system with a pump and CGM.”
