If you had some new, unapproved *type* of blood glucose monitor in consideration w/ some new *type* of insulin, would the former be a “companion device”?

It is certainly possible the blood glucose monitor could be considered a “companion device”. Whether the blood glucose monitor would be considered a “companion device” would ultimately be up to the FDA’s assessment of the study, devices, and insulin at play. Quorum recommends you consult with the FDA if you have any questions about how they intend to regulate a device in this particular scenario.