System characteristics according to the respective manufacturer’s labeling for blood glucose monitoring systems (BGMS) a to r
# | System | Reagent system | Manufacturer’s reference measurement procedure | Test strip enzyme | Manufacturer* | |
Lot number | Expiry date | |||||
a | ABRA | MPD123C006 | 2020/03 | GOD | GOD | Diagnosis S.A., Poland |
b | Accu-Chek Guide | 100551 | 2019/10 | HK | GDH | Roche Diabetes Care GmbH, Germany |
c | AURUM | TD16G115-BEE | 2019/01 | GOD | GDH | TaiDoc Technology Corp., Taiwan |
d | CareSens Dual | QM20HBB2B | 2020/04 | GOD | GDH | i-SENS, Inc., Korea |
e | CERA-CHEK 1CODE | G48D071711 | 2020/04 | GOD | GDH | Green Cross Medis Corp., Korea |
f | ContourNext One | DP8APEG14B | 2020/01 | GOD | GDH | Ascensia Diabetes Care Holdings AG, Switzerland |
g | eBsensor | I2A0B1H05 | 2020/02 | GOD | GOD | Visgeneer Inc., Taiwan |
h | FreeStyle Freedom Lite | 1041095 | 2020/02 | GOD | GDH | Abbott Diabetes Care Ltd., UK |
i | GL50 evo | D07/1 | 2020/02 | GOD | GDH | Beurer GmbH, Germany |
j | GlucoCheck GOLD | WG18A103-BEE | 2020/01 | GOD | GDH | aktivmed GmbH, Germany |
k | GlucoMen areo 2K | HS180320 | 2020/03 | GOD | GOD | A.Menarini Diagnostics S.r.l., Italy |
l | GluNEO | X18C17-5B2 | 2020/03 | HK† | GDH | Infopia Co., Ltd., Korea |
m | MyStar DoseCoach | PM15WD96L | 2019/01 | GOD | GOD | AgaMatrix Inc., USA Distributor‡: Sanofi-Aventis France, France |
n | OneTouch Verio Flex | 4341526 | 2019/08 | GOD | GDH | LifeScan Europe, Division of Cilag GmbH International, Switzerland |
o | Pic Gluco Test | 1018050006 | 2020/05 | GOD | GOD | SD BioSensor, Inc., Korea |
p | Rightest GM700S | 2117A1201 | 2019/09 | GOD | GDH | Bionime Corp., Taiwan |
q | TRUEyou | HLU1243INT | 2020/10 | GOD | GDH | Trividia Health, Inc., USA |
r | WaveSense JAZZ Wireless | QA03WY28L | 2020/02 | GOD | GOD | AgaMatrix Inc., USA |
*Manufacturer names are given according to the imprints on the systems.
†No information about the manufacturer’s reference measurement procedure was available at the time of manuscript submission. Based on literature research19 and the investigator’s experience regarding reliability of measurement results, the HK-based procedure was assigned as primary reference measurement procedure for system accuracy evaluation.
‡Data from the market research institute (IMS MIDAS Customised Insights, analysis period MAT 08/2017) indicated Sanofi as manufacturer of the reagent system used with BGMS m, as opposed to the labels on the BGMS components that indicate AgaMatrix as manufacturer. This discrepancy was only realized after all materials had been procured; therefore, this BGMS was not replaced.
GDH, glucose dehydrogenase; GOD, glucose oxidase; HK, hexokinase.