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ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes technologies: Glucose monitoring

2022; Wiley; Volume: 23; Issue: 8 Linguagem: Inglês

10.1111/pedi.13451

1399-5448

Martin Tauschmann, Gregory P. Forlenza, Korey K. Hood, Roque Cardona‐Hernandez, Elisa Giani, Christel Hendrieckx, Daniel J. DeSalvo, Lori M. Laffel, Banshi Saboo, Benjamin J. Wheeler, Dmitry N. Latpev, Iroro Yarhere, Linda A. DiMeglio,

Diabetes and associated disorders

Since publication of the 2018 guidelines, the area of glucose monitoring has evolved, especially as regards continuous glucose monitoring (CGM) systems. CGM is more widely available in many parts of the world; latest generation devices are factory-calibrated, more accurate, and do not need a confirmatory fingerstick blood glucose measurement. More studies regarding the efficacy of CGM systems, irrespective of the type of insulin delivery, are available including long-term observational studies. With increased availability and wider use, practical considerations related to daily CGM use (e.g., skin issues, physical activity) as well as educational and psychosocial aspects have come to the fore, which are also addressed in this chapter. Regular self-monitoring of glucose (using accurate fingerstick blood glucose [BG] measurements, real-time continuous glucose monitoring [rtCGM] or intermittently scanned CGM [isCGM]), is essential for diabetes management for all children and adolescents with diabetes. A Self-monitoring of glucose has a pivotal role in the management of insulin-treated children and adolescents with diabetes. It tracks immediate and daily glucose levels including periods of hypo- and hyperglycemia, helps guide insulin dose adjustments, facilitates evaluation of therapy responses and achievement of glycemic targets in a safe and effective manner. Along with major clinical trials demonstrating the superiority of intensive insulin therapy in persons with T1D in the early 1990s,1 self-monitoring of capillary blood glucose (SMBG) using hand-held portable meters in combination with glucose test strips and a lancet became the most widely used method of glucose monitoring, replacing urine glucose testing. In recent years, systems for continuously monitoring interstitial fluid glucose concentrations, CGM, using subcutaneously placed glucose sensors have become standard of care in T1D in many countries, particularly for children, adolescents, and young adults,2 and have been successfully employed for insulin-treated type 2 diabetes.3 The purpose of this chapter is to review and update the evidence on glucose monitoring devices (i.e., SMBG and CGM) in children, adolescents, and young adults and to provide practical advice and approaches to their use. Early SMBG measurement methods relied upon reflectance assays coupled with oxidation of glucose allowing for a colorimetric readout. Currently available glucose meters use an electrochemical method with an enzyme electrode containing either glucose oxidase or glucose dehydrogenase. There is considerable variation in the accuracy of widely-used BG monitors.4 Most reliable data are provided by meters meeting current international accuracy standards. The two most used standards are those of the International Organization for Standardization (ISO) (ISO 15197:2013) and the U.S. Food and Drug Administration (FDA) (Table 1). ISPAD recommends exclusive use of glucose meters that achieve these standards. Health care professionals should choose and advise on meters that are accurate and familiar to them as well as affordable to the person with diabetes. 95% within 15% for BG ≥100 mg/dl 95% within 15 mg/dl for BG <100 mg/dl 99% in A or B region of consensus error grida 95% within 15% for all BG in the usable BG rangeb 99% within 20% for all BG in the usable BG rangeb 95% within 12% for BG ≥75 mg/dl 95% within 12 mg/dl for BG <75 mg/dl 98% within 15% for BG ≥75 mg/dl 98% within 15 mg/dl for BG <75 mg/dl The specified accuracy standard achieved during controlled conditions might vary significantly from actual SMBG meter performance in real-world settings.4 Detailed information on the actual performance of SMBG devices is provided by The Diabetes Technology Society Blood Glucose Monitoring System Surveillance Program (www.diabetestechnology.org/surveillance/). SMBG accuracy depends on proper hand washing with complete drying9 and requires proper blood application and use of adequately stored, unexpired test strips, which are not counterfeit nor preowned/second hand.10 Providers and persons with diabetes/caregivers need to be aware of additional factors that can impair meter accuracy: Due to the enzymatic electrochemical reaction, monitors are sensitive to temperature and have a defined operating temperature range.10 Typically, an error message is displayed if the temperature is out of range. Unlike glucose dehydrogenase-based meters, glucose oxidase meters are sensitive to the ambient oxygen and should only be used with capillary blood of people with normal oxygen saturation. Low oxygen tensions (i.e., high altitude, hypoxia, venous blood readings) may result in falsely high glucose readings, higher oxygen tensions (i.e., arterial blood) may lead to falsely low readings.10 There are also several substances that may interfere with glucose readings (Table 2).10 Expert BG meters have integrated bolus advisors to calculate insulin dosages. Randomized controlled trials (RCTs) have shown use of a bolus calculator significantly increases the number of people achieving HbA1c targets and reduces hypoglycemia.11-13 Successful intensive insulin management requires at least 6 to 10 checks per day, appropriate response to the observed values, and regular, frequent review of the results to identify patterns requiring adjustment to the diabetes treatment plan.15 This includes review by the person with diabetes and their caregivers/family in addition to consultation with the diabetes care team. In resource-limited settings, availability and affordability of glucose meters and test strips are not guaranteed. Even though many children are on multiple daily injection regimens, only a few can afford frequent BG testing needed to optimize diabetes management. Very often testing is performed 3–4 times a day (i.e., pre-breakfast, pre-lunch, pre-dinner, and at bedtime). However, many persons with diabetes must resort to two times daily, that is, before breakfast and before dinner. If there are no BG monitoring capabilities, then urine testing is performed. For a comprehensive discussion on aspects of diabetes management in resource-limited settings, including glucose monitoring, please refer to the ISPAD 2022 Consensus guidelines Chapter 25 on 'Management of Diabetes in Children and Adolescents in Limited Resource Settings. Rapid, capillary assessments of BG concentrations have been instrumental in permitting achievement of recommended targets over the past 30 years. However, SMBG only provides single snapshots of glucose concentrations. Consequently, episodes of hyper- and hypoglycemia, in particular nocturnal and asymptomatic episodes, as well as considerable fluctuations in BG concentrations may be missed and therefore not factored into treatment decisions. The emergence of CGM in the late 1990s represented a significant therapeutic milestone. Instead of single-point measurements of capillary blood glucose concentrations, CGM devices measure interstitial glucose concentrations subcutaneously at 1–15 min intervals using enzyme-coated electrodes or fluorescence technology. Significant improvements in device technology over the past decade (including improved accuracy, approval for non-adjunctive use, and reduced need for calibration), availability, smaller size, remote monitoring capability, and overall personal acceptance of CGM systems have contributed to the widespread adoption of this technology in clinical practice. In many countries, CGM use has now become the standard of care for people with T1D.2 According to data from German and Austrian DPV and U.S. T1D Exchange registries, CGM use increased exponentially from 2011 to 2017 in all pediatric age-groups (DPV: 4% in 2015 to 44% in 2017; T1DX: 4% in 2013 to 14% in 2015 and to 31% in 2017), with the highest use among preschool-aged and early school-aged children.17 From 2017 to 2020, further increase in CGM use among individuals with diabetes aged <25 years was seen in both registries each year for all age ranges (DPV: 40% in 2017 to 76% in 2020; T1DX: 25% in 2017 to 49% in 2020).18 Recent data from the Australasian Diabetes Database Network (ADDN) registry and the Australian National Diabetes Service Scheme (NDSS) demonstrate 79% of registry participants with T1D aged <21 years are using CGM.19 DPV and T1D Exchange registry data indicate significant disparities in CGM use by socioeconomic status (SES). Of note, in the T1D Exchange registry, the gap of device use between highest and lowest SES quintiles (52.3% vs. 15.0%) was more pronounced than in the DPV population (57.1% vs. 48.5%).20 Adequate clinic-specific resources and interventions to identify and overcome barriers to CGM uptake are necessary to promote CGM adoption and continued use.21 In a multiclinic quality improvement initiative of the T1D Exchange Quality Improvement Collaborative, center-specific interventions consisting of active person support and education, training and education of the clinical team, as well as interaction with insurance companies and vendors led to increases in CGM use from 34% to 55% in adolescents and young adults over 19–22 months.21 Blinded/retrospective/professional CGM Blinded or professional CGMs were the first widely used CGM devices, for example, the MiniMed CGMS Gold system (Medtronic MiniMed, Northridge, CA) released by Medtronic in 1999. Professional CGM systems obtain short-term glucose data which are not visible to the user. They provide health care professionals with data showing glucose excursions and patterns. In addition to clinical practice, professional CGM systems are sometimes employed in research settings to obtain retrospective glucose data and to reduce potential bias (e.g., in certain settings people may deviate from their usual behavior when seeing their CGM readings in real-time). Real-time CGM Real-time CGM (rtCGM) systems automatically display glucose values at regular intervals and can utilize programmable alarms when sensor glucose levels reach predefined hypo- or hyperglycemia thresholds, as well as rate-of-change alarms for rapid glycemic excursions. Many commercially available rtCGM systems transmit glucose data directly to smartphones. These data can then be stored and retrieved on a web server ("cloud") and used for remote monitoring purposes by caregivers and healthcare professionals. In addition to traditional, self-inserted transdermal sensors with a lifetime from 6 to 14 days, a long-term implantable sensor for up to 6-month use is available (Eversense, Senseonics Inc., Germantown, MD) that received regulatory approval in the European Union (Conformitè Europëenne [CE] Mark) in 2016 and subsequently in other regions. Of note, the Eversense CGM is currently approved only for use in adults over 18 years of age. Its implantation requires a minor in-clinic procedure performed by a trained physician or a nurse practitioner. Unlike traditional CGM sensors, where glucose is measured using the enzyme-based electrochemical method, the Eversense implantable sensor uses non-enzymatic optical fluorescence. The next-generation Eversense CGM has 180-day long-term wear time with daily calibration.22 Intermittently scanned CGM In 2014, the FreeStyle Libre Flash Glucose Monitoring System (FSL) (Abbott Diabetes Care, Alameda, CA) was introduced representing a different CGM category: intermittently scanned CGM (isCGM). IsCGM devices do not automatically display glucose values at regular intervals, but report glucose levels only when the user scans the sensor by holding a reader, or a near field communication protocol (NFC)-enabled smartphone, close to or over the sensor. Current interstitial glucose levels and glucose trend arrows as well as a graph of current and stored glucose readings are provided on demand.23 As with rtCGM, glucose data from isCGM can be transferred from a smartphone to a webserver for remote glucose monitoring purposes by caregivers or health care professionals. The sensor can provide glucose values up to 14 days after a 1-h sensor warm-up period. The second generation of FreeStyle Libre (FSL2) was approved in Europe in 2018 and in the USA in 2020. FSL2 sensors have higher accuracy (mean absolute relative difference [MARD] 9.2% and 9.7% for adults and children,24 respectively) and, in addition to the general FSL capabilities, have optional alarms to alert persons in case the glucose level is out of the target range. To see the actual level, the user must scan the sensor. The third generation, the FSL3, is actually a rtCGM providing real-time alarms and real-time readings without the need to scan. It received CE marking in 2020. The accuracy and precision of first generation CGM systems were notably inferior to those of capillary BG monitors. Over the past 10 years, however, there has been continued improvement in the accuracy. Discrepancies between actual BG and CGM levels, however, continue to occur in the hypoglycemic range and when glucose levels are changing rapidly. To a great extent this is due to the physiological delay of about 5–10 min between the flow of glucose from the intravascular to interstitial compartments.25 Accuracy is also influenced by the time it takes for the sensor to react to glucose26 and the use of digital filters for smoothening of the sensor signal during conversion of the measured sensor signal into a glucose value.26, 27 Sensor performance also may be affected by biomechanical factors such as motion and pressure (typically micro-motion and micro-pressure).28 Methods used to assess the accuracy of CGM systems include the mean absolute relative difference (MARD) between sensor readings and reference BG values (absolute difference divided by the reference value, expressed as percentage) and error grid analysis. MARD is currently the most common metric used to assess the performance of CGM systems. Of note, MARD has its limitations, and its use as the sole performance parameter for CGM systems must be viewed critically.29 The lower the MARD, the closer CGM readings are to the reference glucose values. Error Grid analysis allows one to assess clinical significance of the discrepancy between the sensor and the reference glucose measurement; greater accuracy corresponds to a higher percentage of results in Zone A and B. Accuracy continues to improve with each new generation of CGM sensors and systems. For most commercially available CGM systems, the accuracy in clinical trials reached 8%–10% MARD with about 99% of glucose readings within the clinically acceptable error Zones A and B.24, 30, 31 It should be noted that in the home-use setting CGM system may produce higher average MARDs than during in-clinic studies.32 Unlike BG meters (see Table 1), for CGM, the minimum accuracy requirements have not been determined until recently, and there are no consistent standards in the approval of CGM systems, particularly in relation to the provision of clinical data demonstrating the device's accuracy in the intended use population, as well as transparency and access to this data. Recently, the FDA has outlined a new 510 K (premarket approval) route for some CGM systems, designated as "integrated CGM" (iCGM) with additional special controls governing accuracy ability of this device to work with different types of compatible diabetes management devices, including automatic insulin dosing systems, insulin pumps, and BG meters.33 Certain exogenous and endogenous interstitial fluid substances, including some commonly-used medications, may interfere with CGM system accuracy. This can result in falsely high or low glucose values. In particular, therapeutic doses of hydroxyurea can markedly elevate sensor glucose readings compared with glucose meter values34; likewise, acetaminophen at a dose of 1000 mg can falsely elevate sensor glucose values in certain CGM systems.35, 36 Salicylic acid at doses ≥650 mg may mildly reduce glucose readings, and ascorbic acid (vitamin C) at doses ≥500 mg may cause falsely higher readings.37 CGM readings may also be affected by ingestion of lisinopril, albuterol, atenolol, and red wine.38 The effect of different substances on glucose reading depends on sensor technology. Specifically, CGM systems that use enzymatic electrochemical sensors to measure glucose concentrations seem to be more susceptible to interference than systems using abiotic (non-enzyme based), fluorescent glucose-indicating polymer to measure glucose. In particular, for the long-term implantable fluorescence-based sensor only tetracycline and mannitol produced significant sensor bias when tested in vitro within therapeutic concentration ranges.39 Medications such as salicylic acid, acetaminophen and vitamin C, commonly available over the counter for self-administration, and may be present in combination products or supplement formulations leading to persons with diabetes not knowing that they are taking specific substances. Sensor bias produced from various substances can be most significant for persons using CGM data without confirmatory measurements of capillary BG or for those using CGM data to inform insulin delivery in closed-loop systems. Therefore, CGM users should be aware of how certain systems may be impacted by common medications and always test with a glucose meter whenever symptoms do not match a CGM reading. The latest generations of rtCGM systems (i.e., Dexcom G6, Dexcom G7, Guardian 4) and all available isCGM (FSL1, FSL2) are factory-calibrated, meaning that user calibrations using fingerprick glucose measurements are generally not needed. This eliminates pain and inconvenience and takes away a significant source of error from sensor calibration. Factory calibration is performed under laboratory conditions during the sensor manufacturing process.40 For rtCGM manual calibration is still possible, for example, if CGM readings and results from capillary BG readings do not line up well over a prolonged period of time. For older generation CGM sensors that depend on manual calibrations (i.e., entering BG readings from a meter into the CGM system), the required calibration frequency varies by device. Typically, the first calibration is performed 1–2 h after insertion of the sensor and thereafter a minimum of one calibration is required every 12 h. For these systems, regular calibrations are essential to maintain the accuracy and optimum sensor performance. The optimum times to calibrate are when the interstitial fluid glucose concentration is in equilibrium with the capillary blood, i.e. when glucose levels are least likely to be changing rapidly: before meals, before bedtime, before insulin administration, when trend arrows on the CGM/pump screen show glucose levels are stable. User calibration can lead to wrong sensor reading if at the time of calibration the sensor signal has a temporarily falsely reduced or elevated value, for example, caused by interfering substances or site compression ("compression lows").40 RtCGM systems were originally approved for adjunctive use, meaning the sensor glucose results needed to be verified by capillary SMBG before taking action (e.g., insulin dosing). Along with significant improvements in accuracy, more and more sensors have received approval for non-adjuvant use, that is, diabetes-related decisions and insulin dosing are made based on CGM values alone. Studies utilizing computer modeling have shown that the threshold MARD level of ≤10% is safe for non-adjuvant use of CGM41 and most currently-available commercial CGM systems meet this condition. Furthermore, the T1D Exchange REPLACE BG study provided evidence of the safety and effectiveness of non-adjunctive sensor use.42 Dexcom sensors (G5 and G6™ Mobile CGM, Dexcom, San Diego, CA) have received FDA and CE approval for non-adjunctive use in persons aged 2 years and older. The Abbot Libre Flash Glucose Monitors (Abbott Diabetes Care, Alameda, CA) have received FDA and CE approval for treatment decisions in persons aged 4 and older. The Medtronic Guardian 4 sensor is CE marked for nonadjunctive use from the age of 7 years. Fingerprick testing may still be recommended under certain circumstances: hypoglycemia, if glucose is changing rapidly, and especially if symptoms are not concordant with the system readings. Efficacy of CGM Real-time CGM systems Early-generation rtCGM systems use for children with T1D was associated with only modest benefits in glycemia when compared with SMBG.43-45 The 2008 JDRF landmark randomized clinical trial (RCT)46 showed no overall glycemia benefit with CGM use in the younger age groups (8–14 years and 14–25 years), likely related to <50% sensor wear usage in these groups. A secondary analysis demonstrated benefits across all age groups when the sensor was used ≥6 days/week.47 RCTs and meta-analyses conducted since 2010 utilizing newer generation rtCGM systems more consistently show that use of rtCGM is able to improve glycemia in both children and adults with T1D and, depending on the population studied, benefits are seen in terms of lower HbA1c concentrations, increased TIR, reduced hypoglycemia (including severe hypoglycemia), and reduced glucose variability.3, 43, 48-52 There is now emerging evidence that improvement in glycemia is equivalent in users of insulin pump therapy and MDI therapy.50, 53-57 Contemporary large registry-based studies have shown that compared to SMBG, use of rtCGM is associated with lower HbA1c levels, a higher proportion of people achieving ISPAD HbA1c targets, and fewer episodes of DKA in children and adolescents.2, 17, 58-63 This positive effect on HbA1c has also been seen in a Swedish registry-based study that described a progressive decrease of HbA1c in very young children during the 2008–2018 period, in parallel with the increasing use of pumps and CGM.64 Data from national population-based registries following rtCGM/isCGM reimbursement programs report improvement of T1D glycemic outcomes in children, adolescents, and adults.65-67 In contrast, registry-based studies have not consistently shown a lower number of severe hypoglycemic events in people using rtCGM.2, 60-62 Tauschmann et al. analyzed real world data from people with T1D aged <18 years from Germany, Austria, and Luxemburg in the DPV Registry and showed a reduction in severe hypoglycemic events during the first year of CGM use.59 Interestingly, data from observational studies in children and adolescents, suggest that, irrespective of insulin delivery system, early initiation of CGM within 1 year of T1D diagnosis is associated with fewer severe hypoglycemic events and more favorable glucose outcomes.68, 69 RCTs using the latest-generation non-adjunctive rtCGM systems have shown positive effects on both HbA1c levels and TIR70, 71 in adolescents and young adults. The MILLENIAL Study of a factory-calibrated rtCGM showed that TIR increased when compared with SMBG.71 Supporting this finding, data from single-center observational studies with selected population aged <20 years have reported a decrease of HbA1c levels after initiation and with uninterrupted use of rtCGM.68, 72 Data from RCTs in young children have replicated the results of studies from adolescents and young adults. Though data from small observational studies suggest that CGM can be used successfully in children <8 years,73-75 a more recent trial of non-adjunctive rtCGM in 143 very young children (mean age 5.7 years) did not show a statistically significant improvement in TIR. However there was a substantial reduction in the rate of hypoglycemia seen with rtCGM vs traditional capillary BG measurements over 6 months.76 Using data from the Slovenian National Registry, Dovc et al demonstrated that the use of CGM was well tolerated by pre-school children and that a positive effect was observed in glucose variability.75 isCGM systems To date very few RCTs have been conducted using isCGM,55, 77 and only one in adolescents and young adults.77 The IMPACT multicenter isCGM RCT focused on ameliorating hypoglycemia and involved adults with HbA1c <7.5% at study entry. It demonstrated that isCGM use reduced time spent in hypoglycemia, reduced glucose variability, and improved TIR (3.9 to 10.0 mmol/L, 70 to 180 mg/dl) when compared to SMBG.55 Similar results, including significantly reduced time in hypoglycemia without deterioration of HbA1c were observed in a subgroup analysis of the IMPACT RCT in adults with T1D managed with MDI therapy.78 However, the effect of this technology in those with suboptimal glycemia remains less certain. In a 6-month RCT in youth aged 13 to 20 years with elevated HbA1c (HbA1c ≥ 9%), Boucher et al did not demonstrate differences in HbA1c levels when using isCGM compared to SMBG.77 Nevertheless, this youth population increased testing frequency 2.5 fold and reported a higher satisfaction with its treatment.79 Data from observational clinical studies in children aged 4–18 years at isCGM initiation have shown greater TIR80 and lower HbA1c80, 81 compared to SMBG use prior to isCGM start,80, 81 similar to what has been described in adults.82-84 Interestingly, when comparing isCGM users across different age groups,85, 86 benefits were more pronounced in children under 12 years85 and preschool children86 compared to adolescents85, 86 and adults.85 Scanning frequency (11–13 scans/per day) is associated with favorable glycemic markers (HbA1c and TIR) though not with reduction of time in hypoglycemia.80, 81, 85, 87, 88 These studies were all performed using first-generation systems without alarms for impending hypo- and hyperglycemia. Studies using newer systems with optional real time alarms and improved accuracy are needed. In addition, anonymized real-world data studies have also shown increased scanning frequency benefits time in hypoglycemia.67, 89, 90 One observational study in children and adults using data from 12,256 individuals in the Scotland national diabetes registry found that isCGM initiation was associated with significant reductions in HbA1c with the greatest reductions in those with highest starting HbA1c values and children <13 years of age; DKA episodes were also decreased except in adolescents; among those at higher risk for severe hypoglycemia requiring hospitalization (SHH), a marked reduction in SHH event rates was also observed.91 A prospective real-world cohort study after 1 year of nationwide reimbursement of isCGM in Belgium reported fewer severe hypoglycemia and DKA events with the use of isCGM.66 Rt CGM versus isCGM In recent years, studies directly comparing rtCGM and isCGM systems have been published, including observational studies in children and adolescents92 and adults with T1D,93 and one RCT in adults.94 All showed superiority of rtCGM over isCGM in terms of improved TIR and reduced percentage of time in hypoglycemia. However, the number of studies and the number of trial participants were limited, particularly in children and adolescents. Additionally, mainly older generation devices were used. CGM use from diabetes onset Tight glycemia from diabetes onset has been shown to benefit long-term glycemic trajectories in individuals with T1D.95 Early introduction of CGM among children with new onset diabetes was associated with a 0.66% lower HbA1c at 12 months after diagnosis compared to those who did not start CGM.68 Long-term improvement in HbA1c over a 7-year follow up period was seen when CGM was initiated in the first year after T1D diagnosis compared to no CGM use or when CGM initiation after the first year.96 Residual beta-cell preservation, often assessed by residual C-peptide secretion, has long been a goal of interventions for persons with new onset T1D to decrease risk of long-term diabetes related complications.97-99 There are several ongoing studies investigating the benefit of more modern factory-calibrated CGM and hybrid closed loop systems in preserving beta-cell function in the new onset period. As the role of CGM and CGM-derived metrics in clinical trials as outcome parameters is being established,100 CGM will be used increasingly to monitor glycemic trajectories in pharmacologic intervention studies on diabetes onset or prevention. There will also be a role for CGM in the monitoring of people at high risk of developing T1D following positive islet antibody screening.101, 102 Practical considerations Education Initial and ongoing education and training in CGM use remains a keystone to optimizing CGM uptake and long-term use, as glycemic benefits are only observed if the device is worn consistently.103 While many aspects of CGM use remain largely intuitive,104 structured training of youth and parents/caregivers about CGM device components, insertion, skin care, and data interpretation is critical to assure safe and effective use of this technology.103, 105 Further, ongoing education and support are recognized as essential to overcome barriers to consistent CGM use and as technologies are continuously updated.103, 106 Follow-up training is also recommended to teach users how to analyze and interpret their glucose data.107, 108 In addition, psycho-educational support is helpful to set realistic expectations and to address individual education and training needs.103 Structured educational material and written healthcare plans to support CGM use should also be provided to caregivers of children with diabetes, including daycare providers, school nurses, teachers, babysitters, after-school program supervisors.103, 109, 110 Table 2 provides an overview of the structured education aspects to consider at CGM initiation (Table 3). Before initiation Device insertion and adherence Offer supplementary adhesive products. These include: Calibration For sensors requiring calibrations, discuss frequency of calibrations and ideal times to calibrate