PharmaSens is developing Niia Essential, an all-in-one insulin pump and continuous glucose monitor (CGM), and has recently completed its first successful feasibility study. The trial demonstrated proof of concept, strong performance and accuracy, and zero insulin delivery failures.
Niia Essential is the first of three planned iterations. PharmaSens is building an all-in-one patch pump that integrates an insulin pump and continuous glucose monitor into a single device. The Essential model features a basal-bolus tubeless pump with a 3mL insulin reservoir, semi-reusable electronics, and a focus on ease of use. The device integrated a SynerG CGM sensor, developed by Pacific Diabetes Technologies, to deliver real-time glucose readings within the integrated patch.
The clinical trial was an early feasibility, single-arm study enrolling 18 adults with type 1 diabetes of at least six months duration. Participants wore the investigational device for up to 72 hours, which included mixed meal tests and a supervised free-living day. Glucose was managed using CGM, blood glucose monitoring, and manual insulin dosing. The main goal was to assess accuracy using MARD compared against yellow springs instrument (YSI), the gold standard for blood sugar measurement. Additional goals included looking at pump performance, insulin delivery failures, and how long the device lasted before stopping.
The PharmaSens investigational device achieved an overall MARD of 11.6% versus YSI across 594 data points from 17 devices. Error grid analysis placed 83% of readings in clinically accurate Zone A, with 100% of readings falling within the acceptable Zones A and B. No insulin delivery failures or adverse events were reported.
Looking ahead, PharmaSens plans to initiate a second feasibility study in Q2 2026, evaluating Niia Advance, the next generation model of its pump. In late 2025, PharmaSens announced a collaboration with SiBionics to support the development of its upcoming pump models which could be coming next.
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