Page 122 - Glucose Monitoring Devices
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System user interface and connectivity  123




                  hypersensitivity, itching, pain, redness, and burning, were found in less than 55% of
                  subjects, and the effects were not severe enough to cause wearers to stop using the
                  sensor [20].



                  System user interface and connectivity
                  For a person with diabetes, a continuous glucose monitoring system provides
                  numerous advantages by making important information available both in real time
                  and for historical review. This allows the user to both react to changes in blood
                  glucose levels based on alerts from the system, and to identify trends and patterns
                  over time that will help their diabetes healthcare team make adjustments to their
                  treatment plan to aid in adjusting therapy to optimize diabetes management.
                     In a review of CGM systems, Rodbard noted that usability and system interface
                  play a critical role in the adoption and success of any medical device. He suggested
                  that usability issues to consider for CGM systems include the amount of time and
                  training required for both clinicians and patients to learn the system and be able
                  to interpret the data, reliability of results and ability to apply the information, and
                  usefulness of the information to improve glycemic control and overall quality of
                  life [33].
                     The latest generation of CGM systems has made great strides in developing user
                  interfaces that provide information in a user-friendly way. The interface can be a
                  stand-alone device provided by the manufacturer, such as the Freestyle Libre
                  Reader, or an app that the user can download to a mobile device, such as the Guard-
                  ian Connect.
                     All CGM systems provide users the ability to share information with a clinician
                  by uploading it to cloud-based storage or having the information downloaded
                  directly during an office visit to a data management application. These data manage-
                  ment applications provide various graphical representations of historical data to help
                  identify trends and patterns that can guide decisions about therapy adjustments.
                     One of the most beneficial features of most CGM systems is the ability to present
                  real time and predictive alerts to notify the user of a hypoglycemic or hyperglycemic
                  event when the measured glucose level reaches a predefined value. Alerts can be an
                  audible sound or physical alert such as a vibration from the transmitter the user is
                  wearing or a notification from the app on the user’s phone. Alerts can be triggered
                  when glucose values are either above or below the limits set by the user, are rising or
                  falling above a defined rate, or are predicted to go above or below a defined limit.
                  System-related alerts will also be presented, for example, to let the user know
                  when to calibrate the device or that a system error has occurred. A user who has
                  received an alert can then check the app to find out more and decide whether any
                  action is required. Some products also provide the ability to share data to a remote
                  monitoring app used by caregivers, such as family and friends. This means, for
                  example, that a parent can receive an alert when their child’s glucose is high or low.
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