Dose Accuracy and Reliability of a Connected Insulin Pen System

Area of Science:

• Medical Devices
• Diabetes Technology
• Pharmaceutical Engineering

Background:

• Insulin pen injection therapy is crucial for diabetes management.
• Dose accuracy and reliability are critical for effective insulin therapy.
• The Tempo Pen system with Tempo Smart Button aims to enhance insulin delivery.

Purpose of the Study:

• To evaluate the dose accuracy of the Tempo Pen system.
• To assess the reliability of the Tempo Smart Button in data detection, storage, and transmission.
• To ensure compliance with International Organization for Standardization (ISO) standards.

Main Methods:

• Testing the Tempo Pen system with the Tempo Smart Button under standard atmospheric conditions.
• Evaluating three specific insulin doses for accuracy.
• Assessing the Module's performance in detecting, storing, and transmitting dose data.
• Comparing results against ISO 11608-1:2014 requirements.

Main Results:

• The Tempo Pen system met ISO 11608-1:2014 requirements for dose accuracy across all tested doses.
• Mean doses delivered were 0.010 mL (0.002 mL SD), 0.299 mL (0.002 mL SD), and 0.597 mL (0.004 mL SD).
• The Smart Button Module successfully met data transfer requirements after each injection.

Conclusions:

• The Tempo Pen system demonstrates accurate insulin dose delivery.
• The integrated Smart Button reliably captures and stores essential insulin dosing information.
• The system provides a dependable solution for insulin injection therapy in diabetes management.