Comparative Performance Analysis of Manual and Updated Optional Calibration Algorithms for the CareSens Air CGM...

Area of Science:

• Biomedical Engineering
• Medical Devices
• Diabetes Technology

Background:

• The CareSens Air continuous glucose monitoring (CGM) system (CSAir) initially required manual calibration and had a 2-hour warm-up period.
• Product development led to an updated algorithm reducing the warm-up time to 30 minutes and making calibrations optional.

Purpose of the Study:

• To compare the performance of the CareSens Air CGM system using its original manual calibration algorithm versus the updated algorithm.
• To evaluate the accuracy, reliability, and user satisfaction of the updated CSAir system.

Main Methods:

• Thirty adults with diabetes participated, wearing three CSAir sensors for 15 days each.
• In-clinic sessions involved frequent capillary comparator measurements and glucose level manipulation.
• Accuracy was assessed using mean absolute relative difference (MARD) and 20/20 agreement rates (AR).

Main Results:

• The updated algorithm demonstrated superior accuracy with a 93.9% 20/20 AR and 8.7% MARD, compared to 90.1% and 9.9% for the manual algorithm.
• High clinical accuracy was confirmed by Diabetes Technology Society Error Grid analysis (92.4% in zone A for updated algorithm).
• The system showed good sensor wear time, positive user satisfaction, and no safety concerns.

Conclusions:

• Both CSAir algorithms performed reliably, with the updated version showing enhanced accuracy.
• The CareSens Air CGM system, particularly with the updated algorithm, is suitable for nonadjunctive diabetes management.