Dexcom One+ iOS app version 1.2 fails to update glucose values
The Spanish medicines regulator AEMPS warned that version 1.2 of the Dexcom One+ iOS continuous glucose monitoring app may stop updating blood sugar values and fail to trigger alerts, potentially preventing detection of dangerous glucose episodes or leading to incorrect treatment decisions.
What happened
The Spanish medicines regulator AEMPS identified a fault in version 1.2 of the Dexcom One+ iOS continuous glucose monitoring (CGM) app that could cause it to stop updating estimated glucose values, preventing alerts from activating.
The app's trend graph could continue advancing in time without incorporating new estimated glucose values, potentially causing displayed data points to disappear or the trend graph to vanish entirely.
Reported impact
Users unaware that glucose values are no longer updating could fail to detect hyperglycemia or hypoglycemia episodes, or make treatment decisions based on incorrect data.
The system is designed to measure glucose levels continuously for people over two years old, including pregnant women, and is intended to replace finger-prick blood glucose tests for treatment decisions.
Index analysis
The app's failure to update values removes a critical safeguard for detecting dangerous glucose fluctuations, which the system is specifically designed to identify to facilitate short and long-term therapy adjustments.
Governance controls
Dexcom sent in-app notifications to patients informing them of the problem and recommended actions. The AEMPS instructed patients to verify receipt of the warning notification and check their software version, and to contact Dexcom if they did not receive notification.
Classification
Sources and evidence
This record was researched and written by the Index, based on the following original reporting.