Clinical evaluation of a transcutaneous interrogated fluorescence lifetime-based microsensor for continuous glucose reading.
BACKGROUND
Continuous glucose monitoring is presently used worldwide. Accuracy, precision, durability, invasiveness, and lack of drift of sensors and lag time are key parameters essential to these systems. This article describes a new online minimally invasive biodegradable microsensor for optical, transcutaneous interrogation, which has at least 14 days of functionality.


METHODS
Studies were performed in vitro and in vivo on pigs, as well as on type 1 diabetic humans. Functionality has been ensured in laboratory settings, and precision and durability have been tested in vivo. During in vivo studies, venous blood samples were used as reference. Results were based on one single point calibration per experiment.


RESULTS
Excellent stability was found in 14-day in vitro trials as well as in vivo in up to 70-hour trials. The overall median relative absolute difference of type 1 diabetic patients was 11.4%. Error grid analysis showed 97.7% of all values in the A+B zone. Comparable results were found in animal studies. No sensor drift was observed in any trial.


CONCLUSIONS
Results point toward the possibility of developing a stable and precise minimally invasive glucose reader for at least 2 weeks of continuous use.
Nielsen
Jannik K
JK
Department of Diabetes and Endocrinology, Aarhus University Hospital, Aarhus C, Denmark. j.k.n@dadlnet.dk
Christiansen
Jens S
JS
Kristensen
Jesper S
JS
Toft
Hans O
HO
Hansen
Lars Lundby
LL
Aasmul
Søren
S
Gregorius
Klaus
K
D000328:Adult; D000818:Animals; D015374:Biosensing Techniques / Q000295:instrumentation / Q000379:methods; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000295:instrumentation* / Q000379:methods*; D013552:Swine
D001786:Blood Glucose