1. PRACTICAL ASPECTS OF CONTINUOUS GLUCOSE MONITORING (CGM) Barb Tallant, RN, MA Laurel Messer, RN, BSN, CCRP

2. Eras of diabetes management Urine Glucose SMBGCGM? Pre-1978 1978-2006 2006 -

3. CGM vs. CGM Real-Time Continuous glucose monitoring (CGM) Continuous glucose monitoring (CGM) Retrospective analysis of data Retrospective analysis of data Real-time continuous glucose monitoring (RT-CGM) Real-time continuous glucose monitoring (RT-CGM) Retrospective analysis of data Retrospective analysis of dataPLUS Continuous feedback of data to the wearer in “real time” Continuous feedback of data to the wearer in “real time” Additional features such as alarms, trend arrows Additional features such as alarms, trend arrows

4. Medtronic Minimed CGMS® Gold™ (retrospective data) Available for many years for HCPAvailable for many years for HCP Sensor inserted under skin  cable  receiver Sensor inserted under skin  cable  receiver

5. Medtronic Minimed CGMS® Gold™ Readings recorded every 5 minutes, glucose range 40-400 mg/dl Readings recorded every 5 minutes, glucose range 40-400 mg/dl Patient manually enters at least 4 BG values/day Patient manually enters at least 4 BG values/day Data downloaded from device to computer and HCP can evaluate trends with wearer Data downloaded from device to computer and HCP can evaluate trends with wearer

6. CGM Real Time is here! Wireless Wireless Immediate feedback Immediate feedback Extra features like alarms, line graphs, trending arrows Extra features like alarms, line graphs, trending arrows

7. CGM-RT systems Medtronic/Minimed Guardian® RT (only available in select cities) Medtronic/Minimed Paradigm® Real-Time (CGM available June 19) Freestyle Navigator™ (Investigational Device/Non-FDA approved)) DexCom™ STS™ (available and approved for adults)

8. CGM-RT systems Medtronic/Minimed Guardian® RT (only available in select cities) Medtronic/Minimed Paradigm® Real-Time (CGM available June 19) Freestyle Navigator™ (Investigational Device/Non-FDA approved)) DexCom™ STS™ (available and approved for adults)

9. Medtronic Guardian RT Medtronic Guardian® RT Real time data collected every 5 minutes Uses same type of sensor as CGMS Gold Available in 7 selected cities by prescription, for adults 18+ (Austin TX Boston MA, Chicago IL, Houston TX, Minneapolis MN, San Antonio TX, Tampa FL)

10. Medtronic Guardian RT Medtronic Guardian® RT Unlike CGMS requires a transmitter to project information to the receiver Unlike CGMS requires a transmitter to project information to the receiver Interface is very similar to other Medtronic products Interface is very similar to other Medtronic products

11. CGM-RT systems Medtronic/Minimed Guardian® RT (only available in select cities) Medtronic/Minimed Paradigm® Real-Time (CGM available June 19) Freestyle Navigator™ (Investigational Device/Non-FDA approved)) DexCom™ STS™ (available and approved for adults)

12. Minimed Paradigm® Real Time Insulin Pump and CGM

13. NOT A CLOSED LOOP SYSTEM!! NOT A CLOSED LOOP SYSTEM!! Pump works independently of CGM (CGM optional) Pump works independently of CGM (CGM optional) Transmitter can store 40 minutes of readings in case the connection to the receiver is broken Transmitter can store 40 minutes of readings in case the connection to the receiver is broken

14. CGM-RT systems Medtronic/Minimed Guardian® RT (only available in select cities) Medtronic/Minimed Paradigm® Real-Time (CGM available June 19) Freestyle Navigator™ (Investigational Device/Non-FDA approved) DexCom™ STS™ (available and approved for adults)

15. Freestyle Navigator ™

16. Navigator™ Features Uses the same technology that makes the TheraSense FreeStyle and FreeStyle Flash meters among the most precise and accurate. Uses the same technology that makes the TheraSense FreeStyle and FreeStyle Flash meters among the most precise and accurate. Measures glucose levels in the patient's interstitial fluid every sixty seconds and transmits the results to a wireless pager-sized receiver. Measures glucose levels in the patient's interstitial fluid every sixty seconds and transmits the results to a wireless pager-sized receiver. Sensor can be worn up to 5 days and is waterproof Sensor can be worn up to 5 days and is waterproof

17. Designed as a three-part system: PART 1: a sensor set in a support bracket PART 1: a sensor set in a support bracket PART 2: a transmitter, designed to snap into the sensor mount PART 2: a transmitter, designed to snap into the sensor mount PART 3: a receiver with a built in Freestyle blood glucose meter. It receives information wirelessly from the sensor/transmitter every minute PART 3: a receiver with a built in Freestyle blood glucose meter. It receives information wirelessly from the sensor/transmitter every minute Monica with sensor & support mount Connecting receiver with sensor/transmitter

18. CGM-RT systems Medtronic/Minimed Guardian® RT (only available in select cities) Medtronic/Minimed Paradigm® Real-Time (CGM available June 19) Freestyle Navigator™ (Investigational Device/Non-FDA approved) DexCom™ STS™ (available and approved for adults)

19. DexCom™ STS™ System consists of 4 different parts: System consists of 4 different parts: 1.Sensor designed to be worn for 72 hours. 2.Battery operated transmitter that snaps into support mount and must be replaced. 3.Rechargeable receiver (much like cell phone). 4. One Touch Ultra home glucose meter with a download cable to receiver. One Touch Ultra linked to download BG for calibration Transmitter attached to support mount (not water proof)

20. MiniMed Guardian® RTMiniMed Paradigm® Real-TimeFreestyle Navigator™Dexcom™ STS™ Parts of systemSensor connected to transmitter, receiver Sensor connected to transmitter, insulin pump receiver Sensor, transmitter, receiver Distance of communication6 feet 10 feet5 feet Sensor life3 days 5 days3 days How it obtains BG dataManually enter from any blood glucose meter BD link or manual entryFreestyle meter built into receiver Cable link to One Touch Ultra Initial calibration period2 hours 10 hours2 hours Number of calibrations/day2 per day 4 in 5 days2 per day Frequency of real time readings 5 minutes **Displays 1 minute **Downloads either 1 or 10 minute readings 5 minutes Trend arrowsNYYN Hypo and hyper alarmsYYYY Graphs on monitorNYYY Downloading softwareYYYY Waterproof transmitterYYYN ReconnectionManual Automatic DownloadingDL: ComStation DL Analysis: software DL: Radio-frequency Analysis: CareLink (web-based) DL: Bluetooth Analysis: software DL: cable Analysis: software Unique features**Similar to CGMS in format and sensor design **Can use pump independent of CGM capabilities **Transmitter can hold 40 minutes of data if transmitter and receiver lose connectivity **Pending high and low alarms (in addition to actual high and low alarms) **Option to blind user from the data **Hard low alarm at 55mg/dl cannot be turned off (also programmable low and high) Cost of system$2795.00Cost of Paradigm pump plus $999.00 start up kit: Transmitter and 10 sensors unknown$800.00 (transmitter replaced every 6 months at $250.00 Cost of sensors$35.00 ea (10 per pack) unknown$35.00 ea (5 per pk) FDA approved: adults/childrenYes/No No/NoYes/No Available for purchase?By Rx in 7 select citiesYesNoYes

21. CGM requires calibrations All CGMs require blood glucose tests for calibrating. All CGMs require blood glucose tests for calibrating. Calibrations are necessary to ensure that the system will calculate glucose readings accurately. Calibrations are necessary to ensure that the system will calculate glucose readings accurately. Calibrations work best during periods of stable BG (before meals) Calibrations work best during periods of stable BG (before meals) Time insertions so that calibrations won’t drive you crazy Time insertions so that calibrations won’t drive you crazy

22. Indications for Use To improve glycemic control To improve glycemic control For hypoglycemia prevention For hypoglycemia prevention To assess trends, especially during night or exercise To assess trends, especially during night or exercise To adjust insulin dosing—can assess basal (long- acting) insulin effects and short acting insulin effects, i.e. onset of action, peak and duration To adjust insulin dosing—can assess basal (long- acting) insulin effects and short acting insulin effects, i.e. onset of action, peak and duration Ongoing use for those who can afford it Ongoing use for those who can afford it

23. Is my patient ready for CGM? Like most diabetes care, the patient = family Like most diabetes care, the patient = family Developmental considerations Developmental considerations Responsibility for CGM tasks Responsibility for CGM tasks Who enters blood sugars? (calibrations) Who enters blood sugars? (calibrations) Who uses trend data? Who uses trend data? Who responds to alarms? Who responds to alarms? Who troubleshoots? Who troubleshoots? CSII: clear explanation that CGM does not give insulin CSII: clear explanation that CGM does not give insulin

24. Is my patient ready for CGM? NEEDLE FEAR NEEDLE FEAR Different issue for MDI vs. pump patients Different issue for MDI vs. pump patients Different issue for long vs. short term use Different issue for long vs. short term use DexCom STS and Freestyle Navigator have concealed needles DexCom STS and Freestyle Navigator have concealed needles

25. Is my patient ready for CGM? ANXIETY with real time CGM ANXIETY with real time CGM Example: 4 BG/day versus 288 BG/day Example: 4 BG/day versus 288 BG/day Trend arrows Trend arrows Anxious parent + 284 extra BG values/day + precipitating event Anxious parent + 284 extra BG values/day + precipitating event

27. Evaluate if anxiety component is greater than the need for CGM Evaluate if anxiety component is greater than the need for CGM Discuss tendency to want to correct for every high blood sugar and strategies to avoid this Discuss tendency to want to correct for every high blood sugar and strategies to avoid this Reminding good diabetes practice: Reminding good diabetes practice: Do take a deep breath! Do take a deep breath! Don’t correct more often than every 2 hours Don’t correct more often than every 2 hours Don’t make several insulin changes at once Don’t make several insulin changes at once

28. Efficacy in Clinical Practice 1.Through education/training:  Device set-up  System functions  Sensor insertion  Use of system  Calibrations  Insulin Dosing 2.Through Follow-up  Data review  Diabetes management  Technical support

29. Practical suggestions, solutions, and stories Skin care Alarms Device protection Carrying device

30. Skin care: POSITION POSITION PREPERATION PREPERATION PROTECTION PROTECTION PEELING PEELING PULLING PULLING

31. Alarms: Hypoglycemia HypoglycemiaRanges Hyperglycemia HyperglycemiaRanges Night time Night time 1. Volume 2. Treating Projections ProjectionsMuting

32. Practicalities: Device Protection All CGM-RT transmitters are waterproof except the DexCom STS (uses special shower pad) All CGM-RT transmitters are waterproof except the DexCom STS (uses special shower pad) All devices come with a carrying case and belt clip All devices come with a carrying case and belt clip 2 major dangers of giving a child a wireless device: 2 major dangers of giving a child a wireless device: 1) Drop it (oops) 2) Lose it (big oops)

33. Practicalities Dropping the wireless receiver: Dropping the wireless receiver: Guardian RT receiver has screwed on battery door/ thin leather carrying case Guardian RT receiver has screwed on battery door/ thin leather carrying case DexCom receiver is one piece/ harder carrying case DexCom receiver is one piece/ harder carrying case Navigator receiver has a battery door that may snap open/ harder carrying case Navigator receiver has a battery door that may snap open/ harder carrying case Losing the wireless receiver: Losing the wireless receiver: All devices have same potential for loss (except Paradigm real time because connected to infusion set) All devices have same potential for loss (except Paradigm real time because connected to infusion set) Especially easy to lose in bathrooms, bed, school Especially easy to lose in bathrooms, bed, school

34. Practicalities: Carrying the Wireless Receiver Short term use: Short term use: With child at all times With child at all times Belly bag/fanny pack, pocket, belt clip Belly bag/fanny pack, pocket, belt clip 2 nd choice: backpack, lunchbox, purse, jacket, etc. 2 nd choice: backpack, lunchbox, purse, jacket, etc. Long term use: Long term use: Parent can hold device if child is close (i.e. watching a movie, grocery shopping, car trips) Parent can hold device if child is close (i.e. watching a movie, grocery shopping, car trips)

35. Practicalities: Carrying the Wireless Receiver Sports and activity Sports and activity #1 concern is the receiver #1 concern is the receiver Parent holds receiver on sidelines of soccer game, or kayaks out to swimming child Parent holds receiver on sidelines of soccer game, or kayaks out to swimming child Medtronic technology can store data in transmitter, so can reconnect at breaks and not lose any data Medtronic technology can store data in transmitter, so can reconnect at breaks and not lose any data Bedtime: Bedtime: clip receiver to underwear or pajamas clip receiver to underwear or pajamas leave on bedside table leave on bedside table

36. Conclusion CGM Real Time has potential of revolutionizing diabetes care CGM Real Time has potential of revolutionizing diabetes care Many practical, psycho-social, and economic aspects to consider Many practical, psycho-social, and economic aspects to consider Further discussion is needed in implementing CGM-RT into standard of care management for diabetes Further discussion is needed in implementing CGM-RT into standard of care management for diabetes

37. Questions and discussion