Level 1
I am a CE-certified medical device 
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General description
Additional info
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General description (provided by company)
Main purpose
The Guardian™ Connect application (app) is a component of the Guardian Connect Continuous Glucose Monitoring (CGM) system that helps you manage your diabetes by:
- Recording your glucose values throughout the day and night.
- Displaying your glucose values in a convenient and discrete manner using your mobile device.
- Alerting you to glucose events using your mobile device.
- Showing the effects that diet, exercise, and medication can have on your glucose levels.
- Giving you additional tools, such as alerts and the ability to record diet, exercise, and insulin intake, to help you prevent high and low glucose levels.
- Recording your glucose values throughout the day and night.
- Displaying your glucose values in a convenient and discrete manner using your mobile device.
- Alerting you to glucose events using your mobile device.
- Showing the effects that diet, exercise, and medication can have on your glucose levels.
- Giving you additional tools, such as alerts and the ability to record diet, exercise, and insulin intake, to help you prevent high and low glucose levels.
Target audience
The Guardian™ Connect is designed for diabetic patients and allows to check the evolution of blood glucose levels by simply looking at your smartphone.
Approach
Guardian Connect allows Care Partners to remotely monitor your system data. It also allows you to send your Guardian Connect system data to the CareLink Personal website for daily uploads. This is done using an automatic feature called "Sync to CareLink".
This automatic Sync to CareLink feature sends data displayed in the app to the CareLink Connect tab of the CareLink Personal website. This data is sent approximately every five minutes when an Internet connection to the website is available. This feature also automatically sends sensor history information used to create CareLink reports approximately every 24 hours. This information can be viewed by you or a care partner on the CareLink Personal website at carelink.minimed.eu.
The CareLink Network engages multiple security methods to help customers comply with Global Data Protection Regulations such as “Health Insurance Reform: Security Standards” (HIPAA Security Rule) and the General Data Protection Regulation (GDPR).
This automatic Sync to CareLink feature sends data displayed in the app to the CareLink Connect tab of the CareLink Personal website. This data is sent approximately every five minutes when an Internet connection to the website is available. This feature also automatically sends sensor history information used to create CareLink reports approximately every 24 hours. This information can be viewed by you or a care partner on the CareLink Personal website at carelink.minimed.eu.
The CareLink Network engages multiple security methods to help customers comply with Global Data Protection Regulations such as “Health Insurance Reform: Security Standards” (HIPAA Security Rule) and the General Data Protection Regulation (GDPR).
Connectivity to sensors and platforms
CGM is a technology that lets you continuously view your sensor glucose values. The Guardian Connect system uses a glucose sensor, placed below your skin, to continuously measure the amount of glucose in your interstitial fluid. The Guardian Connect transmitter collects these glucose measurements, which are then converted to sensor glucose values. These sensor glucose values are then displayed on the Guardian Connect app. The Guardian Connect app can also provide alerts regarding your sensor glucose levels.
Financing and pricing model
The App is free
Pathology
Diabetes
Functions
Alerts & Notifications
Health Tracking
Personal Health Record
Remote Clinical Monitoring
Users
Child
Teen
Men
Women
Elderly
Additional info
Compliance to M1 criteria
CE certification
Certificate granted on 11/03/2020
Certificate valid till 26/05/2024
Class type of medical device (More info): 2A
ISO Standards:
FAMHP registration and notification
Company registration number at FAMHP: 00355
Product identification code at FAMHP: 00355
General Data Protection Regulation (More info)
Reference publication
N/A
User instructions
The app is intended for use by patients with a compatible consumer mobile device. The app displays sensor glucose data, and also provides a user interface for sensor calibration, entering data such as exercise and meals, and uploading information to the CareLink™ Personal website. It allows users to track patterns in glucose concentrations and possibly identify episodes of low and high glucose. The app provides alerts if a glucose level reaches, falls below, or rises above your set sensor glucose limits.
Components of the application
Native appWeb applicationWearable / SensorMedical device
Complaints handling
Via e-mail: rs.psdiabetesheerlen@medtronic.comVia telephone: 0800 90 805
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