A Precision Index for Evaluation of Techniques for Self-Monitoring of Blood Glucose

Hallé, Jean‐Pierre; Lambert, Jean; Renaud, E.; Toupin, Aline; Legault, Claudine; Lalumière, Gaston

doi:10.2337/diacare.9.3.319

Cited by 9 publications

(8 citation statements)

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“…All kinds of deviations from the reference curve have been observed (Table 3; Figs. [3][4][5]. The best-performing meter, Accu-Check II, deviated at the hypo-and hyperglycemic ranges to the same small degree (Fig.…”

Section: Resultsmentioning

confidence: 95%

“…[3][4][5]. The total deviation of the best performance equalled 16% (TDF = 1.16, Accu-Check II) and 108% of the poorest performance (TDF = 2.08, Glucocheck SC).…”

Section: Resultsmentioning

confidence: 99%

“…The reproducibility and concordance rate (Table 1C) is mainly used for qualitative or grouped quantitative data. Mean difference or mean relative (percent) difference (Table 1D) represents only a measure of total deviation and does not represent a measure of accuracy or precision, as, for example, the precision index (5) seems to suggest. The precision index in fact uses the mean relative difference to evaluate an SMBG device.…”

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confidence: 98%

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New Approach to Technical and Clinical Evaluation of Devices for Self-Monitoring of Blood Glucose

Koschinsky

Dannehl

1988

Diabetes Care

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Despite the wide distribution of devices for self-monitoring of blood glucose (SMBG), there is no internationally accepted agreement on a standardized procedure for their evaluation. This is due to incomplete or even inappropriate technical evaluation and to inadequate evaluation criteria for their clinical acceptability. To provide adequate information on the performance of these devices over the whole clinically relevant range for SMBG (30-350 mg/dl), a standardized test procedure has been established for technical (accuracy, precision, and total deviation) and clinical (acceptance analysis) evaluation. To demonstrate the potency of this new approach, the following SMBG devices and test strips were evaluated: Chemstrip bG batch (n = 10), Glucostix batch (n = 2), Accu-Check II (n = 5), Diascan (n = 5), Diascan strip batch (n = 4), Glucocheck SC (n = 4), and Glucometer II (n = 4). The devices and test strips were examined by trained technicians, and in addition, 1 Chemstrip bG batch and 2 Accu-Check II meters were examined by 10 and 5 trained diabetic patients, respectively. Even the best-performing device did not achieve the American Diabetes Association's goal that SMBG measurements should be within 15% of the reference value. Instead, the maximal total deviation within the clinically relevant blood glucose range reached values that equalled deviations from the reference value between 16 and 108%. Three of 36 devices were classified as good, 29 as acceptable, and 4 as unacceptable for clinical use. In conclusion, this new approach to the technical and clinical evaluation of devices for SMBG is easy to perform and provides more realistic and comparable information for clinical use and approval than commonly used methods.

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Section: Resultsmentioning

confidence: 95%

“…[3][4][5]. The total deviation of the best performance equalled 16% (TDF = 1.16, Accu-Check II) and 108% of the poorest performance (TDF = 2.08, Glucocheck SC).…”

Section: Resultsmentioning

confidence: 99%

mentioning

confidence: 98%

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New Approach to Technical and Clinical Evaluation of Devices for Self-Monitoring of Blood Glucose

Koschinsky

Dannehl

1988

Diabetes Care

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“…Error scores for Farnsworth-Munsell 100-hue color vision test. *P < 0.01. mean percentage deviation (relative SMBG error) from the reference determination of 8-12 blood glucose samples/patient obtained after intensive training in SMBG (14).…”

Section: Methodsmentioning

confidence: 99%

Color Discrimination and Accuracy of Blood Glucose Self-Monitoring in Type I Diabetic Patients

et al. 1991

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“…Similar arguments should be applied to terms like precision index (7), which does not represent precision. Devices for laboratory use in clinical chemistry are evaluated technically worldwide by the concept of accuracy and precision.…”

Section: Replymentioning

confidence: 99%

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Dannehl¹,

Koschinsky²,

Gries³

1989

Diabetes Care

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A Precision Index for Evaluation of Techniques for Self-Monitoring of Blood Glucose

Cited by 9 publications

References 0 publications

New Approach to Technical and Clinical Evaluation of Devices for Self-Monitoring of Blood Glucose

New Approach to Technical and Clinical Evaluation of Devices for Self-Monitoring of Blood Glucose

Color Discrimination and Accuracy of Blood Glucose Self-Monitoring in Type I Diabetic Patients

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