French bio-wearables developer PKvitality has begun a clinical study to determine the accuracy of, what the company describes as, the world’s first continuous glucose monitoring (CGM) smartwatch.
The trial of the K’Watch Glucose CGM device is to be run in conjunction with the AMCR Institute Inc, a clinical research centre focused on diabetes and obesity with worldwide renown medical device expertise in the metabolic area. The K’Watch Glucose will be the first wearable smartwatch medical device that measures and displays glucose level continuously, effortlessly, and painlessly.
The research undertaken by PKvitality, will be partly financed through the European Commission through the EIC (European Innovation Council) fund, aims to support the rising number of people living with diabetes, which is estimated to rise to 700 million globally by 2045.
Luc Piérart, CEO of PKvitality, said: “PKvitality is a unique blend of Consumer Electronic and Medtech expertise, bringing the best of both worlds: appealing product, ease of use at the service of the diabetes patients. Since 2017, we conducted thousands of interviews with patients, thousands of in vitro tests to improve the product accuracy. The excellent results enable us to enter clinical trial, a major step towards product availability. This study will confirm the precision and patient-friendly experience of using K’Watch Glucose.”
K’Watch will be the first Continuous Glucose Monitor in the form of a smartwatch. It is composed of two parts: K’Watch, the smartwatch and K’apsul, an adhesive patch at the back. It will enable a continuous monitoring of systemic glucose levels anytime and anywhere. This is possible thanks to SkinTaste, a patented biosensor array that uses micropoints (<1mm long) in order to analyze chemical compositions of the interstitial fluid. Completely painless and invisible to others, the diabetes patient will be able to check its level discreetly or follow its average glucose and time in range.
Heidi Kakko, member of the EIC Fund Investment Committee, added: “We are glad to announce the EIC Fund contribution to this funding round for PKvitality to catalyze early-stage venture investments in the high-risk areas to make larger impact: a European medical company developing a breakthrough technology that is increasingly important for the long-term monitoring of patients in many pathologies.”