Real-Time Continuous Glucose Monitoring

Though still costly and challenging to use, this self-management tool can be invaluable for some patients.

he long-term damage to multiple body systems from poorly controlled blood glucose levels is well established, as are the shortterm dangers of extreme hypo- and hyperglycemia. In recent decades, rapid- and slow-acting insulin delivered by using either subcutaneous injection or an insulin pumpand the finger-stick glucose meter have given patients with type 1 diabetes effective tools for the self-management of blood glucose levels. But even the most informed and vigilant person with type 1 diabetes will encounter daily challenges in trying to compensate for a compromised endocrine system through the balancing of physical activity, insulin use, and diet modification, not to mention the added difficulty introduced by the variability in glucose levels that can be caused by stress or medications such as cortisone or caffeine. Although still expensive and relatively more complex to use than finger-stick glucose testing, realtime continuous glucose monitoring (RT-CGM) is an increasingly invaluable tool for patients. Although typical continuous glucose monitoringin which patients dont have direct access to the data gathered by the devicehas been used by clinicians as a diagnostic tool for the last decade, RT-CGM has only been available for the last four or five years as a tool for detecting blood glucose patterns and as a warning system for extreme highs and lows. RT-CGM is also a crucial component of the first generation of closed-loop blood glucose management systems the eventual goal of which is to more accurately mimic the subtlety and responsiveness of the healthy pancreas, maintaining blood glucose levels in a closer-to-normal range and with fewer fluctuations.
HOW IT WORKS

RT-CGM requires the insertion of a small filament (sensor electrode) into the subcutaneous tissue, where it measures glucose levels in the interstitial fluid, the body fluid found in the space between cells. The sensor itself is inserted into subcutaneous fat, using an insertion device, at an angle of anywhere from 60 to 90. Its similar to a miniature angiocatheter,
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except that its not inserted into a blood vessel. The needle is either retracted by the insertion device or removed by the patient. The portion of the sensor thats above the skin is connected to a sensor mount, which is attached to the skin by adhesive. Its this end that connects to the transmitter, which also sits on top of the skin. After an initiation or warm-up period, the sensor gives glucose values every one to five minutes. Sensors are approved for three-to-seven-day use, depending on the manufacturer, and are discarded at the end of that time. The transmitters are reused and are typically cleaned with soap and water. Hold on to that glucose meter. The use of RTCGM may reduce, but wont eliminate, the number of finger-stick glucose meter readings a person with diabetes will need to perform in a given day. Most available sensors require at least two finger-sticks per day, done every 12 hours, for calibration of the sensor, although one of the available sensor systems only requires four calibrations over five days. Sensor accuracy is largely dependent on these calibrations. Finger-stick glucose values obtained three to four times a day will usually ensure better accuracy, provided that the calibrations take place when the patient hasnt eaten or taken insulin, treated a low glucose level, or exercised in the previous two hours. In other words, the glucose values need to be as steady as possible when the calibrations are performed. Patients also need to be aware that there may be lag time between the finger-stick glucose and the sensor glucose values. If the blood glucose level is changing rapidly, the time between capillary and interstitial glucose values can be as long as 30 minutes, depending on the device (research has shown the range to be 0 to 30 minutes).1-3 For this reason, finger-stick readings are needed to check all extreme readings, whether high or low, before beginning corrective treatment such as glucose intake (to raise the glucose level) or an insulin shot (to lower it). If patients dont feel that their sensor correlates with how theyre feeling, they should always perform a finger-stick test.
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By Neesha Ramchandani, APRN, PNP-NP, CDE, Yael Saadon, PNP-BC, and Donna Jornsay, CPNP, CDE

The illustration above shows several different wireless continuous glucose monitoring systems. The man on the left wears a glucose sensortransmitter on his right arm and holds a monitor in his left hand. The woman in the middle wears a sensortransmitter on her abdomen and a monitor clipped to the top of her pants. The woman on the right wears a sensortransmitter beneath her clothing. Continuous glucose monitoring systems provide glucose measurements as often as once per minute. The measurements are transmitted to a wireless monitor.

This issue of calibration cannot be stressed strongly enough when teaching patients. A roller coaster analogy can be helpful in explaining this concept to patients and their families. The finger-stick glucose is in the front car of the roller coaster, and the sensor glucose is in the last car. When the roller coaster is on a flat track the sensor and finger-stick glucose values will be very comparable. If the glucose is rapidly rising, the finger-stick will show this rise first, and the sensor will lag behind. If the glucose is falling, again the finger-stick will show this change earlier than the sensor. The more rapid the rise or fall in glucose, the further the sensor will lag behind. Finger-stick glucose testing shows changes in glucose values more rapidly than testing from alternate sites such as the forearm or legthats why using such alternate sites isnt recommended when the patient feels hypoglycemic. Its also important that patients starting to use a sensor be reminded to wash their hands before testing and make sure their glucose testing technique is reevaluated by a diabetes educator.
THE USES OF RT-CGM

People with type 1 diabetes and their caregivers spend a great deal of time managing medications and equipment even as they attend to other factors influencing their glucose levels. What can they hope to gain from this new technology? Which of them will gain the most? And how should they best integrate RT-CGM to improve their existing regimens?
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A diagnostic tool. RT-CGM can be used for limited or extended periods of time to collect data and track episodes of hyperglycemia and fluctuations in blood glucose levels so that improvements in glycemic control can be achieved. A warning system. RT-CGM can also help detect hypoglycemia. Some people with diabetes may not feel their blood glucose level dropping until its already dangerously low. The lack of awareness of low glucose levels often increases over time in patients with diabetes. Episodes of hypoglycemia that occur while the patient is sleeping may no longer awaken them, even if very severe, increasing the risks of seizure, loss of consciousness, and even coma. In young children, unnoticed but frequent low blood glucose incidents may also result in damage to the developing brain.4 Alarms on real-time continuous glucose monitors can be set so that a patient will be alerted to low glucose levels before becoming severely hypoglycemic or losing consciousness. Some sensor software can also predict glucose levels on the basis of trends. When the feature is activated, it will sound an alert if the patients glucose level is rising or falling rapidly so the patient can intervene before the level becomes dangerously low or high. Long-term improvement in glycemic control. In one study, some clinicians found improved glycemic control over time with RT-CGM use, although others found the improvement lasting only three to six months.5
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Courtesy of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.

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The following composite cases illustrate the benefits of using RT-CGM with patients in an outpatient setting. Although both of these patients are young, RT-CGM has helped patients across all age groups and all types of diabetes. Case 1. A 27-year-old man has had type 1 diabetes for 19 years. His hemoglobin AIc level prior to starting RT-CGM was 9.4%. (The normal range for healthy people is 4% to 6%; the target range for adults with diabetes is 6.5% to 7%; target ranges for children with diabetes are as follows: preschoolers less than 8.5%, school age less than 8%, adolescents less than 7.5%6). Over the 15 months of RT-CGM use, he was able to decrease his hemoglobin AIc level to 7.7% and maintain it at that level for several months. After he stopped using RT-CGM because his insurance didnt cover sensors, his hemoglobin AIc level rose to 8.5%. When he got a new job and was able to resume use of RT-CGM, after three months his hemoglobin AIc level had once again decreased, this time to 7.9%.

The focus of the glucose data analysis should be on the trends in glucose levels.

Case 2. A 10-year-old girl has had type 1 diabetes for almost three years. Her hemoglobin AIc level before starting RT-CGM was 9.8%. By five months after starting RT-CGM her hemoglobin AIc level had decreased to 7.2%. After discontinuing sensor use because of the high cost of RT-CGM supplies and a lack of insurance coverage, her hemoglobin AIc level rose to 8.2%. Both of these cases illustrate the clinical improvements that can occur when patients become more aware of their glucose values throughout the day, have the opportunity to observe glucose trends, and take corrective actions to improve glycemic control. Some of these changes can be maintained even without sensor use because of the knowledge the patient has gained. Over time, however, behavior changes can be difficult to maintain without the reminders of sensor information and alarms.
CONTINUING CHALLENGES

Costs and coverage. Barriers to continued use of RT-CGM include difficulties with insurance coverage
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and the high cost of the product and related supplies. Coverage for sensor use varies among insurance carriers and from state to state. Generally, coverage is more likely to be approved for patients with documented consequences of poor glycemic control, such as chronic microvascular complications of diabetes or severe hypoglycemia resulting in unconsciousness, hospital admissions, or ED visits. Pregnant women and young children often receive coverage for sensors, and Medicare patients generally dont. Where appropriate, its a health care providers responsibility to work with the insurance company to help patients obtain coverage for RT-CGM. In most cases, once a patient has expressed an interest in using RT-CGM, the provider will need to send a letter of medical necessity to the sensor company as well as to the patients insurance company. In some cases the provider will need to speak with the insurance company before the sensor company contacts them. Realistic expectations. Clinicians must also work with patients to create a plan with realistic goals. Many patients and their families may have unrealistic expectations about RT-CGMs ability to help them manage glucose levels. Some patients think they will never have to test their glucose again, or that an insulin pump, working in combination with the sensor, will automatically give them the amount of insulin they require. Clinicians should address both the pros and cons of sensor use so the patient can consider the options and make an educated decision. The advantages of using a sensor include the availability of glucose values every few minutes. a possible reduction in the frequency of hypoand hyperglycemia. tighter glycemic control and a possible decrease in long-term complications. a possible reduction in the frequency of fingersticks. The challenges to using a sensor are that it requires its own insertion site in the body, and the receiver must be within five to 10 feet of the transmitter, depending on the product, for glucose values to be detected. it often requires the patient to carry the receiver around, in addition to the other supplies. (Medtronic currently has a product on the market thats both an insulin pump and CGM receiver in one unit, and Abbotts CGM receiver also functions as a glucose meter. Other companies are also working on creating integrated products that deliver insulin and measure glucose values. Currently, two insertion sites, one for the insulin pump and one for the RT-CGM sensor electrode,
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are needed in the sensor-enhanced pump. Several companies are at work on combining insulin delivery and glucose measurement at a single injection site.) patients may need to actually do more frequent glucose testing. some patients will have difficulty understanding the difference between finger-stick glucose values and sensor values. There is a learning curve here.
A LEARNING CURVE

The number of visits patients need to learn how to use a RT-CGM system varies widely. Some require numerous visits, while others can grasp the information in one or two visits, with follow-up at routine visits to an endocrinologist or another provider who helps them manage their diabetes. During the first visit, clinicians should discuss all of the components of the RT-CGM and their functions. The provider should have the patient insert the sensor and start the initiation process in the office. Sensor calibration, understanding on-screen sensor data, and troubleshooting should be covered. Setting target ranges and alarms. Blood glucose target ranges should also be discussed and set on an individual basis, including target blood glucose ranges before and after meals and at bedtime. Many practices initially set the low alarms at 80 or 90 mg/dL because of the difference that can exist between the sensor reading (taken from the interstitial fluid) and a finger-stick. The alarm setting for a high blood glucose level is individually set as well. Its best in most cases not to set the alarm for a high blood glucose level if a patients blood glucose levels are frequently in the 200 to 300 mg/dL range or higher. The patient may grow frustrated if the high blood glucose alarm is set to go off at a level thats lower than a patients typical readings because the system will constantly be alerting the patient that the glucose level is high. The best approach is to slowly adjust the high glucose alert downward over the course of several visits as the patients blood glucose levels decrease. Emphasizing the data. Ensuing visits include turning on additional alerts and alarms and reviewing and interpreting the data. Setting all of these at the first visit may overwhelm the patient or the patients family. As the patient continues to use the device, the provider can download the data that have been gathered to a computer during followup visits and review the information with the patient to help refine the insulin regimen for better glycemic control. Sensor data can also be downloaded by the patient at home and either analyzed by the patient or sent to a diabetes provider for
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review so that insulin adjustments can be made between visits. The focus of the glucose data analysis should be on the trends in glucose levels. When do the values fall or rise? How long after the meal is the peak postmeal rise in glucose? In our experience, poor understanding of how to use the glucose data is a common reason patients choose to discontinue RTCGM. For example, if a patient is looking at her glucose data but doesnt understand the timing of the insulin shes taking, she may not know how to make the adjustments in her therapy to improve her glucose values. Its important to review data and how best to make use of them with patients and their families. Patients who decide to use RT-CGM devices may initially face frustration while getting used to the system, especially when adjusting to the differences that can occur in either direction between blood glucose and sensor values. Many will need encouragement from nurses. Its nurses responsibility to give their patients the most updated information about the advantages and disadvantages of new tools that may help them better manage their diabetes. M
Neesha Ramchandani is a pediatric NP and a diabetes specialist at Infants and Childrens Hospital of Brooklyn, Maimonides Medical Center, NY. Yael Saadon is a certified pediatric NP in New York City. Donna Jornsay is the diabetes clinical specialist at Long Island Jewish Medical Center in New Hyde Park, NY. Contact author: nramchandani@maimonidesmed. org. Diabetes Under Control is coordinated by Jane Jeffrie Seley, MPH, MSN, GNP, BC-ADN, CDE: diabetesnp@ gmail.com. Yael Saadon and Donna Jornsay have both conducted paid trainings on the use of real-time continuous glucose monitoring for Medtronic, which manufactures one of the devices.

REFERENCES
1. Boyne MS, et al. Timing of changes in interstitial and venous blood glucose measured with a continuous subcutaneous glucose sensor. Diabetes 2003;52(11):2790-4. 2. Feldman B, et al. A continuous glucose sensor based on wired enzyme technology: results from a 3-day trial in patients with type 1 diabetes. Diabetes Technol Ther 2003; 5(5):769-79. 3. Mazze RS, et al. Evaluating the accuracy, reliability, and clinical applicability of continuous glucose monitoring (CGM): is CGM ready for real time? Diabetes Technol Ther 2009; 11(1):11-8. 4. Radermecker RR, et al. [Brain, a gluco-dependent organ: toxic effects of hypoglycaemia and hyperglycaemia]. Rev Med Liege 2008;63(5-6):280-6. 5. Ludvigsson J, Hanas R. Continuous subcutaneous glucose monitoring improved metabolic control in pediatric patients with type 1 diabetes: a controlled crossover study. Pediatrics 2003;111(5 Pt 1):933-8. 6. American Diabetes Association. Clinical Practice Recommendations 2009. Table 15: plasma blood glucose and A1c goals for type 1 diabetes by age group. Diabetes Care 2009; 32 Suppl 1:S37-S38.

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