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Indications for Use

The Gluroo Digital Diabetes Solution (“Gluroo”) is indicated as an aid in the management of diabetes. Gluroo is intended to provide a secondary display of continuous glucose monitoring (CGM) and/or insulin pump data on a consumer electronic device. The software provides for electronic download of blood glucose and CGM data, insulin pump data, manual data entry, storage, display, communication, transfer, and aiding in the understanding of blood glucose and other related health indicators which can be shown in report and graphical format. It is intended to be used by users of blood glucose monitoring devices and their care team to keep a log tracking nutrition, exercise, medication, and other data.

Gluroo is not intended for use in the diagnosis of disease.

Gluroo is not intended to replace the real-time display of continuous glucose monitoring and/or insulin pump data on the primary display device. Gluroo is a companion secondary display application. All therapy decisions should only be based on measurements obtained from the first-party approved devices.

Gluroo is not intended for making treatment decisions or recommendations. This device is not intended to replace self-monitoring practices as advised by a physician. Do not alter any treatment plans without consultation with a qualified physician.

Gluroo is not intended for controlling insulin pumps or other drug delivery systems. Gluroo is not intended for calculating insulin or other drug doses. Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system.

Gluroo is not intended for use by anyone unable to use mobile devices and/or computers proficiently.