Following years in development, Finnish medtech GlucoModicum has unveiled its needle-free glucose monitoring patch, designed as a temporary reader for people with Type 2 diabetes who do not need continuous, 24/7 coverage.
The Sofio system relies on magnetohydrodynamics, using magnetic forces to draw microsamples of the body’s interstitial fluid up out of the skin and into a more traditional electrochemical sensor.
The company said its approach will allow for single-day glucose monitoring sessions. The tech is aimed at tracking the immediate effects of dietary changes or new medication regimens, or simply periodic health checkups.
“Needle-free glucose monitoring has been one of the most elusive goals in diabetes management for over thirty years,” GlucoModicum CEO Jokke Mäki said in a statement. “Our [magnetohydrodynamic]-based approach takes a different route, enabling accurate glucose measurement without needles while relying on the established biosensing chemistry used in clinical devices.”
Sofio includes a rechargeable transmitter designed to last up to two years, plus daily swappable sensors. Formerly known as Talisman, the system’s development has enrolled more than 2,000 clinical participants, according to the company.
Earlier this year, GlucoModicum posted study results that included people with Type 2 diabetes and healthy volunteers, with glucose tolerance tests demonstrating a mean absolute relative difference of 11.5%, shy of the industry benchmark of 10%. The company also said that version of the system used one-point calibration, while the sensor it is developing for commercialization aims to be calibration-free.
The Helsinki-based GlucoModicum said it plans to bring the device to Europe first and that it is working toward CE mark approval on the continent. Other regulatory and commercial updates—including its strategy for the FDA—are slated to be announced in the new year.
The company previously said it has begun setting up manufacturing lines for eventual mass sale, with ultimate production capacities of about 21 million sensors per year, following a planned start of about 100,000.
This past September, Biolinq received FDA clearance for its color-coded glucose sensor patch, billed as a needle-free option with an array of microsensors that are 20 times shallower than the filaments used by typical CGMs.
The company’s Shine system is also designed as an alternative to the wearable diabetes sensors that provide quantitative blood sugar measurements used to calculate insulin doses. Instead, the Shine system aims to provide an illustration of the user’s glucose ranges and trends for a view into metabolic health.