REPORT INTERPRETATION

REPORT INTERPRETATION: Interpreting ipro Professional Continuous Glucose Monitoring (CGM) Reports and Making Therapy Adjustments TARGET AUDIENCE The audience for this section is physicians, mid-level practitioners, and CDEs who would like to gain an in-depth knowledge of ipro CGM report interpretation. READERS WILL RECEIVE GUIDANCE ON: An easy-to-follow methodology to simplify the use and interpretation of ipro CGM reports Strategies to use in making therapy adjustments Suggested ways to monitor the patient Please note that the section below is not intended to offer medical advice. INTRODUCTION Professional CGM reports provide a blueprint for a patient s current glycemic control, which can be used to recommend adjustments in the patient s therapy. The reports offer a valuable educational tool to help patients understand the impact of diet, medication, and exercise on glucose control. PRACTICE GUIDE 1

4 4 14 7 14 7 4 14 7 1/27/9 (Tue) 4 14 7 1/28/9 (Wed) 4 1/29/9 (Thu) 14 7 Paired Meter Value Unpaired Meter Value Sensor Value Meal Insulin Exercise Other Time Change (From) Time Change (To) Breakfast 7-1 hr MEAL +1 hr +2 hr +3 hr Block A (3: AM - 5:59 AM) 7 3:am 4:am 5:am 8:am 7 Lunch -1 hr MEAL +1 hr +2 hr +3 hr Block B (11: PM - 6: AM) 7 11:pm 12:am 1:am 2:am 3:am 4:am 5:am 6:am 7 Dinner -1 hr MEAL +1 hr +2 hr +3 hr Block c (12: AM - 11:59 PM) 7 12:am 4:am 8:am 12:pm 4:pm 8:pm 12:am REPORT INTERPRETATION REPORT INTERPRETATIONS: What to Look for in the Reports The steps outlined in this section represent one method for organizing and evaluating a patient s glucose data. 1 It is intended as a starting point for healthcare providers and patients to review the data systematically. As you become familiar with this process, you will begin to establish your own approach to interpretation. ipro CGM provides five reports. Four are generated by the Solutions Software after a patient s data download is completed: Sensor Summary Detail, Sensor Modal Day, Sensor Modal Time and Sensor Daily Detail. The fifth report is the Patient Log Sheet, which is an important information source to be used in conjunction with the data provided by the four ipro CGM reports. See Figure 1 for a sample of the five ipro CGM reports. The Patient Log Sheet is an essential component of the ipro CGM report package because all of the patient s relevant activities and events are revealed. A precisely maintained Patient Log Sheet with reliable data regarding patient activities and events, such as exercise, meals and medication, provides crucial information for evaluating patient glucose control and guiding therapy adjustment. The Patient log sheet can either be interpreted side-by-side with the ipro CGM reports, or the data from it can be entered into Solutions Software and reflected in the printed reports. Note: Patients must understand that if they do not complete and return the log sheet, the data provided by the system is more difficult to interpret. FIGURE 1: Know your reports Sensor Summary Detail report Sensor Modal Day report Sensor Modal Time report 4 4 4 4 Glucose - 15 7 4 4 4 3: AM 6: AM 9: AM 12: PM 3: PM 6: PM 9: PM Quick Overview Accuracy assessment, snapshot of glucose control Identify patterns or no patterns Review glucose trend Review meals and specific time periods Review glucose trend, meal analysis and time periods for analysis Sensor Daily Detail report Patient Log Sheet report 1/26/9 (Mon) Use Clinical Judgment 1/3/9 (Fri) Use Clinical Judgment Focus on individual days and events (cause and effect/behavior) 1 One may not need to complete all steps in detail every time they perform a report interpretation. 2 PRACTICE GUIDE

SENSOR SUMMARY DETAIL REPORT: QUICK OVERVIEW Description: The Sensor Summary Detail report (Figure 2) provides a summary on the quality of data generated from the ipro CGM evaluation and patient s glucose excursion profile. Specifically, it provides valuable information on the patient s time in blood glucose (BG) target range compared to time high or low, the patient s BG entries, the accuracy of the sensor data, and a quantitative analysis of glucose excursions. Objectives: 1. Confirm if patient tested appropriately during the ipro evaluation period. 2. Evaluate the accuracy of sensor data generated from the evaluation. 3. Review the summary data on glucose excursion. FIGURE 2: Sensor Summary Detail report Click on Icon for Sensor Summary Detail report Sensor and Meter Information Optimal Accuracy Criteria % time in target Glucose Excursion Key steps: 1. Examine the ranges of the sensor data and the blood glucose entries to determine the appropriateness of the patient s testing. 2. Check to determine if the criteria were met in assessing optimal accuracy and if clinical judgement is required in assessing the validity of the data. 3. Evaluate the excursions area (pie chart) to analyze the duration above and below the established BG targets. For additional details on this report, please refer to the Appendix Sensor Summary Detail report. PRACTICE GUIDE 3

SENSOR MODAL DAY REPORT: Identify Glycemic Patterns or Lack of Patterns Description: The Sensor Modal Day report (Figure 3) identifies glycemic patterns by overlaying the sensor readings of each day into one graph. This report helps assist in pattern and trend recognition. Objectives: 1. Identify glycemic patterns or the lack thereof. For some patients, you may see a clear pattern right away, mostly for those who follow a rigid schedule. See Figure 4 for an illustration. 2. Identify glucose excursion/trends which are consistent across different days. FIGURE 3: Sensor Modal Day report Click on Icon for Sensor Modal Day report 4 Glucose - Sensor Modal Day report Overview of daily glucose patterns Hypoglycemia? Hyperglycemia? 7 3: AM 6: AM 9: AM 12: PM 3: PM 6: PM 9: PM FIGURE 4. 4 Clear patterns 4 No clear patterns Glucose - 15 Glucose - 15 7 7 3: AM 6: AM 9: AM 12: PM 3: PM 6: PM 9: PM 3: AM 6: AM 9: AM 12: PM 3: PM 6: PM 9: PM Note: You will initially use the Sensor Modal Day report for the "Three Step Methodology" which is discussed later in this section. 4 PRACTICE GUIDE

SENSOR MODAL TIME REPORT: Identify Specific Patterns Description: The Sensor Modal Time report (Figure 5) overlays all sensor readings into graphs which display glucose patterns, pre and post meals and other specific time periods that are of interest to healthcare providers (e.g., overnight period, early morning hours). Times for meals and specific time periods for closer examination should be entered into preferences before upload. This report is based on meal markers and events entered into Solutions Software. If there is a pattern around a particular meal or timeframe, it should be readily discernable. If no meal markers are used, or no time periods of interest are identified, these reports do not populate with glucose sensor data. For this report to yield valuable information, patients must have captured details in the Patient Log Sheets. No meal period information is provided in the report if meal markers are not entered. Objectives: 1. Evaluate the effects of meals. 2. Evaluate glucose patterns during specific time periods of interest to healthcare providers. FIGURE 5: Sensor Modal Time report Click on Icon for Sensor Modal Time report 4 Breakfast 4 Lunch 4 Dinner For patterns around meals 7 7 7 Can customize data around particular time period, such as overnight, Dawn, exercises 4 MEAL -1 hr +1 hr +2 hr +3 hr 7 Block A (3: AM - 5:59 AM) 4 MEAL -1 hr +1 hr +2 hr +3 hr 7 Block B (11: PM - 6: AM) 4 7 MEAL -1 hr +1 hr +2 hr +3 hr Block c (12: AM - 11:59 PM) Sensor Modal Time report Good for finding a pattern around meals and particular times 3:am 4:am 5:am 8:am 11:pm 12:am 1:am 2:am 3:am 4:am 5:am 6:am 12:am 4:am 8:am 12:pm 4:pm 8:pm 12:am e.g. Dawn Period e.g. Overnight Period e.g. 24 hours PRACTICE GUIDE 5

SENSOR DAILY DETAIL REPORT: Focus on Individual Days and Events Description: The Sensor Daily Detail report (Figure 6) provides visual details of each 24-hour period for up to seven days of individual data plots. The plots show the sensor data (daily highs and lows), meter values, and patient activity (meals, medication and exercise) during each 24-hour period. Many healthcare providers find that this is the most important report for relating meals, insulin and exercise with actual glucose results, in order to identify potential cause and effect. Event markers help to correlate patient events to glycemic excursions. Data gaps indicate that sensor glucose values were not generated during that period of time. Data gaps can be caused by several issues, including infrequent calibrations or the sensor being partially or fully dislodged. Objectives: Cause and effect analysis: Helps identify causes of glucose excursions or glucose patterns. FIGURE 6: Sensor Daily Detail report Click on Icon for Sensor Daily Detail report 4 1/26/9 (Mon) Use Clinical Judgment 4 1/27/9 (Tue) 4 1/28/9 (Wed) 4 1/29/9 (Thu) 4 17 7 17 7 1/3/9 (Fri) Use Clinical Judgment 17 17 17 7 7 7 Paired Meter Value Unpaired Meter Value Sensor Value Meal Insulin Exercise Other Time Change (From) Time Change (To) Sensor Daily Detail report Generate cause and effect analysis for a particular event Track glucose and evaluate individuals days at a snapshot Monitor glucose over time Use this report in conjunction with the log sheets for detailed evaluation. This report helps identify behaviors that would not be revealed during an encounter with the patient, for example, consuming more carbohydrates than recommended. In the ipro CGM quick report preferences, some users like to print each daily report as a separate page, then record information from the Patient Log Book on these individual pages. This method might be useful to reveal a day on which the events, behaviors or diet are very different from the others. It also can allow for closer scrutiny of a particular day or event. For example, if a patient has a hypoglycemic event around 3: a.m. on one night only (with no regular pattern), the healthcare provider can review the report for the prior evening to determine if the patient consumed any notable food, whether they counted the carbohydrates in that food correctly, whether the insulin given matched well to the carbohydrates eaten, as well as the glycemic results after exercising. 6 PRACTICE GUIDE

KEY ITEMS TO LOOK FOR IN EACH OF THE REPORTS To analyze glucose data provided by ipro CGM, utilize a three-step methodology to allow a consistent approach. The three steps are outlined below: Step 1 Step 2 Step 3 Assess the overnight period. Assess the pre-prandial period. Assess the post-prandial period. Healthcare providers can systematically evaluate the data and identify potential cause-and-effect relationships between activities and blood glucose levels, ultimately leading to potential therapy recommendations. For each period, glucose values that are within the patient s individualized glucose target range and outside the patient s individualized target range both below (hypoglycemia) and above (hyperglycemia) can be identified. Assess tracings for hypoglycemia first, and then hyperglycemic trends and patterns. If the patient is within the range, no further assessment is required of this period. For each period, identify potential cause and effect relationships. This helps patients see the relationship between daily activities (meals, medication and activity) and their glucose levels. Consider the cause if the patient s glucose values are above or below the targeted range. These factors may include: Oral medication, insulin or injected medications. The dosage, timing and duration of medication action, storage conditions of insulin and proper use of medications taken. Meal intake and carbohydrate estimates made by patient if medication is based upon carbohydrate estimates. The type, duration and intensity of exercise and activity. The timing, quantity and composition of food, and patient carbohydrate counting accuracy, as applicable. Stress, emotion and hormones. Devices such as pump, settings of devices, and use of Bolus Wizard calculator. Use the three-step methodology when analyzing the Sensor Modal Day report, the Sensor Modal Time Period report, or the Sensor Daily Details report. Note: Excursions outside of the target glucose range need to be analyzed for causes, or what preceded the excursion. This sheds light to the changes made. PRACTICE GUIDE 7

STEP 1: Assess glucose pattern in the Overnight Period Glucose - 14 Definition: The "overnight period is defined as a period of fasting that occurs during a patient s sleep hours. Fasting generally means that the patient is not under the glycemic effect of dietary intake. Often, the true fasting period is usually from 24: (or midnight) to 6: a.m. in the morning, unless the patient eats late in the evening or during overnight hours. 75 3: AM 6: AM 9: AM Key Steps: Identify glucose values that are within the range and outside the range (both below and above) for the time period. Hypoglycemia or hyperglycemic determinations are based upon individualized glucose target ranges as set in the software preferences. If the patient is within the range, no further assessment is required of the period. Look for hypoglycemic excursions: Anything below the low glucose target is defined as hypoglycemia in this analysis. A low sensor glucose value overnight, may indicate the basal rate is too high. Look for hyperglycemia: Anything above the high glucose target is defined as hyperglycemia in this analysis. Assess for a preceeding hypoglycemia event and correct that prior to addressing any hyperglycemia issues. Here are the key considerations for several common patterns of events. Pattern High blood glucose at beginning of the overnight period Hypoglycemia early in overnight period Hyperglycemia later in overnight period Hypoglycemia later in overnight period Potential Considerations Late evening snack; inadequate insulin coverage or carbohydrate counting Basal rate low in preceding segment Physical or emotional stress Excessive insulin for late evening meal or bedtime snack Exercise, including sexual activity Alcohol use Basal rate too high Correction dose of insulin too high Inadequate overnight basal rate Late night snack; inadequate coverage on carbohydrate counting Preceding hypoglycemia Delayed effect of evening exercise Excessive overnight basal Delayed effect of alcohol use 8 PRACTICE GUIDE

STEP 2: Assess glucose pattern in the Pre-prandial Period Glucose - 14 14 75 Definition: The pre-prandial period is the period before a meal or when there is no longer active insulin from a bolus of insulin taken for the prior meal, and there are no post-meal activities (e.g., exercise) which could still have an effect on glucose levels. It is usually a period of time that occurs approximately three to five hours after the last meal. For the breakfast meal, the pre-prandial is also referred to as the fasting glucose period. People who eat frequently may not have a clearly identifiable pre-prandial period. 3: AM 6: AM 9: AM Key Steps: Evaluate the pre-prandial period first for breakfast, followed by lunch, and then for dinner. Snacks can make pre-prandial assessment challenging. Look for hypoglycemic episodes: If you find hypoglycemia, then look for a cause. Potential causes to consider include: Basal insulin too high. An overestimation of insulin required for the previous meal. Perhaps the insulin-tocarbohydrate ratio was incorrectly calculated or there was remaining active insulin from a prior bolus that was not considered, or perhaps carbohydrates were not counted correctly. Exercise or activity. Food: Review the foods and quantities eaten for previous meal. Examine the timing of the insulin given, amount given, and the type of food that was eaten. Look for hyperglycemia: Consider the same causes, such as basal, activity, and food, as above, and also consider the following: Was there an inadequate bolus from previous meal? What was the timing of the bolus for the type of meal? Was it the result of exercise, which can sometimes cause glucose to be elevated? Was this hyperglycemia event preceded by a low? Was the patient s insulin pump infusion set changed? Was the patient s insulin stored appropriately? One special consideration is the pre-prandial period for breakfast, when dawn phenomenon may occur and result in hyperglycemia prior to the breakfast meal. PRACTICE GUIDE 9

STEP 3: Assess glucose pattern in Post-prandial Period Glucose - 14 75 14 75 Definition: The "post-prandial period is defined as the period following the meal, for example, the period observed approximately two to five hours following food intake. Note: According to the American Association of Clinical Endocrinologists 2, glucose should be less than 14 at the 2-hour postprandial time period. What is normally reflected after a meal is the insulin that was given prior to the meal (meal bolus or active insulin), the previous meal s residual insulin, and any post-meal activities. 3: AM 6: AM 9: AM Key steps: Identify hypoglycemia or hyperglycemia, then look for the cause and correct it. Evaluate post-prandial periods focusing first on breakfast, then lunch, and finally dinner. Snacks can make post- prandial assessment challenging. Look for hypoglycemic excursions: If you find hypoglycemia in the post-prandial periods, then look for a cause. Possible causes include: Too much insulin was given; Too little food was eaten for the amount of insulin; Food absorption was delayed; The insulin was timed or given at an inappropriate time; The measurement of the amount of insulin was incorrect; The type of bolus given was mismatched for the type of food eaten; for example, a normal bolus, rather than dual-wave, was provided for a pizza meal; Whether the patient had taken additional medication, which may result in an increased likelihood for hypoglycemia to occur; or The effect from prior exercise. Look for hyperglycemia: If hypoglycemia preceded the hyperglycemia, it needs to be corrected first before proceeding with subsequent evaluation. If hyperglycemia occurs (a peak above 18 post-meal), consider the following: The timing of insulin/bolus (e.g., despite the availability of rapid-acting insulin, insulin needs to be taken in advance of the meal); The type of bolus that was given, and the accuracy of the bolus; and The type of food. 2 AACE Medical Guidelines for Clinical Practice for the Management of Diabetes Mellitus. Endocrine Practice 13 (Suppl 1): 4-68, 7 1 PRACTICE GUIDE

3: AM 6: AM 9: AM 12: PM 3: PM 6: PM 9: PM REPORT INTERPRETATION KEY TAKEAWAYS: I. REPORT INTERPRETATION PROCESS FLOW The process flow outline below represent one method for organizing and evaluating the data. Sensor Summary Detail Quick Overview -Quality of data -Glucose excursion profile Pie Chart Red: Above Limits Green: Within Limits Blue: Below Limits Sensor Modal Day Identify clear patterns or lack of patterns across 24 hour period Glucose - 4 15 7 No Clear patterns? Yes Sensor Modal Time Identify specific patterns at meals or specific time -Review patterns 1 hr pre- & 3 hr post-meal or at customized time block Lunch 4 7 Sensor Daily Detail Identify cause & effect -Relate meals, insulin, exercise with glucose in each individual day -Reveal isolated excursion 4 7 1/28/9 (Wed) MEAL -1 hr +1 hr +2 hr +3 hr Refer to patient log sheet to support analysis with these reports PRACTICE GUIDE 11

II. KEY ITEMS TO LOOK FOR IN EACH OF THE SOLUTIONS SOFTWARE REPORTS 1. Identify hypoglycemia or hyperglycemia Identify the period patient s blood glucose is outside the target range. First, look for patterns of hypoglycemia anywhere anytime. Be sure you look at overnight, pre-prandial and post-prandial periods. Note: If hypoglycemia preceded the hyperglycemia, it needs to be corrected first. Then, look for hyperglycemia trends and patterns at overnight, pre-prandial, and post-prandial periods. 2. Identify a cause based on the identified pattern and correct it For each period, assess patient s activities (meals, medication, exercise) that preceded any excursions to identify potential cause and effect relationships. Consider the following when a certain pattern is identified from the reports: Pattern Nocturnal hypoglycemia Hypoglycemia Hyperglycemia Post-prandial glucose excursion (high or low) Hyperglycemia followed by hypoglycemia Hypoglycemia followed by hyperglycemia Potential Considerations Overnight basal Alcohol Evening exercise Mismatch of late evening snack and insulin delivered Type, quantity, timing and action of medication Reported symptoms Earlier exercise Mismatch of food eaten to insulin taken Basal insulin too high Difficulties in carbohydrate counting or assessing amounts of food Timing of insulin delivery and peak of insulin action related to food intake Over-treatment of hypoglycemia Compensation for fear of hypoglycemia Mismatch of type of bolus (Dual Wave ) for food Rebound hyperglycemia Dawn phenomenon (morning hyperglycemia) Type and quantity and action of medication Meal content high fat and protein meal versus delayed absorption. Timing and peak action of pre-meal medication History of gastroparesis Giving insulin after the meal Carbohydrate counting accuracy Mismatch of insulin with carbohydrates Timing of insulin bolus Correction factor assessment Insulin stacking (manual boluses) Use of Bolus Wizard Over treatment of hypoglycemia Rebound hyperglycemia Insulin stacking/ manual boluses SUMMARY Professional CGM reports provide valuable information in identifying potential cause and effect to help make better therapy decisions. The reports can address the following questions: Question: Are there problems, events, excursions? Answer: SENSOR MODAL DAY and MODAL TIME PERIODS REPORTS - Quick analysis of hypoglycemia and hyperglycemia (e.g., 24 Hour, Meal, Custom Time Views). Question: What is the cause of the problem or excursion? Answer: SENSOR DAILY DETAILS REPORT - Provides complete details of each day s control which may be related to various events during the day. Question: Are the medications and devices being utilized optimally? Answer: Utilize patient interview and pump reports to gain insight to BG monitoring, Bolus Wizard utilization, priming, site changing, use of the suspend feature, use of medication with meals, and so forth. 12 PRACTICE GUIDE

REPORT INTERPRETATION: Options Use the ipro CGM Progress Note (see Appendix form RI1) to document the findings. When interpreting the ipro CGM reports, use the ipro CGM patient log sheet and the patient s medical record as an information source. Noting the reason or indications for performing the ipro CGM evaluation/referral is important as it provides guidance or a focal point for interpretation. This is especially important for patients that are from a referring healthcare provider. It also provides documentation of rationale for performing the ipro CGM procedure. Perform interpretation with or without the patient present. Note that the service under CPT code 95251 is for the interpretation of the data and does not require a face-to-face meeting with the patient. Interpretations can be done in batches, (e.g., once a week), if that is more efficient for your practice. Alternatively, perform the interpretation just before meeting with the patient. Review ipro CGM reports with patients immediately after the data download or in a separate meeting. When you perform it depends on the other steps you have planned for the ipro CGM process, for example, your resources, office clinical flow, and patient scheduling. Review the reports on the computer screen or use a printed copy with patients. Consider handwriting notes on food intake, unusual food intake, or medical changes on the patient s printed report. Point out important events (such as hypoglycemic or hyperglycemic episodes) and their relationship to patient activities, and educate on the impact of meals, medication, and exercise on glucose levels. Provide the patient with a copy of the ipro CGM reports as an education tool. Visual reinforcement is one of the most effective benefits of an ipro CGM evaluation. Have them record recommendations on the report (learning tool). Enter patient activities from patient log sheets into Solutions Software to make it easier to interpret ipro CGM reports. THERAPY ADJUSTMENT: Options Therapy adjustments may be performed face-to-face, although some practices deliver them by telephone. It is still important to send or fax the patient a copy of the ipro CGM report and ipro CGM progress note detailing any therapy adjustments to be made, (e.g., a change in dosage, new medication, or how to correct highs and lows). This can be helpful when discussing the report over the phone with a patient. Therapy adjustments may be communicated to patients on the same day as the data download and interpretation, or on a separate visit such as during a routine visit. If appropriate, ask patients to see a diabetes educator after the visit. The physician and mid-level practitioner can interpret the data with the patient and recommend changes in dosage, new medication, diet, and/or lifestyle. Best Practice - Therapy Adjustments Consider making only one or two changes in a patient s therapy after each ipro CGM evaluation to properly understand cause and effect of therapy. Proactively address any questions patients may have while reviewing reports with them. Consider performing the ipro CGM evaluation (changing the patient's therapy) a few weeks prior to the routine visit. When he/she returns for the routine visit, the physician will be able to assess the effect of the recommendations and answer any questions the patients may have. PRACTICE GUIDE 13

REPORTING/ DOCUMENTATION: Complete the ipro CGM Progress Note, or document in medical record in usual manner. Confirm that the healthcare provider has signed the ipro CGM Progress Note, or document in medical record in usual manner. Include a copy of the ipro CGM Progress Note, Solutions Software Reports, and Patient Log Sheet to the patient s medical record. If applicable, fax or mail a copy to the referring healthcare provider. Confirm that the patient has been instructed on therapy changes. Provide the patient with instructions regarding therapy changes. ONGOING PATIENT ASSESSMENT Most practices follow up with the patient during the next office visit to see if the therapy adjustments are working. Practices may ask the patient to check BG values more frequently the week before the office visit to see how glucose values are, as well as perform A1C testing. In addition to the quarterly checkup, some offices have included these follow up options: Call the patient a week after the therapy adjustment to monitor the patient's progress. Ask the patient to return for a refresher course in diabetes management. Some offices ask the patient to return for a face-to-face with their healthcare provider after they have completed the classes. This visit is another opportunity to review the ipro CGM reports and changes in therapy with the patient. Repeat ipro CGM Evaluations A repeat CGM evaluation (as allowed by the insurance payor) is recommended to follow up on therapy adjustments and to continue to improve overall diabetes control. Some practices build a schedule into their routine care as to procedure frequency or follow-up study (e.g., repeat ipro CGM evaluation annually). Please check with insurance payors to understand specific guidelines for ipro CGM for CPT codes 9525 and 95251. Please refer to the Reimbursement section for further details on Professional CGM Coding and Coverage. The number of variations or visits depends on the patient s progression of care. Schedule follow up visits as needed. 14 PRACTICE GUIDE

APPENDIX REPORT INTERPRETATION SENSOR SUMMARY DETAIL REPORT The Sensor Summary Detail Report provides the healthcare provider with three key pieces of information: 1. Sensor blood glucose information: A full day of sensor wearing allows for up to 288 readings. On the first and last day, however, the report does not typically contain all 288 readings because they are not full days. Before you begin your interpretation, assess the tracings to make sure there is sufficient data. One of the key aspects of the report is tracking the standard deviation of the patient s glucose range. STDev is an abbreviation for standard deviation. It indicates how glucose sensor readings are spread over the glucose range. The lower the standard deviation, the lower the glycemic variability is. There are no absolute cutoff lines, but this gives the user a sense of the range of glucose variability. 2. Optimal accuracy criteria: This evaluates the relative accuracy of the sensor glucose data in relation to the reference Meter BG data. The criteria measurements provide an indication of the relative degree of accuracy and potential clinical reliability of the calibrated sensor data, compared with the entered Meter BG data. Medtronic uses three criteria to measure accuracy of data in Professional CGM: # of Paired Readings (Criteria: at least 3 Paired Readings per day) Mean Absolute Difference (MAD%) (Criteria: less than 28%) Correlation Coefficient (R) (Criteria: greater than or equals to.79) All must be met or the day will be labeled as X: Use Clinical Judgment Often times, the first day and the last day are deemed problematic for accuracy due to having not enough BG meter entries (e.g., less than 3 paired readings). Note: The software will not provide a correlation coefficient (R) if the meter BG values have a range of less than for that day. R will be labeled as N/A. If no correlation coefficient is given, the MAD also must be less than 18% to meet MDT s optimal accuracy criteria. 3. Glucose excursions: In target range In hypoglycemia range 29% 11% 6% In hyperglycemia range Example of an excursion pie chart Glucose excursion provides an overview of glycemic control and the amount of time per day spent in the target glucose range, in the high range, and in the low range. The BG target range set determines what the cutoffs are for hyperglycemia and hypoglycemia. Some set the range from 7 to 14, or 7 to 18 dl. The BG target range is set in the user preference for the practice, or can be individually set or changed before upload on the patient screen. Note: Certain patient populations (e.g., pediatric, pregnant, those with hypoglycemic unawareness) require a special target range. PRACTICE GUIDE 15

APPENDIX SENSOR SUMMARY DETAIL REPORT What do you do when the Sensor Summary Detail report reveals Use Clinical Judgment? 1. Understand the reasons, which are highlighted in blue in the report. Reason #1 (most common): less than 3 paired readings between fingersticks readings and sensors readings. This is quite common for the first day and last day since you do not have a full day. Reason #2: MAD% increase due to a large difference between sensor readings and BG readings. 2. Consider the following: If the blue box is on the first day and last day, use the report as normal. If MAD% is not far from the cutoff point, use them because they are still good for trend. If the patient does not perform fingersticks at least twice per day for most of the days, there may be insufficient data for analysis. In this case, the patient should consider repeating ipro CGM. If only one day is depicted with the Use Clinical Judgment, but the data on that day is consistent with the other days, then use it as normal. 16 PRACTICE GUIDE

APPENDIX REPORT INTERPRETATION SAMPLE REPORTS: Figure 7 provides examples of the Modal Day Summary report using the three-step methodology. FIGURE 7: Modal Day Summary report Dawn Phenomenon Friday Saturday Sunday Nocturnal Hypoglycemia 3: AM 6: AM 9: AM 12: PM 3: PM 6: PM 9: PM Nocturnal Hypoglycemia 14 6 Post-prandial Hyperglycemia 3: AM 6: AM 9: AM 12: PM 3: PM 6: PM 9: PM PRACTICE GUIDE 17

15 No Meal Markers Present REPORT INTERPRETATION APPENDIX SAMPLE REPORTS: Figure 8 demonstrates the importance of adding meal markers and events. FIGURE 8: Report with no meal markers Periods Breakfast 4 Lunch 4 Dinner 4 15 No Meal Markers Present 15 No Meal Markers Present 7 7 7-1 hr Meal +1 hr +2 hr +3 hr -1 hr Meal +1 hr +2 hr +3 hr -1 hr Meal +1 hr +2 hr +3 hr Block A (6: - 5:59 AM) 4 Block B (6: AM - 11: PM) 4 Block C (6: PM - 6: AM) 4 15 15 15 7 7 7 6:am 2:pm 6:pm 1:pm 2:am 6:am 6:am 2:pm 6:pm 1:pm 2:am 6:am 6:am 2:pm 6:pm 1:pm 2:am 6:am FIGURE 8: Report with meal markers and events Periods Breakfast 4 Lunch 4 Dinner 4 15 7 15 7 15 7-1 hr Meal +1 hr +2 hr +3 hr -1 hr Meal +1 hr +2 hr +3 hr -1 hr Meal +1 hr +2 hr +3 hr Block A (6: - 5:59 AM) 4 Block B (6: AM - 11: PM) 4 Block C (6: PM - 6: AM) 4 15 7 15 7 15 7 1:am 2:am 3:am 4:am 5:am 6:am 6:am 1:am 2:pm 6:pm 1:pm 6:pm 1:pm 12:am 2:am 4:am 6:am 18 PRACTICE GUIDE

APPENDIX - FORMS REPORT INTERPRETATION (Form RI1 page 1 of 2)

APPENDIX - FORMS REPORT INTERPRETATION (Form RI1 page 2 of 2)