Continuous Glucose Monitor Use in Pediatric Patients with Type 1 Diabetes Mellitus

Managing Type 1 Diabetes Mellitus (T1DM) is a challenge for the newly diagnosed patient, especially for the newly diagnosed pediatric patient. T1DM is an irreversible disease process with many risks associated, such as, hypoglycemic events, diabetic ketoacidosis, and increased risk of infection. How best to manage care is of paramount importance for the patient and the caregiver, therefore, the most up-to-date technology should be utilized to provide personalized care plans that will help T1DM pediatric patients avoid many of the short term dangers and long term comorbidities that result from unmanaged glucose levels. This state of the science review takes into consideration the current standard of care for diabetic patients, advancements in continuous glucose monitoring (CGM) technology, and proven tangible benefits, as well as, barriers for use in the newly diagnosed T1DM pediatric patient. Some of the benefits with CGM use are: lower HbA1c levels, decreased episodes of hypoglycemia and hyperglycemia levels, increases in time spent in optimal glycemic range, and an increase in patient satisfaction in their management of diabetes. While there are many benefits to CGM usage, there are barriers to CGM use in the pediatric population. Based on the state of the science review, concern for insurance coverage and cost of the device and supplies are two of the most often cited reasons for reluctance to recommend or use a CGM. Provider and caregiver perceptions are also factors influencing the adoption and compliance of utilizing technology in diabetes care. Some clinicians are more willing to promote CGM usage compared to others. There are also personal perceived barriers and disparities in CGM use in pediatrics such as: limited trust in the device, alarm fatigue, difficulty setting up the monitor, short sensor duration, and daily calibration. The barriers to CGM use should be eliminated to allow for this innovative device to be included in the new standard of care for a T1DM pediatric patient.

Running head: CGM USE IN PEDIATRIC PATIENTS WITH T1DM 1 Continuous Glucose Monitor Use in Pediatric Patients with Type 1 Diabetes Mellitus Kristin Gentile, Angie Journell, and Daniel King College of Nursing, Westminster College MSN 610 01: Final Manuscript Dr. Julie Balk December 5, 2021 CGM USE IN PEDIATRIC PATIENTS WITH T1DM 2 Abstract Managing Type 1 Diabetes Mellitus (T1DM) is a challenge for the newly diagnosed patient, especially for the newly diagnosed pediatric patient. T1DM is an irreversible disease process with many risks associated, such as, hypoglycemic events, diabetic ketoacidosis, and increased risk of infection. How best to manage care is of paramount importance for the patient and the caregiver, therefore, the most up-to-date technology should be utilized to provide personalized care plans that will help T1DM pediatric patients avoid many of the short term dangers and long term comorbidities that result from unmanaged glucose levels. This state of the science review takes into consideration the current standard of care for diabetic patients, advancements in continuous glucose monitoring (CGM) technology, and proven tangible benefits, as well as, barriers for use in the newly diagnosed T1DM pediatric patient. Some of the benefits with CGM use are: lower HbA1c levels, decreased episodes of hypoglycemia and hyperglycemia levels, increases in time spent in optimal glycemic range, and an increase in patient satisfaction in their management of diabetes. While there are many benefits to CGM usage, there are barriers to CGM use in the pediatric population. Based on the state of the science review, concern for insurance coverage and cost of the device and supplies are two of the most often cited reasons for reluctance to recommend or use a CGM. Provider and caregiver perceptions are also factors influencing the adoption and compliance of utilizing technology in diabetes care. Some clinicians are more willing to promote CGM usage compared to others. There are also personal perceived barriers and disparities in CGM use in pediatrics such as: limited trust in the device, alarm fatigue, difficulty setting up the monitor, short sensor duration, and daily calibration. The barriers to CGM use should be eliminated to allow for this innovative device to be included in the new standard of care for a T1DM pediatric patient. CGM USE IN PEDIATRIC PATIENTS WITH T1DM 3 Table of Contents ACKNOWLEDGEMENTS…………………………………………………………………….....4 INTRODUCTION………………………………………………………………………………...5 BACKGROUND/REVIEW OF LITERATURE………………………………………………….6 MANAGEMENT STRATEGIES………………………………………………………………..19 RECOMMENDATIONS AND SUMMARY…………………………………………………....22 REFERENCES…………………………………………………………………………………..24 CGM USE IN PEDIATRIC PATIENTS WITH T1DM 4 Acknowledgements Our group would like to express gratitude for the support and encouragement we have been shown throughout this project by our fellow classmates, friends and families. We also would like to acknowledge our project chair, Dr. Julie Balk, for taking the time to answer our questions and guide us through this project. We would not have been successful without you. CGM USE IN PEDIATRIC PATIENTS WITH T1DM 5 Introduction In the United States, there are nearly 1.6 million Americans with Type 1 Diabetes Mellitus (T1DM), including roughly 187,000 children and adolescents (American Diabetes Association, 2021-h; Centers for Disease Control and Prevention, 2020-b). T1DM is a chronic disease in which the pancreas loses its ability to produce insulin. After the body digests carbohydrates, it is broken down into sugar that is transported in the bloodstream. Insulin is a hormone released by the pancreas after the digestion of carbohydrates that helps regulate blood glucose levels by allowing blood sugar to enter cells, thus providing the energy our bodies need to live (American Diabetes Association, 2021-c). T1DM is an irreversible disease process and without insulin, the body is unable to regulate its blood glucose levels (Wood & Peters, 2018). Although T1DM has no cure, there are treatments available to help individuals manage the disease. Treatment requires a T1DM patient to measure their blood glucose levels frequently and administer insulin to correct or maintain their blood glucose levels within a healthy range (American Diabetes Association, 2021-c). There are however many risks associated with the management of T1DM; these risks include hypoglycemia (low blood sugar levels) and hyperglycemia (high blood sugar levels) (American Diabetes Association, 2021-e; American Diabetes Association, 2021-f). Both hypo- and hyperglycemia can result in conditions that are life threatening (American Diabetes Association, 2021-b). Common symptoms of hypoglycemia are: confusion, seizures, and loss of consciousness (American Diabetes Association, 2021-f). Prolonged or frequent hypoglycemic events can lead to increased risks of cardiovascular events, accidents, and overall is associated with decreased quality of life (Lucidi et al., 2018). The most CGM USE IN PEDIATRIC PATIENTS WITH T1DM 6 common symptoms of hyperglycemia are fatigue, blurry vision, frequent urination, increased thirst, and unintentional weight loss (American Diabetes Association, 2021-e). Long term consequences of hyperglycemia can result in systemic complications including cardiovascular disease, hypertension, stroke, nephropathy, glaucoma, and neuropathy (American Diabetes Association, 2021-b). Despite all of this, people with T1DM can live long, healthy, and happy lives, but much of that is contingent upon the proper and often tedious management of their disease. To develop a treatment regimen, it is imperative that the patient and the healthcare provider know the range of the patient's blood glucose levels. This can be done by the traditional method of selfmonitoring blood glucose (SMBG) or with continuous glucose monitors (CGMs) (Pratley et al., 2020). Both are viable options; however, as technology has advanced, there are clear advantages in using CGMs. CGMs provide the patient and provider with continuous blood glucose data, graphs, and trends that can benefit the patient in the day-to-day management of the disease. The provider can use the information to develop customizable treatment plans and goals that can help T1DM patients live healthy lives that are free from the debilitating complications caused by poorly managed care. The management of T1DM is complex, and the frequent monitoring of glucose levels is imperative; there is no better way to do this than with the use of CGMs. Background/Review of Literature The current standard of care for measuring glucose levels in patients with T1DM is the method of SMBG using a finger stick or a CGM (Didyuk et al., 2021). The finger stick method uses a blood sample on an enzymatic strip. From this enzymatic strip, blood glucose levels can be obtained to guide insulin requirements. In 1999, there was the introduction of CGMs (Didyuk CGM USE IN PEDIATRIC PATIENTS WITH T1DM 7 et al., 2021). At that time, the CGM device recorded 72 hours of data that was transmitted to a provider who evaluated the data and directed individual patient care (Didyuk et al., 2021). CGM technology continued to evolve and in 2002, when one example of a revolutionary “real-time” monitoring device was introduced: a wristwatch called the GlucoWatch G2 Biographer from Cygnus Inc. (U.S. Food Drug Administration, 2002). The use of real-time monitoring had the benefit of being non-invasive and allowed the patient to have better self-control of their glucose and insulin levels; while revolutionary, the application was unsuccessful in widespread adoption due to irritation at the site (Hirsch et al., 2019). As with all great ideas, the setbacks of inventions, like the wristwatch, ultimately led to today’s technology of CGMs that require a sensor placed subcutaneously, a transmitter attached to the sensor, and a receiver or smartphone to display readings (Didyuk et al., 2021). This technology is now widely available from multiple companies such as Medtronic’s Guardian Connect, Dexcom’s G6, and Abbott’s FreeStyle Libre (Didyuk et al., 2021). Each of these CGMs have similarities in their purpose of continuous glucose monitoring with more (and potentially greater) advances on the horizon with tangible benefits for the patient with diabetes. The ease of which these CGMs operate provides a newly diagnosed T1DM patient with real-time blood glucose levels, which can benefit their disease management and ultimately improve outcomes. According to Lawton et al. (2018), the benefits of using CGMs are abundant. In their study with in-depth interviews of people who had used a CGM for 4 weeks or more, the interviewers discovered that study participants found CGMs to be an empowering tool because they could easily access glucose data. Additionally, not only was the data easily accessible, but it also gave them more information than just a single number in time. Real time data that showed direction and rate of change demonstrated with trend arrows enabled them to see whether CGM USE IN PEDIATRIC PATIENTS WITH T1DM 8 glucose levels were rising or dropping, and how quickly the change was occurring. This information aided the participants in making appropriate steps in preventing hypo- and hyperglycemia. Interviewers also discovered that the participants' access to continuous data allowed them to understand the individual’s relationship with how insulin administration, activity, and diet impacted their glucose levels. This was said to be a motivator in making dietary changes and in breaking cycles of overtreating hypo- and hyperglycemic episodes. Advances in diabetic care and technology have increased life expectancy in T1DM (Pratley et al., 2020). With longer life expectancy comes increased risk of developing complications from diabetes. These complications may include diabetic ketoacidosis, neuropathy, hypertension, stroke, and complications of the eye, kidneys, and heart (American Diabetes Association, 2021-b). Another complication of having diabetes for a prolonged period is hypoglycemic unawareness: the state of being unaware or desensitized to the feeling of when blood glucose levels are dangerously low (Lucidid et al., 2018). Hypoglycemia unawareness occurs in as much as 36% of people with T1DM (Lucidi et al., 2018). Hypoglycemic unawareness happens over time with recurrent low blood sugars and is a big risk factor in a diabetic patient experiencing a severe hypoglycemic event (Lucidi et al., 2018). As discussed, CGMs provide alerts when glucose levels become too low and too high, as well as, when glucose levels are trending in either direction (Pratley et al., 2020). This predictive information and the associated alerts allow the user time to make adjustments prior to reaching dangerous glucose levels (Lawton et al., 2018; Pratley et al., 2020). These alerts have also been shown to increase a diabetic’s time in range (TIR) which is defined as the amount of time spent in a target blood glucose range, typically between 70 and 180 mg/dL (American Diabetes Association, 2021-a). The more time spent within the TIR also means patients on CGMs spend less time in a CGM USE IN PEDIATRIC PATIENTS WITH T1DM 9 hypoglycemic state (Lucidi et al., 2018; Matsuhisa & Kuroda, 2019). Spending less time in a hypoglycemic state also reduces the risk of T1DM patients developing hypoglycemic unawareness and thus reducing episodes of severe hypoglycemia that can lead to loss of consciousness, seizures, coma, confusion, disorientation, brain damage, and cardiovascular events, all of which can result in serious accidents and death (American Diabetes Association, 2021-b; Lucidi et al., 2018). CGM use has benefited the adult diabetic population; however there is less evidence supporting the benefits experienced by the pediatric diabetic population with this new diabetes technology. Between 2014-2015, there were 18,291 newly diagnosed cases of T1DM in children and adolescents under the age of 20 (Centers for Disease Control and Prevention, 2020-a). For children under the age of 18 living with T1DM, the American Diabetes Association (ADA) recommends a hemoglobin A1c goal of <7.5% (Wood & Peters, 2018). CGMs were first used on pediatric T1DM patients in 1999 but this population has seen a delayed increase in CGM use when compared to CGM use in adults with diabetes (Lal & Maahs, 2017). Implementation of CGM use in adults is usually easier to initiate and easier to maintain than in children due to a variety of reasons; however, use of this advanced technology can greatly benefit the pediatric patient with T1DM (Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, 2009). Initial use of CGMs among the pediatric population was low, but according to a crosssectional comparison of data obtained in 2010-2012 and 2016-2018 there was a 10-fold increase in CGM use amongst children <12 years (Foster et al., 2019). As with CGM use in adults, studies have shown that this device can help to improve the pediatric diabetic patient’s current health with the potential to prevent long term complications from this disease (Lou et al., 2021; CGM USE IN PEDIATRIC PATIENTS WITH T1DM 10 Patton et al., 2019). In addition, there are psychological benefits of CGM use among both children and their parents, as well as the child’s community members including their school teachers and health care providers (Erie et al., 2018; Hilliard et al., 2019; Lawton et al., 2018; Sinisterra et al., 2020; Tanenbaum et al., 2021; Vesco et al., 2018). It is believed that the benefits of CGM use in the pediatric diabetic population far outweigh the risks that initially prohibited the universal use of this device in the younger diabetic population. Pediatric patients with T1DM experience a similar health benefit from CGM use as adults, specifically, T1DM pediatric CGM use is associated with the health benefits of a reduction in mean glucose, glucose fluctuations, coefficient of variation, hemoglobin A1c, and time in hypo- and hyperglycemia (Danne et al., 2017; DeSalvo et al., 2018; Dovc et al., 2019; Lewis et al., 2017; Lou et al., 2021; Thabit et al., 2020; Vesco et al., 2018). In addition, youth that demonstrate frequent CGM use are also more adherent to their diabetes management program (Giani et al., 2016). The cumulative benefit of these health outcomes results in an improvement of overall glycemic control, a reduction in disease progression, and a reduction in the likelihood of future development of potential long term complications (Lewis et al., 2017; Sheikh et al., 2018). In addition to the physical health benefits experienced by T1DM pediatric patients that use CGMs, there are numerous psychological benefits (Lawton et al., 2018; Sinisterra et al., 2020; Vesco et al., 2018). Lawton et al. (2018) found that patients with diabetes have reported improved motivation and empowerment to optimize their diabetes management after using a CGM. This diabetes technology helped them understand the impact of lifestyle and insulin on their blood glucose levels and provided easy access to continuous data related to the state of their disease. In a separate study, researchers found adolescents that use CGMs for their T1DM CGM USE IN PEDIATRIC PATIENTS WITH T1DM 11 management report lower diabetes-specific distress when compared to adolescents with T1DM that do not use diabetes technology (Vesco et al., 2018). Another benefit experienced by T1DM pediatric patients that use CGMs is an improvement in sleep quality (Sinisterra et al., 2020). Unfortunately, the disease management for a pediatric patient with T1DM extends beyond the patient. One must consider that all of the patient’s caregivers are affected by the stress of this chronic disease; however, again, CGM use has shown some perceived benefit by these individuals as well. The caregivers of a T1DM pediatric patient may include their parents, teachers, siblings, partners, and other community members. The benefits experienced by caregivers of children with T1DM that use CGMs are numerous (Erie et al., 2018; Hilliard et al., 2019; Tanenbaum et al., 2021). Parents and teachers have reported that CGM use was life-changing for the child, and has improved the caregiver’s peace of mind and sense of security while also increasing the child’s independence (Erie et al., 2018). According to Hillard et al., (2019) when a pediatric patient uses a CGM, the patient's parents have reported a decrease in worry, improved confidence in the child's safety, and an improvement in the parent’s personal sleep quality. They also found the use of CGMs helps parents of children that are not able to recognize symptoms or express their experience of hypo- and hyperglycemia. Given the numerous benefits of CGM use that are experienced by both the child and the caregiver affected by T1DM, the initiation of CGM should be provided to the patient as early as possible after T1DM diagnosis. The authors from a study by Tannenbaum et al. (2021) found that the timing of CGM introduction can have an impact on perceived disease management for both the patient and the patient’s caregivers. The parents of pediatric patients with T1DM who receive a CGM close to their time of diagnosis report increased satisfaction related to diabetes management; specifically CGM USE IN PEDIATRIC PATIENTS WITH T1DM 12 because the benefits of obtaining a CGM within a month of diagnosis include: fewer finger sticks for the child, decreased parental stress, better sleep for parents, ability to access blood glucose data remotely, and ability to improve diabetes management based on the CGM data. Overall, the early introduction of CGM use reduced the patient and caregiver’s disease-related burden and distress. Additionally, early adoption of CGM may prevent increases in hemoglobin A1c during the recent-onset period for pediatric patients newly diagnosed with T1DM (Patton et al., 2019). Unfortunately, provision of a CGM at time of diagnosis is not the current standard of practice, and there are multiple barriers to obtaining and maintaining CGM use in the T1DM pediatric patient population. Throughout the literature review, recurrent themes for barriers of CGM usage arise. Concern for insurance coverage and cost of the device and supplies are two of the most often cited reasons for reluctance to recommend or use a CGM device. There are also personal perceived barriers and disparities in CGM use in pediatrics. The barriers to using a CGM for a pediatric patient are numerous, yet, in light of these barriers there are justifications to recommend use by providers, to encourage use by patients, and to approve coverage by insurance companies. In the United States, reviewing and obtaining insurance coverage for a CGM is complex. It is difficult to determine if a device is covered by insurance plans because of the variability of insurance plans and coverage (Anderson et al., 2020; Yan, 2019). Disparity exists not just in Medicare/Medicaid/CHIP programs, but also in coverage by private insurance companies (Anderson et al., 2020). The requirements for a person to obtain a CGM through their insurance vary greatly from evidence of having a diabetes diagnosis and requiring treatment with insulin, to the more stringent requirements of 1) maintaining a personal log of blood glucose testing at CGM USE IN PEDIATRIC PATIENTS WITH T1DM 13 least four times per day for 60 consecutive days, 2) documentation of using three or more types of insulin per day, 3) one year of subcutaneous insulin therapy, 4) completion of a diabetes education program, 5) suffering from one or more hypoglycemic episode, and 6) inability to meet target hemoglobin A1c of 7% (Anderson et al., 2020; Select Health, 2020; University Health Plans, 2020). A recent review of Medicaid plans showed that 13 states required that patients prove SBGM a minimum of four times daily (Anderson et al., 2020; Datye et al., 2021). And while some states have criteria to provide a CGM, there are states that do not provide CGM coverage at all (Yan, 2019). Some insurance providers and pharmacy benefits managers consider CGMs as durable medical equipment (DME) requiring a prior authorization (DiaTribe, 2019). The prior authorization process can cause delays in treatment as reported by various physicians of the American Medical Association (American Medical Association, 2017). Also, the fact that a CGM is considered as DME means that some patients can buy their CGM and supplies through their pharmacy, while others must purchase necessary supplies through a third party, such as an online prescription company, like a GoodRx.com or online retailer, like Amazon.com (American Diabetes Association, 2021-a; American Diabetes Association, 2021-d). Having to go to multiple places for supplies while navigating a complex system can be deterrents for patients and caregivers. While insurance may cover some expenses, there is the initial and ongoing financial burden by the patient to maintain a base level of health. With increasing health insurance premiums, more families are selecting high deductible plans which impacts the ability to pay out-of-pocket for a CGM (American Diabetes Association, 2021-i). As of 2021, if a patient does not have insurance coverage, the cost of a CGM and its supplies may be cost prohibitive to many CGM USE IN PEDIATRIC PATIENTS WITH T1DM 14 people, therefore, the patient may be deprived of life-changing technology used to best manage a diabetic patient’s care (American Diabetes Association, 2021-i). CGM is an exciting technology moving towards becoming the standard of diabetes care. Comparing the cost of some of the CGMs currently on the market highlights the expenses incurred on a yearly basis, and costs of the device and supplies are consistently cited reasons for lack of device adoption (Anderson et al., 2020; Didyuk et al., 2021). Currently, the cost of a CGM has been estimated at $15.20/day, which includes the cost of three components: the device, a receiver, and the transmitter (Wan et al., 2018). Pricing for a CGM as stated on the website www.healthline.com is shown below: Device Transmitter Sensors Dexcom G6 $1200 G6 transmitters needed, total for 4 $4800 box of $500 per sensors, each month/$6,000 per sensor lasts 10 days year Medtronic Minimed Guardian Connect $620 $345 $351 per month/$4208 per year Abbott NA - this device does not need a separate transmitter $58-69 Approximately $160 per month/ $1582 to $1868 per year FreeStyle Libre 2 Cost per month/year (https://www.healthline.com/diabetesmine/when-you-cant-afford-a-cgm#Abbott-FreeStyleLibre-2-) Looking at racial disparity in healthcare, there is evidence supporting disparities in diabetes management and technology usage among African American and non-Hispanic white CGM USE IN PEDIATRIC PATIENTS WITH T1DM 15 T1DM patients as compared to White T1DM patients (Lai et al., 2021). In a study by Argahal et al. (2020), results indicated that technology usage, such as insulin pumps and CGMs, of African American and Hispanic youth was lower than that of White youth patients. Insurance coverage was not a factor in this study as to whether or not a patient had access to or usage of diabetes technology. Explanations as to these disparities need further study, and implicit bias by providers may be a factor in not promoting CGM usage in racial minority patients. Patient acceptance of diabetes technology may be a factor, as well. Agarwal et al. (2020) stated that “studies highlighting literacy barriers in technology, promotional materials, and minority patient preferences for quality of life over medical outcomes underscores the need to more fully explore patient factors in acceptance of diabetes technology” (p. e2965). The comparison of socioeconomic status (SES) and technology use in children <18 years highlights a widening gap between higher and lower socioeconomic backgrounds. In the US, data from 2012-2016 study notes that the usage of a CGM in a higher versus lower SES patients was 37.3% v. 8.6% (Lipman & Hawkes, 2021). Lanning et al. (2020), found that providers play an important role in the adoption and sometimes in the compliance of utilizing technology in diabetes care. One of the surprising barriers in CGM usage is the subjective perceptions of clinicians—it has been noted that some clinicians are more willing to promote CGM usage compared to others. In this study, clinicians' perceptions were categorized as “personas” to describe willingness to promote a CGM—these 3 personas are Ready, Cautious, Not Yet Ready. Those clinicians who were categorized as Ready had a lower number of perceived barriers for patients and were the most willing to promote CGMs. For the Cautious providers, they held positive perceptions of CGMs and the usage, but still held perceived barriers for their patients’ willingness to use them. The Not Yet Ready CGM USE IN PEDIATRIC PATIENTS WITH T1DM 16 providers were categorized as the least likely to promote CGMs due to the negative opinions and attitudes about technology and hold their perceptions that their T1DM patients have multiple perceived barriers to use. While providers would not necessarily recognize that they hold a bias or let their perceptions influence their clinical decision-making, there are consistent barriers they perceive that impact their patients (Datye et al., 2021; Tanenbaum et al., 2017). Clinicians hold perceptions that do not necessarily align with their T1DM patients’ perceptions (Tanenbaum et al., 2017). Perceived barriers as noted by providers were their patient’s: 1) dislike of devices in or on their body, 2) lack of knowledge and understanding of the technology and data from the CGM, and 3) annoyance with the CGM alarms (Datye et al., 2021). As researchers found, it is theorized that the subjective perceptions of providers could potentially influence their willingness to prescribe or recommend a CGM to their pediatric T1DM. Just as clinicians have perceptions regarding new and existing technology, parents of diabetic children have their own perceptions and attitudes. In a study by Messer & Weinzimer, (2021), five profiles were identified: assessing parental attitudes on diabetes technology, barriers to use, fear of hypoglycemia, diabetes distress, and child’s diabetes device use. These five parental profiles are: Embracers, Burdened, Hopeful but Hassled, Distrusting, and Data Minimalists. The “Embracers” ranked the highest with 50.7% of parents expressing positive perceptions of data technology, high device usage, and fewer barriers to usage. The other four profiles describe more realistic or negative perceptions. “Burdened” parents (15.7%) expressed the highest amount of diabetes concerns, barriers, and fear of hypoglycemia. The “Hopeful but Hassled” parents (14.2%) expressed barriers to use because of on-body devices, and had lower device use. Parent profile of “Distrusting” (12.7%) attitudes expressed the most negative CGM USE IN PEDIATRIC PATIENTS WITH T1DM 17 perceptions towards technology, lowest level of trust in systems, and the lowest overall device usage. The last profile of the “Data Minimalists” were parents that expressed barriers related to not wanting information about diabetes, but they did have positive attitudes towards diabetes devices. For many providers, the ability to maintain current information is challenging, with not all providers’ offices having T1DM educators and resources available. The speed at which technology changes makes it challenging for providers to stay abreast of the newest advancements in equipment. Some providers are more comfortable with treatments and diagnoses, but they lack the exposure to the most current technologies, meaning they may or may not be comfortable with evolving technology. There is also a time commitment to become fully educated on the newest technologies, therefore, training sessions should be tailored to meet the needs of the patients and the providers (Tanenbaum et al., 2017). The perception by providers that their patients lack knowledge or understanding about the devices and the data is a barrier to promotion of these highly reliable CGMs (Tanenbaum et al., 2017). Authors in a study by Tanenbaum et al. (2017), found: A large disparity between clinicians and patients with T1DM regarding the barrier of not understanding what to do with information or features of the devices. Nearly half of clinicians endorsed this barrier while only a small percentage of patients with T1DM endorsed it. The reason for this disparity may be due to actual differences (i.e., patients have knowledge that clinicians think they lack) or perceived differences (i.e., patients do not know what information they lack, while providers have greater awareness of this). The lack of alignment of provider and patient perceptions of barriers may impact uptake CGM USE IN PEDIATRIC PATIENTS WITH T1DM 18 and adherence to diabetes devices. If clinicians anticipate greater barriers to device uptake than their patients do, they may be reluctant to encourage uptake. (p.490) To overcome barriers to technology use, it is important to recognize the personal experience of the T1DM patient and their families/caregivers. For the pediatric T1DM, there are unique barriers to CGM use as they pertain to self-image, to personal experiences, and to the psychological and physical impacts; all of which should be addressed (Datye et al., 2021). Concern for having a device attached to the body, or pain at the site of insertion can impact a child’s body awareness and potentially lead to negative self-image and lack of compliance (Datye et al., 2021; Lawton et al., 2018; Tanenbaum et al., 2021). Episodes of hypo- or hyperglycemic values cause the CGM to alert the wearer and the caregiver leading to alarm fatigue which has been cited as a negative feature of the CGM (Lin et al., 2020; Shivers et al., 2013). If these alerts are ignored, it could potentially lead to a life threatening emergency (American Diabetes Association, 2021-b). In addition, alerts from CGMs can become distractions at school or work, drawing unwanted attention to themselves, which may cause consternation in a pediatric T1DM patient (Lawton et al., 2018). Few studies have been conducted regarding CGM use and sleep disturbance. Studies by Sinisterra et al. (2020) and Tanenbaum et al. (2021) evaluated sleep in pediatric diabetic patients and their parents’ sleep patterns as it relates to diabetes management and quality of life. Authors from the Sinisterra et al. (2020) study found that parents of children with T1DM have a shorter sleep duration of 5.8 hours of sleep per night compared to the recommended 7-9 hours of sleep per night. Both studies state that the exact causes of sleep disturbances are varied, but it was determined that nighttime CGM usage contributed to interrupted sleep patterns. Device alarms CGM USE IN PEDIATRIC PATIENTS WITH T1DM 19 and fear of hypoglycemia were two of the reasons parents cite for sleep disturbances. These may be contributing factors in parents’ reluctance to select a CGM for T1DM management. Management Strategies There are numerous barriers to CGM use for the pediatric T1DM patient, and these barriers could potentially delay the success of diabetes management amongst this patient population. There are potential solutions for each of the barriers presented above. These solutions may include finding ways to reduce cost, improve insurance coverage, lessen racial and SES disparities, change perceptions, increase knowledge, and to alleviate lifestyle disruptions. Unfortunately, cost is a barrier for all medical interventions and especially for innovative medical devices such as the CGM (Anderson et al., 2020; Didyuk et al., 2021; Wan et al., 2018). As progress is made and technology advances the hope is that the cost of a CGM decreases. Today, there are drug discount programs through many retail pharmacies: Walgreens, CVS, Costco, Walmart, etc. These programs vary in their availability for and costs of a CGM and necessary supplies. For instance, in 2021, a patient can save 17% on a CGM transmitter and supplies going through an online pharmacy program, GoodRx.com (GoodRx, 2021). According to the GoodRx.com website, at this discount, the cost of the CGM is approximately $300 and a month’s supply of sensors is $350 out of pocket (GoodRx, 2021). Additionally, though, when considering the high cost of a CGM one must also contemplate the cost of a preventable hospital admission due to improperly managed diabetes such as that for a severe hypoglycemic event at ~$12,000 per admission or diabetic ketoacidosis at ~$21,000 per admission (Bajpai et al., 2021; Everett et al., 2021). With this comparison in mind, it is more reasonable to pursue CGM use through discounts as CGM device use has been shown to decrease incidence of preventable hospital admission due to these diabetes related events (Bergenstal et al., 2021). The preceding CGM USE IN PEDIATRIC PATIENTS WITH T1DM 20 factor to the cost barrier is insurance coverage, as this will determine the amount of out of pocket costs a patient incurs. Insurance coverage is a common barrier for all medical interventions, and insurance coverage regulations often control provider’s practice process (Aimed Alliance, 2018). Currently, the process to obtain a CGM varies greatly based on the patient’s insurance, but ultimately always requires a prior authorization so the timing to obtain a CGM can vary as well (DiaTribe, 2019). A solution to this insurance coverage dilemma is to require all insurance companies, private and public, to have a universal process for obtaining a CGM with removal of the prior authorization requirement. Standardizing the insurance coverage to include CGMs for all patients newly diagnosed with T1DM would alleviate this insurance coverage barrier and could also improve provider perception and knowledge of the device as it would change the standard of practice for treating a T1DM pediatric patient. A key barrier in healthcare equity is that of racial and socioeconomic disparities (HillBriggs et al., 2021; Lai et al., 2021; Lipman & Hawkes, 2021). Unfortunately, there is no easy solution to combat these problems but increased interventions targeting these groups could help to improve outcomes. Pilot programs for the implementation of CGM use should be organized for these groups so that there is an increase in opportunity for this population to obtain a CGM. In addition, there should be more research to understand the underlying reasons for disparities amongst pediatric patients with T1DM that belong to a racial minority and/or lower SES group, then once these reasons are identified further interventions can be applied to mitigate the existing healthcare inequities. CGM USE IN PEDIATRIC PATIENTS WITH T1DM 21 In order to improve knowledge and change provider perception of CGMs, the standard of practice and recommended treatment guidelines for T1DM pediatric patients must be updated. Providers in training should be educated on CGM output and how this medical device can greatly benefit all patients with diabetes. Throughout their training, providers should be taught that prescribing a CGM at time of diagnosis for all T1DM pediatric patients is the gold standard in treatment, as this will change the provider’s perception and improve their knowledge on the device. If this practice change is made, when a parent of a pediatric patient newly diagnosed with T1DM learns that CGM use is the gold standard in treatment then their perception and knowledge of the device will improve also. Another way to change the parent’s perception and knowledge on CGMs is to improve educational interventions about CGM use and all of the benefits that this device could provide to their child with T1DM (Haslund-Thomsen et al., 2020; Lawton et al., 2018). Finally, if CGM insurance coverage is universal and the prior authorization requirement is removed then it will be easier for a pediatric patient newly diagnosed with T1DM to obtain a CGM. This will allow for a change in process that will expedite the provider’s practice of prescribing a CGM, and ultimately affect the perception of CGM use for both providers and parents. The perceived lifestyle disruptions caused by CGM use that the pediatric patient with T1DM experiences, including tarnished self image and alarm fatigue, could be minimized through increased education on the benefits of CGM use and empowerment of the pediatric patient to improve their health with CGM use. It is likely that as CGM use increases among the pediatric patient population, the barriers of self image will decrease due to the normalization of wearable medical devices like the CGM. Medical device manufacturers should focus on pediatric-sized CGMs for this unique patient population to reduce the barrier of negative self CGM USE IN PEDIATRIC PATIENTS WITH T1DM 22 image caused by CGM use (MedTech Dive, 2018). To address the barrier of alarm fatigue, there should be more thorough education on how to optimize CGM use and how to modify the CGM settings, as this can reduce the hindrance of alarms (Lawton et al., 2018). It is important that the provider take a person-centered approach when treating a patient with personal perceived lifestyle disruptions caused by CGM use (Miller & Midyett, 2021). Recommendations and Summary The ultimate goal for T1DM pediatric patients and their caregivers is optimal management of blood glucose to avoid life threatening hypo- and hyperglycemic events. In order to obtain this goal, a multifactorial approach is warranted with healthcare providers setting the new standard of care for T1DM. This new, and improved standard, includes the use of a CGM. With T1DM, the patient’s basic management involves SMBGs and insulin requirements, but with proven technologies such as CGMs, this elevates the basic level of diabetes management. Evidence supports the effectiveness of the CGM, therefore, it is incumbent upon healthcare providers to set the stage for universal adoption of the CGM by prescribing one for every T1DM pediatric patient at the time of diagnosis (Anderson et al., 2020). There is significant economic impact in the adoption and usage of CGMs. Lessening the economic burden for using a CGM becomes a challenge that requires sweeping changes in insurance coverage and access to affordable devices (Anderson et al., 2020). At the time of this paper, the Medicaid/CHIP program coverage is inconsistent across the United States; however, some states have made recent changes such as lifting restrictions, and authorizing reimbursement of a CGM for use in the T1DM population (American Diabetes Association, 2021-g). In July 2021, Medicare lifted the requirement for four time daily fingersticks as a requirement for obtaining a CGM thus making this innovative technology more accessible for patients with CGM USE IN PEDIATRIC PATIENTS WITH T1DM 23 diabetes (American Diabetes Association, 2021-g). As these public insurance programs are moving towards coverage expansion and lifting criteria, private insurance companies are surely considering the cost impacts. Insurance companies can see the value in investment of CGMs in a newly diagnosed diabetic patient when considering the cost of one hospital stay due to diabetic ketoacidosis or severe hypoglycemia. It is in the financial interests of insurance companies to lift any requirements and provide coverage for a CGM for the newly diagnosed pediatric patient. It is important to recognize perceptions and attitudes around new and emerging DM technology, therefore, more education and robust training introducing CGMs to healthcare providers should occur. As the pace of technology advances, the burden on providers to be current on emerging DM technology increases. Reducing these barriers and creating ease of access to information is imperative. There are limited studies in children, and the inclusion of pediatric T1DM patients in research studies is imperative in advancing diabetes management and technology. Children are adaptable, and more “tech savvy” and should be part of developing new technologies with input around accessibility, education, and adaptations of new devices. Our pediatric population armed with the CGM can lead the way towards the goal of optimal diabetes management. It is incumbent upon healthcare providers, patient advocacy groups, insurance companies, government entities, and private industry to meet the needs of pediatric T1DM populations with a CGM that addresses all challenges and aims to be accessible to groups originally disadvantaged in obtaining one. 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Medicaid and CGM: Who’s Covered? Retrieved November 21, 2021, from https://diatribe.org/medicaid-and-cgm-whos-covered APPROVAL of a thesis/project submitted by Author(s): Daniel King Angie Journell Kristin Gentile School Department: MSN Title of Thesis: Continuous Glucose Monitor Use in Pediatric Patients with Type 1 Diabetes Mellitus The above named master's thesis/project has been read by each member of the supervisory committee and has been found to be satisfactory regarding content, English usage, format, citations, bibliographic style, and consistency, and is ready to be deposited and displayed in the Westminster College—Institutional Repository. Chairperson, Supervisory Committee: Julie Balk, DNP Approved On 1/12/2022 5:41:06 PM Dean, School: Sheryl Steadman Ph.D Approved On 5/9/2022 1:15:05 PM STATEMENT OF PERMISSION TO DEPOSIT & DISPLAY THESIS IN THE INSTITUTIONAL REPOSITORY Name of Author(s): Daniel King Angie Journell Kristin Gentile School Department: MSN Title of Thesis: Continuous Glucose Monitor Use in Pediatric Patients with Type 1 Diabetes Mellitus With permission from the author(s), the staff of the Giovale Library of Westminster College has the right to deposit and display an electronic copy of the above named thesis in its Institutional Repository for educational purposes only. I hereby give my permission to the staff of the Giovale Library of Westminster College to deposit and display as described the above named thesis. I retain ownership rights to my work, including the right to use it in future works such as articles or a book. Submitted by the Author(s) on 12/16/2021 1:45:21 PM The above duplication and deposit rights may be terminated by the author(s) at any time by notifying the Director of the Giovale Library in writing that permission is withdrawn.