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InTouch™•diabetes is intended for use in home settings to aid people with diabetes and healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data management capabilities. This system is intended for use by people 18 years of age and older. InTouch™•diabetes is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

InTouch™ediabetes is an online tool that helps patients to manage their diabetes and communicate their blood glucose readings to their invited healthcare professionals, who they partner with in managing their diabetes. InTouch™diabetes enables a blood glucose meter to connect via a Bluetooth accessory, the Polymap Wireless Polytel® GMA Glucose Meter Accessory (GMA), to a cellular phone in order to transmit meter readings to online system, which is accessible by the the InTouch™.diabetes healthcare provider as well as the patient. The Polymap Wireless Polytel® GMA(s) that are utilized by InTouch™.diabetes are currently marketed accessories cleared for OTC use via 510(k) K091296. Patients are offered insights into their condition and in partnership with their HCPs can engage in new self-management activities, including monitoring regimens. Education content and interactive communications with their caregivers, disease managers, or educators, are available. The InTouchTModiabetes application software that resides on the mobile phone transmits the patient's blood glucose measurement data from a glucose meter to the InTouch™, diabetes central repository database. The data is analyzed to recognize health patterns, show trends, and this information is displayed visually along with personalized health information and education. InTouch™odiabetes does not provide alerts/alarms, specific treatment or insulin does recommendations; or any advertisements and it meets the applicable HIPAA privacy requirements.

The SymCare Diabetes Management Program is intended for use in home settings to aid people with diabetes and healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data management capabilities. This system is intended for use by people 18 years of age and older. The SymCare Diabetes Management Program is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

The SymCare Diabetes Management Program (DMP) is an online tool that helps patients to manage their diabetes and communicate their blood glucose readings to their healthcare providers, healthcare providers manage their diabetes patient population, and insurance companies manage their diabetes patient and health care provider populations. The DMP enables a blood glucose meter to connect via a Bluetooth accessory, the Polymap Wireless Polytel® GMA Glucose Meter Accessory (GMA), to a cellular phone. Once the mobile phone has gathered the data from the meter, it transmits the data to a centralized repository database. The data is analyzed to recognize health patterns, show trends, and offer personalized health information.