PharmaSens Unveils Promising Data for All-in-One Diabetes Patch Pump

BIEL/BIENNE, Switzerland – April 10, 2026 – Swiss medical technology firm PharmaSens AG has announced a significant milestone in diabetes care, publishing data from a first-in-human study that demonstrates the feasibility of a single, wearable patch combining both continuous glucose monitoring (CGM) and insulin delivery. The findings, detailed in the Journal of Diabetes Science and Technology, suggest a future where the complex, multi-device systems currently used by people with diabetes could be replaced by a discreet, all-in-one solution.

The study evaluated an investigational version of the company's niia device, an insulin patch pump integrated with a glucose sensor. For millions living with the daily burden of managing diabetes, this development represents a potential paradigm shift, moving closer to a technology that, as PharmaSens CEO Marcel Both stated, "works quietly in the background and fits into everyday life."

The Quest for a Simplified System

For people with type 1 diabetes and many with intensive insulin-treated type 2 diabetes, modern management often involves a delicate and constant technological juggle. Automated Insulin Delivery (AID) systems, which connect an insulin pump to a separate CGM device via a smart algorithm, are now designated as the "preferred insulin delivery system" by the American Diabetes Association in its 2026 "Standards of Care." Clinical data shows these systems are superior to multiple daily injections in helping users maintain their blood glucose levels within a target range.

Despite this clinical endorsement, adoption remains strikingly low. Of the estimated 11 million intensive insulin users across Europe and the United States, only about 1.5 million—or 13%—are currently using an AID system. The barriers are significant and well-documented: the high cost of purchasing and maintaining multiple devices, persistent connectivity issues between pumps and sensors, and a steep learning curve that can be overwhelming for patients and caregivers alike. This "diabetes burden" involves not just the physical toll of wearing multiple devices, but also the mental load of managing them.

PharmaSens aims to directly address this gap. "This feasibility study shows that combining continuous glucose monitoring and insulin delivery into a single, discreet patch device is not only desirable, but achievable," said Both. The company's vision is to create a single-patch system that eliminates the need for separate devices, potentially reducing complexity, improving reliability, and making the benefits of advanced diabetes therapy accessible to a much broader population.

A First Look at Clinical Feasibility

The data published today provides the first concrete evidence supporting this vision. The early feasibility study, led by Professor David O’Neal at St. Vincent’s Hospital Melbourne, enrolled 18 adults with type 1 diabetes. Participants wore the investigational device—a PharmaSens niia insulin pump integrated with a SynerG™ glucose sensor—for up to 72 hours.

The primary goal was to assess the accuracy of the combined device. The results showed a Mean Absolute Relative Difference (MARD) of 11.6% when compared to a highly accurate laboratory glucose analyzer. MARD is the standard metric for CGM accuracy, with lower numbers indicating better performance. While today's leading standalone CGM systems often aim for MARD values under 10% in pivotal trials, the 11.6% figure is considered highly encouraging for a first-in-human feasibility study of a novel integrated technology.

Furthermore, an error grid analysis, which evaluates the clinical significance of any inaccuracies, found that 100% of the readings fell within clinically acceptable zones, with 83% being in the most accurate zone. Crucially, the study reported no insulin delivery failures and no device-related adverse events, demonstrating the fundamental safety and reliability of the pump's performance during the trial.

"The PharmaSens niia insulin pump offers an excellent platform by which insulin delivery and CGM may be combined, and this study has demonstrated the feasibility of such an approach," said Professor O'Neal, the study's principal investigator. He noted that a successful all-in-one device "could substantially reduce the physical and psychological burden of managing diabetes, while also lowering the cost and environmental impact."

Charting a Course in a Crowded Market

PharmaSens is entering a competitive landscape dominated by established giants like Insulet, Medtronic, and Tandem Diabetes Care. These companies have pioneered the AID market with systems like the Omnipod 5, MiniMed 780G, and t:slim X2 with Control-IQ, respectively. However, a key distinction remains: all current commercially available AID systems require users to wear and manage at least two separate devices—a pump and a CGM sensor—which must communicate wirelessly.

This is where PharmaSens sees its disruptive potential. By engineering a truly integrated device with a single insertion site and no external communication required between sensor and pump, the company could leapfrog the current generation of technology. This approach could appeal not only to existing pump users frustrated with multi-device complexity but also to the vast, untapped market of people on multiple daily injections who have been hesitant to adopt pump therapy due to its perceived burden.

The company's strategy appears to be multi-pronged, with a portfolio of niia devices planned. The niia Essential, a standalone basal-bolus patch pump, is already under FDA review. This will be followed by an niia Advanced model with external CGM connectivity, and ultimately the niia Signature, the fully integrated all-in-one system. This phased approach could allow the company to build a market presence while perfecting its most ambitious technology.

The Long Road from Lab to Patient

While the feasibility data is a promising first step, the journey to a commercially available all-in-one device is long and rigorous. The initial study used a sensor from Pacific Diabetes Technologies, but PharmaSens has already pivoted for its next phase. The company plans to initiate a second, more advanced feasibility study in the second quarter of 2026, this time integrating its pump with advanced CGM technology from SiBionics, a partner announced in mid-2025.

This next study will be a critical step in refining the technology and gathering more extensive data. Beyond that, the device will need to navigate the stringent regulatory pathways of the FDA in the U.S. and equivalent bodies in Europe. Approval will require larger, pivotal clinical trials to definitively prove the device's safety, accuracy, and efficacy over longer periods and in more diverse patient populations.

Robert Gabbay, MD, PhD, a PharmaSens advisor and former chief scientific and medical officer for the American Diabetes Association, highlighted the importance of this work. "PharmaSens is committed to developing an all-in-one insulin therapy system that reduces the daily burden of diabetes and empowers insulin users to achieve better glycemic control," he stated. "This type of innovation has the potential to fundamentally reshape and improve how diabetes is managed in everyday life." For the millions waiting for a simpler solution, this first glimpse of a truly integrated future offers a powerful dose of hope.