GlucoModicum Reports Positive Clinical Results with its Needle-Free CGM and Advances Toward Market Launch
- Comprehensive clinical performance study encompassed 646 participant visits, including both Type 2 diabetic patients and healthy volunteers
- Magnetohydrodynamic (MHD) technology achieves 11.5% MARD in extensive clinical performance study using mass-manufactured devices, validating commercial-scale production capability
GlucoModicum, a health technology innovator focused on needle-free glucose monitoring, today announced positive results from its Clinical Performance Study (CPS), marking a milestone in the development of its needle-free continuous glucose monitor (CGM), placing the Company on a clear path to commercialization.
High clinical accuracy achieved, in a commercial-scale product
In Q1 2025, GlucoModicum completed a large Clinical Performance Study in accordance with the European Union In Vitro Diagnostic Regulation (IVDR). The study involved 646 participant visits, including both individuals with type 2 diabetes and healthy volunteers, representing one of the largest clinical evaluations of its kind in the continuous glucose monitoring (CGM) industry.
Participants in the study used GlucoModicum’s next-generation, needle-free CGM across both standard multi-hour glucose tolerance tests and ambulatory conditions involving exercise and meals. All the sensors used in the study were produced using GlucoModicum’s proprietary mass-manufacturing blueprint.
The study demonstrated a Mean Absolute Relative Difference (MARD) of 11.5%*, approaching the industry benchmark of 10% set by leading needle-based CGM systems. The full study results (ID: 2023/00915/FIMEA/K485) will be reported to Finland’s medicines agency, FIMEA, as a part of the regulatory process, anticipated in 2H 2025.
Jokke Mäki, CEO of GlucoModicum commented: “GlucoModicum has solved the technical and manufacturing challenges that have long held back needle-free CGMs and done so at low cost, putting us at the forefront of the field and within reach of delivering the world’s first truly needle-free continuous glucose monitoring solution.
“To the best of our knowledge, no other needle-free technology designed for use in the general diabetic population has passed beyond early lab-stage concepts (TRL 3), GlucoModicum is entering TRL 8 – the final stage before market launch**. We believe our technology has enormous potential to make continuous glucose monitoring accessible to millions more people worldwide.”
Key Regulatory Milestones Reached ahead of CE Marking
These positive results from the clinical studies follow key regulatory milestones GlucoModicum has achieved:
- In Q1 2025, GlucoModicum successfully completed an ISO 13485 audit conducted by Eurofins Electric & Electronics Finland, which is designated by European Commission as a Notified Body according to the Medical Device Regulation (MDR). The audit concluded with zero non-conformities and zero deviations, establishing a strong foundation for the final stages of the regulatory approval process. This Notified Body is expected to oversee GlucoModicum’s CE marking process.
- In Q2 2025 Finland’s medicines agency, FIMEA, granted GlucoModicum authorization to initiate a new clinical investigation under Article 62 of the EU MDR (2017/745), enabling GlucoModicum to generate clinical data about the device’s safety and performance as required for CE marking and market entry.
MARD (Mean Absolute Relative Difference) measures the average difference between a device measurement (or test result) and the reference measurement at normal to high glucose levels. The lower the MARD, the better the agreement between the device and the reference/comparator measurement. A MARD of 10% is considered excellent for current needle-based systems.
