Device Dossier

Diabetes patient management software

Device Dossier for Diabetes patient management software (Diabetes patient management software, Class IIb, sponsor Emergo). ARTG record, intended purpose,…

Intended purpose

The iSage Rx/Dose Check device is intended to help adult patients understand and follow their Healthcare Professional’s (HCP) Titration Plan for the following: • Titration of basal insulins • Titration of combinations of basal insulin and GLP-1 receptor agonists Patients using iSage Rx/Dose Check can record their blood glucose levels, view their Healthcare Professional’s dosing plan for supported medications2, and record the medication dose taken. iSage Rx/Dose Check connects with the following devices: • Glucose meters to transmit Blood Glucose (BG) data. • Smart Insulin pens, caps, and attachments to transmit insulin dosage data to iSage Rx/Dose Check and record the dose taken. iSage Rx/Dose Check is not intended to replace the care and management provided by a Healthcare Professional trained in the management of diabetes. iSage Rx/Dose Check should not be used by patients with type 1 diabetes, gestational diabetes, or patients using an insulin pump.

TGA Public Summary