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Investigation on the accuracy of the blood glucose monitoring device Prestige IQ.
Diabetes Nutr Metab. 2003 Aug; 16(4):257-61.DN

Abstract

The aim of this study was to investigate the accuracy and reliability of the blood glucose self-monitoring system Prestige IQ (Home Diagnostics, Inc., Ft. Lauderdale, USA) in comparison to an established blood glucose reference method and four commercially available blood glucose self-monitoring devices. Over a 3-month period, 61 patients with Type 1 (T1DM) and Type 2 diabetes mellitus (T2DM) participated in this study. The patients entered the study clinic for two visits. Each visit consisted of 7 glucose determinations in samples of capillary whole blood drawn from the fingertip. The first and last measurements were determined using the laboratory reference and the mean of both readings was used as the reference value for statistical analysis. The 5 remaining glucose measurements were performed in randomized order using the 5 commercially available blood glucose devices. One hundred twenty-one data sets were generated and used to evaluate accuracy. Prestige IQ blood glucose results obtained from the fingertip agreed well with the laboratory reference (linear regression analysis: slope = 1.016; intercept = 0.4 mg/dl; SD = 13.555 mg/dl; correlation r = 0.972) and were comparable to the results generated using the other four blood glucose devices. Bland-Altman analysis for reliability confirmed that 119 out of 121 Prestige IQ results (98.3%) exhibited acceptable accuracy as defined in the new ISO/DIS guideline 15197.2 (85.1-99.2% in this area for the other devices). Error-grid-analysis shows all Prestige IQ glucose results in clinically acceptable zones A and B (95.9% in zone A and 4.1% in zone B). In conclusion, Prestige IQ showed excellent performance with clinically acceptable accuracy and reliability as compared to both the laboratory reference and the four commercially available self-monitoring blood glucose systems.

Authors+Show Affiliations

Institut für Klinische Forschung und Entwicklung (IKFE GmbH), Mainz, Germany. MartinL@ikfe.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

14768776

Citation

Larbig, M, et al. "Investigation On the Accuracy of the Blood Glucose Monitoring Device Prestige IQ." Diabetes, Nutrition & Metabolism, vol. 16, no. 4, 2003, pp. 257-61.
Larbig M, Forst T, Mondok A, et al. Investigation on the accuracy of the blood glucose monitoring device Prestige IQ. Diabetes Nutr Metab. 2003;16(4):257-61.
Larbig, M., Forst, T., Mondok, A., Forst, S., & Pfützner, A. (2003). Investigation on the accuracy of the blood glucose monitoring device Prestige IQ. Diabetes, Nutrition & Metabolism, 16(4), 257-61.
Larbig M, et al. Investigation On the Accuracy of the Blood Glucose Monitoring Device Prestige IQ. Diabetes Nutr Metab. 2003;16(4):257-61. PubMed PMID: 14768776.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Investigation on the accuracy of the blood glucose monitoring device Prestige IQ. AU - Larbig,M, AU - Forst,T, AU - Mondok,A, AU - Forst,S, AU - Pfützner,A, PY - 2004/2/11/pubmed PY - 2004/5/15/medline PY - 2004/2/11/entrez SP - 257 EP - 61 JF - Diabetes, nutrition & metabolism JO - Diabetes Nutr Metab VL - 16 IS - 4 N2 - The aim of this study was to investigate the accuracy and reliability of the blood glucose self-monitoring system Prestige IQ (Home Diagnostics, Inc., Ft. Lauderdale, USA) in comparison to an established blood glucose reference method and four commercially available blood glucose self-monitoring devices. Over a 3-month period, 61 patients with Type 1 (T1DM) and Type 2 diabetes mellitus (T2DM) participated in this study. The patients entered the study clinic for two visits. Each visit consisted of 7 glucose determinations in samples of capillary whole blood drawn from the fingertip. The first and last measurements were determined using the laboratory reference and the mean of both readings was used as the reference value for statistical analysis. The 5 remaining glucose measurements were performed in randomized order using the 5 commercially available blood glucose devices. One hundred twenty-one data sets were generated and used to evaluate accuracy. Prestige IQ blood glucose results obtained from the fingertip agreed well with the laboratory reference (linear regression analysis: slope = 1.016; intercept = 0.4 mg/dl; SD = 13.555 mg/dl; correlation r = 0.972) and were comparable to the results generated using the other four blood glucose devices. Bland-Altman analysis for reliability confirmed that 119 out of 121 Prestige IQ results (98.3%) exhibited acceptable accuracy as defined in the new ISO/DIS guideline 15197.2 (85.1-99.2% in this area for the other devices). Error-grid-analysis shows all Prestige IQ glucose results in clinically acceptable zones A and B (95.9% in zone A and 4.1% in zone B). In conclusion, Prestige IQ showed excellent performance with clinically acceptable accuracy and reliability as compared to both the laboratory reference and the four commercially available self-monitoring blood glucose systems. SN - 0394-3402 UR - https://www.unboundmedicine.com/medline/citation/14768776/Investigation_on_the_accuracy_of_the_blood_glucose_monitoring_device_Prestige_IQ_ L2 - https://medlineplus.gov/diabetestype2.html DB - PRIME DP - Unbound Medicine ER -