Diabetes Care Devices

Diabetes Care Devices

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Diabetes Care Devices Ronald Silver, BSc, BScPharm Date of Revision: August 2013

Diabetes Management

Technology has empowered patients with diabetes by giving them the tools to be more responsible for their health management on a daily basis. In addition to measuring blood glucose (BG) levels, some meters also measure glycated hemoglobin (HbA1C) levels. The primary goals of therapy are to maintain health and avoid acute and long-term complications. Diabetes care depends upon the daily commitment of those with diabetes to self-management practices, with support from their health care professionals. Effective diabetes self-management has been demonstrated to improve HbA1C values and BG levels to near-normal range.3 This reduces the frequency of microvascular complications in patients with type 2 diabetes and macrovascular risk in individuals with type 1 diabetes.1,2,3,4

Blood Glucose Levels

Optimal BG levels are associated with a low risk of developing complications (Table 1). However, in some cases, these levels may be impossible to attain because of severe side effects (e.g., hypoglycemia),2 diminished quality of life or cost. 4

Table 1: Recommended Targets for Glycemic Control HbA1C (%)

Type 1 and type 2 diabetes

≤7

FPG or Preprandial PG (mmol/L) 4–7

2-hour Postprandial PG (mmol/L) 5–10

(5–8 if HbA1C targets not being met)

Abbreviations: FPG = fasting plasma glucose; HbA1C = glycated hemoglobin; PG = plasma glucose

Fasting BG >5.6 mmol/L is associated with an increased risk of cardiovascular disease, however postprandial hyperglycemia appears to be a better predictor with values >7.8 mmol/L associated with an increase in all-cause mortality, and values >10 mmol/L with both microvascular complications and risk of myocardial infarction.4 Blood glucose levels correlate well with HbA1C levels. When HbA1C values are high, the major influence is the fasting BG. When HbA1C levels approach 7%, postprandial plasma glucose becomes more significant.4

Glycemic targets should be individualized based on the age, duration of diabetes, risk of severe hypoglycemia, presence or absence of cardiovascular disease, and life expectancy.4 More intensive control with an HbA1C <6.5% may be beneficial if it can be achieved without a significant increase in hypoglycemia, and may be appropriate in patients with a shorter duration of diabetes, no evidence of significant cardiovascular disease and a longer life expectancy.4 An HbA1C target of <8.5% may be considered in patients with a limited life expectancy, a higher level of functional dependency, a history of severe hypoglycemia, or advanced comorbidities.4

Blood Glucose Monitoring

Blood glucose monitoring provides feedback for patients, which allows for assessment of the effects of diet, exercise and changes in treatment.4

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All available blood glucose meters test a capillary blood sample, which is whole blood. Meanwhile, laboratories use venous plasma glucose as the benchmark (plasma is whole blood without the red blood cells). Blood glucose meters are adjusted to give results which correlate with lab test results. At BG levels >4.2 mmol/L, a difference of <20% is considered acceptable.5 Experts recommend comparing laboratory and meter results at least annually, or when meter results do not appear to match HbA1C or other indicators.

Frequency of Testing The optimal use of blood glucose monitoring is controversial. The quality of evidence to support testing is variable.6 Health care professionals can assist patients in determining the frequency and timing of their blood glucose measurements. Factors to consider are the potential benefits of monitoring versus cost and pain associated with the procedure.7 Patients with type 1 diabetes should test at least 3 times a day; this has been associated with a 1% reduction of HbA1C levels.5 Testing can be done on a twice-daily basis: before breakfast and after supper one day, and after lunch and at bedtime the next day. Patients with type 2 diabetes using insulin more than once a day should also test 3 times a day.5 Patients using multiple insulin injections or insulin pump therapy should be testing 3 times a day or more.8 Patients with type 2 diabetes on oral medication should test periodically, with tests reflecting pre-meal, after-meal and bedtime levels. Testing in these patients has demonstrated a reduction in HbA1C levels of 0.2–0.6%.5 Testing may also be used to achieve post-prandial glucose targets.8

Testing

Patients should track their results in a journal log, or use meters with memory and graphing options so they can share this information with their physician and other health care providers. For optimal self-monitoring of blood glucose, the patient is educated on the use of a meter, interprets the results and modifies treatment based on current blood glucose levels according to individual guidelines provided by health care professionals.8

Lancing Devices

The first step in blood glucose monitoring is obtaining a blood sample. A capillary blood sample is collected by puncturing the skin with a lancet, which is a small needle of varying gauge or size. When the lancing device is triggered, the needle is projected into the skin and retracts. Since diabetic patients are more susceptible to infection, the area must be well cleansed. Washing hands with soap and water is acceptable. When travelling, patients can use alcohol swabs instead. Most lancets are designed to be used 2–4 times. Most lancing devices have a depth adjustment. The majority of models are pen-shaped and accept a variety of lancets. However, some lancets can only be used by a specific lancing device. For example, Softclix lancing devices accept only Softclix lancets. To use a lancet device, apply the device to the skin, exert gentle pressure and press the trigger. Site rotation is also important. Frequent users will rotate between fingers; occasionally, right-handed users might prefer lancing the left hand and vice versa. The target area is the side of the finger beside the fingernail. For product selection, consult Products for Minor Ailments. Diabetes Products: Blood Glucose Meters.

Alternate Site Testing

Meters are available that allow using blood samples from sites other than the fingertip, such as the forearm, palm of the hand or thigh. During periods of rapid change in BG levels (e.g., after meals, after exercise and during periods

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of hypoglycemia), fingertip testing is the most accurate.5 Blood samples taken from the palm near the base of the thumb provide a closer correlation to fingertip samples than the forearm or thigh.

Blood Glucose Meters

There are many meters available, and health care professionals can assist patients in choosing an appropriate device by considering the following factors: The amount of blood required for the sample.

The calibration method: for some models it is as simple as putting in a test strip; others require pushing a button or inserting a code key for calibration. The size of the test strips: patients with poor dexterity may prefer larger strips.

The screen size and display size are important to visually impaired diabetic patients. The ability to provide an audible readout is important to blind diabetics. The battery type and battery life.

The ability to link to a computer for in-depth reports.

The ability to add comments, such as meals and levels of activity, and access built-in graphs. The ability to communicate with insulin pumps.

For product selection, consult Products for Minor Ailments. Diabetes Products: Blood Glucose Meters.

Testing with a Blood Glucose Meter

Healthcare professionals assisting patients with blood glucose meters must have a thorough knowledge of available products. Demonstrations and detailed owner's manuals are available. As well, a quick reference guide is available with each meter for rapid consultation.

Troubleshooting Blood Glucose Meters

Although newer meters are easier to use, patients may still experience difficulties. Many meters provide directions or error codes that patients or health care professionals can verify in the owner's manual or discuss with the manufacturer's technical support team. Most problems are due to: Errors in user technique.

Improper meter calibration. It is important that the meter's calibration number corresponds with the calibration number on the strip container. Outdated or poorly stored strips. Check manufacturer's specifications regarding temperature, light and humidity. Inadequacy of blood samples, e.g., size, traces of alcohol used to clean puncture site. Not respecting temperature and humidity requirements.

Change in patient's situation (e.g., illness, stress, pregnancy), which can produce unexpected but accurate results. Changes in medications (including adding or removing nonprescription drugs).

Diabetes Management Software

With the appropriate interface, data can be downloaded from a blood glucose meter to a computer. The software will enable the patient to see the information in different formats, such as patient profiles, logbooks, means,

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variations, deviations from pre-set goals, charts, standard day and insulin doses. This information can also be printed. The software is available through the manufacturer, or one may be able to download the file from the manufacturer's web site. The cables to link meters to computers are available from the manufacturer. Pharmacists may wish to set up their own computer so they are able to download patients' data and provide interpretive counselling.

HbA1C Monitoring HbA1C is formed by a nonenzymatic interaction between glucose and hemoglobin. Formation of HbA1C is irreversible, and the level in the red blood cell depends on the plasma glucose concentration over the life of the cell. Since red blood cells have a lifespan of about 3 months, the HbA1C level reflects the average amount of glucose that has been present during that time. A normal HbA1C level is below 5.7%. Prediabetic levels are between 5.7–6.4%.8 Diabetes is defined as a level above

6.5%.9 The accuracy of the HbA1C test may vary by as much as 0.5%, that is, a level of 7.0 could mean a true HbA1C

level between 6.5 to 7.5%.10 False HbA1C readings can occur in patients with anemia, iron-deficient anemia, kidney failure and liver disease. HbA1C readings should not be used on their own to diagnose diabetes, as they do not reflect the frequency and severity of hypo- and hyperglycemic events.9 Recommendations for HbA1C testing are: Every 6 months in patients who are meeting treatment goals.8

Every 3 months in patients whose therapy has changed or who are not meeting treatment goals.5,8 When patients monitor their own HbA1C levels, it provides the opportunity for more timely treatment changes and reaffirms their blood glucose results. This may be of particular benefit to patients who do not see a physician on a regular basis.8 It is useful to understand the relationship of HbA1C to mean plasma glucose levels (Table 2). A calculator for converting HbA1C to an estimated mean plasma glucose is available at the American Diabetes Association's DiabetesPro web site. Table 2: HbA1C and Corresponding Estimates of Mean Plasma Glucose Values HbA1C (%)

8

Estimated Mean Plasma Glucose (mmol/L)

6

7.0

7

8.6

8

10.2

9

11.8

10

13.4

11

14.9

12

16.5

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Urine sampling for the presence of glucose in the urine is not ideal, as it does not reflect current blood glucose levels and will not detect hypoglycemia. However, there may be select circumstances under which urine glucose monitoring may be used, such as when blood glucose monitoring is not available, too costly or too painful.

Ketone Monitoring

When insulin levels fall too low, the body shifts from carbohydrate to fat metabolism. Ketones are a by-product of this process. Ketones are normally excreted by the kidneys, but under these circumstances, elimination is not rapid enough and ketones accumulate in the bloodstream, causing the blood to become acidic. The levels of blood glucose continue to rise, causing diabetic ketoacidosis (DKA), which is accompanied by the following symptoms: thirst, dry mouth and frequent urination; nausea and vomiting; blurred vision; pain in the abdomen; and fruity smelling breath. Ketone testing is recommended for those with type 1 diabetes during periods of acute illness accompanied by elevated BG, when preprandial BG levels are >14 mmol/L or when symptoms of DKA are present. If all of these conditions are present in individuals with type 2 diabetes, ketone testing should also be considered.5 During DKA, the equilibrium that is usually present between ketone bodies shifts toward the formation of betahydroxybutyric acid. Blood assays of this acid have been associated with an earlier detection of DKA than urine testing for acetoacetate or acetone levels.5 Urine testing is done with strips (such as Ketostix) or with blood, using the ketone measuring test strips of a blood glucose meter such as Precision Xtra. For product selection, consult Products for Minor Ailments. Diabetes Products: Urine Glucose and Ketone Test Kits.

Continuous Glucose Monitoring Systems

Continuous glucose monitoring (CGM) systems have been shown to improve HbA1C levels and reduce the duration of hypoglycemia, hyperglycemia and nocturnal hypoglycemia in patients treated with insulin.5 CGM, used in conjunction with intensive insulin regimens, can be a useful tool to lower HbA1C in selected adults (>25 years) with Type 1 diabetes.11 CGM may also be helpful in children.5 CGM may be a supplemental tool to BG monitoring in those patients with hypoglycemia unawareness and/or with frequent hypoglycemic episodes.

CGM systems measure glucose levels in interstitial fluids. These levels relate well with BG values, although there may be significant differences due to lag time, particularly when BG levels are rapidly changing (such as a few hours after eating). BG tests are still required during these times, for the purpose of calibrating the CGM system device and for making decisions regarding medication changes.12 The glucose sensor is a tiny electrode inserted under a patient's skin (subcutaneous tissue) that continuously records glucose levels. The sensor is worn for up to 3 days before it is discarded and replaced. Glucose readings are transmitted to a meter or insulin pump where the readings are displayed. Trend reports and charts can be viewed after the data is downloaded to a computer. Using a CGM system chart is like watching a movie—anyone can follow the storyline and anticipate what is going to occur next. CGM systems allow patients and their health care professionals to discover how diet, exercise, medication and lifestyle affect their glucose levels. CGM system devices that display real-time readings allow patients to see how fast, and in what direction, their glucose levels are heading, allowing them to intervene earlier to reduce the frequency and severity of high and low blood sugar episodes.12,13

Insulin Administration Devices

Syringes are required to measure the number of units of insulin to be administered. Various sizes and measurement increments are available. The 100-unit size has 2-unit increments for measuring larger doses, while the 50- and 30-unit syringes have 1-unit increments. The choice of syringes should be based on the total amount of insulin to be administered, keeping in mind that smaller-volume syringes will offer a more accurate measurement. Needles vary in length and diameter. The shortest available needles are 5 mm; the longest, 12.7 mm. The diameter will

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vary from 28–33 gauge, with higher numbers indicating a smaller diameter. Thinner and shorter needles cause less resistance in skin penetration and usually less discomfort for the patient. However, some patients, such as obese patients, may find longer needles provide better penetration to the subcutaneous tissue and will prevent insulin leakage from the injection site. Waiting 3–5 seconds before taking a needle out of the skin after injection will prevent insulin leakage from the injection site. If 5 seconds is not sufficient, this interval should be prolonged. Reusing needles diminishes the point sharpness and removes the silicon coating. This may lead to micro-traumas which are linked to nodule formation; manufacturers recommend single use only. Insulin pens look like large fountain pens. Instead of retrieving the insulin from vials, the pen uses insulin cartridges which contain 300 units of insulin. Insulin pens are ideal for patients who are travelling, on a frequent insulin administration program, on a very low number of units per day and those who are visually impaired, since they can count the audible clicks made when selecting the number of units to administer. They are not suited for patients requiring a custom mix of insulins as patients will require 2 pens to inject the insulins separately. Insulin pens should be kept at room temperature (between 2 and 30°C) for up to 28 days, but unused cartridges can be refrigerated and kept until their expiry date. Disposable pens should be stored refrigerated until opened, then kept at room temperature (below 30°C) for up to 28 days. Ensure patients understand the particular technique associated with the use of the pen. It is also advisable to keep a few syringes at home in case of pen malfunction. There are a number of major companies in the pen/cartridge market and patients must be aware that cartridges are not interchangeable. For product selection, consult Products for Minor Ailments. Diabetes Products: Insulin Delivery Systems.

Insulin Pumps

It can be easier to match insulin requirements with lifestyle (allowing for more flexibility with meals and activity) using an insulin pump rather than multiple daily doses of insulin. Insulin pumps provide a constant supply of insulin to the patient, adjustable to the time of day, as well as the option to provide extra insulin required for meals and snacks. An insulin pump is a battery-operated device that is designed to be worn 24 hours a day. A small plunger pushes insulin out of a reservoir or cartridge through tubing to a cannula that has been inserted in the patient's subcutaneous tissue. Advantages of pump therapy:12 Useful for those with type 1 diabetes.

Provides more consistent control of blood glucose levels than daily and multiple daily injections.

More convenient than multiple daily injections and allows the patient more flexibility in the timing and size of meals. Provides a more consistent rate of insulin absorption (3% versus 25%) due to fewer injection sites. Often results in lower HbA1C values without increasing the risk of hypoglycemia. Disadvantages of pump therapy:12 An insulin pump can cost between $6000 and $8000, and pump supplies can cost about $250/month. Many provinces have programs to offset some of these costs. Malfunctions may occur, resulting in ketoacidosis within a few hours due to a disruption in insulin delivery.

Patients need to change their infusion sites every 2–3 days; regular skin care and wearing the pump 24 hours a day must be considered. Patients must be trained by an experienced diabetes educator and be technologically savvy.

Pump Features

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Insulin pumps are programmed to provide a basal rate of insulin, which can vary for each patient and at different times of the day. More insulin is usually required at night for those who experience the dawn phenomenon. Patients can adjust the pump to provide a bolus amount of insulin according to what and when they are eating. The insulin pump helps to calculate the dose required based on the number of grams of carbohydrates eaten, but this can be overridden depending on planned activities or other factors. Patients must learn the skill of carbohydrate counting. Some meters have a database of favourite foods, which can make the calculations easier and faster. The pump can also be programmed to provide the bolus all at once for a regular meal, or over a period of time (e.g., 1–2 hours) when a patient wishes to nibble.12 Insulin pumps can be linked to a blood glucose meter through wireless technology, and adjustments to insulin delivery can be made and monitored. The CGM device communicates with the insulin pump every 5 minutes, showing the direction and rate of change in glucose levels. The advantage of this is to foresee problems regarding hypo- or hyperglycemia before they arise. The disadvantage of CGM is that the sensors must be calibrated 2–3 times daily with a blood glucose meter when blood glucose values are stable. Also, the sensors are expensive and need to be replaced every 3 days.12 The insulin pump may be worn around the abdominal area, or at various other sites including the leg. The pump contains a reservoir to hold fast-acting insulin. Insulin is withdrawn from a vial and moved to the reservoir with a needle-attached adapter. The reservoir typically holds 170–300 units of insulin and should be replaced every 3 months. The pump can be programmed to set basal rates and bolus settings, along with connectivity to a glucose meter and/or computer for reporting activity. An infusion set consists of tubing with either a needle or a cannula to deliver insulin from the pump to the body. Infusion sets are available with 2 lengths of tubing, ranging from 24 inches (60 cm) to 43 inches (110 cm). These lengths allow users to wear their pumps in a variety of locations. The tubing needs to be replaced every 3 days. For subcutaneous administration, patients have a choice between steel needles (which must be changed every 1–2 days) or soft Teflon cannula sets (which can be used for 2–3 days). These are available in 2 or 3 lengths and are designed to be inserted at 90° or at 30–45° angles. An autoinjector is available to assist insertions. The 90° insertion provides better penetration for obese patients. Shorter needles can be used (an advantage for those with needle phobias) but they are more prone to kinking, which may inhibit insulin flow.12 Pharmacists can assist diabetic patients who are using pumps by having consumable supplies available. These include infusion sets, reservoirs, transparent dressings, batteries and adhesive removers. For information on available insulin pumps, consult the Canadian Diabetes Association web site (see Resource Tips).

Miscellaneous Supplies

Plastic syringe cases allow for the transportation of pre-filled syringes without accidentally applying pressure to the plunger. They are available for 1 or 7 syringes. This tool is excellent for health care professionals who pre-fill and deliver insulin to patients with special needs. Travel kits organize all diabetes needs in one place. Most travel kits contain ice packs, useful for patients travelling to areas of extreme temperature. Sharps containers (which are tamper-proof) should be used to dispose of used syringes, needles and lancets. The containers should be turned into a needle disposal site for safe destruction. There are also manual and electric needle cutters which retain the exposed needle in a compartment, which when full can be safely destroyed. Logbooks can be used by patients to record their blood glucose results, diet and activity level. Specialized socks provide extra cushioning and warmth while wicking perspiration away from the feet. They also have loose elastics and no rough seams, so as not to impair circulation or irritate the feet. Callus and blister protectors are also very useful for individuals with diabetes to prevent damage to the skin on the feet.

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Dextrose gels or tablets are a useful means to treat hypoglycemia by providing an exact amount of sugar in a convenient format. The gels are slow-acting and the tablets are fast-acting. Glucagon is a hormone that counteracts the action of insulin. Glucagon stimulates the release of glucose from the liver into the bloodstream, thereby easing the symptoms of low blood glucose. Glucagon kits contain a preloaded syringe, and are mainly for use by family or friends in treating a severe insulin reaction in patients unable to take sugar by mouth. Medical attention should follow for patients not recovering after a few minutes. Filling new and refill prescriptions for diabetes medications is a convenient opportunity for the pharmacist to ask the patient if they are using and/or require diabetes supplies:8 Alcohol swabs

Blood glucose strips Glucagon

Glucose tablets Lancets

Needles/syringes

Needle disposal containers Pump supplies

Urine ketone strips Other aids

Resource Tips

American Diabetes Association. Available from: www.diabetes.org. Canadian Diabetes Association. Available from: www.diabetes.ca. Diabetes in Control. News and information for medical professionals. Available from: www.diabetesincontrol.com. FIT Forum for Injection Technique Canada. Recommendations for best practice in injection technique. Available from: www.bd.com/resource.aspx?IDX=25063. Insulin Pumpers. Provides information and support for adults and children with diabetes and their families interested in insulin pump therapy. Available from: www.insulin-pumpers.org. Mayo Clinic. Health Information. Available from: www.mayoclinic.com. Mendosa D. On-line diabetes resources. Part 14: Blood glucose meters. Available from: www.mendosa.com/meters.htm. Public Health Agency of Canada. Diabetes. Available from: www.phac-aspc.gc.ca/cd-mc/diabetes-diabete/indexeng.php.

References 1. Ohkubo Y, Kishikawa H, Araki E et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 1995;28:103-17. 2. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993;329:977-86. 3. Jones H, Berard LD, MacNeill G et al. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the

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Prevention and Management of Diabetes in Canada: Self-management education. Can J Diabetes 2013;37:S26-30. Available from: guidelines.diabetes.ca/Browse/Chapter7. 4. Imran SA, Rabasa-Lhoret R, Ross S. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada: Targets for glycemic control. Can J Diabetes 2013;37:S31-4. Available from: guidelines.diabetes.ca/Browse/Chapter8. 5. Berard LD, Blumer I, Houlden R et al. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada: Monitoring glycemic control. Can J Diabetes 2013;37:S35-9. Available from: guidelines.diabetes.ca/Browse/Chapter9. 6. Ahuja TK, Bai A, Belanger D et al. Systematic review of use of blood glucose test strips for the management of diabetes mellitus. Ottawa: Canadian Optimal Medication Prescribing and Utilization Service (COMPUS), Canadian Agency for Drugs and Technologies in Health (CADTH). COMPUS Optimal Therapy Report 2009;3:1-157. 7. Goldstein DE, Little RR. Monitoring glycemia in diabetes. Short-term assessment. Endocrinol Metab Clin North Am 1997;26:475-86. 8. American Diabetes Association. Standards of medical care in diabetes–2012. Diabetes Care 2012;35:S11-63. 9. Goldenberg RM, Cheng AYY, Punthakee Z et al. Use of glycated hemoglobin (A1C) in the diagnosis of Type 2 diabetes mellitus in adults. Can J Diabetes 2011;35:247-9. 10. The National Institute of Diabetes and Digestive and Kidney Diseases; National Diabetes Information Clearinghouse. How accurate is the A1C test? Available from: diabetes.niddk.nih.gov/dm/pubs/A1CTest/#11. 11. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Monitoring glycemic control. Can J Diabetes 2008;32:S32-3. 12. Montopoli T. Pump it up, a pharmacist's guide to insulin pump therapy. Pharmacy Practice 2009 April/May:D6-D9. 13. Medtronic MiniMed. Distinctions between standard glucose meters and glucose sensors. 2006. CPhA assumes no responsibility for or liability in connection with the use of this information. For clinical use only and not intended for for use by patients. Once printed there is no quarantee the information is up-to-date. [Printed on: 03-03-2016 05:41 AM] RxTx, Compendium of Therapeutics for Minor Ailments © Canadian Pharmacists Association, 2016. All rights reserved

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