Medical device software company Voluntis has received an updated FDA clearance (as well as an updated CE mark) for its Insulia app, a "digital companion" app for people with Type 2 diabetes. Insulia offers realtime basal insulin dose coaching, and the new clearance makes the app usable with two additional brands of insulin: Basaglar and Tresiba. The app had already worked for users of Lantus, Levemir, and Toujeo.
"It's complicated enough worrying about how to titrate your insulin, without having to worry about whether your brand of insulin is compatible with automatic titration tools such as Insulia," Pierre Leurent, CEO of Voluntis, said in a statement. "We are very excited to make Insulia available to all those with Type 2 diabetes, regardless of the basal insulin brand they're using."
Insulia is accessible via the web, or via iOS or Android phones or tablets. It offers the users dosage recommendations, educational coaching, and diabetes-related data. The app can work with a variety of treatment plans and dosage guidelines based on the user’s clinician-prescribed personalized treatment plan, including their insulin prescription and blood glucose targets. Then, Insulia uses a dose-adjusting algorithm to help the user manage their diabetes and work towards their goals, while the data is automatically shared with the user's healthcare team, who can also monitor the patient’s progress toward their goal in a separate provider-facing app.
This clearance brings every brand of basal insulin into the app. Next, Voluntis is working on making the service available to those using other insulin therapies, including NPH insulin and GLP-1/basal insulin combinations. That release is scheduled for 2018.
A couple of other diabetes-related 510(k)s also came through the FDA in the last two months:
- Taipei, Taiwan-based iXensor received clearance for the PixoTest Blood Glucose Monitoring System. The system consists of a small test strip reader that contains a lancet and clips on to a smartphone. It uses the phone's camera to read the strip, effectively turning the phone into a glucometer. The clearance allows the device to be used on an iPhone 5, 5s, 6, or 6s. According to iXensor's website, blood glucose is just the first use case of the device, which theoretically could be used to perform all kinds of biomarker measurements.
- Seoul, South Korea-based i-SENS received clearance for its CareSens N Premier Blood Glucose Monitoring System. The clearance is essentially for two glucometers, one of which is Bluetooth-connected. The Bluetooth-connected meter sends data to an app called SmartLog.