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# Voluntis Diabetes Management Tool Cleared
- URL: https://www.fdaweb.com/voluntis-diabetes-management-tool-cleared/
- Published: 2016-12-07T12:00:00.000Z
- Updated: 2026-09-14T21:52:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137515

FDA has granted Voluntis 510(k) clearance for Insulia, a digital solution intended to support the effective management of Type 2 adult diabetes patients treated with basal insulin. According to the company, the prescription-only medical device provides patients with insulin dose recommendations and educational coaching messages in response to blood glucose values and other diabetes-related data. It supports a variety of treatment plan configurations and evidence-based insulin adjustment rules used in routine clinical practice. Clinicians set up a personalized treatment plan based on a patient’s profile, insulin prescription and blood glucose targets. This enables Insulia to provide automated insulin dosing recommendations to the patient. The dose adjustment algorithm is embedded in the application, and is accessible to the patient via a Web portal or smartphones and tablets. The patient data is automatically shared with the health care team, who can remotely monitor the patient’s progress toward their goal with tailored notifications, Voluntis says.