1. Making The Most of Continuous Glucose Monitoring Gary Scheiner MS, CDE
Owner/Director, Integrated Diabetes Services
333 E. Lancaster Ave., Suite 204
Wynnewood, PA
(877) 1

2. Making the Most of Continuous Glucose Monitoring
What Information Is Available?
How to Use Immediate Data?
How to Use Intermediate Data?
What Can Be Learned from Retrospective Analysis?
Optimizing CGM System Performance

3. MiniMed Paradigm® & Guardian® REAL-Time CGM Systems
On-Screen Reports
3-hr and 24-hr graphs (pump); 3 / 6 / 12 / 24-hr graphs (Guardian)
Can scroll back for specific data points
 “direction” indicators
Updates every 5 minutes
Hi/Low Alerts
Predictive Alerts (Guardian)

4. MiniMed Paradigm® & Guardian® REAL-Time CGM Systems
CareLink™ Personal:
Online Reports
Sensor daily overlay
Sensor overlay by meal

5. MiniMed Paradigm® & Guardian® REAL-Time CGM Systems
CareLink™ Personal Online Reports
Daily summaries & layered reports, including…
Sensor tracing
Basal & bolus delivery
Carbohydrate & logbook entries

6. DexCom™ Seven Plus® On-Screen Reports 1, 3, 6, 12, 24-hr graphs
Updates every 5 minutes
Hi/Low alerts
Rate of Change alerts

7. DexCom™ 7 STS®
Dexcom DM2 Download Reports
Glucose Trend
Hourly Stats

8. DexCom™ 7 STS® Dexcom DM2 Download Reports Trend Analysis BG
Distribution

9. Freestyle Navigator™ On-Screen Reports 2/4/6/12/24-hr line graphs
Predictive alerts
 “direction” indicators
Can scroll back to data points
Customizable time range:
Highest, Lowest, Avg, SD
% Time High, Low, In-Range
# Hypo, Hyper events
Updates every minute

10. Freestyle Navigator™ Download to CoPilot Software Modal Day Report
Glucose Line Report
Statistics Report

11. Practical Benefits of Real-Time CGM
Rumble strips (avoid serious extremes)
Peace of mind
Basal & bolus fine tuning
Postprandial analysis
Insulin action curve determination
Short-term Forecasting
Learning tool & immediate feedback
Eliminates some blood glucose checks???
Partially derived from: Hirsch, et al. Clinical Application of Emerging Sensor Technologies in Diabetes Management: Consensus Guidelines for Continuous Glucose Monitoring (CGM). Diabetes Technology & Therapeutics, 10:4, 2008,

12. How to Look at the Information
Immediate
Intermediate
Retrospective
                                                

13. Immediate Info: Alerts
Customizable settings
Vibrate and/or beep
Alert the user of glucose levels that have crossed specified high or low thresholds
(predictive) Alert of anticipated crossing of high or low thresholds

14. Setting Alerts Hi/Low alarm thresholds are not BG target ranges
Balance need for alerts against “nuisance factor”

15. Alert Settings Recommendation
LOW: 80 mg/dl
(90+ if hypo unaware)
HIGH: mg/dL
(lower progressively toward 180)
It is Medtronic’s recommendation that the starting alert setting on initiation should be a low of 80 mg/dL and a high of 240 mg/dL. It is important that patients do not confuse these alert settings with blood glucose targets. For instance, the low threshold of 70 might mean that the patient would miss hypoglycemia in the 60 or 50 range, or a high setting of 140 would mean that the patient would unnecessarily get alarms when glucose was in the normal range of 120 or multiple alarms when the glucose was in the 160 range.
NOT RECOMMENDED: Low 70 mg/dL
NOT RECOMMENDED: High 140 mg/dL
Derived from: Hirsch, et al. Clinical Application of Emerging Sensor Technologies in Diabetes Management: Consensus Guidelines for Continuous Glucose Monitoring (CGM). Diabetes Technology & Therapeutics, 10:4, 2008,

16. Special Alert Settings
Young children (higher, wider range)
Hypoglycemia unawareness, high-risk professions (higher hypo setting)
Pregnancy (lower, narrower range)
HbA1c of 11.0% (higher initially)

17. Immediate Info: Glucose and Trend
Prediction/Forecasting
Safety/Performance
Driving
Sports
Tests
Third, REAL-Time Trend Arrows.
One arrow up or down indicates a change of 1-2 mg/dl/min in the last 20 minutes.
Two arrows up or down indicate a change of more than 2 mg/dl/min in the last 20 minutes.
Arrows are only displayed if there has been at least a 1 mg/dl/min change in the last 20 minutes.
Patients should think about where glucose may be in 20 minutes if it continues at the same rate.

18. Immediate Glucose Info:
Can it Replace Fingersticks?
Not during first 1-2 cycles of using the system
Wait at least 12 hrs after sensor replacement
If BG Stable
If Recent calibrations in-line
If No recent alarms
Third, REAL-Time Trend Arrows.
One arrow up or down indicates a change of 1-2 mg/dl/min in the last 20 minutes.
Two arrows up or down indicate a change of more than 2 mg/dl/min in the last 20 minutes.
Arrows are only displayed if there has been at least a 1 mg/dl/min change in the last 20 minutes.
Patients should think about where glucose may be in 20 minutes if it continues at the same rate. 18

19. Immediate Info: Potential Bolus Adjustment Based on BG Direction
BG Stable:
Usual Bolus Dose
BG Rising Gradually:
 bolus 10%
BG Rising Sharply:
 bolus 20%
BG Dropping Gradually:
 bolus 10%
BG Dropping Sharply:
 bolus 20%
Third, REAL-Time Trend Arrows.
One arrow up or down indicates a change of 1-2 mg/dl/min in the last 20 minutes.
Two arrows up or down indicate a change of more than 2 mg/dl/min in the last 20 minutes.
Arrows are only displayed if there has been at least a 1 mg/dl/min change in the last 20 minutes.
Patients should think about where glucose may be in 20 minutes if it continues at the same rate. 19

20. Immediate Info: Hypoglycemia Alerts
Predictive Hypo Alert or Hypo Alert & recovering: Subtle Treatment
50% of usual carbs
Med-High G.I. food
Hypo Alert & Dropping: Aggressive Treatment
Full or increased carbs
High G.I. food
Third, REAL-Time Trend Arrows.
One arrow up or down indicates a change of 1-2 mg/dl/min in the last 20 minutes.
Two arrows up or down indicate a change of more than 2 mg/dl/min in the last 20 minutes.
Arrows are only displayed if there has been at least a 1 mg/dl/min change in the last 20 minutes.
Patients should think about where glucose may be in 20 minutes if it continues at the same rate. 20

21. Intermediate Info: Use of 2/3/4 Hr Trend Graphs
Effects of different food types
Effectiveness of bolus amt.
Reveals postprandial spikes
Pramlintide/Exenatide Influence
Exercise effects
Impact of Stress

22. Intermediate Info: Use of 9 / 12 / 24 Hr Trend Graphs
Facilitates decision-making for basal insulin doses
Shows delayed effects of exercise, stress, high-fat foods
Reveals overnight patterns
Lets user know when bolus action is complete

23. Specific Insights to Derive
(a purely retrospective journey)

24. Before You Analyze, Qualify.
Were sufficient calibrations performed?
Did the calibrations match the CGM data reasonably well?
Was the data mostly continuous?
Was the time/date set correctly?

25. These Are a Few of My Favorite Stats…
Mean (avg) glucose
% Of Time Above, Below, Within Target Range
Standard Deviation
# Of High & Low Excursions Per Week

26. Case Study 1: Effectiveness of Current Program
Type 1 diabetes; using insulin glargine & MDI
Overnight readings are OK; HbA1c levels are elevated
Glucose (mg/dL)
400
300
200
100
3 AM AM
9 AM PM PM PM PM
Meal doses insufficient; not covering snacks?

27. Case Study 2a: Basal Insulin Regulation
Glucose (mg/dL)
400
300
200
100
400
300
200
100
3 AM AM PM PM
3 AM AM PM PM
Stable 12 AM – 4 AM, then dropping pre-dawn
Dropping late afternoon
Rising 2 AM – 8 AM

28. Case Study 2b: Basal Insulin Regulation
Type 1 diabetes; using insulin glargine & MDI
History of morning lows
Now not “covering” highs at night
Glucose (mg/dL)
400
300
200
100
3 AM AM AM PM PM PM PM
BG dropping overnight; insulin dose too high

29. Case Study 3: Detection of Silent Hypoglycemia
Type1 diabetes; on pump
Frequent fasting highs (9 AM)
Glucose (mg/dL)
400
300
200
100
3 AM AM AM PM PM PM PM
Somogyi effect during the night

30. Case Study 4: Determination of Insulin Action Curve
3-Hour Duration
4-Hour Duration
5-Hour Duration

31. Case Study 5: Fine-Tuning Meal Boluses
Glucose (mg/dL)
400
300
200
100
3 AM AM AM PM PM PM PM
Breakfast and lunch doses may be too low
Dinner dose appears OK
Night-snack dose clearly insufficient

32. Case Study 6: Fine-Tuning Correction Boluses
Dropping low after correcting for highs at bedtime and wake-up time
Glucose (mg/dL)
400
300
200
100
3 AM AM AM PM PM PM PM
Need to change correction factor & insulin sensitivity during AM hours

33. Case Study 7: Postprandial Analysis
Pre-meal BG levels are usually in target range
HbA1c are higher than expected based on SMBG
Tired and lethargic after meals
Significant postprandial spikes (300s)
Glucose (mg/dL)
400
300
200
100
Meal

34. Case Study 8: Impact of Physical Activity
Type 1 diabetes; pump user
Basal rates confirmed overnight
Exercises in the evening (9 PM)
Glucose (mg/dL)
400
300
200
100
Exercise
3 PM PM PM AM AM AM AM PM
Experiencing delayed-onset hypoglycemia

35. Case Study 9: Impact of Stress
Type 1 diabetes; pump user
40 years old; athletic
Handsome, excellent speaker
Glucose (mg/dL)
400
300
200
100
Late for meeting
Gets flat tire; eats 15g carbs to prepare for tire change
Spare is flat too!!
9 AM 12 PM 3 PM 6 PM 9 PM
STRESS CAN RAISE BLOOD GLUCOSE… A LOT!!!

36. Case Study 10: Impact of Various Food Types
Pasta Meal
Stir-Fry Over Rice
Cereal
Oatmeal
Yogurt
BG peaks later with pasta than rice
Postprandial peak: cereal > oatmeal > yogurt

37. Case Study 11: Impact of Hi-Fat Meals
Saturday Nights, Dinner Out
Temp basal increase following hi-fat meals

38. CGM “Homework” Assignments
Verify basal doses
See effect of dietary fat
Study effects of specific exercises
Evaluate impact of different food types
Measure insulin sensitivity
Determine insulin action curve
                                                           

39. Optimizing CGM System Performance
Calibration
Site selection/care
Signal reception
Ingredients for success 39

40. Optimal Calibration
Calibrate at times when blood glucose (BG) is stable (fasting, pre-meals)*
Avoid calibrations during times of rapid glucose change*
Post meal
UP or DOWN arrows are displayed
In the period following a correction with food or insulin
During exercise
* Not required w/Dexcom system
The best time to calibrate is when the blood glucose (BG) is stable — before meals or at bedtime—for then it is less likely that rapid changes in BG are going to take place.
NOTE: When the BG is rapidly changing and a patient attempts to calibrate with a “single point in time” BG fingerstick reading, there may be enough of a change taking place to cause a calibration error to occur. If 2 calibration errors occur in a row, the glucose sensor can no longer be used and must be replaced. For this reason, patients should try not to calibrate within 2 hours after a meal or when 2 UP or DOWN arrows are displayed beside the current glucose reading on the insulin pump screen.
The continuous glucose monitoring system must be calibrated a minimum of every 12 hours. However, 3 to 4 times a day is preferred. If calibration is not done every 12 hours, the insulin pump screen will stop displaying sensor glucose readings until a fingerstick BG value is entered
Remind your patient to calibrate before going to sleep to prevent a METER BG NOW alarm from sounding during sleep hours

41. Optimal Calibration
Calibrate before bedtime to avoid alarms during the night
Use good technique when performing BG checks for calibration
Proper coding
Clean hands
USE FINGERSTICKS
Enter the calibration immediately after the fingerstick (Dexcom, Medtronic systems)
The best time to calibrate is when the blood glucose (BG) is stable — before meals or at bedtime—for then it is less likely that rapid changes in BG are going to take place.
NOTE: When the BG is rapidly changing and a patient attempts to calibrate with a “single point in time” BG fingerstick reading, there may be enough of a change taking place to cause a calibration error to occur. If 2 calibration errors occur in a row, the glucose sensor can no longer be used and must be replaced. For this reason, patients should try not to calibrate within 2 hours after a meal or when 2 UP or DOWN arrows are displayed beside the current glucose reading on the insulin pump screen.
The continuous glucose monitoring system must be calibrated a minimum of every 12 hours. However, 3 to 4 times a day is preferred. If calibration is not done every 12 hours, the insulin pump screen will stop displaying sensor glucose readings until a fingerstick BG value is entered
Remind your patient to calibrate before going to sleep to prevent a METER BG NOW alarm from sounding during sleep hours 41

42. Sensor Sites Site Selection Bleeding/Irritation “Fleshy” areas
At least 3” Away from insulin infusion
Avoid tight clothing areas, scars, bruises, lipoatrophy
Rotate sites
Bleeding/Irritation
Slight bleeding OK
Profuse bleeding: remove
Remove introducer needle at proper angle

43. Sensor Sites Adhesive Site Irritation
Completely cover the Transmitter & Sensor (Navigator & Medtronic systems)
Check sensor daily for loose tape
Apply extra tape over sensor & transmitter if tape patch begins to “curl” around edges
Site Irritation
Watch for redness, swelling, tenderness
Remove sensor with prolonged irritation (>1 hour)

44. Signal Reception Heed transmitter ranges
Medtronic: 6 ft.
Dexcom: 5 ft.
Navigator: 10 ft.
Signals do not travel well through water
Wear receiver on same side of body as sensor
Keep receiver very close while charging (Dexcom)
Charge transmitter fully every 6 days (Medtronic)
                   
In clinics that have utilized the MiniMed Paradigm REAL-Time System in studies, certain experiences can be gained. An analysis of patients who did well experienced benefits from using it continuously or at least 90 percent of the time. Patients who have experience with insulin pump therapy seemed to benefit more than those who were new to pump therapy and therefore still learning how to optimize their insulin pump usage. Patients who looked at it frequently, almost times per day, but did not overreact to the data. Patients who had their CareLink data examined by the healthcare team, and with the help of the healthcare team, looked at trends and patterns and responses of glucose to insulin and made changes in carbohydrate to insulin ratios and basal rates. Patients who used the Bolus Wizard calculator did best and avoided hypoglycemia. It can also be said to the contrary that a lot has been learned from patients who do not benefit as much of the time: patients who did not wear the sensor at least 50 percent of the time; patients who did not trust the readings, and therefore did not look at the sensor; and patients who became extremely frustrated with nuisance alarms, causing them to stop using the sensor.
So patient behavior during wearing CGM is also a key factor to achieve a better outcome.

45. Ingredients For Success
Wear the CGM at least 90% of the time
Look at the monitor times per day
Do not over-react to the data; take IOB into account
Adjust your therapy based on trends/patterns
Calibrate appropriately
Minimize “nuisance” alarms
In clinics that have utilized the MiniMed Paradigm REAL-Time System in studies, certain experiences can be gained. An analysis of patients who did well experienced benefits from using it continuously or at least 90 percent of the time. Patients who have experience with insulin pump therapy seemed to benefit more than those who were new to pump therapy and therefore still learning how to optimize their insulin pump usage. Patients who looked at it frequently, almost times per day, but did not overreact to the data. Patients who had their CareLink data examined by the healthcare team, and with the help of the healthcare team, looked at trends and patterns and responses of glucose to insulin and made changes in carbohydrate to insulin ratios and basal rates. Patients who used the Bolus Wizard calculator did best and avoided hypoglycemia. It can also be said to the contrary that a lot has been learned from patients who do not benefit as much of the time: patients who did not wear the sensor at least 50 percent of the time; patients who did not trust the readings, and therefore did not look at the sensor; and patients who became extremely frustrated with nuisance alarms, causing them to stop using the sensor.
So patient behavior during wearing CGM is also a key factor to achieve a better outcome.
Source: Dr. Bruce Bode & Gary Scheiner, personal observation. 45

46. Think Like A Pancreas!