FDA & Regulatory:
EndoTool is class-II FDA-cleared clinical decision support software platform.
Caregivers using EndoTool IV and EndoTool SubQ can safely and effectively achieve and maintain glucose control for patients. EndoTool IV has demonstrated: 54% reduction in hospital acquired infection, 46% finger stick reduction, Less than 3 hours average time to control, .36% hypoglycemia rates < 70 mg/dl (Based on total number of BG readings), .07% hypoglycemia rates < 54 mg/dl (Based on total number of BG readings), .009% hypoglycemia rates < 40 mg/dl (Based on Total number of BG readings)
EndoTool comes with analytics that provides access to pre-configured data reports and audit logs via any web browser. With EndoTool Analytics, healthcare providers have the ability to identify and analyze trends, track safety and clinical effectiveness, and enhance productivity.
Platforms & Modalitiy:
The EndoTool system fully integrates with most major EMR systems and can be accessed on any device that supports a browser.
Security & Privacy:
HIPAA Compliant. As a class II FDA-cleared medical device we adhere to the guidance in the Postmarket Management of Cybersecurity in Medical Devices as defined by the FDA.
Cost & Payment:
EndoTool is marketed to hospital systems and requires a subscription license for providers to order EndoTool for patients while in the hospital.
EndoTool IV and EndoTool SubQ are software-only devices which easily integrate with the hospital’s EMR and use feedback mathematics to individualize insulin dosing by calculating limited proportional incremental changes in the insulin dosing model or carbohydrate recommendations based on a patient’s previous blood glucose readings in response to prior insulin doses.
These calculations are repeated by the software when new data is entered into the system, constantly seeking the optimal, patient specific insulin dose for the targets set by the physician.
EndoTool IV and EndoTool SubQ provide three primary functions:
- set-up or initialization of a patient’s mathematical model (i.e., initial total daily insulin dose) based on 11 patient-specific factors in EndoTool IV and 13 patient-specific factors in EndoTool SubQ, including the presence of steroids and kidney function
- update of the patient’s mathematical model, based on glucose responses
- determination of therapeutic recommendations consisting of insulin or carbohydrate recommendations, based on entered clinical and laboratory data and confirmed by the bedside caregiver (nurse).
EndoTool IV provides two unique functions for dosing recommendations:
- EndoXTM that offers enhanced customization for patients suffering from extreme health conditions such as Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Nonketotic Syndrome requiring higher goal ranges and a more structured step-down process
- Estimated Residual Extracellular Insulin (EREI) that provides additional refinement to the next dose recommendation, further reducing the risk of hypoglycemia
EndoTool SubQ provides one additional function for dosing recommendations:
- Dosing modes enable the ordering physician to choose basal, bolus, and correction insulin therapy or a limited dosing mode, either correction only or bolus and correction only, if appropriate and enabled by the medical director.
- EndoTool IV and EndoTool SubQ software is installed on a hospital/health care facility server and deployed via a website. Insulin and carbohydrate therapy are managed using blood glucose measurements and available patient information entered into the software using a user friendly, interactive interface. The entered data is evaluated by the EndoTool IV and EndoTool SubQ software to recommend a dose of insulin based on the regimen set by the subject’s physician and calculated by the software.
Therapy goals and limits are adjustable in the system as directed by the local physician’s orders and plans. Additional decision support is provided to the nursing and physician staffs through electronic advisories that are presented on the screen in response to unexpected observations and circumstances which may require intervention.