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SiBionics PharmaSens: The Race to a Single-Patch Artificial Pancreas
At EASD 2026 in Milan, the SiBionics PharmaSens partnership presented the first data from SMART02, a feasibility study of an investigational device that combines glucose sensing, insulin delivery and a control algorithm in a single wearable patch. The device, called niia signature, is designed to replace the separate sensor, pump and controller that automated insulin delivery (AID) currently requires. The pitch is one patch instead of three devices.
It is a genuine engineering milestone. It is also early — and the road to a product is long.
What the SiBionics PharmaSens patch is
The device is being developed by PharmaSens, a Swiss insulin-pump maker, and SiBionics, a Chinese continuous glucose monitoring (CGM) company, under a collaboration announced in June 2025.
The idea is integration. Standard AID systems combine an insulin pump, a separate CGM and a dosing algorithm — three things to wear, charge and manage. niia signature aims to put all three in one patch. Patented technology lets the device both measure glucose and deliver insulin from the same site.
The platform is semi-reusable. A reusable part carrying the pump and CGM electronics lasts about two years; a disposable part holds a 3ml insulin reservoir. That design is meant to cut both cost and waste.
The problem they had to solve
Combining the sensor and the insulin delivery in one patch creates a specific engineering problem: insulin delivered close to a glucose sensor can disturb the sensor’s readings.
SMART02 was built to measure that. The finding, as presented, was reassuring. Temporary interference after a bolus dose was uncommon overall. It occurred mainly at higher doses — 10 units or more — where the probability was 20% to 25%. On average, the sensor signal recovered fully about 20 minutes after the dose.
The study also tested the prototype with an automated glucose control algorithm developed by Prof. Ahmad Haidar. The pump, the sensor and the algorithm performed consistently together. That is the result that matters: it is one thing to combine hardware, and another to make the combination controllable.
The earlier evidence — and its limit
SMART02 is the second study. The first, published in the Journal of Diabetes Science and Technology in April 2026, tested an earlier version pairing the PharmaSens niia essential pump with a sensor from Pacific Diabetes Technologies.
That study enrolled 18 adults with type 1 diabetes. Accuracy, measured as MARD against a laboratory reference, was 11.6%. Error-grid analysis found 83% of readings clinically accurate, and 100% within the acceptable zones. There were no insulin delivery failures or adverse events.
The caveat is the number. A MARD below 10% is generally considered ideal for a CGM. At 11.6%, the earlier device was close but not there. The company calls that encouraging for an early feasibility study, which is fair — but it is not yet the accuracy a commercial product would need.
The two companies behind it
SiBionics is the sensor half. Founded in 2015 and headquartered in Shenzhen, it makes CGM systems and other biosensing products. Its GS1 sensor was China’s first calibration-free continuous glucose monitor, approved in 2021. The company says it serves more than 4 million users across 100-plus countries and works with over 4,000 medical institutions. Its newer GS3 sensor is billed as the world’s thinnest CGM.
PharmaSens is the delivery half. The Swiss company has spent years developing the niia patch-pump platform, which spans three devices: a simple basal-bolus pump, a smartphone-controlled version, and the integrated niia signature. Its engineering pedigree is in insulin pumps, not sensors — which is why the SiBionics partnership matters.
The SiBionics PharmaSens pairing is complementary: a sensor specialist and a pump specialist, each contributing the half the other lacks.
The race they are in
The context is a market moving fast toward integration. CGM-integrated pumps are the fastest-growing segment of a patch-pump market worth about US$1.36 billion in 2025, heading for US$2.23 billion by 2030.
The leaders are large. Insulet dominates tubeless AID with its Omnipod franchise. Medtronic’s spun-out MiniMed owns a full stack of CGM, pump and algorithm, with a patch pump and a closed-loop algorithm in development. Tandem competes with its t:slim X2.
Yet none of them has shipped a true single-patch device that does everything in one wearable. That is the gap. And it is a large one: among 11 million intensive insulin users in Europe and the United States, only about 13% use an AID system at all. A simpler, cheaper, single-patch option could widen that pool.
What to watch
Three markers will show whether niia signature becomes a product or stays a promising study.
First, the full SMART02 data. The release gives the interference findings but not the headline accuracy or time-in-range results. Those numbers will decide whether the next-generation device improved on the 11.6% MARD of the first study.
Second, the regulatory path. An investigational device is years from market. Watch for a pivotal trial and a filing.
Third, the majors’ response. Insulet, MiniMed and Tandem are all working toward simpler, more integrated systems. If a large player ships a single-patch device first, the advantage of being early evaporates.
SiBionics and PharmaSens have shown that the hardest part of a single-patch artificial pancreas is solvable. Turning that into a device people can wear is the harder part.
Editor’s Note
Sources: SiBionics‘ release of 4 October 2026 and the PharmaSens release of the June 2025 collaboration. The earlier clinical study’s design and results are from the Journal of Diabetes Science and Technology publication, as reported by PharmaSens and Drug Delivery Business News. SMART02’s design, sites and timeline are from PharmaSens and Drug Delivery Business News.
SiBionics’ company background and sensor specifications are from its corporate materials. Market data on patch pumps, CGM-integrated systems and automated insulin delivery is from independent market research and MedTech Dive. The SMART02 findings, the niia signature specifications and the development timeline are as stated by the companies; the device is investigational and not approved or cleared in any market, and TechRecast has not independently verified the clinical results.