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The d-Nav® System calculates the next dose of insulin to aid in optimizing insulin management. The d-Nav System contains two user-interactive software elements: • The patient user interface software is intended for use by adults with Type 2 diabetes as an aid in optimizing insulin management. It resides on a hand-held device, e.g. cellular phone or enabled glucose meter, and is used to enter glucose event data and receive a recommended insulin dose. · The HCP user interface software tool is intended for use by Health Care Providers (HCPs) to set up the patient software for its intended use. Setup consists of entering the physician-prescribed, patient-specific starting insulin dose instructions (insulin prescription) and sending the patient user software. Insulin instructions include the treatment algorithm (treatment plan), insulin drug, and dose(s). The d-Nav System also contains the d-Nav Get-Dose Library that provides the next insulin dose. The System can receive glucose measurement data entered manually into the patient user software or automatically via the cloud from a linked blood glucose meter. The d-Nav Get-Dose Library Recommend Dose function resides locally on the phone while the d-Nav Get-Dose Library Update Insulin Instruction may reside locally on the phone or be hosted in the cloud. Configurations are as follows: Model 1: Patient user software resides on a hand-held device and uses manual glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides locally within the device. Model 2: Patient user software resides on a hand-held device and uses manual glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides in the cloud. Model 3: Patient user software resides on a hand-held device and uses automated glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides locally within the device. Model 4: Patient user software resides on a hand-held device and uses automated glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides in the cloud. Use of the d-Nav System is limited to Health Care Providers who have been trained by Hygieia trained person on the use of the d-Nav System, including setup of the patient's Phone App.

The d-Nav System is a software-based, prescription-only product designed to provide the next insulin dose recommendation as an aid for personal insulin management. The product integrates the Health Care Provider (HCP) prescribed starting insulin dose instructions with automated dosing quidance to the patient based on comparing reqularly measured blood glucose data trends to a device specified target range. The d-Nav System contains two userinteractive software elements; the d-Nav Phone App and the d-Nav Website. - . The Phone App is for use by persons with Type 2 diabetes as an aid in optimizing insulin management. The Phone App resides on a cellular phone and is used by the patient to enter qlucose event data and receive a recommended insulin dose. The blood qlucose data is obtained from an over-the-counter, cleared Blood Glucose (BG) device and entered into the software system either through manual BG data entry using the Phone App kevpad or via a cloud-pushed mechanism from a linked blood qlucose meter. The Phone-App allows change in insulin dose recommendations to be sent to the patient without concurrence from the prescriber. - The d-Nav Website is for use by Health Care Providers that have been trained by Hygieja or . a Hygieia trained trainer on the use of Phone App and website to set up the patient's Phone App software for its intended use. Setup consists of entering the physician prescribed, patient-specific starting insulin dose instructions and sending the information to the intended patient's Phone App. Insulin instructions include the treatment algorithm (treatment plan), insulin druq, and dose(s). The d-Nav System also contains the d-Nav Get-Dose library that provides the next insulin dose. The System can receive glucose measurement data entered manually into the patient user software or automatically via the cloud from a linked blood qlucose meter. The d-Nav Get-Dose Library Recommend Dose function resides locally on the phone while the d-Nav Get-Dose Library Update Insulin Instruction may reside locally on the phone or be hosted in the cloud.