Helsinki, Finland-based GlucoModicum said in a news release that the study helps put the company on “a clear path to commercialization.”
The study involved 646 participant visits, including individuals with type 2 diabetes and healthy volunteers. The company says it represents one of the largest clinical evaluations of its kind in the CGM industry. Participants used the company’s next-generation, needle-free CGM across both standard multi-hour glucose tolerance tests and ambulatory conditions involving exercise and meals.
All sensors used in the study featured GlucoModicum’s proprietary mass-manufacturing blueprint.
GlucoModicum reported a mean absolute relative difference (MARD, a measure of CGM accuracy) of 11.5%. This approaches the industry benchmark of 10% set by needle-based CGM, the company says. The study used different variations of the system as part of the optimization process. This recorded MARD corresponds to the best-performing system, which used one-point calibration. However, the company intends for its first product to be calibration-free.
The company now moves toward seeking CE mark for the CGM. It already reported multiple regulatory milestones this year, including an audit that serves as a foundation for the final stages of approval. Finland’s medicine’s agency also granted the company authorization to initiate a new clinical investigation to support CE mark and market entry.
“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,” said Jokke Mäki, GlucoModicum CEO. “We believe our technology has enormous potential to make continuous glucose monitoring accessible to millions more people worldwide.”
