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

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)

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




Freestyle Navigator™(Investigational Device/Non-FDA approved))


Minimed Paradigm® Real Minimed Paradigm® Real Time Time

Insulin Pump and CGMInsulin Pump and CGM

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




Freestyle Navigator™(Investigational Device/Non-FDA approved)


Freestyle Navigator ™Freestyle Navigator ™

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




Freestyle Navigator™(Investigational Device/Non-FDA approved)


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


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


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

Questions and discussionQuestions and discussion

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

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