PRACTICAL ASPECTS OF CONTINUOUS GLUCOSE MONITORING (CGM) Barb Tallant, RN, MA Laurel Messer, RN, BSN, CCRP Eras of diabetes management Urine Glucose Pre-1978 SMBG 1978-2006 CGM? 2006 - CGM vs. CGM Real-Time Continuous glucose monitoring (CGM) Retrospective analysis of data Real-time continuous glucose monitoring (RT-CGM) Retrospective analysis of data PLUS Continuous feedback of data to the wearer in “real time” Additional features such as alarms, trend arrows Medtronic Minimed CGMS® Gold™ (retrospective data) •Available for many years for HCP • Sensor inserted under skin cable receiver Medtronic Minimed CGMS® Gold™ Readings recorded every 5 minutes, glucose range 40-400 mg/dl Patient manually enters at least 4 BG values/day Data downloaded from device to computer and HCP can evaluate trends with wearer CGM Real Time is here! Wireless Immediate feedback Extra features like alarms, line graphs, trending arrows CGM-RT systems Medtronic/Minimed Paradigm® Real-Time (CGM available June 19) DexCom™ STS™ (available and approved for adults) Medtronic/Minimed Guardian® RT (only available in select cities) Freestyle Navigator™ (Investigational Device/Non-FDA approved)) CGM-RT systems Medtronic/Minimed Paradigm® Real-Time (CGM available June 19) DexCom™ STS™ (available and approved for adults) Medtronic/Minimed Guardian® RT (only available in select cities) Freestyle Navigator™ (Investigational Device/Non-FDA approved)) 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) Medtronic Guardian® RT Unlike CGMS requires a transmitter to project information to the receiver Interface is very similar to other Medtronic products CGM-RT systems Medtronic/Minimed Paradigm® Real-Time (CGM available June 19) DexCom™ STS™ (available and approved for adults) Medtronic/Minimed Guardian® RT (only available in select cities) Freestyle Navigator™ (Investigational Device/Non-FDA approved)) Minimed Paradigm® Real Time Insulin Pump and CGM Minimed Paradigm® Real Time Insulin Pump and CGM NOT A CLOSED LOOP SYSTEM!! Pump works independently of CGM (CGM optional) Transmitter can store 40 minutes of readings in case the connection to the receiver is broken CGM-RT systems Medtronic/Minimed Paradigm® Real-Time (CGM available June 19) DexCom™ STS™ (available and approved for adults) Medtronic/Minimed Guardian® RT (only available in select cities) Freestyle Navigator™ (Investigational Device/Non-FDA approved) Freestyle Navigator ™ Navigator™ Features 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. Sensor can be worn up to 5 days and is waterproof Designed as a three-part system: PART 1: a sensor set in a support bracket 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 Monica with sensor & support mount Connecting receiver with sensor/transmitter CGM-RT systems Medtronic/Minimed Paradigm® Real-Time (CGM available June 19) DexCom™ STS™ (available and approved for adults) Medtronic/Minimed Guardian® RT (only available in select cities) Freestyle Navigator™ (Investigational Device/Non-FDA approved) DexCom™ STS™ 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. Transmitter attached to support mount (not water proof) One Touch Ultra linked to download BG for calibration MiniMed Guardian® RT MiniMed Paradigm® Real-Time Freestyle Navigator™ Dexcom™ STS™ Parts of system Sensor connected to transmitter, receiver Sensor connected to transmitter, insulin pump receiver Sensor, transmitter, receiver Sensor, transmitter, receiver Distance of communication 6 feet 6 feet 10 feet 5 feet Sensor life 3 days 3 days 5 days 3 days How it obtains BG data Manually enter from any blood glucose meter BD link or manual entry Freestyle meter built into receiver Cable link to One Touch Ultra Initial calibration period 2 hours 2 hours 10 hours 2 hours Number of calibrations/day 2 per day 2 per day 4 in 5 days 2 per day Frequency of real time readings 5 minutes 5 minutes **Displays 1 minute **Downloads either 1 or 10 minute readings 5 minutes Trend arrows N Y Y N Hypo and hyper alarms Y Y Y Y Graphs on monitor N Y Y Y Downloading software Y Y Y Y Waterproof transmitter Y Y Y N Reconnection Manual Manual Manual Automatic Downloading DL: 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 $2795.00 Cost 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) $35.00 ea (10 per pack) unknown $35.00 ea (5 per pk) FDA approved: adults/children Yes/No Yes/No No/No Yes/No CGM requires calibrations All CGMs require blood glucose tests for calibrating. Calibrations are necessary to ensure that the system will calculate glucose readings accurately. Calibrations work best during periods of stable BG (before meals) Time insertions so that calibrations won’t drive you crazy Indications for Use To improve glycemic control For hypoglycemia prevention To assess trends, especially during night or exercise To adjust insulin dosing—can assess basal (longacting) insulin effects and short acting insulin effects, i.e. onset of action, peak and duration Ongoing use for those who can afford it Is my patient ready for CGM? Like most diabetes care, the patient = family Developmental considerations Responsibility for CGM tasks Who enters blood sugars? Who uses trend data? Who responds to alarms? Who troubleshoots? (calibrations) CSII: clear explanation that CGM does not give insulin Is my patient ready for CGM? NEEDLE FEAR Different issue for MDI vs. pump patients Different issue for long vs. short term use DexCom STS and Freestyle Navigator have concealed needles Is my patient ready for CGM? ANXIETY with real time CGM Example: 4 BG/day versus 288 BG/day Trend arrows Anxious parent + 284 extra BG values/day + precipitating event 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 Reminding good diabetes practice: Do take a deep breath! Don’t correct more often than every 2 hours Don’t make several insulin changes at once 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 Practical suggestions, solutions, and stories •Skin care •Alarms •Device protection •Carrying device Skin care: POSITION PREPERATION PROTECTION PEELING PULLING Alarms: Hypoglycemia Ranges Hyperglycemia Ranges Night time 1. Volume 2. Treating Projections Muting Practicalities: Device Protection All CGM-RT transmitters are waterproof except the DexCom STS (uses special shower pad) All devices come with a carrying case and belt clip 2 major dangers of giving a child a wireless device: 1) 2) Drop it (oops) Lose it (big oops) Practicalities Dropping the wireless receiver: Guardian RT receiver has screwed on battery door/ thin leather carrying case DexCom receiver is one piece/ harder carrying case Navigator receiver has a battery door that may snap open/ harder carrying case Losing the wireless receiver: All devices have same potential for loss (except Paradigm real time because connected to infusion set) Especially easy to lose in bathrooms, bed, school Practicalities: Carrying the Wireless Receiver Short term use: With child at all times Belly bag/fanny pack, pocket, belt clip 2nd choice: backpack, lunchbox, purse, jacket, etc. Long term use: Parent can hold device if child is close (i.e. watching a movie, grocery shopping, car trips) Practicalities: Carrying the Wireless Receiver Sports and activity #1 concern is the receiver 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 Bedtime: clip receiver to underwear or pajamas leave on bedside table Conclusion CGM Real Time has potential of revolutionizing diabetes care Many practical, psycho-social, and economic aspects to consider Further discussion is needed in implementing CGM-RT into standard of care management for diabetes Questions and discussion