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Clinical Chemistry 53: 1122-1128, 2007. First published May 3, 2007; 10.1373/clinchem.2006.083493
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(Clinical Chemistry. 2007;53:1122-1128.)
© 2007 American Association for Clinical Chemistry, Inc.

General Clinical Chemistry

Assessing the Quality of Glucose Monitor Studies: A Critical Evaluation of Published Reports

John Mahoney1,a and John Ellison2

Departments of1 Global Product Support and 2 Clinical Research, LifeScan, Inc.

aAddress correspondence to this author at: LifeScan, Inc., 1000 Gibraltar Dr., M/S 3I, Milpitas, CA 95035-6312. Fax 1-408-941-9892; e-mail address jmahoney{at}lfsus.jnj.com.


   Abstract
Top
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Background: In recent years, a large number of studies have been published on the performance of glucose monitors. The quality of these reports is not known.

Methods: We searched the PubMed database for performance evaluations of handheld glucose monitors published from August 2002 to November 2006. Relevant articles were compared to 20 recommendations from the Standards for Reporting Diagnostic Accuracy (STARD) and 18 recommendations from the Clinical and Laboratory Standards Institute (CLSI).

Results: A total of 52 reports met our inclusion criteria and were reviewed. None (0%) of the reports conformed to all 38 STARD and CLSI recommendations. The range of compliance to these recommendations varied widely (median 53%; range 21%–84%). Only 1 study of the 52 reported following a CLSI recommendation for checking reference test results. Fewer than half (42%) of the reports contained STARD-recommended statements regarding how and when comparative measurements were performed.

Conclusions: None of the glucose monitor reports from our review conformed to all STARD and CLSI recommendations. Our finding that the average rate of compliance to recommendations was low suggests that many of the researchers did not follow published recommendations for study design, methodology, and reporting and that study quality and conclusions may have been affected. Future studies evaluating the performance of glucose monitoring systems should be carefully designed and follow published recommendations for methodological and reporting quality.


   Introduction
Top
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 References
 
Glucose monitors, when used in conjunction with appropriate interventional treatment, can effectively improve glycemic control (1). The US Food and Drug Administration (FDA)1 has cleared more than 200 glucose monitors for home and institutional use (2). To ascertain whether or not a monitor is acceptable for its intended use, the FDA carefully reviews clinical and laboratory evidence provided by the device manufacturer (3).

Clinicians are advised to evaluate medical devices before initial use (4). Some glucose monitor evaluations published by clinicians have reported poor results and have concluded that data from glucose monitors are unreliable (5), unsatisfactory (6), or show concentration dependency (7). Other clinicians have reported positive results—in some cases using the same monitor—and have concluded that data from glucose monitors are accurate and meet performance expectations (8)(9). This inconsistency in the literature is problematic because it causes confusion and may slow adoption of new indications for glucose monitors (e.g., continuous glucose monitoring).

Four potential sources of error must be considered in the evaluation of any analytical device: (a) analytical imprecision, (b) analytical bias, (c) protocol-specific bias, and (d) random patient interferences (10). Device manufacturers are generally knowledgeable about these sources of error and carefully follow procedures to control them. Bias and imprecision are controlled by testing products that conform to specifications, protocol-specific bias by adherence to careful study design, and random patient interferences by inclusion and exclusion criteria for recruitment of study participants.

Clinicians performing evaluation studies also need to be cognizant of protocol-design factors and potential sources of error (11). Guidelines have been published in an attempt to educate clinicians on proper study methodology and reporting (12)(13). Although the Standards for Reporting Diagnostic Accuracy (STARD) guidelines are intended for studies of diagnostic accuracy (13) rather than for studies of analytical performance, many of the items of the STARD checklist are important for the readers’ interpretation of either type of study. The purpose of our study was to compare recent reports on blood glucose monitor performance to these guidelines.


   Materials and Methods
Top
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
search strategy and report criteria
We searched the PubMed database for articles from August 2002 to November 2006 using combinations of the words: blood glucose, performance, evaluation, accurate, accuracy, point-of-care, meter, glucometer, and monitor. The reference lists of the selected articles were also reviewed and personal files were hand searched for additional reports. Studies selected for inclusion were published analytical evaluations of marketed, handheld, blood glucose monitoring systems that used a laboratory method as a comparison method. We excluded studies that were not in English, studies of nonhuman blood samples, and studies of continuous monitoring and noninvasive devices. Our PubMed search terms and details were as follows: ("blood glucose"[MeSH Terms] OR blood glucose[Text Word]) AND (performance[Text Word] OR evaluation[Text Word] OR accurate[Text Word] OR accuracy[Text Word] OR point-of-care[Text Word] OR meter[Text Word] OR meters[Text Word] OR glucometer[Text Word] OR glucometers[Text Word] OR monitor[Text Word] OR monitors[Text Word]) AND ("2002/08/01"[PDAT]: "2006/11/01"[PDAT]) AND English

Formula

AND "humans"[MeSH Terms].

assessment
One reviewer (J.E.) screened the titles from the computer-based search to determine relevant articles for retrieval. If the title did not provide enough information to decide whether or not to include the study, the abstract was read. The full article was retrieved if the abstract did not provide enough information. Studies were eliminated if both reviewers (J.M., J.E.) agreed that the report did not meet inclusion criteria. We obtained printed copies of all articles meeting our inclusion criteria. To evaluate the quality of reporting, we chose the 25-item STARD checklist (13)(14). However, because whole blood glucose monitors are not diagnostic devices, 5 STARD criteria (STARD checklist items 1, 9,12, 21, and 23) were deemed not applicable and were not scored. Because study methodology should be evaluated independently of the quality of the reporting (15), we developed an additional 18-item method checklist based on Clinical and Laboratory Standards Institute (CLSI) C30-A2 (12).

In analyzing published reports, we found that not all STARD or CLSI factors were obvious or clearly reported. In addition, the omission of procedural statements in the report was considered to indicate only that the procedures were not reported, not that they were not performed. Therefore, we assigned a yes (1-point) or no (0-point) value to each recommendation on our checklists depending on whether the authors had (1) included the recommended procedure in the report, (2) included supporting data confirming the use of the recommended procedure, or (3) acknowledged in the report that the recommended procedure had been considered. Differences in interpretation and discrepancies in ratings between the 2 reviewers were rare and were settled via consensus after additional review of the report for supporting evidence.

Each checklist item was given a numerical value of 1 point. Possible points included 20 STARD (reporting) items and 18 CLSI (methodological) items, for a possible maximum of 38 points. Calculations were based on percentages of 38 total points, 20 (STARD), and 18 (CLSI) points. Correlation with P = 0.05 was considered significant.


   Results
Top
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
A total of 1407 titles/abstracts were retrieved, of which 93 were initially proposed (Fig. 1 ). On further review, 41 of these studies were found ineligible and were excluded. Exclusions were because of inappropriate (nonhuman fresh whole blood) test samples or the use of an inappropriate reference method (e.g., methods not traceable to materials or methods of higher order). For the 52 selected reports published between August 2002 and November 2006, the scores ranged from a high of 32 points (84%) to a low of 8 points (21%) (Table 1 ). The average score of the glucose monitor reports was low (median score, 20 of 38 points or 53%). No published report incorporated 100% of the quality factors recommended by STARD or CLSI. The CLSI checklist developed by the authors and the percentage of conforming reports to 18 CLSI recommendations (range 2%–92%) is shown in Table 2 , and the STARD checklist and the percentage of reports that conformed to 20 STARD recommendations (range 0%–100%) in Table 3 .


Figure 1
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  		Figure 1. Flow chart of literature search and the number of studies meeting search criteria.


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  		Table 1. Clinical glucose monitor studies and their conformance to 38 recommended study factors [STARD (20) + CLSI (18) = 38].


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  		Table 2. CLSI quality recommendations for glucose monitor evaluation studies, and the percentage of 52 studies that were found to contain conforming statements or data pertaining to these CLSI recommendations.


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  		Table 3. STARD recommendations applied to 52 published glucose monitor evaluation studies, and the percentage of these studies that were found to contain conforming statements or data regarding STARD recommendations.

No significant trend was found when the report scores were grouped by journal type or assessed by date of publication (P = 0.5). Neither the source journal nor dates of publication were found to be predictive of report conformity to published recommendations.


   Discussion
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
Our study shows that the average glucose monitor report used only ~50% of the combined CLSI and STARD recommendations and that the overall quality of reports is low. Compliance to these recommendations varied widely (range 21%–84%), and none of the 52 reports conformed to all recommendations. These findings suggest that many investigators disagree with, are unaware of, or are neglectful of published CLSI and STARD recommendations for conducting and reporting glucose monitor evaluation studies.

A report’s procedural statements, especially how and when monitor and reference measurements are performed, provide important information regarding the quality and reproducibility of the study. We found that only 42% of the studies reported this information (Table 3Up ) and only 13% reported following appropriate sample timing and handling procedures (Table 2Up ). Control of sampling time is important because after a carbohydrate load blood glucose can change rapidly at a sampling site (63). Postcollection control of sample handling time is also important because glycolysis can cause rapid glycemic change, depending on the hematocrit (64). If either of these circumstances is not controlled, observed differences in the data could be caused by glycemic concentration differences in the comparative samples instead of differences between the 2 methods.

We observed that many investigators made a number of assumptions. Some assumed that the concentration of glucose in capillary and venous blood is equivalent, although equivalence cannot be assumed for individuals in the postprandial state (65). In addition, 29 (56%) of 52 studies reported testing the same sample with both monitor and comparative methods (Table 2Up ). Thus for the other 23 reports, observed differences in the data may be attributable to glycemic concentration differences in the comparative samples. Most investigators also assumed that there is little error associated with their reference method; only 19% checked the bias of their reference with traceable materials (Table 2Up ), although reference glucose methods can have a total error of up to 10% (66). Only 1 of the studies reported that they followed CLSI advice to check that duplicate reference tests were stable and acceptable.

Reports differed considerably in regard to the use of appropriate acceptance criteria for glucose monitor performance. Many reports used expert opinion, medical society opinion, or their own acceptance criteria, whereas relatively few used CLSI acceptance criteria for glucose monitors (12) (Table 2Up ), which are identical to acceptance criteria published by the International Standards Organization (67).

One limitation of our study was our choice to limit our search to English language reports, although we believe that inclusion of studies published in other languages would not alter our conclusions. In addition, glucose monitor evaluation studies exist (not revealed by our search) that are, in our opinion, of relatively high quality. The Scandinavian Evaluation of Laboratory Equipment for Primary Health Care (SKUP) has performed a number of monitor evaluation studies and has issued reports. A review of 2 reports found that SKUP followed 100% of CLSI recommendations and 85% of STARD recommendations (68), (69). These 2 reports emphasized monitor training, performed a thorough reference method evaluation, tested duplicate monitor tests, tested the reference method before and after the monitor testing, properly checked [within 4% or 0.22 mmol/L (4 mg/dL)] the duplicate reference tests to ensure both method and glycemic stability, and emphasized control of elapsed time and glycolysis. Unfortunately, these SKUP reports are not found in the PubMed database.

To our knowledge, a single, published checklist that includes key reporting and methodological factors for glucose monitor evaluations does not exist. We selected the STARD and CLSI checklists because they are published and both contain important elements. Our study shows that although a large number of glucose monitor evaluation studies have been published over a 4-year period, investigators did not address many of the variables that can adversely impact internal and external validity. All glucose-monitoring systems have performance limitations [e.g., hematocrit extremes (70)] that are included in the published manufacturer labeling, yet we found several studies in which the devices were evaluated under off-label conditions. The availability and ease with which clinicians can perform evaluation studies using glucose monitors is relatively unique among in vitro tests. With the growing incidence of diabetes and new technologies for measuring blood glucose on the horizon, it is reasonable to believe that the number of such studies will continue to grow. We believe that a checklist that combines key elements from the STARD and CLSI recommendations, if published and used, would help to improve the quality of monitor evaluation studies and could form the basis for future checklists applicable to continuous monitoring and noninvasive devices. Such a tool has the potential to improve the quality of future studies.

We conclude that none of the glucose monitor evaluation reports in our review conform to all published quality recommendations, and that the overall quality of reports is low. The range of conformance to STARD and CLSI recommendations varied widely, suggesting that many of the researchers did not follow published recommendations for study design and methodology, an omission that may have adversely affected study quality. Future studies evaluating glucose monitoring systems should be carefully designed and should follow published recommendations for methodological and reporting quality.


   Acknowledgments
 
Grant/funding support: LifeScan, Inc., provided funding for this study.

Financial disclosures: Both authors are employees of LifeScan, Inc., a Johnson & Johnson company, and both hold equity interests in Johnson & Johnson.

Acknowledgements: We thank Drs. David Horwitz and David Price for their helpful suggestions and comments. A portion of this work was presented in poster format at the 2006 AACC Annual Meeting, Chicago, IL.


   Footnotes
 
1 Nonstandard abbreviations: FDA, Food and Drug Administration; STARD, Standards for Reporting Diagnostic Accuracy; CLSI, Clinical and Laboratory Standards Institute; SKUP, Scandinavian Evaluation of Laboratory Equipment for Primary Health Care.


   References
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 Introduction
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 Discussion
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