Table 3

Results of performance on each of their three studies, including total number of studies meeting the predetermined accuracy standard and total number of data points within protocol limits

Brand BGM Test stripStudy 1Study 2Study 3Total number of studies meeting accuracy standard/number of valid trialsTotal data points within protocol limits
NPercentage compliantMet accuracy standard?NPercentage compliantMet accuracy standard?NPercentage compliantMet accuracy standard?N%
BayerContour NextContour Next9899Pass101100Yes113100Yes3/312311100
RocheAccu-Chek Aviva PlusAccu-Chek Aviva Plus9797Yes101100Yes11398Yes3/31130698
ARKRAYWalmart ReliOn Confirm (Micro)ReliOn Confirm/Micro10096Yes11496Yes10399Yes3/31730797
AgaMatrixCVS AdvancedCVS Advanced10196Yes11496Yes10398Yes3/31830797
Abbott Diabetes CareFreeStyle LiteFreeStyle Lite9892Yes10196Yes11398Yes3/31229896
RocheAccu-Chek SmartViewAccu-Chek SmartView10898Yes10696Yes10692Yes3/32030595
ARKRAYWalmart ReliOn PrimeReliOn Prime9885No10195Yes11396Yes2/31228892
LifeScanOneTouch VerioOneTouch Verio10887No10698Yes10591Yes2/31929492
ProdigyProdigy AutoCodeProdigy No Coding9886No10192Yes11393Yes2/31228290
LifeScanOneTouch Ultra 2OneTouch Ultra9792Yes10184No11394Yes2/31128090
Abbott Diabetes CareWalmart ReliOn UltimaReliOn Ultima10796Yes10697Yes10675No2/31928589
BayerContour ClassicContour10895Yes10685No10686No1/32028489
Omnis HealthEmbraceEmbrace No-Code10287No11493Yes10384No1/31928288
HDI/NiproTRUEresultTRUEresult10194Yes11483No10386No1/31827988
HDI/NiproTRUEtrackTRUEtrack10283No10380NoNo*0/20516781
BioSense MedicalSolus V2Solus10856No10684No10689No0/32024476
Diabetic Supply of SuncoastAdvocate Redi-Code +Advocate10288No11471No10368No0/31924176
Philosys, Inc.Gmate SMARTGmate10861No10679No10672No0/32022671
  • In studies 1, 2, and 3, each of the 18 BGMs was tested at three different sites. Over the three studies, each BGM was tested once by each site. The number of compliant readings needed to meet the accuracy standard depends on the number of trials. For 100 trials, at least 91 readings must be within 15% or 15 mg/dL (0.83 mmol/L) of the reference value.

  • *No study 3 data for HDI/Nipro TRUEtrack because of test strip recall.

  • †Within 15% of reference value if ≥100 (5.55 mmol/L) or 15 mg/dL (0.83 mmol/L) of reference value if ≤100 mg/dL (5.55 mmol/L).