The TÜV Rheinland European regulatory body recently awarded Swedish-based Brighter two EC certifications for Actiste, the company’s single-device solution for diabetes monitoring and treatment management. The regulatory granted Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD) CE certifications for Actiste because the comprehensive solution performs both functions.
With patient consent, Actiste also sends data to Brighter’s The Benefit Loop open cloud-based service via a secure mobile connection. Given the rapid increase in the global prevalence of diabetes, any progress helping people manage the disease is welcome, but the implications of Brighter’s comprehensive solution are far-reaching.
We’ve written about developments with artificial pancreas technology several times, particularly Medtronic’s FDA-approved hybrid closed-loop system. We’re enthusiastic about Actiste and The Benefit Loop because they appear to move artificial pancreas technology at least two large steps further for people with Type 2 Diabetes.
Actiste Diabetes Management as a Service (MaaS) is a subscription-based, end-to-end service for patients with insulin-dependent diabetes. The device measures glucose levels in blood samples, calculates and administers insulin injections, and logs all activities via a secure connection.
Other services can used the data shared with The Benefit Loop open database to motivate patients to monitor and modify their behavior to mitigate or even hopefully avoid diabetes-related outcomes from unhealthy lifestyle decisions.
Brighter’s initial focus for establishing the Actiste service program is in Sweden, Southeast Asia, and the Middle East. Earlier this year the United Arab Emirates’ Ministry of Health and Preventions (MOHAP) launched Actiste to improve healthcare in the UAE.
Type 1 and Type 2 diabetes take heavy tolls on human health and quality of life. The Brighter solution is big news for patients, families, and healthcare professionals worldwide.
