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The Health-e-Connect System with IDA is intended for use in the home and clinical settings by people with diabetes and healthcare providers as an aid in the review, analysis, and evaluation of historical glucose test results and associated usage data in support of an effective diabetes management program. The Insulin Dose Adjustment (IDA) feature is intended only for insulin-requiring Type 2 diabetes patients to provide the physician with two reference doses. The IDA feature is not indicated for patients who utilize insulin pumps and it is limited to adults with Type 2 diabetes on fixed dose regimen of insulin. The Health-e-Connect System with IDA is for patients under the supervision of a physician / healthcare provider trained in the management of diabetes. Final drug dose recommendations for a patient must be made only after careful consideration of the full clinical status of the patient. No medical decision should be based solely upon the results provided by this software program.

The ALRT Health-e-Connect System (HeC) allows healthcare providers, ALRT staff, and other authorized caregivers to remotely monitor the blood glucose values of patients with diabetes and therefore can assist healthcare providers in making adjustments to the patient's care plan based upon trends in the patient's blood glucose data. There are no physical, electrical, biocompatible, or sterility specifications for this device as it is software only. The original Health-e-Connect system (K102063) performed two functions: 1. A data management tool and 2. A communication platform (Health-e-Connect Remote Care System). Modification: The proposed modification is to add a module - Insulin Dose Adjustment (IDA) - to the Healthe- Connect System. This is an additional module of software that monitors patient blood glucose levels uploaded from the patient's blood glucose meter, to ascertain whether the patient's current insulin dose may or may not be optimal. If trends in the patient's blood glucose are outside of the guidelines set by the AACE and ADA, the patient is flagged for a potential insulin dose adjustment. The IDA system will then employ the AACE and ADA algorithms to calculate reference doses that can be compared with the patient's current insulin dose. If there is an inconsistency between the patient's current insulin dose as compared to the reference doses calculated by AACE and ADA algorithms, this discrepancy will be flagged and an alert sent to the managing HCP requesting an insulin dose review.

The Health-e-Connect System is intended for use in the home and clinical settings by people with diabetes and healthcare providers as an aid in the review, analysis and evaluation of historical glucose test results and associated usage data in support of an effective diabetes management program.

The ALRT Health-e-Connect System (HeC) is an internet based blood glucose monitoring system that allows healthcare providers and patients the opportunity to review, analyze and evaluate the efficacy of a diabetes management program. It is expected that this functionality will significantly improve HbA1C levels in patients with diabetes. Note there are no physical, electrical, biocompatibility or sterility specifications for this device as it is software only. It performs two functions: it is a data management tool and a communication platform. The Health-c-Connect System is comprised of a home based application, legally marketed peripherals (blood glucose meters) and a server. The home based application software collects data from blood glucose meters and transmits the data over the home's existing internet connection where it is uploaded to the Health-e-Connect System's web-based servers. The server is a web-based application that collects, range checks, stores and displays historical patient blood sugar levels. It also allows patients, healthcare providers, patient relatives and other healthcare providers involved in the case to send messages to each other and share patient information. This communication is retrospective and not a real- time alert or alarm. The Healthe-Connect System is a tool to monitor patients remotely and motivate them through notifications.