Abstract
Background:
This study was designed to evaluate the accuracy and tolerance in children of an experimental device for continuous glucose monitoring. This real-time glucose sensing (RTGS) system measures transdermal fluid glucose through micropores in the stratum corneum that are kept open by continuous vacuum pressure.
Design and Methods:
A comparison of self-monitored blood glucose values and RTGS values was obtained in 110 children with type 1 diabetes ranging in age from 2 to 18 years. The RTGS system was worn for two periods of 48–56 h each. Children went home and had no restrictions in diet during the data collection period. Physical activity also was not restricted, with the exception of swimming or other water immersion that would interfere with or damage the RTGS.
Results:
The procedure for obtaining transdermal fluid was well tolerated, and adequate flow was maintained out to 48 h or more in most study participants. Comparison of RTGS glucose and self-measured glucose paired values (3,064 values) indicated 69% within Clarke Error Grid Zone A and 21% within Grid Zone B when device tracking was maintained. Errors in tracking occurred with displacement of the vacuum device, or damage to the glucose sensor.
Conclusions:
Transdermal fluid glucose measurements using a prototype device system were well tolerated by children with type 1 diabetes and showed good correlation with concomitant capillary glucose blood measurements. Changes in glucose as tracked by the RTGS system appeared accurate. The durability of the prototype system will need improvement.
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