[Studie] The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System

Zitat:

Zitat

Seventy-two study participants with type 1 or type 2 diabetes were enrolled by four U.S. clinical sites. A sensor was inserted on the back of each upper arm for up to 14 days. Three factory-only calibrated sensor lots were used in the study. Sensor glucose measurements were compared with capillary blood glucose (BG) results (approximately eight per day) obtained using the BG meter built into the reader (BG reference) and with the YSI analyzer (Yellow Springs Instrument, Yellow Springs, OH) reference tests at three clinic visits (32 samples per visit). Sensor readings were masked to the participants. Results: The accuracy of the results was demonstrated against capillary BG reference values, with 86.7% of sensor results within Consensus Error Grid Zone A. The percentage of readings within Consensus Error Grid Zone A on Days 2, 7, and 14 was 88.4%, 89.2%, and 85.2%, respectively. The overall mean absolute relative difference was 11.4%. The mean lag time between sensor and YSI reference values was 4.5 – 4.8 min. Sensor accuracy was not affected by factors such as body mass index, age, type of diabetes, clinical site, insulin administration, or hemoglobin A1c. Conclusions: Interstitial glucose measurements with the FreeStyle Libre system were found to be accurate compared with capillary BG reference values, with accuracy remaining stable over 14 days of wear and unaffected by patient characteristics.

Kanns inhaltlich bestätigen, die Sensoren taugen. Anfänglich lagen "meine" auch mal chronisch 10-30 Punkte unter Par, seit mehr als einem halben Jahr kann ich mich auf die Readings verlassen. Berücksichtigen muss man, dass nach heiß Duschen eher höhere Werte kommen (bis zu 15 Punkte) und bei richtiger Ruhe auch mal 5-10 unter. Die kleine Verzögerung ist vollkommen akzeptabel, alleine der Trend wiegt diese mehr als nur etwas auf. Bei einer Blutmessung alle 3-5h hab ich keinen Trend, die etwas höhere Genauigkeit nützt mir also wenig bis nichts.

Nettes Futter für einen Erstattungsantrag nebt dazugehöriger Zankerei