Interoperability Standards (iCGM) and System Integration

The Vision of Interoperability

Interoperability standards allow diabetes devices from different manufacturers to communicate and work together seamlessly.

FDA Framework

iCGM (Integrated CGM)

Special controls for CGMs intended to work with automated insulin delivery systems.

ACE Pump

Alternate Controller Enabled insulin pump designation for devices that can receive commands from external algorithms.

Benefits of Interoperability

For Patients

• Choose best-in-class components
• Not locked into single manufacturer
• More options for personal preferences

For Innovation

• Smaller companies can develop algorithms
• Faster iteration on individual components
• Competitive pressure improves all devices

For Healthcare

• Easier data integration across platforms
• Standardized data formats
• Improved clinical decision support

Current Interoperable Systems

| Component Type | Examples | |----------------|----------| | iCGM | Dexcom G6, G7 | | ACE Pump | Tandem t:slim X2, Omnipod 5 | | AID Algorithm | Control-IQ, Omnipod 5 algorithm |

Challenges

Technical

• Bluetooth reliability between devices
• Data format standardization
• Security across device boundaries

Regulatory

• Complex approval pathways
• Liability across multiple manufacturers
• Post-market surveillance

Future Directions

• More devices achieving interoperable status
• Standardized APIs and data formats
• Cloud-based algorithm updates
• Smartphone-based control options