Accuracy results from the 10 latest SKUP evaluations of blood glucose systems for self-monitoring of blood glucose (SMBG)

 

Accuracy results from the latest SKUP evaluations of SMBG systems are shown in the table below. In some cases, it may be difficult to compare earlier reports with more recent reports, since SKUP evaluations are under continuous development. For all evaluations, a glucose hexokinase method is used as comparison method. The trueness of the comparison method is documented by means of standard reference material (SRM 965b) from National Institute of Standards & Technology (NIST). The method of each evaluation is given at this website.

 

 

Assessment of accuracy for SMBG systems according to the quality goal in ISO 15197:2013a and a stricter quality goalb, as performed by biomedical laboratory scientists (BLS) and people with diabetes.

SMBG system

Manufacturer

Year/SKUP evaluation no.

Measurements

performed by

n1

Results within ISO 15197:2013

limits (%)

Results within stricter quality

limits (%)

Accu-Chek Instant

Roche Diagnostics

2017/113

BLS

85

Yes (100)

Yes (99)

 

 

 

People with diabetes

85

Yes (99)

No (91)

Accu-Chek Guide

Roche Diagnostics

2017/112

BLS

89

Yes (100)

Yes (96)

 

 

People with diabetes

88

Yes (100)

No (85)

Accu-Chek Aviva

Roche Diagnostics

2014/105

BLS

88

Yes (99)

No (78)

 

 

People with diabetes

88

Yes (95)

No (81)

mylife Unio

Bionime Corporation

2013/100

BLS

81

Yes (100)

Yes (96)

 

 

People with diabetes

81

Yes (99)

No (93)

Accu-Chek Mobile

Roche Diagnostics

2013/99*

BLS

90

Yes (96)

No (78)

Mendor Discreet

Mendor Oy

2012/95

BLS

79

Yes (100)

No (94)

 

 

People with diabetes

80

Yes (96)

No (88)

Contour XT

Bayer Healthcare

2012/94

BLS

81

Yes (100)

Yes (96)

 

 

People with diabetes

82

Yes (100)

No (91)

Accu-Chek Performa

Roche Diagnostics

2011/93*

BLS

89

Yes (99)

No (88)

OneTouch Verio

LifeScan, Johnson & Johnson

2011/86

BLS

87

Yes (99)

No (86)

 

 

People with diabetes

87

No (91)

No (78)

FreeStyle Lite

Abbott Diabetes Care

2010/89*

BLS

90

Yes (100)

No (90)

aMinimum requirement: 95 % of the results shall fall within ±0,83 mmol/L of the average measured values of the reference measurement procedure at glucose concentrations <5,55 mmol/L or within ±15 % at glucose concentrations ≥5,55 mmol/L

bMinimum requirement: 95 % of the results shall fall within ±0,42 mmol/L at glucose concentrations <4,2 mmol/L or within ±10 % at glucose concentrations ≥4,2 mmol/L vs a comparison method

1Number of results included in the assessment of accuracy

*The evaluation was performed only under optimal conditions

 

 

 

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 Last modified: 2018-11-05