Performance Variability of Seven Commonly Used Self-Monitoring of Blood Glucose Systems: Clinical Considerations for Patients and Providers
Open Access
- 1 January 2013
- journal article
- research article
- Published by SAGE Publications in Journal of Diabetes Science and Technology
- Vol. 7 (1), 144-152
- https://doi.org/10.1177/193229681300700117
Abstract
Background: Blood glucose data are frequently used in clinical decision making, thus it is critical that self-monitoring of blood glucose (SMBG) systems consistently provide accurate results. Concerns about SMBG accuracy have prompted the development of newly proposed International Organization for Standardization (ISO) standards: ≥95% of individual glucose results shall fall within ±15 mg/dl of the results of the manufacturer's reference procedure at glucose concentrations 100 mg/dl. We evaluated seven marketed systems against the current and proposed ISO criteria (criterion A). Method: Capillary blood samples were collected from 100 subjects and tested on seven systems: Accu-Chek Aviva Plus, Advocate Redi-Code, Element, Embrace, Prodigy Voice, TRUEbalance, and WaveSense Presto. Results were compared with manufacturer's documented reference system, YSI or perchloric acid hexokinase; three different strip lots from each system were tested on each subject, in duplicate. Results: Compared against current ISO criteria (≥95% within ±15 mg/dl for values <75 mg/dl and ±20% for values ≥75 mg/dl) the Accu-Chek Aviva Plus, Element, and WaveSense Presto systems met accuracy criteria. However, only the Accu-Chek Aviva Plus met the proposed ISO criteria (criterion A) in all three lots. The other six systems failed to meet the criteria in at least two of the three lots, showing lot-to-lot variability, high/low bias, and variations due to hematocrit. Conclusions: Inaccurate SMBG readings can potentially adversely impact clinical decision making and outcomes. Clinicians can reduce controllable variables by prescribing accurate SMBG systems. Adherence to the proposed ISO criteria should enhance patient safety by improving the accuracy of SMBG systems.Keywords
This publication has 15 references indexed in Scilit:
- Point-of-Care Glucose Monitoring in a Critical Care SettingPoint of Care: The Journal of Near-Patient Testing & Technology, 2011
- Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 DiabetesDiabetes Care, 2011
- ROSSO-in-praxi: A Self-Monitoring of Blood Glucose-Structured 12-Week Lifestyle Intervention Significantly Improves Glucometabolic Control of Patients with Type 2 Diabetes MellitusDiabetes Technology & Therapeutics, 2010
- System Accuracy Evaluation of 27 Blood Glucose Monitoring Systems According to DIN EN ISO 15197Diabetes Technology & Therapeutics, 2010
- Evaluation of a simple policy for pre- and post-prandial blood glucose self-monitoring in people with type 2 diabetes not on insulinDiabetes Research and Clinical Practice, 2010
- The Effects of Normal as Compared with Low Hematocrit Values in Patients with Cardiac Disease Who Are Receiving Hemodialysis and EpoetinNew England Journal of Medicine, 1998
- Diabetes in the ElderlyDiabetic Medicine, 1995
- Counterregulatory Hormone Responses to Hypoglycemia in the Elderly Patient with DiabetesDiabetes, 1994
- The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes MellitusNew England Journal of Medicine, 1993
- The Effect of Haematocrit on Reagent Strip Tests for GlucoseDiabetic Medicine, 1991