Table 1.

Checklist A for “Accuracy” Studies: Identifying Weaknesses in Study Designs in Blood Glucose System Accuracy Publications

	Yes	Partial	No
Reference method	Use of reference method specified by the manufacturer. Reference samples analyzed in duplicate and checked for differences. Information given on imprecision, quality assurance, bias, and traceability to higher reference methods.	Reference method appropriate but protocol and performance not fully specified.	Use of a reference method other than specified by the manufacturer. Inappropriate comparison against a hexokinase- or glucose oxidase-based reference.
Comparing “like with like” samples	Comparisons of “like” fresh whole blood specimens. Ideally capillary versus capillary and split sample analysis. Correct collection with minimal delay in analysis and post-collection control of sample handling time. Capillary and venous blood glucose levels should not be assumed to be equivalent.	Appropriate specimens described, but information on collection, protocol, and delays not supplied.	Comparison of capillary against venous samples or other dissimilar correlations.
Number of samples	At least 100 fresh capillary samples and 200 data points.	Minimum of 40 different samples and donors.	Less than 40 samples from different donors.
Spread of glucose concentrations	Sufficient spread of results spanning the analytical range. Percentage of results as in ISO 15197. Capillary samples with very high/low glucose concentrations can be provided by using appropriately modified samples.	Spread of sufficient sample results illustrated diagrammatically but percentage within ranges not provided	No indication of or inappropriate spread of results.
Accuracy criteria	a. A plot of the difference between individual results from meters against the mean of specific reference values plotted as the dependent variable.	Appropriate information only partially supplied.	Information supplied in forms differing to specified acceptance criteria.
	b. Tables of degree of meter results difference compared with the reference method. For reference glucose values (i) <4.2 mmol/L (75 mg/dL) showing the number of meter samples (%) within±0.28 mmol/L (5 mg/dL),±0.56 mmol/L (10 mg/dL), ±0.83 mmol/L (15 mg/dL) of the reference method. For reference glucose values (ii) ≥4.2 mmol/L providing the number of samples (%) within±5%, 10%, 15%, 20% of the reference method.
	c. A summary of results identified as acceptable using current acceptance guidelines.
	d. A clinical accuracy assessment such as by Parkes or consensus error grid analysis.
Number of strip lots	Number of lots used stated. Use of several lots, ideally three different lots, indicates robustness of accuracy.	Use of only one lot of strips. Information of multiple lot use not supplied.	Not applicable.
Full details provided	Sufficient information provided to verify the study was of appropriate design and conclusions were justified and correct. ISO standard 15197 contains a full list of requirements and information. This includes diverse protocol information such as the number of meters, details of lots and reagents, dates of expiry, temperature range, exclusion criteria based on the instructions for use, serial numbers of meters, etc.	A majority of relevant details supplied.	No or few relevant additional details provided.
Independency	Unbiased and independent; conducted at external sites, outpatient clinics or hospital settings; no potential manufacturer bias.	Not applicable.	No clear information if the study was performed independently; no peer review.
Concordance ISO 15197	Full details provided to establish if the study was undertaken appropriately in accordance with ISO standard 15197 or other relevant guidelines and recommendations.	Partial concordance with ISO 15197.	Clear differences in protocol and study design from ISO 15197.