The Health Sciences Authority (HSA) Singapore has issued an advisory to users of app-enabled medical devices, including continuous glucose monitors (CGMs), insulin pumps, automated insulin dosing systems, and other diabetes devices.
This advisory is based on overseas cases where notification alerts failed to activate on users’ smartphones during glucose and/or insulin level fluctuations, potentially leading to serious health risks such as:
- Severe hypoglycemia (low blood sugar)
- Severe hyperglycemia (high blood sugar)
- Diabetic ketoacidosis
- Death
Possible Causes of Alert Failures
- Software Configuration Issues: Changes in app notification permissions, activation of “Do Not Disturb” or “Focus Mode,” or apps entering “deep sleep” after inactivity.
- Newly Connected Hardware: Devices such as wireless earphones or car audio systems may change default volume settings or prevent alerts from being delivered.
- Operating System (OS) Updates: Compatibility issues between new smartphone OS updates and the medical device app.
Additional Resources
Stakeholders should conduct a comprehensive review of their Smartphone-Compatible Diabetes Devices to ensure alerts function properly.
For further details, refer to the official HSA advisory:
🔗 Missing Safety Alerts for Smartphone-Compatible Diabetes Devices
For related guidance from the U.S. FDA, visit:
🔗 FDA Safety Communication
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