Wearable Patch Prototype Advances Toward Integrated Automated Insulin Delivery

Diabetes management requires individualized care, reliable glucose and ketone monitoring, and timely intervention. For automated insulin delivery, a key challenge is maintaining accurate glucose measurements when insulin is delivered near the sensor. A new investigational wearable patch is now being evaluated to combine continuous glucose monitoring, insulin delivery, and automated glucose control in one device.

The device, niia signature, is an investigational wearable patch jointly developed by PharmaSens and SiBionics following their collaboration announced in June 2025. It is designed to combine continuous glucose monitoring, insulin delivery, and an automated glucose control algorithm in a single wearable system, with the goal of reducing the burden of managing separate devices for automated insulin delivery.

At the 2026 Annual Meeting of the European Association for the Study of Diabetes (EASD 2026), SiBionics presented its “See More, Act Earlier” concept through three exhibition chapters linking continuous sensing with future diabetes care. The concept was further explored during the SiBionics industry symposium, “From Sensors to Integrated Care: Emerging Technologies Shaping the Future of Diabetes Management,” where researchers presented initial findings from the SMART02 feasibility study evaluating an early prototype of niia signature.

The study examined whether glucose measurement performance could be maintained when insulin was delivered close to the sensor. In the second part of the study, the prototype was also evaluated together with the automated glucose control algorithm, providing an early assessment of the integrated system.

Temporary interference following a bolus was uncommon overall and occurred mainly with doses of 10 units or more, where the probability ranged from 20% to 25%. When interference occurred, the sensor signal fully recovered on average within approximately 20 minutes after bolus delivery. The PharmaSens niia patch pump, SiBionics sensor, and automated glucose control algorithm otherwise performed consistently throughout the study.

The findings represent an early development milestone for the integrated system, although further research is needed to confirm its performance, evaluate longer-term use, and determine its potential clinical role. niia signature remains investigational, has not been approved or cleared in any market, and is not available for sale.

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