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The BlueStar® CGM insulin dose calculator is software intended for the management of type 1 or type 2 diabetes in persons aged 18 years and older requiring fast-acting insulin. The BlueStar CGM insulin dose calculator allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent CGM glucose reading and rate of change, activity, and, optionally, insulin on board (IOB). The BlueStar CGM insulin dose calculator requires a prescription.

The BlueStar® CGM insulin dose calculator is a software device module existing in the same mobile medical application as BlueStar® Rx (K203434), which is intended for the management of diabetes. When connected to a compatible integrated continuous glucose monitor (iCGM) and under authorization from a qualified healthcare provider, the BlueStar CGM insulin dose calculator allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent iCGM glucose reading and its rate of change, activity, and, optionally, insulin on board (IOB). Other patient-specific inputs from BlueStar Rx are used in the calculation of the recommended dose- specifically, duration of insulin to carb ratio, correction factor, and target glucose. In addition to calculating specific dosing recommendations, the BlueStar CGM insulin dose calculator also provides coaching messages to assist the user in maintaining glucose within the target range. The use of CGM inputs differentiates the BlueStar CGM insulin dose calculator from the insulin dose calculator included in the previously cleared BlueStar Rx, which uses blood glucose (BG) values from a BG meter using a "fingerstick" method. The CGM insulin dose calculator is intended to coexist with the BG insulin calculator function in the BlueStar Rx software application as the BG calculation may be necessary when CGM is unavailable or the CGM estimated blood glucose does not match how the user feels.

BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar Rx automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar Rx analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information. • For bolus insulin users with type 2 diabetes, BlueStar Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insultin for a given amount of carbohydrates and/or glucose value. · For basal insulin users with type 2 diabetes, BlueStar Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the IAP and configure it for patient-specific parameters. BlueStar Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. BlueStar® is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

BlueStar® (subject device) combines the existing diabetes self-management features of the predicate (BlueStar® and BlueStar® Rx, K193654) with the automatic tracking of insulin delivery functionality of the reference InPen System (K160629). BlueStar maintains all of the features of the predicate and adds the capability to connect with compatible devices connected with insulin pens via Bluetooth wireless technology. In this submission, the predicate device is being modified such that it can receive insulin dose-related data when connected to a Tempo Smart Button™ (TSB). The TSB when attached to a disposable Tempo Pen (insulin pen), can transfer dose-related data (corresponding to the brand of insulin, dose amount, date, and time) via Bluetooth® Low Energy (Bluetooth) wireless technology. BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to assist patients in managing their diabetes with guidance from their providers. BlueStar has two versions – BlueStar (Over the Counter, OTC) and BlueStar Rx (prescription use version). BlueStar is comprised of the following software applications (app): - iOS and Android based mobile apps for patients . - web-based app (web-portal) for HCPs ● BlueStar requires initial registration before the patient can access the software applications. BlueStar is compatible with devices including Blood Glucose Meters (BGM), Blood Pressure Monitors, Continuous Glucose Monitors (CGM) , Tempo Smart Button™ 2, Weight Scales, Activity Trackers. Data, including blood glucose values, blood pressure, medications, carbohydrates, physical activity, weight, and sleep are entered, stored and processed in the patient software applications. Data can be entered manually or automatically via Bluetooth for compatible devices. Additionally, the mobile application for patients is capable of automatically receiving, storing, processing, and displaying insulin data from the Tempo Smart Button via Bluetooth. The BlueStar apps for patients function as an information repository (logbook and Personal Health Record) and diabetes education resource (curriculum, articles, videos). Patients also receive in-the-moment coaching (Real Time Feedback messages), Pattern Reports and SMART Visit Reports that can be shared with their providers. Coaching messages are motivational, behavioral, and educational in nature and are based on data (and trends) including real-time blood glucose, blood pressure, and weight. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. Patients also receive insights based on data entered and trends detected by the app. BlueStar patient apps include a secure communication system (Message Center) as well as a medication information repository (dose and schedule). Qualified type 1 and type 2 diabetes patients have access to a bolus insulin calculator (cleared under K190013). Qualified type 2 diabetes patients have access to the Insulin Adjustment Program (IAP) to titrate long-acting basal insulin (cleared under K193654). Patients use their mobile software applications to follow their HCP's bolus insulin prescription or basal insulin titration plan. The bolus insulin calculator and basal insulin titration features are only available in BlueStar Rx for use under the direction of their HCP. The provider can review patient information, workflows and decision support information using the web-based software application for HCP. The HCP can initiate and manage basal insulin titration (IAP) and the bolus insulin calculator prescription / parameters through the web-based software application for HCP. The SMART Visit Report includes data summary, analysis, and decision support for treatment as well as psychosocial issues identified by patient survey responses within the app. The SMART Visit Report can be sent by the patient to his/her HCP from the mobile app. The HCP can also generate SMART Visit Reports from their web portal.

The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their patients - aged 18 years and older - who have Type 1 or Type 2 Diabetes. The system is intended to assist Type 1 and Type 2 Diabetes patients to self-manage their disease, as cleared under K162532. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® - BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a licensed HCP with prescribing authority. BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications: - Enterprise Director Portal - HCP Service - Patient Mobile Application - Patient Web Portal The Enterprise Director application is used for administrative purposes. The HCP Service houses the Medication Reconciliation feature, which allows for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273). The Patient Web Portal and the Patient Mobile application have a similar feature set. Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications are stored in the database and can be retrieved for display in either application. Both applications require the initial web- or mobile-based registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers. In BlueStar® Rx, the patient web portal and mobile application also provide an insulin calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. This submission introduces Insulin on Board to be considered in the calculation. The insulin dose calculator is indicated for prescription-use only. Furthermore, as cleared under K162225, BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends. The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only. These modifications do not change the fundamental scientific technology of the device.