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DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who: - use insulin pumps as their insulin delivery therapy: . - . monitor their glucose levels using either of the following: - CGM, or O - CGM and self-management blood glucose meter O - . are above the age of 6 and under 65 years old; and - . use rapid acting U-100 insulin analogs in their pump DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing continuous glucose monitoring (CGM), self-monitoring blood glucose (SMBG) and pump data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, carbohydrate ratio (CR), and correction factor (CF); without considering the full clinical status of a particular patient. DreaMed Advisor Pro does not replace clinical judgment.

DreaMed Advisor Pro is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump and a continuous glucose monitoring (CGM) system. The DreaMed Advisor Pro gathers and analyzes information inputted through qualified 3rd party Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by DreaMed Advisor Pro includes glucose readings (CGM sensor readings with the option for capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care. Following data collection and analysis, the DreaMed Advisor Pro generates results containing summary data and recommendations for adjustments to the patient's insulin therapy parameters, including: basal insulin delivery rate(s), insulin to carbohydrate ratio, and correction factor (insulin sensitivity)(b) (4) DreaMed Advisor Pro may also advise behavioral changes. Results are sent to a qualified 3th party Diabetes Management Systems, which displays results to physicians and a report provided by DreaMed Diabetes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient.