The central design problem in all-in-one diabetes patches is whether a glucose sensor placed next to an insulin delivery site can still read accurately right after a bolus. Data from the SMART02 feasibility study, presented at EASD 2026 in Milan, put a number on that interference: with doses under 10 units, temporary signal disruption was uncommon, but at 10 units or more the probability rose to 20 to 25 percent. The sensor signal recovered on average within 20 minutes. For a device meant to replace a separate pump and CGM, that recovery window is the clinical variable worth watching.
SMART02 tested an early prototype of niia signature, an investigational wearable patch that SiBionics and PharmaSens have been jointly developing since announcing their collaboration in June 2025. The device aims to fold continuous glucose monitoring, insulin delivery, and an automated glucose control algorithm into a single patch. Ahmad Haidar, who developed the algorithm, presented the feasibility data at the SiBionics industry symposium alongside findings on the PharmaSens niia pump and SiBionics sensor performing consistently when the algorithm ran alongside both hardware components. The existing AID market already includes approved closed-loop systems such as the Medtronic MiniMed 780G, cleared by the FDA in April 2023, and the Tandem t:slim X2 with Control-IQ, but all require separate pump and sensor components worn on different sites.
The EASD presentation sat inside a broader exhibition SiBionics structured around three themes: sensing beyond glucose (including ketone and combined monitoring), moving from multimodal insight to active intervention, and longer-horizon biosensing applications. Prof. Andrej Janež addressed continuous ketone monitoring specifically in the context of GLP-1 receptor agonist use, a clinically timely question given how widely that drug class is now prescribed. Prof. Karolina Kędzierska-Kapuza covered CGM in type 3c diabetes, a population that does not fit neatly into standard type 1 or type 2 management frameworks. PharmaSens had previously run a first-in-human feasibility study pairing its niia essential basal-bolus pump with an integrated glucose sensor, giving the partnership a foundation in human data before SMART02.
niia signature has no regulatory approval or clearance in any market. The 20-minute interference recovery window is the concrete metric that future studies will need to address: an automated algorithm making dosing decisions on sensor data has little tolerance for gaps that length.
SMART02: the facts in one place
- Also written: niia signature
- Sponsor: PharmaSens and SiBionics
- Mechanism: Integrated continuous glucose monitoring, insulin delivery, and automated glucose control algorithm in a single wearable patch
- Indication studied: Integrated glucose sensing and insulin delivery for automated insulin delivery (AID)
- Phase: Feasibility study
- Primary endpoint: Accurate glucose measurement performance despite insulin delivery in close proximity to the sensor
- Headline result: Temporary interference after an insulin bolus was uncommon, primarily occurring with doses of 10 units or more (20-25% probability); sensor signal typically recovered within approximately 20 minutes
- Registry identifier: not publicly listed
- Current status: Feasibility study completed; results presented at EASD 2026 on October 4, 2026
- Collaboration announcement: June 2025
- EASD 2026 presentation: October 4, 2026
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
