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The Insulia Bolus Companion is indicated for the management of diabetes by adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software. This can be done through a dedicated, secured web portal.

Insulia Bolus Companion is a prescription device indicated for the management of diabetes, for adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data; and for healthcare professionals (HCP) having experience in the management of people with diabetes treated with bolus insulin. Insulia Bolus Companion is for prescription use and is not for over-the-counter sale. Insulia Bolus Companion includes a Bolus Calculator intended to provide direction to the patient in response to blood glucose (BG) and health events, within the scope of a preplanned treatment program prescribed by their HCP for insulin suggestions. The guidance is similar to the directions provided to patients as a part of routine clinical practice: prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software. An HCP can only start using Insulia Bolus Companion after having been registered by the Manufacturer or the delegate field-support team. Insulia Bolus Companion includes three components: - · A mobile application for use by people with diabetes on commercially available smartphones (iPhone or Android) and tablets, enabling patients to document BG measurements, meals, and generate dose suggestions for bolus insulin - · A web-based application for use by HCPs in professional healthcare settings through a compatible web browser on a computer, allowing patient inclusion and patient monitoring in-person and by distance - · A secure database hosted in a private cloud environment and used to securely store patient data