practical aspects of continuous glucose monitoring (cgm) barb tallant, rn, ma laurel messer, rn,...
Post on 21-Dec-2015
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PRACTICAL ASPECTS OF CONTINUOUS
GLUCOSE MONITORING(CGM)
Barb Tallant, RN, MABarb Tallant, RN, MA
Laurel Messer, RN, BSN, Laurel Messer, RN, BSN, CCRPCCRP
Eras of diabetes Eras of diabetes managementmanagement
Urine Glucose SMBG CGM?
Pre-1978 1978-2006 2006 -
CGM vs. CGM Real-TimeCGM vs. CGM Real-Time Continuous glucose monitoringContinuous glucose monitoring (CGM) (CGM)
Retrospective analysis of data Retrospective analysis of data
Real-time continuous glucose monitoringReal-time continuous glucose monitoring (RT-CGM)(RT-CGM)
Retrospective analysis of dataRetrospective analysis of data
PLUSPLUS
Continuous feedback of data to the wearer in “real Continuous feedback of data to the wearer in “real time” time”
Additional features such as alarms, trend arrowsAdditional features such as alarms, trend arrows
Medtronic Minimed Medtronic Minimed CGMS® Gold™CGMS® Gold™
(retrospective data)(retrospective data)•Available for Available for many years for many years for HCP HCP
• Sensor inserted Sensor inserted under skinunder skin cable cable receiver receiver
Medtronic Minimed Medtronic Minimed CGMS® Gold™CGMS® Gold™
Readings recorded every 5 minutes, Readings recorded every 5 minutes, glucose range 40-400 mg/dl glucose range 40-400 mg/dl
Patient manually enters at least 4 BG Patient manually enters at least 4 BG values/dayvalues/day
Data downloaded from device to Data downloaded from device to computer and HCP can evaluate computer and HCP can evaluate trends with wearertrends with wearer
CGM Real Time is here!CGM Real Time is here!
WirelessWireless Immediate feedbackImmediate feedback Extra features like Extra features like
alarms, line graphs, alarms, line graphs, trending arrowstrending arrows
CGM-RT systemsCGM-RT systems
Medtronic/Minimed Guardian® RT(only available in select cities)
Medtronic/MinimedParadigm® Real-Time(CGM available June 19)
Freestyle Navigator™(Investigational Device/Non-FDA approved))
DexCom™ STS™(available and approved for adults)
CGM-RT systemsCGM-RT systems
Medtronic/Minimed Guardian® RT(only available in select cities)
Medtronic/MinimedParadigm® Real-Time(CGM available June 19)
Freestyle Navigator™(Investigational Device/Non-FDA approved))
DexCom™ STS™(available and approved for adults)
Medtronic GuardianMedtronic Guardian® RT 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 GuardianMedtronic Guardian® RT RT
Unlike CGMS requires Unlike CGMS requires a transmitter to project a transmitter to project information to the information to the receiverreceiver
Interface is very Interface is very similar to other similar to other Medtronic productsMedtronic products
CGM-RT systemsCGM-RT systems
Medtronic/Minimed Guardian® RT(only available in select cities)
Medtronic/MinimedParadigm® Real-Time(CGM available June 19)
Freestyle Navigator™(Investigational Device/Non-FDA approved))
DexCom™ STS™(available and approved for adults)
Minimed Paradigm® Real Minimed Paradigm® Real Time Time
Insulin Pump and CGMInsulin Pump and CGM NOT A CLOSED LOOP SYSTEM!!NOT A CLOSED LOOP SYSTEM!!
Pump works independently of CGM Pump works independently of CGM (CGM optional) (CGM optional)
Transmitter can store 40 minutes of Transmitter can store 40 minutes of readings in case the connection to readings in case the connection to the receiver is brokenthe receiver is broken
CGM-RT systemsCGM-RT systems
Medtronic/Minimed Guardian® RT(only available in select cities)
Medtronic/MinimedParadigm® Real-Time(CGM available June 19)
Freestyle Navigator™(Investigational Device/Non-FDA approved)
DexCom™ STS™(available and approved for adults)
Navigator™ FeaturesNavigator™ Features
Uses the same technology that Uses the same technology that makes the TheraSense FreeStyle makes the TheraSense FreeStyle and FreeStyle Flash meters among and FreeStyle Flash meters among the most precise and accurate. the most precise and accurate.
Measures glucose levels in the Measures glucose levels in the patient's interstitial fluid every sixty patient's interstitial fluid every sixty seconds and transmits the results to seconds and transmits the results to a wireless pager-sized receiver.a wireless pager-sized receiver.
Sensor can be worn up to 5 days and Sensor can be worn up to 5 days and is waterproofis waterproof
Designed as a three-part Designed as a three-part system:system:
PART 1:PART 1: a a sensorsensor set in a support set in a support bracketbracket
PART 2:PART 2: a a transmittertransmitter, designed to , designed to snap into the sensor mount snap into the sensor mount
PART 3:PART 3: a a receiverreceiver with a built in with a built in Freestyle blood glucose meter. It Freestyle blood glucose meter. It receives information wirelessly from receives information wirelessly from the sensor/transmitter every minute the sensor/transmitter every minute
Monica with sensor & support mount
Connecting receiver with sensor/transmitter
CGM-RT systemsCGM-RT systems
Medtronic/Minimed Guardian® RT(only available in select cities)
Medtronic/MinimedParadigm® Real-Time(CGM available June 19)
Freestyle Navigator™(Investigational Device/Non-FDA approved)
DexCom™ STS™(available and approved for adults)
DexCom™ STS™DexCom™ STS™ System consists of 4 different parts:System consists of 4 different parts:
1.1. SensorSensor designed to be worn for 72 designed to be worn for 72 hours.hours.2.2. Battery operated Battery operated transmittertransmitter that that snaps into snaps into support mount and must be support mount and must be replaced.replaced.3.3. Rechargeable Rechargeable receiverreceiver (much like (much like cell cell phone).phone).4.4. One Touch UltraOne Touch Ultra home glucose home glucose meter with meter with a download cable to receiver. a download cable to receiver.
One Touch Ultra linked to download BG for calibration
Transmitter attached to support mount (not water proof)
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 beturned 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
Available for purchase? By Rx in 7 select cities Yes No Yes
CGM requires CGM requires calibrationscalibrations
All CGMs require blood glucose tests All CGMs require blood glucose tests for calibrating.for calibrating.
Calibrations are necessary to ensure Calibrations are necessary to ensure that the system will calculate glucose that the system will calculate glucose readings accurately.readings accurately.
Calibrations work best during periods Calibrations work best during periods of stable BG (before meals) of stable BG (before meals)
Time insertions so that calibrations Time insertions so that calibrations won’t drive you crazy won’t drive you crazy
Indications for UseIndications for Use
To improve glycemic controlTo improve glycemic control For hypoglycemia preventionFor hypoglycemia prevention To assess trends, especially during To assess trends, especially during
night or exercisenight or exercise To adjust insulin dosing—can assess To adjust insulin dosing—can assess
basal (long-acting) insulin effects and basal (long-acting) insulin effects and short acting insulin effects, i.e. onset of short acting insulin effects, i.e. onset of action, peak and durationaction, peak and duration
Ongoing use for those who can afford it Ongoing use for those who can afford it
Is my patient ready for Is my patient ready for CGM?CGM?
Like most diabetes care, the patient = familyLike most diabetes care, the patient = family Developmental considerationsDevelopmental considerations Responsibility for CGM tasksResponsibility for CGM tasks
Who enters blood sugars? Who enters blood sugars? (calibrations)(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 CSII: clear explanation that CGM does not give insulingive insulin
Is my patient ready for Is my patient ready for CGM?CGM?
NEEDLE FEARNEEDLE FEAR Different issue for MDI vs. Different issue for MDI vs.
pump patients pump patients
Different issue for long vs. Different issue for long vs. short term use short term use
DexCom STS and Freestyle DexCom STS and Freestyle Navigator have concealed Navigator have concealed needles needles
Is my patient ready for Is my patient ready for CGM?CGM?
ANXIETY with real time CGMANXIETY with real time CGM Example: 4 BG/day versus 288 BG/dayExample: 4 BG/day versus 288 BG/day Trend arrowsTrend arrows
Anxious parent + 284 extra Anxious parent + 284 extra BG values/day + BG values/day + precipitating eventprecipitating event
Evaluate if anxiety component is greater Evaluate if anxiety component is greater than the need for CGMthan the need for CGM
Discuss tendency to want to correct for Discuss tendency to want to correct for every high blood sugar and strategies to every high blood sugar and strategies to avoid thisavoid 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 hoursDon’t correct more often than every 2 hours Don’t make several insulin changes at onceDon’t make several insulin changes at once
Efficacy in Clinical PracticeEfficacy in Clinical Practice1.1. Through education/training:Through education/training:
Device set-upDevice set-up System functionsSystem functions Sensor insertionSensor insertion Use of systemUse of system CalibrationsCalibrations Insulin DosingInsulin Dosing
2.2. Through Follow-upThrough Follow-up Data reviewData review Diabetes managementDiabetes management Technical supportTechnical support
Practical Practical suggestions, suggestions,
solutions, and solutions, and storiesstories
•Skin care•Alarms•Device protection•Carrying device
Skin Skin care:care:
POSITIONPOSITION
PREPERATIONPREPERATION
PROTECTIONPROTECTION
PEELINGPEELING
PULLINGPULLING
AlarmsAlarms::
HypoglycemiaHypoglycemiaRangesRanges
HyperglycemiaHyperglycemiaRangesRanges
Night timeNight time1. Volume1. Volume
2. Treating2. Treating ProjectionsProjections
MutingMuting
Practicalities: Practicalities: Device ProtectionDevice Protection
All CGM-RT transmitters are waterproof except All CGM-RT transmitters are waterproof except the DexCom STS (uses special shower pad)the DexCom STS (uses special shower pad)
All devices come with a carrying case and belt All devices come with a carrying case and belt clipclip
2 major dangers of giving a child a wireless 2 major dangers of giving a child a wireless device:device:
1) 1) Drop it (oops)Drop it (oops)
2) 2) Lose it (big oops)Lose it (big oops)
PracticalitiesPracticalities
Dropping the wireless receiver:Dropping the wireless receiver: Guardian RT receiver has screwed on battery Guardian RT receiver has screwed on battery
door/ thin leather carrying casedoor/ thin leather carrying case DexCom receiver is one piece/ harder carrying DexCom receiver is one piece/ harder carrying
casecase Navigator receiver has a battery door that may Navigator receiver has a battery door that may
snap open/ harder carrying casesnap open/ harder carrying case
Losing the wireless receiver:Losing the wireless receiver: All devices have same potential for loss All devices have same potential for loss
(except Paradigm real time because connected to (except Paradigm real time because connected to infusion set)infusion set)
Especially easy to lose in bathrooms, bed, schoolEspecially easy to lose in bathrooms, bed, school
Practicalities: Practicalities: Carrying the Wireless Carrying the Wireless
ReceiverReceiver Short term use: Short term use:
With child at all timesWith child at all times Belly bag/fanny pack, pocket, belt clipBelly bag/fanny pack, pocket, belt clip 22ndnd choice: backpack, lunchbox, purse, choice: backpack, lunchbox, purse,
jacket, etc.jacket, etc.
Long term use:Long term use: Parent can hold device if child is close (i.e. Parent can hold device if child is close (i.e.
watching a movie, grocery shopping, car watching a movie, grocery shopping, car trips)trips)
Practicalities:Practicalities:Carrying the Wireless Carrying the Wireless
ReceiverReceiver Sports and activitySports and activity
#1 concern is the receiver#1 concern is the receiver Parent holds receiver on sidelines of soccer Parent holds receiver on sidelines of soccer
game, or kayaks out to swimming childgame, or kayaks out to swimming child Medtronic technology can store data in Medtronic technology can store data in
transmitter, so can reconnect at breaks and transmitter, so can reconnect at breaks and not lose any datanot lose any data
Bedtime:Bedtime: clip receiver to underwear or pajamasclip receiver to underwear or pajamas leave on bedside tableleave on bedside table
ConclusionConclusion
CGM Real Time has potential of CGM Real Time has potential of revolutionizing diabetes carerevolutionizing diabetes care
Many practical, psycho-social, and Many practical, psycho-social, and economic aspects to considereconomic aspects to consider
Further discussion is needed in Further discussion is needed in implementing CGM-RT into standard implementing CGM-RT into standard of care management for diabetesof care management for diabetes