KWatch Glucose: A Wearable Painless Continuous Glucose Monitoring Smartwatch

Project Information

K Watch Glucose

Grant agreement ID: 960071

DOI

10.3030/960071

Project closed

EC signature date 5 October 2020

Start date 1 November 2020

End date 31 October 2023

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 271 376,25

EU contribution

€ 2 289 963,38

Coordinated by

PK VITALITY
France

Periodic Reporting for period 1 - K Watch Glucose (KWatch Glucose: A Wearable Painless Continuous Glucose Monitoring Smartwatch)

Reporting period: 2020-11-01 to 2021-10-31

Summary of the context and overall objectives of the project

Diabetes is a major public health burden accounting for 10% of global health expenditure. In Europe, there are 60m people with diabetes, resulting in €90B in direct costs for treatments and hospital stays.
To minimize healthcare costs, effective management of diabetes is essential, relying on the monitoring of blood glucose (BG) concentration several times a day.
Traditional finger-prick glucometers or BGMs are burdensome for the patients who are poorly compliant vs the number of tests they are supposed to do each day. If BGMs is still the main tool to check its Glucose, Continuous Glucose Monitors (CGM) are offering a much better alternative, reducing the pain, proposing a curve to better understand its glucose evolution. Despite a recent massive adoption (4m users end 2020 with 50% annual growth), major pain points remain: pain at installation, issue with the adhesive, stigmatisation of the patch which is visible, cost of the solution.
The objective of K’Watch Glucose is to provide to diabetes patients a CGM which would solve these pain points: painless, no adhesive issue, discreet and affordable.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

K’Watch Glucose project has progressed very swiftly over the past 12 months.
Pre-clinical and clinical: the extensive in vitro tests conducted shown great results. The sensor chemistry and architecture have been validated. The glucose sensor gets excellent sensitivity, linearity and sensitivity test results. More than 3500 sensors have been used in tests paving the way for early First in Human trials under the supervision of an external organization (CRO). Clinical trials shall start in November 2022 with preliminary results from January 2022. In parallel, the irritation risk linked to microneedles and patch being in the same spot have been mastered. Several patents have been filed and a specific trial will be done in 1Q 2022 to confirm the internal results.

Regulatory & quality: the stage 1 ISO 13485 audit has been passed with BSI as our notified body. The internal quality system is ready for the acceleration phase with an eQMS now in place. A clear regulatory pathway, for Europe, US and other countries has been drafted and shall be reviewed with the local authorities.
Industrial: for the watch we have signed with a tier 1 Original Design Manufacturer and are finalizing the final engineering sample taking into account all the industrial constraints. For the sensor we have secured the location of our factory and are starting to implement the tools and equipment to move from prototype to industrialization.
IP: we now have filed 36 patents securing our concept.
Dissemination: More than 60 000 people subscribed to our newsletter, mainly people wanting to know when the product will be out. We have also won the 12th IOT Innovation World Cup in April in the medical category.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

PKvitality aims to develop the ultimate CGM.
One that would be integrated into the day-to-day usage of the diabetes patient, either type 1 or type 2. Painless thanks to tiny micro sensors that you don’t feel with a friendly adhesive, soft and strong, protected by the watch. Invisible, the patch being hidden behind the watch. Affordable and highly recyclable, as no applicator is required and the electronic is in the watch.
A CGM that will evolve in time, with a product enabling:
-multi analyte such as Ketone + Glucose on the same patch to avoid ketoacidosis, a major cause of hospitalization for diabetes patients
-smart prediction and advices, mixing the glucose data and the wellness data captured by the watch: medium term glucose prediction and advices for behavioral change to better control its glycemic evolution
-integration of 3rd party Open Loop and Closed Loop controller software into K’Watch to control the connected insulin pen or pump and make the diabetes patients life even simpler.
Beyond Glucose we are also developing other analytes for other population such as lactate tracking for professional athletes and others.
These developments are made together with patients and population that will use our products. With cost in mind to enable a broad diffusion of these products not only in wealthy countries but also in countries where reimbursement is not available and price is the barrier to accessing the solution.

Pk Watch. Front view

Pk Watch. Needle view.