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PharmaSens enrolls first patient in feasibility study for all-in-one automated insulin patch pump

June 3, 2026 By Sean Whooley

PharmaSens Niia Essential insulin patch pump
The Niia insulin patch pump. [Image from PharmaSens on LinkedIn]
PharmaSens said today that it enrolled the first patient in a clinical feasibility study of its all-in-one automated insulin patch pump system.

The all-in-one pump pairs the Niaa insulin patch pump with a continuous glucose monitor (CGM) made by SiBionics. The companies announced a collaboration aimed at developing the all-in-one solution last year. Their all-in-one wearable device would integrate insulin delivery and glucose sensing into a single, compact automated patch pump system.

Existing pump systems on the market that are similar — like the leading Insulet Omnipod platform.  — offer automated insulin delivery by pairing a pump with a CGM.

Today, PharmaSens said on LinkedIn that it enrolled the first patient in its SMART02 feasibility study in Toronto. Conducted with McGill University and ClinSurge Research, the study will include 40 participants evaluating the all-in-one pump.

“Because people with diabetes already manage hundreds of additional decisions every day, we believe technology should help reduce that burden, not add to it,” the company said on LinkedIn.

The launch of this study comes on the heels of positive data from the first clinical study evaluating the pump with the SynerG CGM. PharmaSens said its clinical feasibility study of Niia demonstrated for the first time ever that the combined offering is, in fact, feasible. It believes its device addresses the need for alternatives to multi-device diabetes management systems.

(PharmaSens CEO Marcel Both and SiBionics Chief Strategy Officer Patrick Nowlin provided insights into the pump in an interview with Drug Delivery Business News at ADA 2025. Read more here.)

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: PharmaSens

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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