FDA & Regulatory:
CareLink™ Connect App is an FDA cleared Class II Medical Device.
Data sharing is available for up to five care partners who can follow a pump user and receive high and low notifications. The CareLink™ Connect app requires internet access in order to sync to CareLink™ software. In addition, the person with diabetes must be using the MiniMed™ Mobile app with the Sync to CareLink™ feature on and have internet access for care partners to view up-to-date data.
Security & Privacy:
HIPAA compliant when the pump communicates with other devices in the system, such as the BG meter, transmitter, or compatible mobile device, the data is encrypted. This encryption helps prevent others from interfering with insulin pump therapy or seeing system data, unless the MiniMed™ Mobile app user has given a care partner permission to view data with the CareLink™ Connect app.
Cost & Payment:
The CareLink™ Connect app is available for download via the App Store® and Google Play™ store at no cost to the user. The care partner can download and use the CareLink™ Connect app on their own once the MiniMed™ Mobile user has given permission and approved the linking process. The app does not require a prescription or license.
The CareLink™ Connect app is intended to provide a secondary display of insulin pump and CGM (Continuous Glucose Monitor) data on a supported mobile device. CareLink™ Connect app is not intended to replace the real-time display of insulin pump or CGM data on the primary display device. All therapy decisions should be based on the primary display device. CareLink™ Connect app is not intended to analyze or modify the insulin pump and CGM data that it receives. Nor is it intended to control any function of the insulin pump or CGM system to which it is connected. CareLink™ Connect app is not intended to receive information directly from the insulin pump or CGM system.