Indications for Use

Last Updated: June 11, 2024

The Gluroo Digital Diabetes Solution (“Gluroo”) is a companion secondary display application 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 only a companion secondary display application. Gluroo requires that you also continue to use 1st-party secondary displays in conjunction with Gluroo. All therapy decisions should only be based on measurements obtained from the first-party approved devices following their guidelines. 

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 make any medical interpretation or alter any therapy or 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. Warning: 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.

Medical Warnings

NOTHING IN THIS APPLICATION IS INTENDED TO PROVIDE MEDICAL OR HEALTH-RELATED ADVICE OR WARNINGS.

Gluroo is a logging application to help an extended group message each other and manage shared state. It is NOT a medical device or application and MUST NOT BE USED AS A MEDICAL DEVICE OR APPLICATION.

You and your group MUST CONTINUE TO USE ANY AND ALL MANUFACTURER-SUPPLIED DEVICES, PROCESSES, AND SYSTEMS.

You and your group MUST CONTINUE TO FOLLOW YOUR PHYSICIAN’S ORDERS AND DIRECTIVES.

You and your group MUST CONTINUE TO USE A PRIMARY TRUSTED SOURCE FOR TRACKING INSULIN ON BOARD AND OTHER DATA (other than Gluroo).

You are using Gluroo entirely at your own risk.