Occlusion Detection Time in Insulin Pumps at Two Different Basal Rates

Area of Science:

• Medical Devices
• Diabetes Technology
• Patient Safety

Background:

• Insulin infusion set (IIS) occlusions are critical safety concerns for insulin pump users.
• Current insulin pump standards lack defined time limits for occlusion alarm triggers.
• The IEC 60601-2-24 standard provides guidelines for testing occlusion detection time (ODT) in insulin pumps.

Purpose of the Study:

• To evaluate the occlusion detection time (ODT) of various insulin pump systems.
• To assess ODT performance across different basal insulin delivery rates.
• To identify potential safety risks associated with delayed occlusion detection.

Main Methods:

• Tested ODT for six insulin pump models using different IIS, totaling 10 systems.
• Evaluated pump performance at two basal rates: 1.0 U/h and 0.1 U/h.
• Applied standard test settings and procedures as per IEC 60601-2-24.

Main Results:

• All tested systems demonstrated acceptable ODT (<5 hours) at a 1.0 U/h basal rate.
• At a 0.1 U/h basal rate (common in pediatric patients), median ODT varied widely (approx. 4 to >40 hours).
• Nine out of 10 systems exhibited median ODT exceeding 6-8 hours at the lower basal rate.

Conclusions:

• Insulin pump occlusion alarms may not provide timely warnings at low basal rates.
• Patients using insulin pumps should consistently monitor blood glucose levels.
• Manufacturers need to enhance occlusion detection mechanisms for improved safety, particularly at low delivery rates.