The Need for Point-of-Care HbA1c Testing for Diabetes

Continuously improving POC technologies offer benefits for patients, practices, and payors

By Rick San George, PhD, and Gillian Parker

Effective diabetes management is key to reducing the personal and economic burdens of the disease, but for healthcare practitioners, delivering such care can be complex, costly, and time-consuming. Despite such challenges, products and scientifically proven strategies can help alleviate the burdens of diabetes for individuals, clinicians, and society at large.

Regular, accurate, and easy-to-interpret point-of-care (POC) testing of patient hemoglobin A1c (HbA1c) levels may be an important and effective tool in a comprehensive approach to diabetes management. When performed at the frequency recommended by American Diabetes Association (ADA) guidelines, HbA1c testing can enable practitioners to help patients reach their treatment targets and improve clinical outcomes.¹ Such testing may also benefit healthcare practices and payors, while showing great promise for treating historically hard-to-reach patient subgroups.^2–5

Consider what’s at stake. Diabetes has become a global epidemic. The International Diabetes Federation (IDF) reports that more than 425 million people worldwide currently have diabetes. By 2045, the global incidence of diabetes may rise to 629 million people—a 48% increase.¹ In the United States, more than 30 million people currently have diabetes; if present trends continue, 1 out of 3 Americans will have diabetes by 2050.^1,6

The prevalence of diabetes places a huge economic burden on the US healthcare system. According to IDF estimates, the United States spent $320 billion on diabetes-related health costs in 2015—nearly half of the staggering worldwide total of $673 billion.¹

Diabetes-related complications contribute significantly to the extraordinary costs of this challenging disease.¹ In addition to direct healthcare costs, diabetes results in indirect costs associated with absenteeism, reduced productivity, disability, and premature death.¹ The impact of diabetes on patients’ lives cannot be underestimated. Uncontrolled diabetes and the hyperglycemia associated with it can affect a wide range of the body’s systems, including the cardiovascular system (coronary artery disease, acute coronary syndrome, heart failure, myocardial infarction); central nervous system (neuropathy, stroke); circulatory system (peripheral artery disease that can lead to ulceration, gangrene, and amputations); ocular system (cataracts, glaucoma, retinopathy); renal system (nephropathy); and sensory system (peripheral neuropathy, including neuropathic foot problems).^7,8

HbA1c and Other Routine Tests

ADA recommends that patients with diabetes undergo comprehensive routine testing, enabling healthcare providers to assess disease stability, monitor treatment adherence, and determine whether treatment modifications are needed (see “Recommendations for HbA1c Testing in Diabetic Patients“). Routine tests to be performed include albumin:creatinine ratio (ACR), blood pressure, fasting lipid panel, HbA1c, and liver function (Figure 1).⁹

Current ADA guidelines recommend that HbA1c tests be conducted at least two times annually for patients with stable glycemic control who are achieving treatment goals, and quarterly for patients who have not met glycemic goals or who have recently changed medications. According to ADA, HbA1c “has strong predictive value for diabetes complications.”⁹

Implementing a routine testing protocol is critical for the effective management of diabetes, and for helping to monitor patients for potential complications. However, results from a nationally representative cross-sectional survey showed that while 95% of diagnosed diabetes patients had a usual care provider, only 26.7% achieved their combined ‘ABC’ targets (A1c, blood pressure, cholesterol)—a disturbingly low percentage considering the risks and complications associated with the disease.¹⁰

Despite the fact that ADA recommendations for the frequency of HbA1c testing are supported by robust clinical evidence, compliance with the recommendations is exceptionally poor. A large, retrospective, landmark study conducted multiple analyses involving diabetes testing and treatment. Among 42,837 patients analyzed for compliance with ADA’s frequency recommendations for HbA1c testing, the compliance rate over the course of a year was alarmingly low, at less than 7%. Compliance with testing guidelines was even lower among patients with elevated HbA1c test results.¹¹

The same study also looked at 1,337 patients who had received a new diabetes diagnosis within the previous year. Of those patients, only 3% had undergone HbA1c tests at the ADA-recommended frequency along with recommended treatment modifications.

The need to improve such disturbing statistics is illustrated by another analysis conducted by the study investigators. It showed that complying with ADA recommendations for HbA1c testing frequency and treatment modifications more than doubled the number of patients who achieved their HbA1c goals (70%) over the proportion of patients who did not meet guidelines either for testing frequency or for treatment modification (30%).⁹ Put another way, compliant patients had a fivefold greater likelihood of achieving the goal of an HbA1c level less than 7%, when compared to patients who were not tested or treated in accordance with ADA guidelines (P < 0.0001)—demonstrating the indisputable clinical importance of implementing ADA guidelines.¹¹

The Rationale for POC HbA1c Testing

Lower socioeconomic status and cultural barriers both contribute to poor diabetes testing compliance (Figure 2). Additionally, time limitations may prevent providers from fully explaining to patients the importance of testing. Patients may avoid testing due to fears it may reveal treatment noncompliance, or they may not have the resources needed to pay for their tests, or the time needed to attend follow-up appointments.⁹

The Diabetes Study of Northern California (Distance) involved 186,306 adults with diabetes, and found that patients’ median time for going to the lab for HbA1c testing after a provider referral was 28 days. More troubling, the study also found that one in seven patients (14%) did not follow through with a lab visit within 6 months of receiving a referral. Study investigators suggest that such a rate of noncompliance may contribute to the suboptimal diabetes management often seen by healthcare services. Those less likely to undergo scheduled HbA1c tests were men, younger patients (those under 65), and patients who were referred by phone, letter, or pharmacists (P < 0.001).¹²

Maintaining HbA1c within the guideline-recommended range is of the utmost importance, as unstable or high HbA1c increases the risk of morbidity and mortality. According to recent studies, the mortality rate increases when HbA1c is above 7.5% or below 6.0%.¹³

POC testing eliminates the burdensome step of a separate lab appointment, and the risk of patients being lost to follow-up, by enabling providers to test patients during regular office visits and immediately identify those with HbA1c values outside the optimal range. ADA includes the use of POC HbA1c testing in its recommendations, pointing out that “use of point-of-care testing for A1c provides the opportunity for more timely treatment changes.”⁹

Multiple studies have shown that POC testing offers a wide range of benefits. Results from these studies suggest that patients’ understanding of their disease and treatment increased, along with their motivation, satisfaction, and—most importantly—glycemic control.^4,5,14–16 POC testing also improved compliance with ADA-recommended testing frequency, operational efficiencies, and care for underprivileged patients.^2–5

Improving Testing Compliance and Glycemic Control

A study conducted in a primary care setting demonstrated the direct impact of POC testing on HbA1c levels. Study investigators assessed provider compliance with the ADA-recommended testing frequency before and after POC testing was instituted, and found that performing HbA1c tests in the physician’s office dramatically increased compliance with ADA testing guidelines—from 66% to 95%—within 6 months. Moreover, a review of patient charts revealed that with POC testing, HbA1c levels decreased significantly (P = 0.008).¹⁴

The availability of patient HbA1c values at the point of care has been shown to positively influence clinical decisionmaking. In a prospective, controlled trial, 587 diabetes patients being treated at an urban neighborhood health center were assigned to one of two groups. In the ‘rapid’ group, patients’ HbA1c values were available to providers during the patients’ clinic visits; in the ‘routine’ group, the values were available following the visits. The trial demonstrated that providers were significantly more likely to intensify treatment for patients with HbA1c levels of 8% or more if they had access to test results at the point of care. Study investigators also evaluated a subset of 275 patients who had two follow-up visits. While HbA1c levels for patients in the rapid (POC) group decreased significantly, from 8.4% to 8.1% (P = 0.04), patients in the routine group experienced only a small decrease, from 8.1% to 8.0%, which was not considered significant (P = 0.31).¹⁷

Accurate POC HbA1c testing may be particularly meaningful for patient populations with low socioeconomic status and poor health literacy. A comprehensive diabetes management program treating patients with these challenges included POC HbA1c testing. The program saw a twofold increase in the percentage of controlled patients—from 23% to 49%—in less than 3 years. By the end of the assessment period, more than three out of four patients had HbA1c levels less than 8%, and only 14% were uncontrolled, with HbA1c levels greater than 9%.¹⁵

Improving Practice Efficiency

In addition to increasing compliance with ADA-recommended HbA1c testing frequency and helping to improve glycemic control among diabetes patients, POC testing offers other benefits that can result in cost savings for healthcare practices. A 2014 study conducted in a primary care practice at an academic medical center measured practice efficiency before and after general POC testing was implemented. Metrics included the total number of tests ordered, letters and phone calls to patients, and revisits as a result of abnormal test results. Across all metrics, POC testing significantly improved efficiencies, with a potential cost savings of $24.64 per patient. POC testing reduced the number of tests ordered per patient by 21% (P < 0.0001), follow-up phone calls by 89% (P < 0.0001), follow-up letters by 85% (P < 0.0001), and patient revisits by 61% (P = 0.0002).⁵

In a subsequent study looking at a more typical community primary care practice, similar practice efficiencies and cost savings were observed. Letters to patients decreased by 99% (P < 0.001), follow-up phone calls by 75%, follow-up tests per visit by 50% (P = 0.044), and follow-up visits due to abnormal test results by 38% (P = 0.178). By implementing POC testing for HbA1c and lipids, the practice achieved an estimated net financial benefit of between $11.90 and $14.74 per patient (see “The Need for ACR and Lipid Tests“).¹⁶

In the aforementioned comprehensive diabetes management program, which instituted POC HbA1c testing as one of the program components, per-patient Medicare costs dropped by 14% as a result of decreased hospital admissions and readmissions.¹⁵

Reducing testing and revisits may be particularly important for providers who are treating patients with limited access to care or challenges that may make it difficult for them to attend multiple appointments, such as advanced age, disability, or lower income. Using POC testing to better guide and optimize care for such patients is a highly sensible approach.

Improving Patient Satisfaction

While it seems intuitive that patients would prefer to have immediate results from a simple fingerstick, it remains important to demonstrate that POC HbA1c testing has a major effect on patient satisfaction. One randomized, controlled trial involving 4,968 patients compared POC testing with central laboratory testing for various measures of patient satisfaction, including the collection process (fingerstick at the point of care versus a venipuncture at the central lab), confidence in results, convenience, and disease management. Patient satisfaction with POC testing was significantly greater for all four of these metrics. The results showed that POC testing can improve the patient-provider relationship and increase patients’ motivation to be more proactive in their care.¹⁸

The Importance of Accuracy in Testing

While there are many point-of-care methods available worldwide for HbA1c testing, not all offer the same level of performance in terms of accuracy and precision. When critical decisions about patient care are being made and test results are used in aggregate to measure the quality of overall patient population management, it is essential that clinicians be able to safely rely on results from POC testing platforms.

Fortunately, POC testing technologies have continued to improve over the years (see “Diabetes Testing: Future Considerations“). A recent proficiency survey from the College of American Pathologists measures the performance of HbA1c testing methods in the United States, and includes results from two market-leading POC systems that are comparable to large central laboratory methods.¹⁹

When selecting a POC method, it is critically important that it is simple, reliable, and accurate.^20,21 Fortunately, there are many studies and proficiency testing results available to demonstrate which POC HbA1c testing methods meet these criteria.^20,22,23 Furthermore, some POC methods now include important failsafes—operator IDs, QC lock-outs, and connectivity for transmission and monitoring of results—which further help to ensure the accuracy of the results used in patient management.²⁴

HbA1c Testing in Outcome-Based Payment Models

Among Medicare and Medicaid providers, ‘value, not volume’ encapsulates the growing trend away from fee-for-service and toward pay-for-performance models that reward providers for delivering high-quality, cost-effective patient care.²⁵ Many of these providers belong to accountable care organizations (ACOs) in which hospitals, groups of physicians, and other healthcare professionals have joined forces to give Medicare patients coordinated, high-quality care.

The mandate to improve outcomes and reduce costs for Medicare patients is being propelled by the new quality payment program (QPP) created by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).²⁶ QPP’s merit-based incentive payments system (MIPS) and alternative payment models (APMs) include rigorous performance standards that Medicare providers and ACOs must meet in order to optimize compensation for their services.

Under MIPS, positive payment adjustments are contingent on satisfying at least six quality measures, including at least one high-priority or outcome measure. HbA1c control is MIPS quality measure number one, is designated as high priority, and is in the specialty measure set for providers in general practice/family medicine, internal medicine, and preventive medicine.²⁴

Another high-priority quality measure under MIPS is patient experience and engagement, as measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Physician Quality Reporting System (PQRS) Survey.^25,27 POC HbA1c testing offers demonstrated benefits for improving glycemic control as well as for patient satisfaction among diabetic patients, making it a potentially valuable tool for providers seeking to achieve high marks in both of these high-priority measures.^4,17,18

As a new program, MIPS is still being evaluated, and its future is uncertain. Whether it is retained in its current form, modified, or replaced, the goal established by MACRA remains the same: shifting the Medicare system from volume to value. And POC HbA1c testing can play a role in helping to meet that goal.

Conclusion

Diabetes is a global and national epidemic affecting more than 30 million people in the United States and burdening the US healthcare system with billions of dollars in related health costs. Uncontrolled diabetes can lead to serious comorbidities and increased risk of premature mortality, yet many patients are not receiving the recommended routine HbA1c tests, which have been shown to improve glycemic control and reduce the costs of this challenging disease.

Simple and accurate POC HbA1c testing can help overcome barriers that reduce compliance with ADA-recommended HbA1c testing frequency, by consolidating the patient’s care at the provider’s office. Adopting a POC strategy gives patients access to the tests they need, when they need them, and can improve patient satisfaction, foster a stronger patient-provider relationship, and motivate patients to be more involved with self-care. Implementation of POC testing also helps to alleviate the burden of diabetes on providers by streamlining operations and creating efficiencies within the practice. Finally, POC HbA1c testing can help ACOs and other providers within the QPP program to deliver greater quality of care to their diabetic patients, which in turn means greater financial rewards.

ADA recommends using POC testing to routinely measure HbA1c in patients with diabetes. Given its considerable benefits for all stakeholders, consideration should be given to making POC HbA1c testing a standard of care in diabetes management.

 

Rick San George, PhD, is vice president of global clinical affairs for cardiometabolic and informatics at Abbott. Gillian Parker is senior director of marketing for cardiometabolic and informatics at Abbott. For further information, contact CLP chief editor Steve Halasey via [email protected].

 

Featured Image: The Afinion point-of-care platform by Abbott, Abbott Park, Ill, measures HbA1c in 3 minutes and albumin:creatinine ratio in 5 minutes, facilitating implementation of American Diabetes Association guidelines on point-of-care testing for patients with type 2 diabetes.

 

References

1. IDF Diabetes Atlas, 8th ed. Brussels: International Diabetes Federation, 2017. Available at: www.diabetesatlas.org. Accessed March 21, 2018.

2. Shepard MD. Cultural and clinical effectiveness of the ‘QAAMS’ point-of-care testing model for diabetes management in Australian aboriginal medical services. Clin Biochem Rev. 2006;27(3):161–170.

3. Schnell O, Crocker JB, Weng J. Impact of HbA1c testing at point of care on diabetes management. J Diabetes Sci Technol. 2017;11(3):611–617; doi: 10.1177/1932296816678263.

4. Rust G, Gailor M, Daniels E, et al. Point of care testing to improve glycemic control. Int J Health Care Qual Assur. 2008;21(3):325–335; doi: 10.1108/09526860810868256.

5. Crocker JB, Lee-Lewandrowski E, Lewandroski N, Baron J, Gregory K, Lewandrowski K. Implementation of point-of-care testing in an ambulatory practice of an academic medical center. Am J Clin Pathol. 2014;142(5):640–646; doi: 10.1309/ajcpyk1kv2kbcddl.

6. Fast Facts: Data and Statistics about Diabetes [online]. Arlington, Va: American Diabetes Association, 2015. Available at: https://professional.diabetes.org/sites/professional.diabetes.org/files/media/fast_facts_12-2015a.pdf. Accessed March 21, 2018.

7. Living with Diabetes: Complications [online]. Arlington, Va: American Diabetes Association, 2018. Available at: http://www.diabetes.org/living-with-diabetes/complications/?loc=lwd-slabnav. Accessed March 21, 2018.

8. Fowler MJ. Microvascular and macrovascular complications of diabetes. Clin Diabetes. 2008;26(2):77–82; doi: 10.2337/diaclin.26.2.77.

9. American Diabetes Association. Standards of medical care in diabetes, 2018. Diabetes Care. 2018;41(Suppl 1):S55–S64; doi: 10.2337/dc18-s006.

10. Ali MK, Bullard KM, Gregg EW, del Rio C. A cascade of care for diabetes in the United States: visualizing the gaps. Ann Intern Med. 2014;161(10):681–689; doi: 10.7326/M14-0019.

11. 11. Lian J, Lang Y. Diabetes management in the real world and the impact of adherence to guideline recommendations. Curr Med Res Opin. 2014;30(11):2233–2240; doi: 10.1185/03007995.2014.952716.

12. Moffet HH, Parker MM, Sarkar U, et al. Adherence to laboratory test requests by patients with diabetes: the diabetes study of Northern California (Distance). Am J Manag Care. 2011;17(5):339–344.

13. Arnold LW, Wang Z. The HbA1c and all-cause mortality relationship in patients with type 2 diabetes is J-shaped: a meta-analysis of observational studies. Rev Diabet Stud. 2014;11(2):138–152; doi: 10.1900/rds.2014.11.138.

14. Eugbunike V, Gerard S. The impact of point-of-care A1c testing on provider compliance and A1c levels in a primary setting. Diabetes Educ. 2013;39(1):66–73; doi: 10.1177/0145721712465340.

15. Presser E, Penalo PJ, Darling M, Samuels K. Texas: Enhancing Diabetes Care through Personalized, High-Touch Case Management. Merkin Series on Innovation in Care Delivery. Washington, DC: Center for Health Policy, Brookings Institution, 2016. Available at: www.brookings.edu/wp-content/uploads/2016/06/rio-valley-aco.pdf. Accessed June 27, 2018.

16. Lewandrowski EL, Yeh S, Baron J, Crocker JB, Lewandrowski K. Implementation of point-of-care testing in a general internal medicine practice: a confirmation study. Clin Chim Acta. 2017;473:71–74; doi: 10.1016/j.cca.2017.08.019.

17. Miller CD, Barnes CS, Phillips LS, et al. Rapid A1c availability improves clinical decisionmaking in an urban primary care clinic. Diabetes Care. 2003;26(4):1158–1163.

18. Laurence CO, Gialamas A, Bubner T, et al. Patient satisfaction with point-of-care testing in general practice. Br J Gen Pract. 2010;60(572):e98–e104; doi: 10.3399/bjgp10X483508.

19. College of American Pathologists (CAP) GH5 Survey Data (updated 12/17) [online]. Columbia, Mo: National Glycohemoglobin Standardization Program, 2017. Available at: www.ngsp.org/cap/cap17c.pdf. Accessed March 21, 2018.

20. Lenters-Westra E, Slingerland RJ. Three of 7 hemoglobin A1c point-of-care instruments do not meet generally accepted analytical performance criteria. Clin Chem. 2014;60(8):1062–1072; doi: 10.1373/clinchem.2014.224311.

21. Malone B. Spotlight on point-of-care testing. Clinical Laboratory News. October 1, 2012. Available at: www.aacc.org/publications/cln/articles/2012/october/point-of-care-testing. Accessed April 25, 2018.

22. Solvik UØ, Røraas T, Christensen NG, Sandberg S. Diagnosing diabetes mellitus: performance of hemoglobin A1c point-of-care instruments in general practice offices. Clin Chem. 2013;59(12):1790–1801; doi: 10.1373/clinchem.2013.210781.

23. Paknikar S, Sarmah R, Sivaganeshan L, et al. Long-term performance of point-of-care hemoglobin A1c assays. J Diabetes Sci Technol. 2016;10(6):1308–1315; doi: 10.1177/1932296816645362.

24. Buyers’ guide: point of care devices for the measurement of HbA1c and low concentration albumin in urine. London: National Health Service Center for Evidence-Based Purchasing, 2009. Available at: www.healthcheck.nhs.uk/document.php?o=12. Accessed April 25, 2018.

25. The Merit-Based Incentive Payment System: MIPS Scoring Methodology Overview [online]. Baltimore: Centers for Medicare & Medicaid Services, n.d. Available at: www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/mips-scoring-methodology-slide-deck.pdf. Accessed March 21, 2018.

26. Quality Payment Program: Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year [online]. Baltimore: Centers for Medicare & Medicaid Services, 2017. Available at: www.federalregister.gov/documents/2017/11/16/2017-24067/medicare-program-cy-2018-updates-to-the-quality-payment-program-and-quality-payment-program-extreme. Accessed April 25, 2018.

27. Quality Payment Program: MIPS Quality Measures [online]. Baltimore: Centers for Medicare & Medicaid Services, 2018. Available at: https://qpp.cms.gov/mips/quality-measures. Accessed March 21, 2018.

28. Take Charge of Your Diabetes, 4th ed. [online]. Atlanta: Centers for Disease Control and Prevention, n.d. Available at: www.cdc.gov/diabetes/pdfs/library/takechargeofyourdiabetes.pdf. Accessed March 21, 2018.

29. The A1c Test & Diabetes [online]. Bethesda, Md: National Institute of Diabetes and Digestive and Kidney Disease, National Institutes of Health, 2014. Available at: www.niddk.nih.gov/health-information/diabetes/overview/tests-diagnosis/a1c-test. Accessed March 21, 2018.

30. Handelsman Y, Bloomgarden ZT, Grunberger G, et al. American Association of Clinical Endocrinologists and American College of Endocrinology: clinical practice guidelines for developing a diabetes mellitus comprehensive care plan, 2015. Endocr Pract. 2015;21(Suppl 1):1–87; doi: 10.4158/ep15672.gl.

31. Alere Afinion [package insert]. Oslo, Norway: Alere Technologies AS, 2017.

32. Cholestech LDX [package insert]. San Diego: Alere, 2010.

33. Foerster V, Severn M. Point-of-Care Glycated Hemoglobin Testing to Diagnose Type 2 Diabetes. CADTH Issues in Emerging Health Technologies no. 156. Ottawa: Canadian Agency for Drugs and Technologies in Health, 2017. Available at: www.cadth.ca/dv/ieht/point-care-glycated-hemoglobin-testing-diagnose-type-2-diabetes. Accessed June 28, 2018.

34. Levenson D. Diabetes decision time: proficiency for testing hurdle slows use of point-of-care HbA1c tests for diagnosis. Clinical Laboratory News. March 1, 2017. Available at: www.aacc.org/publications/cln/articles/2017/march/diabetes-decision-time-proficiency-testing-hurdle-slows. Accessed April 25, 2018.

35. Jain A, Rao N, Sharifi M, et al. Evaluation of the point-of-care Afinion AS100 analyzer in a community setting. Ann Clin Biochem. 2017;54(3):331–341; doi: 10.1177/0004563216661737.

36. Leong A, Daya N, Porneala B, et al. Prediction of type 2 diabetes by hemoglobin A1c in two community-based cohorts. Diabetes Care. 2018;41(1):60–68; doi: 10.2337/dc17-0607.

37. Whitley HP, Hanson C, Parton JM. Systematic diabetes screening using point-of-care HbA1c testing facilitates identification of prediabetes. Ann Fam Med. 2017;15(2):162–164; doi: 10.1370/afm.2035.