The regulatory milestone unlocks access for U.S. care providers and health systems to leading-edge diabetes care technology demonstrated to increase patients' adherence and reduce cost of treatment
MADRID--(BUSINESS WIRE)--Insulcloud, a pioneering healthtech company revolutionizing diabetes management, today announced its strategic expansion into the U.S. market following the FDA's clearance of its award-winning Insulclock CAP smart device, designed to monitor patient use of disposable insulin pens in real time and increase patient adherence to prescribed therapy. This commercialization milestone underscores the safety, efficacy, and quality of the Insulclock CAP, and helps clear the way for millions of Americans living with diabetes to take control of their insulin therapy with unprecedented precision and confidence.
The Insulclock CAP transforms disposable insulin pens into leading-edge diabetes management tools. The bluetooth-enabled medical device provides visual and audible warnings to empower users to optimize their insulin therapy and promotes proper use of insulin pens for enhanced safety and control. The Insulclock CAP also captures critical information including insulin brand, insulin dose measurement, injection date and time, and the temperature of the insulin pen at the time of the injection, and it also differentiates bolus insulin from priming insulin automatically.
"We understand the challenges faced by individuals living with diabetes, and we are committed to improving their quality of life. Our outperforming smart pen cap not only empowers patients to manage their condition more effectively, but also helps reduce costs for insurance providers by minimizing complications and hospitalizations," said Insulcloud General Manager Judith Ruiz de Esquide. "At Insulcloud, we believe that everyone deserves access to life-changing technology. Together, we can transform diabetes care for the better, paving the way for a healthier future."
The Insulclock CAP is designed for patients using disposable insulin pens who have been diagnosed with type I or type II diabetes mellitus, and it works across insulin brands. The diabetes care solution, along with a companion app, is already in use across Europe with thousands of daily users. The technology is validated* in peer-reviewed research to improve on-time injections by 13.5%. Adopting the Insulcloud Insulclock CAP solution has shown an average cost savings per patient of nearly $1,000 annually.
"Insulcloud offers patients and doctors a sense of well-being. Knowing it's easy to adhere to their treatment plan with the smart Insulclock CAP, this reassures me as a provider that my patients are more likely to follow treatment plans and track their progress with the support to promote proper use of their insulin pen," said Dr. Guillermo Umpierrez, American Diabetes Association President for Medicine and Science, 2022.
Insulclock is designed to be integrated into existing healthcare apps through an Insulclock FDA-cleared software development kit (SDK). Insulcloud is now in the process of sourcing partners for distribution into the U.S. market and considering locating its first international office in Boston.
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About Insulcloud
Founded in Spain in 2014 to empower diabetes care providers with the latest technology to improve the quality of life for patients with diabetes, Insulcloud now produces a suite of diabetes-related products including the first-of-its-kinda Insulclock CAP and the 360o Digital HEALTHCARE Solution for healthcare providers. Insulcloud has raised more than $14M in venture funding to date. Its strategic partners include Dexcom, IBM, and Ascensia Diabetes Care. The company has more than 30 employees and distributes its solutions through global partners. The company's mission is to improve the lives of hundreds of millions of diabetes patients around the world.
*Diabetes Care. 2022 DOI: 10.2337/dc22-0525
Contacts
Media Contact:
Eric Schudiske
eric@bioscribe.com