678263

review-article2016
DSTXXX10.1177/1932296816678263Journal of Diabetes Science and TechnologySchnell et al

Review Article

Journal of Diabetes Science and Technology

Impact of HbA1c Testing at Point of

2017, Vol. 11(3) 611­–617
© 2016 Diabetes Technology Society
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DOI: 10.1177/1932296816678263
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Oliver Schnell, MD1, J. Benjamin Crocker, MD2,

and Jianping Weng, MD3

Abstract
Diabetes is a highly prevalent disease also implicated in the development of several other serious complications like
cardiovascular or renal disease. HbA1c testing is a vital step for effective diabetes management, however, given the low
compliance to testing frequency and, commonly, a subsequent delay in the corresponding treatment modification, HbA1c at
the point of care (POC) offers an opportunity for improvement of diabetes care. In this review, based on data from 1999 to
2016, we summarize the evidence supporting a further implementation of HbA1c testing at POC, discuss its limitations and
propose recommendations for further development.

Keywords
diabetes management, glycemic control, HbA1c testing, point-of-care

One and a half decades ago, the worldwide prevalence of management optimization. We will also discuss potential
diabetes was 171 million, while the prediction was 366 mil- risks while presenting potential venues for implementation
lion patients by 2030.1 More recent estimates point to more and risk mitigation.
than 640 million people being affected by this disease by
2040.2 With clear links to multiple comorbidities such as car-
Background: Rationale for HbA1c
diovascular disease (including hyperlipidemia, coronary
artery disease, and stroke),3,4 renal disease, (chronic renal Testing
insufficiency, dialysis and transplantation), infections, malig- HbA1c measurement has for decades been considered one of
nancy, and functional impairment, diabetes places a tremen- the most important laboratory medical advances in diabetes
dous financial burden on both patients and health care care. Its implementation in clinical practice in the 1970s rep-
systems. In 2012 the American Diabetes Association (ADA) resents a milestone in follow-up and treatment guidance of
estimated total economic cost of diabetes care in the United patients with diabetes.9 Soon thereafter, both landmark stud-
States at $245 billion,5 accounting for more than 1 in 5 of all ies of the Diabetes Control and Complications Trial (DCCT)
health care dollars spent. in type 1 diabetes10 and the United Kingdom Prospective
Glycated hemoglobin A1c (HbA1c) testing plays a key Diabetes Study (UKPDS) in type 2 diabetes11 emphasized
role in the management of diabetes.6 Guidelines on HbA1c the role for HbA1c in diabetes management.7 A link between
testing frequency and treatment modifications aim at sup- HbA1c and diabetic complications was confirmed and the
porting the achievement of glycemic targets. However, low need for adequate glycemic control underscored.9
adherence to these recommendations among adult patients HbA1c values represent average glycemic control over the
with type 2 diabetes has been reported.7 Even when no clear past 2-3 months and account for both preprandial and postpran-
explanation has been found as to why this is the case, the dial blood glucose levels. Regular HbA1c measurement is
rapid availability of HbA1c testing results has been shown to
facilitate diabetes management.7 In response to this, HbA1c
1
testing at the point-of-care is currently increasing. The ADA Forschergruppe Diabetes e.V., Neuherberg Munich, Germany
2
recommends point-of-care (POC) testing for HbA1c to offer MGH, Ambulatory Practice of the Future, Boston, MA, USA
3
Department of Endocrinology and Metabolism, The Third Affiliated
the opportunity for more timely treatment changes, while the Hospital Sun Yat-Sen University, Guangzhou, China
International Diabetes Federation (IDF) recommends deter-
mination of HbA1c either at the POC or in the laboratory Corresponding Author:
Oliver Schnell, Forschergruppe Diabetes e.V. at the Helmholtz Center,
before clinical consultation.6,8 The aim of this paper is to Munich, Ingolstaedter Landstrasse 1, 85764 Neuherberg Munich,
present current evidence supporting the utility of HbA1c Germany.
testing at POC and to summarize its usefulness for diabetes Email: [email protected]
612 Journal of Diabetes Science and Technology 11(3)

Figure 1.  Comparison process duration between lab testing and POC testing.

recommended by international guidelines for all patients with patient visit due to the turnaround time required for testing
diabetes for the assessment of glycemic control6,12,13 by provid- and reporting. Thus, health care providers have to communi-
ing information on long-term glycemic status and reliably pre- cate the test result and treatment modifications sometime
dicting risk for diabetes-related complications.6,14-20 However, after the patient’s visit. This delay in communicating results
even though glycemic control has been shown to be signifi- can delay intensification or modification of treatment and
cantly related to adherence to HbA1c testing frequency and reduce patient adherence to the treatment plan.23 Previsit
treatment modification recommendations, compliance to these HbA1c testing (taken some days before the clinical visit),
recommendations is observed in only about 3% of patients.7 can be inconvenient and costly for patients due to the extra
A major challenge in successful diabetes management is time and cost invested and lost in a second visit,24 moreover
addressing poor glycemic control. According to NHANES patients often arrive for clinical consultation without having
(National Health and Nutrition Examination Survey), only visited the laboratory as instructed. For a comparison on time
63.7% of the patients with diagnosed diabetes met their indi- costs of POC testing versus lab testing, see Figure 1.
vidual goal for HbA1c.21 Approximately 50-60% of patients POC testing is defined as “testing at or near the site of
with HbA1c levels above target are either not adherent to patient care wherever that medical care is needed.”25 The
their diabetes care plan or are not on an aggressive enough intention of POC testing is to facilitate immediate medical
care plan to intensify glycemic control.22 Delays in treatment decisions and therefore, to improve patient outcomes.25 The
escalation are reported to cause not only long (>12 months) rapid availability of HbA1c results permits the discussion of
periods of hyperglycemia, but also to diminish the chance of the results face-to-face, and has the potential to improve
success once therapy is eventually intensified.22 patient-doctor dialogue and patient satisfaction, thereby
Good glycemic control is a prerequisite for prevention and facilitating improved glycemic control.26 HbA1c testing at
reduction of complications. Given the importance of good POC was shown to potentially improve diabetes manage-
glycemic control in general health outcomes, regular HbA1c ment if undertaken within an adequate comprehensive qual-
testing is recommended for all patients with diabetes.6 HbA1c ity management system.11
testing should be performed based on the clinical situation To assess the current knowledge on HbA1c testing at
and treatment strategy. In general, patients with stable glyce- POC, a literature research including PubMed/Medline,
mia should have at least biannual testing, while patients with EMBASE, and Cochrane library was conducted. Keyword
unstable glycemia or unmet glycemic targets should be tested sets combined primarily “HbA1c” and 1 of the following
every 3 months.6 As indicated by the ADA, the implementa- terms: “point of care” and “point of service.” The list of titles
tion of HbA1c testing at POC provide an opportunity for and abstracts contained 621 articles, which were reviewed
more timely treatment modifications.6 for relevance. The span of literature reviewed covers from
the end of the 1990s (1999) to the present year (2016). With
regard to the progressive improvement of measurement
HbA1c Testing at POC systems,27 more recent publications were preferred as far as
possible. We included all publications fulfilling a set of qual-
Why POC HbA1c Testing? ity criteria including patient number, statistical method/
One potential disadvantage of traditional HbA1c laboratory bias.28,29 A summary of the reviewed evidence on POC can
testing is that results are not available at the time of the be found in Table 1.
Schnell et al 613

Table 1.  Summary of Evidence For/Against the Use of POC patients with type 2 diabetes in a primary care setting were
HbA1c Testing Depending on Selected Parameters. reviewed.33 Data were collected 6 and 3 months before POC
Parameter Positive studies Negative studies testing implementation, and again at 3 and 6 months after
implementation. Documentation of adherence to guideline
Diabetes management 31-33 30 compliant HbA1c testing frequency by health-care providers
Treatment adaptation 31-33, 36 30 increased from 65.9% and 68.3% (6 and 3 months before
Glycemic control 23, 32, 35, 36 30 implementation) to 82.9% and 95% (3 and 6 months after
Patient satisfaction 26, 32, 37, 38 — implementation).34 There was also a reduction in mean
Cost effectiveness 38-43 — HbA1c from 8.1% (6 months preimplementation) to 7.7% (6
Accuracy 27, 49, 51-57, 72 59-62
months postimplementation) (P = .008). Attending to these
results, HbA1c testing at POC can potentially contribute to
an improved adherence to guideline recommended testing
Strong Evidence Supports POC Positive Effects on frequency. Furthermore, the possibility to provide and dis-
Glycemic Control and Patient Satisfaction cuss HbA1c results face-to-face has the potential to improve
Although a 2011 meta-analysis concluded that there was a patient-doctor dialogue and patient satisfaction, thereby
lack of evidence supporting the use of POC HbA1c testing facilitating glycemic control.26
for diabetes management, the limited number of studies
b. Improved glycemic control.  A randomized controlled trial in
included in the meta-analysis (n = 7), together with the het-
201 insulin-treated patients (type 1 or type 2 diabetes)
erogeneity of patient groups and trial designs, precluded a
showed an association between prompt availability of HbA1c
thorough analysis. Therefore, the conclusions reached by the
results and a significant improvement of glycemic control.23
aforementioned article are disputable.30
In 100 patients, HbA1c results were available at the begin-
ning of the visit, whereas for the 101 control patients results
a. Improved diabetes management/treatment adaptation. A
were provided by the laboratory after consultation. The
range of studies have demonstrated the benefits of POC
favorable effect of rapidly available HbA1c results on glyce-
HbA1c testing for improved diabetes management and gly-
mic control was detected at 6-month follow-up (–0.57 ±
cemic control. In a trial with 597 people with type 2 diabetes 1.44%; P < .01) and persisted for another 6 months (–0.40 ±
visiting a neighborhood primary care clinic, prompt avail- 1.65%, respectively; P < .01). Conversely, patients in the
ability of HbA1c results was associated with an increasing control group had no significant HbA1c changes.23 Since no
frequency of treatment intensification and a decrease in change of total insulin dose was appreciated, the immediate
HbA1c levels.31 Beneficial effects of rapid HbA1c analysis feedback of HbA1c results may possibly facilitate appropri-
on diabetes management were also reported by a randomized ate insulin regimen adjustments.
study conducted at an outpatient facility. More than 1000 An even more sustainable benefit of readily available
patients with type 2 diabetes were randomly assigned to a HbA1c results at the POC was demonstrated in a large, retro-
“rapid” group (HbA1c results immediately available) or a spective, cross-sectional study based on more than 16,000
conventional group (measurements available after the patient HbA1c analyses. Significant HbA1c improvements associ-
left the clinic). Not surprisingly, over 2-7 months of follow- ated with POC testing were detectable even after 3.5 years.35
up, diabetes management was more appropriate in the POC also resulted in glycemic control improvement in a
“rapid” group (79 vs 71%; P = .003), which was mainly pilot-study set in an urban community health center from a
attributable to a less frequent treatment escalation in patients low-income and low empowerment zone. 106 patients with
with ≤7% HbA1c levels (10 vs 22%, P < .0001). In patients diabetes were enrolled, of whom 69 had both pre- and post-
of the POC group with HbA1c results >7%, the therapy was POC implementation data. The trial evaluated the implemen-
slightly more frequently intensified (67 vs 63%; P = .33). In tation of finger-stick HbA1c testing at POC.36 This intervention
conclusion, rapid availability of HbA1c results facilitates was associated with an HbA1c testing rate increase from 73.6
diabetes management. Since the beneficial effects on HbA1c to 86.8% (P = .40) and was well accepted by both nurses and
profile in the “rapid” group were found to be independent physicians. Comparison of pre- and postintervention results
from the decision to intensify treatment, other factors such as revealed a significant decrease in HbA1c levels (7.84 vs
enhanced provider and/or patient motivation might be 8.55%; P = .004).36 This finding corresponded to an increase
involved.32 As emphasized by the authors, rapidly available in treatment escalation in patients with HbA1c values >8.0%
HbA1c results facilitate identification of patients with good from 28.6 to 53.8% (P = .03). The positive outcome was
metabolic control (HbA1c levels ≤ 7%) and, therefore, miti- mainly credited to the opportunity for immediate face-to-face
gates potential hypoglycemia risk from inappropriate treat- counseling once the POC HbA1c results were known.36
ment escalation.32
To evaluate the potential effects of the implementation of c. High patient satisfaction.  Further to the positive effects on
POC HbA1c testing in a primary care setting, data from 164 glycemic control that are associated with the use of POC,
614 Journal of Diabetes Science and Technology 11(3)

there are also reports of increased patient satisfaction and through reduced complications and in-hospital admissions. A
motivation. For instance, in the framework of a large multi- considerable potential for cost savings due to HbA1c testing
center, randomized, controlled trial assessing the extent of at POC was also reported in a budget impact analysis for
POC testing in Australian general practices, patient satisfac- Ontario, Canada.43 Regardless of present evidence, calculat-
tion was assessed via questionnaire.37 Patients randomized to ing cost-effectiveness for POC testing remains an open ques-
POC testing reported higher satisfaction levels with the sam- tion, especially considering the multilevel impact of diabetes
ple collection process (P < .001) and more confidence in the management.27
process (P < .001). Moreover, according to patients assess-
ments, POC testing was able to enhance their relationship
POC Analytical Accuracy and Performance: Room
with their physician (P = .010).37
Subjective perceptions of health-care providers and for Improvement
patients regarding POC testing impact on diabetes manage- An important issue regarding POC HbA1c testing evaluation
ment were examined in a qualitative study based on in-depth is that while some systems have been shown to have accept-
interviews.26 All interviewees agreed that an improved able analytical performance not all have.27,34,44,45 So far, the
opportunity for treatment adoption provided by the rapid insufficient evidence for analytical performance of HbA1c
availability of HbA1c results was an important advantage of testing devices in diagnosis of diabetes has limited their use
POC testing. A positive reception of HbA1c testing at POC in this application. In fact, in the past decade only hospital
by both patients and physicians was reported.23,38 laboratory HbA1c instruments have been recommended for
Furthermore, POC testing was regarded as offering an excel- use in diabetes diagnosis and to date only a handful of these
lent opportunity to enhance patient’s diabetes education and have been cleared by the US FDA for this use.46
motivation.26 With the endorsement of HbA1c for diagnostic use and
Higher patient satisfaction might also be a result of the the tightening of the NGSP criteria in recent years,47 POC
decreased patient revisits associated with POC implementa- technology has experienced strong development, improving
tion. Up to 61% reduction in patient revisits has been reported both hardware and software of POC devices,27,48 so much
with implementation of POC testing.39 A lower frequency of that a review of an external quality assurance survey in
patient visits may contribute to a substantial reduction in Norwegian general practice offices and hospital laboratories,
annual diabetes care costs for patients.38 In addition, from a showed very good results for certain POC testing devices.34
patient’s perspective, revisits may also involve other incon- Over the course of 6 years, about 60%–90% of general prac-
veniences and/or additional costs due to travel, parking, tices using POC testing met the quality specifications both
copayments, and potentially lost wages.39 for truthfulness (≤6.0%) and imprecision (≤0.3%) in diabetes
diagnostics. This was comparable and even slightly higher
Emerging Evidence Supports POC Cost- than the 54-84% of the hospital laboratory methods, which
met the same quality specifications. There is growing evi-
Effectiveness dence for a high quality of analytical performance. Moreover,
Despite the wealth of studies focusing on effects over glyce- analysis of POC results has demonstrated a strong correla-
mic control and/or patient psychological well-being, there is tion between values obtained from capillary and venous
relatively little published evidence on the cost-effectiveness blood samples.49 Furthermore, a moderate quality evidence
of POC.38-42 Even when it seems clear that the unit cost of for a positive correlation between HbA1c testing at POC and
POC tests is higher than testing at a central laboratory,40 the lab results was also reported by an evidence-based analysis
reduction of patient revisits associated with HbA1c POC of studies published between January 2003 and June 2013.50
testing may result in a reduction in health care costs.38 In a High accuracy and precision of HbA1c testing at POC with
recent study, HbA1c testing at POC was found to be cost- different devices has been repeatedly reported,51-57 making
effective in a primary care setting.39 POC testing resulted in POC a useful aid in diabetes management.58
increased operational efficiency in primary care practice. However, several studies of the analytic performance of
With POC testing implementation the total test number/per various POC HbA1c systems have found significant differ-
patient visit decreased (-21%; P < .0001), as did telephone ences in performance. While some POC methods have a high
calls to patients (-89%; P < .0001), the number of results let- quality performance, others might meet the criteria for preci-
ters mailed to patients (-85%; P < .0001), and the number of sion but not for bias, or simply result inferior to laboratory
follow-up visits for an abnormal laboratory result (-61%; P = systems.59-61 Therefore it is important to evaluate the perfor-
.002).39 In agreement with this result, the analysis of approxi- mance of POC systems in independent evaluations of ana-
mately 300 cases showed significant potential financial sav- lytical performance to understand the clinical utility and
ings opportunities for primary care practices with the potential risks of various POC methods.
adoption of POC testing.39 With increased focus on pay for Further factors that might limit POC HbA1c accuracy are
performance and accountability for care, improved glycemic more related to measuring HbA1c itself. For instance, certain
control associated with POC testing may lead to cost savings blood related illnesses (anemia), which affect red blood cell life
Schnell et al 615

span can impact HbA1c results. In addition, race/ethnicity might impacts on individual and population health outcomes.71 The
also affect HbA1c results (for example, African Americans aforementioned innovative evaluation approach together
might have higher HbA1c levels than non-Hispanic whites with continued focus on accuracy and cost-effectiveness will
despite similar fasting glucose levels), although this is advance the use of HbA1c testing at POC in the management
ontroversial.62,63 In children, HbA1c has been shown to signifi- and diagnosis of patients with prediabetes/diabetes.
cantly correlate to mean blood glucose. Similarly as for differ-
ent ethnicities, so far the ADA has not differentiated its
Conclusion
recommendations for HbA1c depending on age.62,63 Importantly,
these considerations are not unique to POC HbA1c testing HbA1c testing at POC
methods and can affect central laboratory results as well.
Despite the above, some POC HbA1c systems can achieve •• increases compliance with recommendations for
the analytical quality specifications for diagnosing diabetes HbA1c testing frequency and treatment adoption
mellitus, while their performance has demonstrated analyti- •• improves clinical outcomes
cal quality equivalent to that of hospital laboratory systems.34 •• facilitates patient education and motivation
The remarkable improvement of analytical performance of •• improves patient’s quality of life
POC devices for HbA1c testing in recent years, together with •• appears to contribute to cost/time savings both for
the development of new diagnostic materials64 or the minia- health-care professionals and patients
turization of devices48 argue in favor of an expansive diag- •• in the future, may prove useful for increased early
nostic potential in the near future.65 detection of prediabetes/diabetes and thus the preven-
A further consideration for POC testing success is the tion of diabetes-associated complications
implementation of appropriate quality control measures.
Participation in external quality control programs or profi- All the advantages mentioned above make HbA1c testing at
ciency testing (EQA, external quality assessment)66,67 is a POC a highly advantageous technique for diabetes manage-
possibility and can assist in monitoring quality of results. It ment. Indeed POC testing of HbA1c is recommended by the
is critical to follow the manufacturer’s instructions in the use ADA for monitoring patients with diabetes. Continued evi-
of external quality control materials for regular quality con- dence of the accuracy improvements of various POC sys-
trol surveillance. Although CLIA waived tests have been tems and cost-effectiveness evaluations, together with the
shown to have a significant correlation with lab tests,68,69 implementation of effective quality control measures will
several reports on the use of waived tests have pointed to the support the expansion of these POC testing systems as the
need for proper personnel education to ensure the reliability methods of choice for HbA1c testing in daily practice.
of the results of POC testing.70 Therefore, adequate training
and continuous personnel education is recommended to Abbreviations
ensure POC reliability. BG, blood glucose; ISO, International Organization for
Standardization; NGSP, National Glycohemoglobin Standardization
Program; pO2, partial pressure of oxygen; POC, point of care.
Necessary Future Developments
The great expansion and serious consequences of the diabe- Acknowledgments
tes epidemic creates a growing need for innovative diagnos- We thank Matthew J. Thompson and Gillian Parker for their input
tic tools. The ADA already includes in its treatment guidelines and comments, which greatly improved the present article.
a recommendation toward regular prediabetes testing.6,62
However, despite the positive impact on glycemic control Declaration of Conflicting Interests
and patient satisfaction of POC HbA1c testing for monitor-
The author(s) declared the following potential conflicts of interest
ing patients with diabetes, POC HbA1c is not yet recom-
with respect to the research, authorship, and/or publication of this
mended by the ADA for identification of prediabetes or article: OS has acted as member of advisory boards and/or given
diabetes diagnosis.62 To that end, an agreement on evaluation lectures under support from Abbott, Astra Zeneca, Bayer Healthcare,
parameters that include both accuracy and patient centered Boehringer-Ingelheim, Eli Lilly, Medtronic, Novartis, Roche
outcomes in an integrated approach might be warranted.27 A Diagnostics, Sanofi; and is CEO and founder of Sciarc GmbH. JBC
new method to incorporate multiple test attributes in evaluat- has no conflicts of interest to disclose. JW has not reported any
ing POC tests was presented at the NIH-IEEE 2015 Strategic conflicts of interest.
Conference on Healthcare Innovations and Point-of-Care
Technologies for Precision Medicine (9-10 November, 2015, Funding
Bethesda, USA). This method aims at outlining and visual- The author(s) disclosed receipt of the following financial support
izing the balance between the benefits and harms associated for the research, authorship, and/or publication of this article:
with tests, the multiple attributes of POC tests, the interac- Generation of the article was supported by an unrestricted grant
tions that potentially occur between these attributes, and from Alere GmbH.
616 Journal of Diabetes Science and Technology 11(3)

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