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INTRODUCTION

Diabetes mellitus (DM) is a global epidemic that impacts millions of Americans every year. Based on 2017 data from the CDC, the overall incidence of diabetes in the United States (US) is approaching 10% and continues to increase, with no apparent slowing down.¹ DM is a complex chronic disease that requires a multifaceted approach to successful treatment that includes appropriate self-monitoring of disease through blood glucose (BG) monitoring, also known as self-monitoring of blood glucose (SMBG).² A basic understanding of the function of BG meters is important for health care practitioners (HCPs) to effectively educate patients on their use in performing appropriate SMBG. Also, an understanding of glycemic targets, such as fasting blood glucose (FBG), 2-hour postprandial blood glucose (PPBG), and glycosylated hemoglobin A1c (A1C), is paramount in achieving individualized glycemic goals.

BG METERS

BG meters are used to perform SMBG, with studies showing that appropriate SMBG is important in effectively controlling diabetes.^3,4 Proper functioning and, thus, accurate results are dependent on the patient’s and caregiver’s appropriate use of the BG meter.⁵ There are an assortment of such meters available for patients on the market, although most of these instruments have a very similar basic functionality. The essential supplies involved in the testing process are the glucose meter, a lancing device with disposable lancets (or single-use disposable lancets), test strips with a control solution (not always required), alcohol wipes (See Figure 1), a sharps container or sharps-resistant vessel (See Figure 2), etc.

The general steps involved in testing BG include:⁷

1. Choose a finger in which to test the BG. Wash the site of testing with warm water and soap or use an alcohol swab to clean the site. If using an alcohol swab, ensure that the site dries before testing, as the alcohol may impact the testing result. Please note that alternate-site testing is allowed with some meters.
2. Insert the test strip in the meter and wait for the confirmatory sign to test, which is usually a flashing illustration of a blood drop on the screen.
3. Use the lancing device or single-use lancet to prick the finger according to the diagram in the package.
4. Touch the drop of blood to the appropriate area of the test strip and wait for the result. A cotton ball or gauze pad may be used to wipe remaining blood from the finger.
5. Once the result is received, remove the test strip from the meter and place in the trash along with the cotton ball. Put the lancet in a sharps-resistant container.

Note: All meters are slightly different, so patients should always refer to the user’s manual for specific instructions.

Error readings can be frequent occurrences when using BG meters. If there is an issue with the glucose result when using the meter, an error code will usually show on the screen, which will vary based on the type of meter used. One of the most common error codes is caused by an insufficient drop of blood applied to the test strip. Strategies to increase blood flow prior to lancing and, thus, improving the chances of avoiding this error include washing the hands with warm water, lowering the hand below heart level, and shaking the hand to improve blood flow. Avoid squeezing the finger too hard after lancing as this can affect the result.⁹ Other possible error codes may be a result of expired or altered test strips, a low battery, or faulty meters. Patients should always be encouraged to consult their user’s manual if they encounter error codes while testing.

Patients may note pain at the site of lancing, especially when using the end of the finger to test BG. Some patients report that pricking the side of the finger by the nail bed reduces the pain, as the end of the finger is usually more sensitive compared with the side due to fewer nerve endings on the side. In addition, many lancing devices may be adjusted to alter the depth of the lancet prick, thus potentially lessening the pain on lancing.⁶ Patients should keep in mind, however, that reducing the depth of lancing may affect the ability to obtain an adequate-sized blood drop for testing and could result in errors. Some BG-meter kits might also include devices to test at alternate sites such as the thigh or forearm.⁷

Counseling patients on how to choose from among the various BG meters in the marketplace includes providing the contrasting variables and factors involved that are specific to the patient’s situation and concerns. The features include the cost of the meter, the accuracy of the results, the dimensions of the meter, and the size of the blood drop required for testing. Keep in mind that accuracy is difficult to gauge other than comparing a meter test at home with one done in the HCP’s office to ensure that the BG readings are similar. Many meters now come with special features that can link with smartphone applications to help track and store BG results. In most situations, it is important to instruct patients to call their insurance company or to check their insurance firm’s drug formulary to help them choose a meter that is covered for them.

BG-meter accuracy is a trending concern. Some literature, including a study published in Diabetes Technology and Therapeutics, raises concerns about the accuracy of BG meters, particularly in the “Low-glucose range.”^8,9 Previous standards required that “95% of all meter test results to be within 20% of the actual BG level for results greater than 75 mg/dL and within 15 mg/dL for values below 75 mg/dL.”¹⁰ In response to accuracy concerns, the U.S. Food and Drug Administration (FDA) updated and approved the standards to ensure more precise results in those BG meters available. Importantly, HCPs should understand and communicate to patients and caregivers the potential for variability in accuracy of BG results. The Diabetes Technology Society Blood Glucose Monitoring System Surveillance Program provides information on the performance of devices used for SMBG, which can be readily accessed on the internet.¹¹ It is important to also consider that certain substances can interfere with SMBG readings. Examples of substances that have been reported to interfere with SMBG results include uric acid, galactose, xylose, acetaminophen, L-dopa, and ascorbic acid.²

Another recently raised concern by the FDA is a growing trend on the sale and purchase of glucose test strips through online marketplaces such as Amazon, eBay, and Craigslist.¹² The FDA warns that purchase and use of strips through unauthorized sellers may lead to inaccuracy of results and could potentially result in infection. The following reasons are provided by the FDA in warning against purchase of pre-owned test strips:

• The test strips may not be stored properly, potentially leading to inaccurate results with use
• The expiration dates might have been changed or covered up
• The test strips may have been tampered with and could be damaged causing them to not work properly
• If a user receives an inaccurate result from a test strip and uses this result as a basis for their treatment, they could take too much or not enough medication, potentially leading to serious patient injury or death
• The test strip vials may have small amounts of blood from the previous owner on them, which can put users at risk for infection.

CONSUMER GUIDE FOR BLOOD GLUCOSE METERS

To aid patients with choosing among the growing number and variety of glucose monitors, Diabetes Forecast, which is published by the ADA, has available a consumer guide containing information that can assist with decisions. Details for each meter include blood sample size, battery requirements, manufacturer's suggested retail price (MSRP), and test strip MRSP. Features of each meter are also provided. The options listed as features are audio capability, backlight, measures both blood glucose and blood pressure, wireless Bluetooth capability, requires user coding, can save data to the cloud without having to push the data to another device, computer download capability, also tests blood ketones, communicates in insulin pump, port light, logs insulin dose, calculates insulin dose, meter program offers access to certified diabetes educators, app compatible, microliters, and sold only with insulin pump. The 2020 guide is available at  http://www.diabetesforecast.org/2020/02-mar-apr/consumer-guide-2020.html.

SUGGESTIONS FOR TESTING FREQUENCY IN SMBG

The appropriate recommendation for frequency of SMBG testing in patients with DM is a complex issue that is often misunderstood in practice. How often to test is dependent on a number of factors, but the most important issue to consider is the patient’s safety, namely preventing severe episodes of hypoglycemia and hyperglycemia. HCPs, however, should also consider whether evidence in the literature supports more frequent or less frequent testing.

Testing more often is particularly important for those on multiple daily insulin (MDI) injections or other pharmacologic agents that may acutely lower BG, such as the sulfonylurea class.² The ADA Standards of Medical Care in Diabetes recommend that patients on intensive insulin therapy, defined as patients on MDI or insulin pump therapy, consider testing BG “prior to meals and snacks, at bedtime, occasionally postprandially, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they are normoglycemic, and prior to critical tasks such as driving.”² This suggestion most commonly applies to patients with type 1 diabetes mellitus (T1D), who are naturally more prone to significant fluctuations in BG due to their insulin sensitivity; however, HCPs should realize that those with type 2 diabetes mellitus (T2D) may progress to insulin therapy, including MDI and insulin pump therapy, usually after having T2D for many years. Evidence is inconclusive, however, on how often patients with T2D using basal insulin with or without oral agents should engage in SMBG. Assessment of fasting glucose by SMBG in patients using basal insulin to adjust doses has been shown to lower A1C.^13,14

Available literature does support benefits of more frequent SMBG testing in children and adolescents with T1D,¹⁵ and this evidence is oftentimes extrapolated to adults on MDI or insulin pump therapy. Evidence for patients who do not fit within the category of intensive insulin therapy, however, is far less clear. Studies have examined the benefits and cost-effectiveness of more frequent SMBG testing in people who do not use insulin therapy, with mixed results.^16-18 In 2019 the ADA changed their recommendations for SMBG in people not using insulin to acknowledge that routine glucose monitoring is of limited additional clinical benefit in this population.² Clinical judgment is often required by HCPs to decide on the appropriate frequency of testing in these individuals; but as mentioned above, the patient’s safety and whether or not SMBG contributes to meaningful clinical decision making should be the primary concerns. One common intervention that can be made by pharmacists, including in the community setting, is to challenge prescriptions and orders for frequent (more than once daily) SMBG testing in patients with prediabetes or diabetes on monotherapy with agents that have minimal hypoglycemic risks. In these cases, when HCPs prescribe frequent SMBG testing, pharmacists may consider challenging the utility of this approach given frequent testing may introduce cost and management burdens on the patient. On the flip side, pharmacists can advocate for patients in working with insurance companies’ denials of testing supply quantities where frequent SMBG may be indicated, such as when unexplained blood sugar fluctuations are occurring.

INTERPRETATION OF SMBG RESULTS

A basic understanding of the general diagnostic criteria and glycemic targets for BG are important before interpretation of results is possible. See Table 1 for a summary of diagnostic criteria. The ADA guidelines distinguish between FBG and PPBG. In most cases, HCPs will target the A1C (discussed below) and FBG goals initially and then progress to targeting PPBG if the FBG readings are at goal concurrently with an elevated HbA1C.² See Table 1 for a summary of glycemic targets in DM. HCPs may consider individualization of glycemic targets based on various factors, as discussed more in the section on A1C monitoring (below). All pharmacists in any setting in which they encounter patients with diabetes should reiterate glycemic targets to ensure that the patient understands how to properly interpret blood glucose readings.

Proper interpretation of SMBG results requires that all parties involved have a complete understanding of all the factors that may impart changes in BG. Assuming that BG testing is properly done, many circumstances may affect the end result, including physical activity, changes in carbohydrate content in meals, compliance with medications that lower BG, and concurrent stress or illness.²

Physical activity in the context of SMBG can affect BG results in 2 major ways. In most individuals, physical activity will lower BG during and after exercise.²¹ When physical activity is combined with insulin or insulin secretagogues (e.g., sulfonylureas), or a significant reduction in carbohydrate consumption pre-exercise, the combination of factors can cause hypoglycemia. These patients should be counseled to pretreat with a serving of carbohydrates before exercise, especially if the pre-exercise BG is less than 90-100 mg/dL. This situation occurs less frequently in those not taking insulin or secretagogues, and pretreatment is not usually needed.²

The second and much less common manner in which physical activity can have a significant impact on BG readings is in the small subset of patients with T1D who are insulin-deficient with ketosis. In this instance, physical activity can actually increase BG levels and worsen ketosis,²² causing hospitalization in worst-case scenarios. In any case, HCPs should always counsel patients on these potential effects and how to avoid them. If a low BG value is obtained, questions to ask the patient should include an assessment of recent physical activity.

Acute changes in carbohydrate consumption may also significantly alter SMBG results, especially for patients who are on intensive insulin therapy. Consistent carbohydrate content will help avoid fluctuations in SMBG and may help improve overall glycemic control.²³ Significant reductions in the quantity of carbohydrates, particularly in patients on mealtime insulin, may result in hypoglycemia, while increases in carbohydrate content may lead to hyperglycemia. Foods with high glycemic index values, such as non-diet soft drinks or sweets, are more likely to cause acute hyperglycemia when ingested, given the more rapid absorption of macronutrients, especially when patients forget or neglect to take concurrent insulin doses. HCPs should remember to inquire about carbohydrate intake and adherence with medications when interpreting SMBG results.

Concurrent stress and illness, such as infection, trauma, or surgery, can worsen hyperglycemia in patients with diabetes.² This is caused by the increased circulation of cortisol and inflammatory markers that mobilize glucose for energy utilization. Incidences of severe hyperglycemia, including progression to diabetic ketoacidosis, are not uncommon in those with T1D, and people with T2D who are managed on intensive insulin therapy. Patients should be counseled to frequently monitor BG daily during concurrent illness to avoid hospitalization as well as to maintain adequate hydration and other treatment modalities.

A1C TESTING

The A1C test is routinely done in practice to evaluate long-term glycemic control, as it represents an estimation of the average BG over approximately 3 months. Table 2 shows the estimation of average BG correlated with the corresponding measured A1C, as derived from clinical studies.²⁴ As noted above and in Table 1, the general glycemic target for most adults is an A1C of less than 7%, although individualization of this goal is essential for effective management of diabetes. Given the nature of the test, in general, it is appropriate to recommend quarterly testing in patients who are not at their individualized goal or those who have had therapy adjustments, while people at goal may be monitored less frequently.²

The A1C test is considered a valuable glycemic control marker as it is strongly associated with diabetes complications; thus, a reduction in A1C over an extended period can significantly prevent morbidity and mortality related to diabetes.^25,26 As noted in the ADA’s guidelines, the test has some notable advantages compared with SMBG or laboratory-based FBG, including the convenience of non-fasting status and improved pre-analytical stability. Also, given that the test is one of long-term glycemic control, it is less prone to variations caused by acute changes in BG such as those noted above. On the other hand, the test is more expensive and less available in certain regions of the world as well as subject to fluctuations from such patient-specific factors as age, race, and certain blood disorders.²

INTERPRETING A1C RESULTS

The interpretation of A1C results requires the ability to identify diagnostic criteria (Table 1) and evaluate appropriate individualization of A1C goals. While ADA guidelines recommend a general goal of below 7%, certain studies suggest less stringent goals based on a number of modifiable and non-modifiable patient- and disease-specific factors.² As represented in Figure 3, factors that would cause HCPs to target less aggressive A1C goals (such as below 8%), include long duration of the disease, extensive cardiovascular complications or known cardiovascular disease, along with short life expectancy. These patients are representative of those encompassed by a large clinical trial that showed more aggressive targets (e.g., A1C below 6%) could actually cause more harm than benefit.²⁷ It is also reasonable, however, for HCPs to assign more aggressive A1C goals (such as below 6.5%) for patients who are young, newly diagnosed, or relatively healthy with few comorbidities as long as doing so does not create an inappropriate risk of hypoglycemia.²

A1C evaluation at the patient’s initial diagnosis, particularly in T2D, may suggest important characteristics about the individual’s state of disease. For instance, those with mild elevations in A1C above diagnostic criteria (e.g., 7%) at baseline may indicate short-standing disease. Given that diabetes is often asymptomatic in patients with mild elevations in BG along with symptoms of hyperglycemia potentially being insidious, it is not unusual for patients to be diagnosed with an A1C that is significantly elevated at baseline, such as 9- 10%. This may indicate longer-standing disease or more acute progression of underlying insulin deficiency or resistance. Certainly, patients presenting with more significant hikes in the A1C at baseline who have multiple comorbid complications associated with diabetes (such as retinopathy or neuropathy or other maladies) suggest more long-standing disease. In patients with T2D, significantly elevated A1C at diagnosis (such as an A1C of 11% or greater) may necessitate initial initiation of insulin therapy, at least in the short-term.²⁸

Importantly, discuss how to interpret A1C that is not at goal in patients with diabetes who are already on anti-hyperglycemic therapy. As noted above; the A1C does not reflect the daily fluctuations in BG that can be affected by physical activity or acute changes in carbohydrate content. However, uncontrolled diabetes may reflect more consistent issues with such lifestyle behaviors as persistently poor diets, physical inactivity, and nonadherence with medications. These factors must be considered along with the evaluation of whether the patient’s current diabetes treatment regimen is appropriate. In T1D, assuming all other factors discussed are stable, A1C values not at target might suggest inadequate insulin therapy to properly address the insulin deficiency, the degree of which is linked to the rise in A1C.

In T2D, uncontrolled A1C in relation to the adequacy of the treatment regimen must take into account the mechanisms of the glucose-lowering agents and how they address the underlying pathophysiology of diabetes. For instance, an elevated A1C in patients on sulfonylurea monotherapy may suggest that either the mechanism of stimulating insulin release is not countering the more significant underlying issue (such as insulin resistance), or it might indicate that treatment failure has occurred, which has been shown in studies with sulfonylureas presumably due to more rapid decline in beta-cell function.^29,30 However, elevated A1C values may also suggest that the mechanism of the agent itself simply does not completely control the situation, and a combination of medications with different mechanisms is required to obtain an acceptable A1C goal. HCPs must be well-versed on the mechanisms of every anti-hyperglycemic agent to properly evaluate treatment goals for patients with diabetes. For a complete summary of the most up-to-date medications available for diabetes therapy, along with their mechanisms, see the ADA Standards of Medical Care in Diabetes.²

It is also important to consider individuals with A1C test results that may be too “low.” The main concern in this situation is that the diabetes treatment regimen may be too aggressive and could contribute to hypoglycemia. In patients who are reporting such hypoglycemic symptoms as shakiness, sweating, and tachycardia,³¹ in combination with an A1C significantly below goal (e.g., an A1C of less than 6 to 6.5%), it is possible that the agents being used are leading to frequent and consistent episodes of hypoglycemia. This is particularly notable in patients on regimens with agents that have a higher risk of causing hypoglycemia, such as sulfonylureas, glinides, and, of course, exogenous insulin. In this case, HCPs must note the considerable dangers that come with severe hypoglycemia, such as coma, hospitalization, and even death.

Lastly, similar to the discussion above on SMBG accuracy, the A1C test can be impacted be a variety of comorbidities and other factors.¹⁹ For example, conditions that affect red blood cell turnover (such as hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, recent blood transfusion, use of drugs that stimulate erythropoiesis, end-stage kidney disease, and pregnancy) may result in discrepancies between the measured A1C result and the patients true mean blood glucose and should be considered if A1C values do not appear to match SMBG or other data.

ADJUSTING DIABETES TREATMENT REGIMENS BASED ON RESULTS

The adjustment of therapy regimens requires careful consideration by trained HCPs in diabetes care, considering a multitude of factors such as those described above, and incorporating a strong understanding of the pharmacotherapy involved in treating diabetes. This is particularly important for patients with T1D, given their propensity for more acute fluctuations in BG after changes in treatment; thus, these patients should always be referred to their endocrinologist or other clinical specialist for recommendations on titrating insulin doses. In any event, considering treatment adjustments in diabetes must always include assessment of all factors described above that could impact glycemic control.

The ADA and the European Association for the Study of Diabetes have valuable summaries of the tactics to use when considering revisions or advancements in treatment regimens. The ADA Standard of Care contains information (Figure 3) that describes the basic principles to consider when weighing treatment decisions in patients with T2D, noting such key factors as cardiovascular effects, drug efficacy, adverse events, cost, risk of hypoglycemia, and effects on weight when deciding how to advance therapy. These guidelines also have recommendations on initial therapy in T2D, which in most cases involves initiation of metformin before advancement to additional therapies.^2,29

HCPs who are not authorized to make independent adjustments to treatment regimens either by scope of licensure or under appropriate therapy protocols should focus on making simple interventions that will not add significant complexity to the patient’s treatment regimen. For example, a community pharmacist in a retail setting who does not have a diabetes treatment protocol in place may encounter patients with mildly uncontrolled diabetes on metformin (Fortamet, Glucophage, Glumetza) monotherapy, on a dose that is not yet optimized. In this situation, the pharmacist may consider contacting the appropriate HCP by phone to suggest increasing the metformin dose to the clinically recommended maximum of 2 grams daily to appropriately optimize this component of care. It is imperative to note that in all cases of interventions, HCPs should provide basic education and counseling on the disease state and the medications.

In other cases, when patients present with more significant hyperglycemia (e.g., A1C above 10% despite treatment), HCPs may consider more advanced therapy recommendations such as adding another oral or injectable agent. In such cases recommendations should follow the principles outlined in the ADA guidelines and consider patient-centered factors such as willingness to adhere to treatment, cost impact, and the effects on quality of life. Also note that the literature has suggested each additional agent added on after metformin can lower the A1C by approximately 1%.³² This may cause the HCP to elect moving to more aggressive therapy such as insulin if it seems unlikely that the patient will achieve glycemic targets with multiple oral and/or noninsulin injectable agents. A full and complete review of approaches to glycemic treatment requires a more detailed discussion, which is outlined elsewhere in this program.

CONCLUSIONS

Diabetes continues to be a significant health problem that affects millions of people in this nation and worldwide. One important component of the comprehensive care required to properly manage patients with diabetes is an understanding of BG monitoring and how to instruct them on appropriate use and frequency of testing. In addition, an understanding of how to interpret BG results in the context of individual patients, taking into account the numerous key factors that can impact results, is imperative for HCPs to make appropriate recommendations or effectively intervene in care.

REFERENCES

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26. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. 2000;321(7258):405-412.
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30. Kahn SE, Haffner SM, Heise MA, et al; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355(23):2427-2443.
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