InSpark Technologies has announced the results of a recent meeting with the US Food and Drug Administration (FDA) regarding the development and regulatory strategy for Vigilant diabetes management software.
Vigilant is an iPhone-enabled software application that analyzes blood glucose data and provides feedback about daily patterns of hyperglycemia, hypoglycemia, glucose variability, and test frequency in real-time, as well as patterns indicative of increased risk of severe hypoglycemia in the next 24 hours.
It is designed to provide concise messages prior to periods of risk so that users with diabetes can take action to improve their glucose control.
The FDA cited no significant concerns with a comprehensive package of completed and planned future studies, performance assessments for Vigilant’s three principal pattern recognition algorithms and validation plans for the software system. Furthermore, the FDA was aligned with InSpark’s perspective on the level of patient risk associated with the software system.
InSpark Technologies regulatory affairs consultant Dr Diane Horwitz noted that this is a testament to the work the company has done to create a well-thought out development plan that addresses patient safety and the user’s interaction with their pattern analysis algorithms.
"It will be exciting to see people benefiting from the actionable information provided by Vigilant soon," Dr Horwitz added.