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1 INFUSYSTEMS USA. INFUSYSTEM INFUSYSTEMS USA - INFUSYSTEMS USA - INFUSYSTEMS USA - INFUSYSTEMS USA - INFUSYSTEMS USA - INFUSYSTEMS USA - INFUSYSTE Role of Continuous Glucose monitoring in Patients With Diabetes using multiple Daily Insulin Injections satish K. Garg, md, Professor of medicine and Pediatrics, Barbara Davis Center for Childhood Diabetes, University of Colorado Health Sciences Center Department of Internal Medicine and Department of Preventive Medicine and Biometrics, University of Colorado at Denver Aurora, CO, USA Continuous glucose monitoring (CGM) is perhaps the most important tool to date for the management of insulin-requiring diabetes and is rapidly becoming a standard of care. Until recently, patients relied solely on self-monitoring blood glucose (SMBG) to determine their glucose levels, which allows measurement of blood glucose levels at any time but provides minimal information on glucose patterns and trends. Traditional monitoring via SMBG does not provide any information on the direction or rate of glucose change it reflects only glucose values at that time and intermittent SMBG misses many hypoglycemic and hyperglycemic events. Even with as many as 4 to 6 tests a day, low and high levels can be missed (see Figure), whereas CGM devices report glucose every 1 or 5 minutes depending on the device and provide a complete 24-hour picture of glucose patterns and control. Although there is now ample evidence of the adverse impact that sustained chronic hyperglycemia can have on the patient, more recent data indicate that glucose variability may also adversely impact patients. Wide glucose fluctuations are known to activate oxidative stress, Vol.6 No INfusystems usa 2492 Walnut Avenue, Suite 130 Tustin, Ca , USA Tel: (949) Fax: (949) infuusa@yahoo.com editorial BOARD editor in Chief J-L. Selam, MD Associate editors: D. Selam M. Arthur Charles, MD, PhD Board members H. Peter Chase, MD Paul Davidson, MD Lutz Heinemann, PhD Francine Kauffman, MD Laurence A. Leiter, MD James Lenhard, MD Robert Murtfeldt Christopher D. Saudek, MD Philip Raskin, MD Jay S. Skyler, MD Neil H. White, MS, CDE Franklin Zieve, MD, PhD Bernard Zinman, MD PuBLIsHeR Publiscripts 2492 Walnut Avenue, Suite 130 Tustin, Ca., 92780, USA Tel: (949) Fax: (949) Note: The contents of the articles published are under the sole responsibility of their authors. Introducing The SEVEN PLUS YOUR PATIENTS G.P.S. The SEVEN PLUS gives your patients dynamic glucose information with easy-to-understand widescreen trending. Knowing where they are, and where they re going will help them make the right decisions to stay on track. Glucose Protection System For more on the latest high-performance CGM system from DexCom the sensor specialists visit or call SEVENGO ( ). The SEVEN PLUS CGM System is a glucose monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is for prescription use only. Use of acetaminophen-containing medications during Sensor wear may affect device performance. WARNING: This device is not designed to replace a blood glucose meter. Always confirm with a blood glucose meter. PRECAUTION: The Sensor has currently only been tested in adult persons with type 1 and type 2 diabetes. The device has not been tested in children or adolescents, pregnant women, or persons on dialysis. Contact DexCom for detailed indications for use and safety information ( SEVENGO ( ), option 2. LBL , Rev 01

2 Page 10 Vol.6 No which in turn may activate a number of other pathways that may amplify the damaging effect of hyperglycemia and may be a precursor to other complications. (1) In addition, although measurement of A1C levels has proven to be a valuable tool, it is not a perfect metric since it does not provide a measure of hypoglycemic episodes or the amplitude of glycemic excursions. It is therefore important that we consider reducing the effect of all of the different components of dysglycemia, including A1C, fasting and postprandial glucose, and glucose variability. In this regard, CGM may further benefit the patient because of its ability to detect these acute fluctuations. The Diabetes Control and Complications Trial (DCTT) (2) showed the benefit of achieving strict glycemic control in patients with type 1 diabetes and documented that increased frequency of blood glucose monitoring has a major impact on achieving optimal glycemic control. However, the trial also indicated that the main limiting factor in glycemic control is fear of hypoglycemia, since the attempts to achieve near-normal glucose levels resulted in a 3.3-fold increase in the rate of severe hypoglycemia. (2) CGM provides real-time information about current glucose levels, trends, and rate of change, as well as warnings when glucose concentrations are moving outside of the specified target range and/or changing rapidly up or down. Patients can set alert levels that are appropriate for their personal history in order to preemptively avoid hypo- and hyperglycemia and increase time in the target range. CGM provides almost immediate feedback about the effectiveness of interventions performed by the patient, which can result in motivation for behavior change. The potential to obtain almost immediate access to real-time glucose level data and trend information, as well as an increased understanding of glucose rate of change and patterns, opens up the possibility of providing the patient with tools for improving his/her self-management skills, thus allowing modification of diabetes management in real time to improve outcomes. CGm Devices currently in clinical use. GlucoWatch was the first real-time CGM approved by the FDA, but it is no longer commercially available. The more recent devices work on the premise that interstitial fluid glucose levels are related to blood glucose levels. These include sensor devices developed by DexCom (DexCom SEVEN PLUS) and Medtronic (MiniMed Paradigm REAL-Time and Guardian REAL-Time), which use a glucose oxidase methodology, and the Abbott Diabetes Care FreeStyle Navigator sensor, which utilizes a wired enzyme technology. use of CGm in mdi Historically, CGM has been thought of in terms of its use with continuous subcutaneous insulin infusion (CSII, insulin pumps). However, patients on multiple daily insulin injections (MDI) benefit just as significantly from the use of CGM as do those on CSII. In analyzing the literature (see Table), (3-6, 8-10) it is apparent that the studies we have been using as benchmarks of success achieved with CGM devices have enrolled a substantial number of patients on MDI. In some of these studies, subpopulation analyses have indicated that there is no difference in the benefit derived from the use of CGM, regardless of whether the patient is using CSII or MDI, and in 1 study (4) it has been shown that patients on MDI actually do better than those on CSII when using CGM. The Juvenile Diabetes Research Foundation (JDRF) study (3) was the first clinical trial designed to show the value of CGM in improving outcomes. The study evaluated 322 patients: 256 (80%) on CSII and 66 (20%) on MDI. Patients in this study had type 1 diabetes for at least 1 year and a baseline A1C level of 7% to 10%. They were randomly assigned to CGM or SMBG and were stratified by age ( 25 years, years, 8-14 years) and A1C level ( 8% and >8 %) and provided with 1 of the following CGM devices: DexCom SEVEN, Medtronic MiniMed Paradigm, or Abbott FreeStyle Navigator (the trial evaluated the use of CGM, not specific devices). Patients were followed for 26 weeks. In patients aged 25 years or older, there was a significant decrease in mean A1C from a baseline of 7.6% to 7.1% with CGM, whereas in the control group, A1C increased slightly, from 7.6% to 7.62%. Patients in this age group used the CGM devices more frequently than did those in the other age groups, with 83% of them using CGM an average of 6.0 days or more per week. Also, there were statistically significantly more patients in this age group achieving A1C levels <7% and no severe hypoglycemia. The study concluded that there was a significant decrease in A1C in patients aged 25 or older, more consistent use of CGM in this age group (average 6 days per week), a significantly greater decrease in A1C related to frequency of use, and no increase in hypoglycemia, even in the adult group who lowered A1C values. In general, patients who used their CGM devices nearly every day derived a greater benefit, regardless of age group, with patients who used their CGM devices at least 6 days per week, regardless of age, achieving a 0.5% reduction in A1C as well as a significant reduction in nocturnal hypoglycemia, an increased time in target range, and a decreased time in hypo- or hyperglycemia. Although a subpopulation analysis comparing MDI to CSII patients was not done in the JDRF study, it is impor- To date, 5 real-time CGM systems have been approved by the United States Food and Drug Administration (FDA), and 4 are figure 1

3 Vol.6 No Page 11 tant to note that MDI patients comprised 20% of the total population and that the study authors noted no apparent differences between the 2 groups. A study by Deiss et al. (4) evaluated the Medtronic Guardian REAL-Time Monitor in 81 children and 81 adults with type 1 diabetes. In this 12-week study, 78 patients (48.1%) were using CSII and 84 (51.9%) were using MDI. The study compared continuous-use CGM (arm 1) vs. biweekly CGM for 3 periods every 2 weeks (arm 2) vs. SMBG with blinded CGM use (arm 3). Mean baseline A1C values were 9.5 in the continuous-use CGM group and 9.6 in the intermittent-use (biweekly) CGM group. The greatest decrease from baseline was seen with continuous-use CGM, which resulted in reductions from baseline A1C of 0.6 at 1 month and 1.0 at 3 months (p=.008 vs. control). These differences were significantly better than those in the control group, whereas intermittent-use CGM did not show a significant difference vs. the control group. At 3 months, A1C decreased by at least 1% in 50% of patients in the continuous-use CGM group and by at least 2% in 26% in this same group. Bailey et al. (5) evaluated the impact of CGM on A1C using an early version of the DexCom CGM system. In this 12-week Study Length of Study Number of Subjects Conclusions Total CSII MDI Deiss et al., 2006 (4) Garg et al., 2006 (6) 12 weeks Continuous use of CGM resulted in gradual improvement in glycemic control over 3 months, and reduction in A1C by at least 1% in 50% of patients and at least 2% in 26% of patients. 21 days Similar improvement in hours in target range for CSII and MDI patient groups (number of hours per day). Glucose Range <55 mg/dl mg/dl mg/dl mg/dl >240 mg/dl CSII Blinded 1.1 ± ± ± ± ± 3.5 CSII Display 0.8 ± ± ± ± ± 2.5 MDI Blinded 0.7 ± ± ± ± ± 4.9 MDI Display 0.4 ± ± ± ± ± 3.9 Bailey et al., 2007 (5) 12 weeks MDI patients achieved greater reduction in A1c vs. CSII patients Week A1C in CSII patients A1C in MDI patients Garg et al., 2007 (8) 12 weeks The 24 patients in the CGM group achieved a significant decrease in A1C (0.4±0.5%) vs. the comparator group of 23 patients. Use of CGM was associated with improved metabolic control. Weinzimer et al., 2008 (10) JDRF Study Group, 2008 (3) 13 weeks 23* 23 Mean A1C fell from 7.9%±1.0% at baseline to 7.3%±0.9% at week 13 (p=.004). Glycemic variation decreased, and there were no severe hypoglycemic events. 26 weeks Near daily use of CGM was associated with a similar benefit in A1C for patients in all age groups. Patients at least 25 years used CGM more and achieved better results. Garg et al., 2009 (9) 15 days DexCom SEVEN and Abbott FreeStyle Navigator demonstrated similar results vs. YSI. DexCom SEVEN measurements were closer to the laboratory blood glucose reference in the hypoglycemic range. table 1: CGM in Patients Using CSII and MDI. (3-6, 8-10) *Evaluable patients out of 27 originally enrolled in the study.

4 Page 12 Vol.6 No study, 58 patients (43.6%) used MDI, 75 patients (56.4%) used CSII, and 7 (5%) used oral agents. The study concluded that the more frequent the interaction with CGM, the greater the decrease in A1C. Patients with a baseline A1C >9% showed the most significant decrease in A1C. Patients on MDI had a 0.5% reduction in A1C from baseline compared to a reduction of only 0.3% for CSII patients. Thus, in this study, patients on MDI did better with CGM than did those on CSII. The authors concluded that use of an insulin pump is not required to derive benefit from realtime CGM. Garg and Jovanovic (6) conducted a study of 86 patients 50% on CSII and 50% on MDI. This study showed that, in the overall study population, CGM was associated with an increase in time spent in the target range ( mg/dl) by 1.4 hours/day (22.6%; p<.0001) and a mean reduced time spent at <55 mg/dl by 0.3 hours/day (33.3%; p=.0039). Time at >240 mg/dl was also reduced by a mean of 1.5 hours/day (28.3%; p<.0001). These findings were repeated in the subgroup analysis of MDI vs. CSII patients, with statistically significant improvement in time spent at <55 mg/dl, mg/dl, and >240 mg/dl for the MDI patients when unblinded CGM use was compared to blinded CGM use. Overall, there was a significant increase in time spent in euglycemia by all patient groups in this study, including the MDI group of patients. Numerous measures of quality of glycemic control have been proposed. Although these measures usually give consistent results, this is not always the case. In a recent paper, Rodbard (7) outlined a systematic approach to the interpretation of CGM data to be used to evaluate the quality of glycemic control, glucose variability, and changes in response to therapy. When Rodbard applied this approach to assess the Garg and Jovanovic study (6) described above, he found a very high correlation between 5 in a series of 6 measures. Correlation coefficients were calculated for glucose ranges of mg/dl and mg/dl, as well as for other data from 2 additional 1-week periods, and a 2-week period. These data add further support to the validity of the study reported by Garg and Jovanovic. Another study by Garg et al. (8) evaluated glucose control and its relationship to glucose target ranges with the use of CGM. Out of 47 patients, 24 were given the DexCom STS sensor (an early version of the current DexCom SEVEN PLUS). Of these, 18 were on MDI and 6 were on CSII. Patients were told to wear sensors as they felt necessary. Baseline and 12-week A1C was measured in all patients. Baseline A1C for the CGM group was 7.43±1.0. No fingerstick SMBG measurements were available for patients in the control group (n=23), who received similar diabetes care. Study results showed a significant decrease in A1C in the CGM group (0.4±0.5%) vs. the control group. The authors concluded that the use of real-time CGM was associated with improved metabolic control over 12 weeks in this patient population with primarily MDI type 1 diabetes. A study conducted by Garg et al. in 2009 (9) evaluated the efficacy and safety of the DexCom SEVEN PLUS and the Abbott FreeStyle Navigator worn concurrently by 14 patients with type 1 diabetes: 8 patients (57%) on MDI and 6 patients (43%) on CSII. On days 5, 10, and 15, the patients participated in an 8-hour in-clinic session during which CGM measurements were compared to YSI (Yellow Springs Instrument) measurements every 15 minutes. The mean absolute relative difference (ARD) vs. YSI was 16.8% for the DexCom SEVEN PLUS compared with 16.1% for the Navigator (p>.05). The median ARD vs. YSI was 13.3% for the DexCom SEVEN PLUS compared with 10.4% for the Navigator (p<.05). However, when evaluating the median ARD in the hypoglycemic range, the DexCom SEVEN PLUS was 15.8% compared with 22.8% for the Navigator (p<.05). The DexCom SEVEN system provided measurements closer to the laboratory blood glucose reference in the hypoglycemic range. CGM performance remained consistent between the MDI and the CSII groups. A study by Weinzimer (10) evaluated the use of the FreeStyle Navigator in 27 children aged 4 to 17 years who had type 1 diabetes and used glargine-based MDI, 23 of whom completed the study. After 1 week of blinded use, data were collected with unblinded home use for 3 months. Patients averaged more than 100 hours of sensor wear per week. Mean A1C fell from 7.9±1.0% at baseline to 7.3±0.9% at week 13 (p=.004), with the greatest reduction when baseline A1C was <7.5%. Glycemic variation decreased, and there were no severe hypoglycemic events during the study. The clinical benefit of CGM is clearly apparent from all of these studies, in which a large percentage of the patients were on MDI. When MDI patients were assessed separately or compared to CSII patients, they did as well as or better than the CSII patients. Thus, data published to date using CGM devices clearly show that MDI patients are excellent candidates for CGM and should be considered for CGM use when other factors indicate they might be appropriate candidates. Patient selection Criteria for CGm The Consensus Guidelines for Continuous Glucose Monitoring (CGM) published in 2008 (11) began to address the question of how to select the appropriate candidate for CGM. Among adults, the guidelines recommended the following criteria when choosing a candidate for CGM: (1) patients with type 1 diabetes who are not reaching treatment goals in terms of A1C, (2) patients who intentionally keep blood glucose levels above target because of fear of hypoglycemia as well as patients with hypoglycemia unawareness or frequent episodes of severe hypoglycemia, and (3) patients with type 2 diabetes who would wear the sensor intermittently to learn about their own diabetes. What are some of the practical considerations in selecting patients for CGM? First and foremost, the patient must be motivated, because being taught to use this new technology will require time from both the patient and the health care provider team. Second, the concept of time lag must be taught to and understood by the patient in order for CGM to be successful. Some patients have difficulty understanding the time lag between blood and interstitial fluid levels and may find this unacceptable or just confusing at first. Variations in time lag are related to the particular device the patient uses, with lag times ranging from 5 to 20 minutes (as reported in the product literature for each product), depending on the technology employed with any given device as well as the rate of change of glu-

5 Vol.6 No Page 13 cose. The shortest lag time is reported with the DexCom SEVEN PLUS device (average 5 minutes) (12), with lag time and rate of change apparently having little effect on sensor accuracy. Third, because patients will be learning to focus on a glucose trend as opposed to a specific glucose value at a specific time point but insulin dose adjustments will still be made based on SMBG, the patient needs to understand that the glucose value is only part of the total picture and that glucose direction and rate of change are secondary information sources that help provide the complete picture needed for optimal control and for determining insulin requirements. Patients who are motivated and willing to change behaviors will do the best. Observable patient behavior changes as noted by Hirsch (13) include reduction in overall carbohydrate consumption and increasing the time interval between the prandial insulin and eating. In most clinical studies conducted to date, frequency of sensor use has been a major factor in the successful use of CGM. The more motivated the patient is, the more likely he/she will be to adapt to the use of CGM. To some extent this might also be related to poor/lack of reimbursement by the payers. Also, as part of the training process, it is important for the health care provider team to stress the importance of adherence to CGM use. Whether on CSII or MDI, the patient must accept the need for ongoing sensor use and the presence of a new device, be it an additional device (in CSII patients) or the only device (in MDI patients), as well as establish the practice of reading this device on a regular basis. All of this requires education from the health care team and motivation on the part of the patient. However, because MDI patients do as well as CSII patients in this regard, the decision to select a patient for CGM should be based on the factors mentioned above rather than on the method of insulin delivery. The bottom line is that more data/information is likely to improve clinical benefit. Obviously, the time required to educate patients and their families on the use of CGM is a factor in every clinical practice today. Messer et al. (14) recently described this process in a study using the Navigator CGM device. Because this was a study from the Diabetes Research in Children Network (DirecNet), the patients were mostly children. There were 30 CSII patients (52.6%) and 27 MDI patients (47.4%), and the study focused on the similarities and differences of training these 2 patient groups. The time spent on protocol visits and phone calls was recorded for the MDI patient group and averaged 9.6 hours during the first 13 weeks of the study, including 6.2 hours of CGM training. Both the MDI and the CSII participants called the DirecNet educators, with 13.3 calls per person for the MDI patients and 7.9 calls per person for the CSII patients, with MDI patients requiring slightly longer intervention per person (106 minutes vs. 82 minutes). Most of the phone calls related to problems and questions about the Navigator device, with the most common difficulty for both patient groups involving the magnitude of skin issues related to Navigator use, which may be specific to this device. In this study, 306 reports of skin and sensor issues occurred. In both patient groups, the most crucial teaching point was the explanation of lag time. (14) Calibration of the Navigator was also an important concern requiring educational time. Both groups of patients had never used a CGM system before and required instruction on proper calibration of the Navigator device, which, unlike other CGM devices, requires a 10-hour warm-up period after sensor insertion and before the first calibration. However, calibration is simpler and lag times have been reduced with other more recently introduced CGM systems, such as the DexCom SEVEN PLUS. Also, both groups required time to explain the insulin dosing guidelines based on the CGM data. (14) Differences between MDI and CSII patients included the need for more time to teach insulin dosing with the CSII patients vs. more time to teach about skin issues and sensor insertion with the MDI patients. (14) Because MDI patients may have been less accustomed to making insulin management changes on their own, they required training regarding making these adjustments. This study taught us that CGM uncovered glucose patterns in both groups that required action to be taken, that CGM is practical to use, that the diabetes educator must use assessment skills throughout the training process, and that MDI patients may require additional time for learning sensor insertion techniques and making insulin adjustments. Advances in Convenience, Performance, and simplicity Increase Patient Acceptance of CGm Over the past 40 years, CGM systems have evolved from the fundamental concepts described in 1967 by Updike and Hicks from their pioneering research on implanted glucose sensors. (15) Today s CGM systems are smaller, simpler, and more convenient to use. The MiniMed Guardian REAL-Time, approved in 2005, displays real-time glucose values every 5 minutes after a 2-hour warm-up period. In 2006, the MiniMed Paradigm REAL-Time was approved. It is currently the only CGM device that is integrated into an insulin pump, where it provides display of CGM. The Abbott FreeStyle Navigator, approved in 2008, utilizes a wired enzyme technology based on an osmium mediator rather than the hydrogen peroxide technology employed by the other CGM devices. It reads and displays real-time glucose values every minute after a 10-hour warm-up period. The Navigator is also the only CGM device that has a built-in glucose meter. DexCom SEVEN PLUS is the CGM most recently approved by the FDA. This is the third-generation CGM device available from DexCom in the United States. With each succeeding generation, CGM technology has been improved upon from a 3- day device, to a 7-day device, to an enhanced 7-day device with capabilities that include remote downloading of data and easy blinded and unblinded use. The DexCom SEVEN PLUS utilizes an advanced technology and contains many new features. (12) As with the DexCom SEVEN, this device is less affected by glucose rate of change and, as such, can be calibrated during high rate of change. (12). The system is designed in such a way that if the sensor reading does not match the fingerstick reading, a confirmation fingerstick is requested. Is CGm Advancing Patient Care? Multiple studies (3-10) have demonstrated the clinical benefits of CGM. These include continuous and timely feedback on diet, exercise, and insulin requirements; reduction of hypoglycemic and hyperglycemic events; increased time in glucose target range; reduction in A1C without increasing

6 Page 14 Vol.6 No hypoglycemia; increase in the percentage of patients achieving target A1C; and reduction in glucose variability and fluctuations. More frequent use of CGM helps to educate insulin-requiring patients about their glucose trends and patterns and reinforces necessary behavior modification. It may also help create an understanding of the effect of insulin on glucose levels by showing patients data in real time and providing a complete picture of glucose levels at all times, allowing more informed decisions about diet, exercise, or insulin dosing. Timing of rapid-acting insulin analogues may need to be modified (earlier) to minimize postmeal glucose excursions. Also, use of CGM has highlighted the need for developing ultra fast-acting insulins to match the meal-related rise in glucose levels. Just as the availability of fingerstick data revolutionized the ability of patients with diabetes to control their glucose levels, CGM offers a new era of control for many insulin-requiring patients with diabetes. We have learned that the technology works when used. Now the challenge for diabetes health care providers and educators will be to understand how best to integrate this new tool into daily practice and to promote the use of real-time continuous glucose information as a necessary tool for glycemic management. When we began these studies, inadequate reimbursement for CGM may have contributed to lower sensor usage. However, based on these emerging new data, reimbursement has since improved for patients with type 1 diabetes. We also hope that, with the availability of all of the new data on the value of CGM, payers will offer even better reimbursement in the future. With the availability of this new tool, we may be able to close the loop ( bionic/artificial pancreas) in patient management in the near future. However, use of CGM improves patient care regardless of the mode of insulin delivery (MDI or CSII). financial Disclosure Dr. Garg has been a speaker for Abbott, DexCom, Medtronic MiniMed, Roche, LifeScan, Eli Lilly, and Sanofi-Aventis. He has no stocks/equity in any of the pharmaceutical or device companies References 1. monnier L, Colette C. Glycemic variability: should we and can we prevent it? Diabetes Care. 2008; 31(suppl 2):S150-S Diabetes Control and Complications trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulindependent diabetes mellitus. N Engl J Med. 1993; 329(14): Juvenile Diabetes Research foundation Continuous Glucose monitoring study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008; 359(14): Deiss D, Bolinder J, Riveline JP, et al. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006; 29(12): Bailey ts, Zisser HC, Garg sk. Reduction in hemoglobin A1c with real-time continuous glucose monitoring: results from a 12-week observational study. Diabetes Technol Ther. 2007; 9(3): Garg s, Jovanovic L. Relationship of fasting and hourly blood glucose levels to HbA1c values: safety, accuracy, and improvements in glucose profiles obtained using a 7-day continuous glucose sensor. Diabetes Care. 2006; 29(12): Rodbard D. Interpretation of continuous glucose monitoring data: glycemic variability and quality of glycemic control. Diabetes Technol Ther. 2009; 11(suppl 1):S55-S Garg sk, Kelly WC, Voelmle mk, et al. Continuous home monitoring of glucose: improved glycemic control with real-life use of continuous glucose sensors in adult subjects with type 1 diabetes. Diabetes Care. 2007; 30(12): Garg sk, smith J, Beatson C, Lopez-Baca B, Voelmle m, Gottlieb PA. Comparison of accuracy and safety of the SEVEN and the Navigator continuous glucose monitoring systems. Diabetes Technol Ther. 2009; 11(2): Weinzimer s, Xing D, tansey m, et al, for the Diabetes Research in Children Network (DirecNet) Study Group. FreeStyle Navigator continuous glucose monitoring system use in children with type 1 diabetes using glargine-based multiple daily dose regimens: results of a pilot trial. Diabetes Care. 2008; 31(3): Hirsch IB, Armstrong D, Bergenstal Rm, et al. Clinical application of emerging sensor technologies in diabetes management: consensus guidelines for continuous glucose monitoring (CGM). Diabetes Technol Ther. 2008; 10(4): DexCom seven PLus users Guide. San Diego, CA: DexCom Inc. 2009: Hirsch IB. Realistic expectations and practical use of continuous glucose monitoring for the endocrinologist [published online ahead of print April 21, 2009]. J Clin Endocrinol Metab. doi: /jc messer L, Ruedy K, Xing D, et al. Educating families on real-time continuous glucose monitoring: the DirecNet Navigator pilot study experience. Diabetes Educ. 2009; 35(1): updike sj, Hicks GP. The enzyme electrode. Nature. 1967; 214(5092): Correspondence Satish K. Garg, MD Barbara Davis Center for Childhood Diabetes, University of Colorado at Denver 1775 Aurora Court Aurora, CO satish.garg@ucdenver.edu. Evaluating investigational medications from pharmaceutical companies on diabetic subjects under FDA-approved study protocols.. For Phase 1-4 Clinical Trials For Phase 1-4 Clinical Trials. Tel: Website:

7 Vol.6 No Page 15 managing type 1 Diabetes in the school setting Angie middlehurst, Paediatric Diabetes educator melinda morrison, Paediatric Diabetes Dietitian Health & Education Division, Diabetes Australia-NSW, Sydney, Australia As the incidence of type 1 diabetes increases in children and young people (1), it is inevitable that more schools will encounter children with diabetes. In recent years, intensive diabetes management with multiple daily injections or insulin pump therapy has become the preferred form of management for young people with type 1 diabetes. There is evidence that this intensive management reduces the risk of long-term complications of diabetes (2). However, with intensive management also comes additional diabetes related tasks, many of which must be performed in the school setting. the student with Diabetes The student with type 1 diabetes has the right to attend school without discrimination, to participate in the same activities as their peers and be provided with a safe environment while at school. However, they also have additional needs with special consideration for blood glucose testing, insulin administration, treatment of hypoglycaemia, regular meal times, provisions for examinations and sick day management. A lack of support at school can impact on a child s attendance, participation, as well as their physical and emotional development (3). Younger children in particular require additional assistance and supervision in the school setting as they face a range of tasks and problems that are beyond their level of cognitive development. When a child with diabetes starts school, parental anxiety may be more pronounced than for other children, as parents must trust the school to attend to their child s diabetes needs (3). Young people spend the greater part of their day at school; therefore it is imperative that schools have the resources and proficiency needed to assist with the daily care of children with diabetes and any unforeseen diabetes related emergencies. support at school Schools have a responsibility to provide a safe environment and adequate supervision. According to the American Diabetes Association effective school based diabetes management requires 1) basic training of all school staff in regards to diabetes; 2) training of a core group of staff from a qualified health professional in diabetes management and emergency care; 3) provision for students with diabetes to self manage their condition in the classroom and during all activities (4). However, the degree of responsibility of school staff for diabetes related tasks may vary from country to country depending on legislation and, at a local level, on individual school policies. Even where staff are willing to perform diabetes management tasks, anecdotally, it is suggested that fear of litigation may preclude some staff from taking responsibility for this care during school hours. the Role of Parents Parents have a responsibility to advise the school of their child s medical condition and particular requirements for the management of their child s diabetes. The school should be consulted on the development of a written individual diabetes health care plan. Problems can sometimes arise at school if there is a lack of understanding of diabetes and its management, poor communication between parents and staff or unrealistic expectations on all sides. International research has demonstrated that the majority of parents believe teachers were most likely to be relied upon if their child required help in managing their diabetes at school (5). This research also highlighted the areas in urgent need of improvement in school diabetes support as better management of emergencies, improved teacher education and increased availability of hypoglycaemia treatment. It has been reported that there is heightened parent satisfaction when schools have staff trained in diabetes management (5). Data from training programs conducted in the US have demonstrated that diabetes education programs targeted to school personnel are highly effective (6). managing Diabetes at school School staff require adequate information to ensure the safety of the student with diabetes at school. While older students may be able to undertake day to day tasks, they still may require supervision or assistance. For the younger student, school staff may be required to perform diabetes management tasks, if they are willing and adequately trained.

8 Page 16 Vol.6 No Insulin pump therapy: Appropriate management of the child with diabetes, needs to be addressed with the school. While some issues are pertinent to all children with diabetes, there are extra considerations for those on insulin pump therapy. These include: staff Awareness A basic understanding of type 1 diabetes and its management and awareness of any students with diabetes at school. Familiarity with equipment used (e.g. pump and blood glucose meter). The provision of a written diabetes health care plan and additional resources to assist in the management of the student. Awareness of the need for privacy for diabetes related tasks. staff training Access to diabetes training from a qualified diabetes health professional. The requirement to provide a trained member of staff (with a back up) at the school every day and the need to contact parents regarding diabetes management decisions. Blood Glucose monitoring Agreement on who is responsible for blood glucose monitoring and blood glucose testing times. The importance of documentation of blood glucose test results. The need to allow the student to test blood glucose levels in the classroom. Awareness of target blood glucose levels and when to contact the parent in the event of high or low blood glucose levels. Insulin Administration Agreement on who is responsible for administering insulin. Training on how to administer an insulin bolus via the pump (if required), correction doses and the importance of eating after insulin is given. Contact with parent/guardian for advice as needed. Hypoglycaemia Recognising hypoglycaemia symptoms, the need to treat and re-treat if necessary, and the location of hypo kits around the school. What to do in the event of severe hypoglycaemia. Hyperglycaemia What to do in the event of high blood glucose levels or a problem with insulin delivery or pump malfunction. The need to test for blood ketones and contact parent/guardian if ketones are present Allowing extra provisions for toilet breaks and maintaining hydration. Managing illnesses at school and seeking prompt advice. food Choices The need for information about the carbohydrate content of meals for bolus calculations. Information from parents on insulin doses for special occasions and school canteen choices. Awareness of the need to eat at certain times in the event of pre-programmed boluses. school sport The need for extra blood glucose testing and (possible) additional carbohydrates for sport. Procedures for disconnection of the pump for contact or water based sports. Camps & excursions The need for preparation prior to camps and excursions including blood glucose monitoring, insulin administration, changes to basal rates, food choices, hypoglycaemia and hyperglycaemia management, and infusion set changes. exams Awareness of special provisions available for school exams. Conclusion With intensive diabetes management (including insulin pump therapy) becoming the preferred option for young people, there is an expectation that schools will have a greater role in the care of the child with diabetes. Health professionals have an important role in assisting parents and schools in facilitating diabetes management in this setting. Due to the chronic nature of diabetes, and the complex management required; which varies depending on the stage of growth and development; it is imperative that schools have the capacity to provide a supportive environment in which the child s safety is paramount, diabetes management is optimal and which supports and encourages the development of age appropriate skills to manage their condition. References 1. International Diabetes federation. Diabetes Atlas. 2nd Ed, Brussels: IDF DCCt Research Group. Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatrics 1994: 125: Diabetes uk. Making all children matter: Support for children with diabetes in schools, American Diabetes Association. Safe at School, Retrieved Dec from chool.jsp 5. Lange, K. The DAWN verdict on diabetes support in schools: could do better. Diabetes Voice, 2008:53: siminerio, L.m, Clougherty, m., Gilliland, A, Kelly, K. Evaluating children with diabetes and their parents preparedness and involvement in diabetes care for the school (abstract). Diabetes 2000:49(Suppl.):A173. Acknowledgements We would like to thank Karen Jameson, Paediatric Diabetes Educator, Royal North Shore Hospital, Sydney, Australia and Carmel Smart, Paediatric Diabetes Dietitian, John Hunter Children s Hospital, Newcastle, Australia for reviewing this article.

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