INTRODUCTION TO CONTINUOUS GLUCOSE MONITORS H Peter Chase

INTRODUCTION TO CONTINUOUS GLUCOSE MONITORS H. Peter Chase, MD Vicky Gage, RN, CDE Laurel Messer, RN, CDE Susie Owen, RN, CDE Sally Sullivan, RN, CDE Barbara Davis Center for Childhood Diabetes April 2010 1

Agenda • Dr. Chase will present a general CGM overview • Nurses will explain device features and comparisons between sensors • You will have an opportunity to handle each device and ask questions Barbara Davis Center for Childhood Diabetes April 2010 2

What is a CGM? (Continuous Glucose Monitor) • A device that provides “real-time” glucose readings and data about trends in glucose levels • Reads the glucose levels under the skin every 15 minutes (10 -15 minute delay) • Provides alarms for high and low glucose levels and trend information • The 3 rd era in diabetes management Barbara Davis Center for Childhood Diabetes April 2010 3

Who Should Use a CGM? 1) The person and the family must both want a CGM 2) A youth must be willing to wear the sensor (and carry the receiver) 3) Using good diabetes care (4 BGs/day) 4) Good support system 5) Adequate body “real estate” 6) Cost of CGM (RNs to elaborate) Understanding Pumps and CGMs, p. 100 Barbara Davis Center for Childhood Diabetes April 2010 4

WHY Use CGM? A. Prevention of low blood sugars (alarms) B. Prevention of high blood sugars (ketones) C. Minimize wide glucose fluctuations D. Behavior Modification E. Prevention of Complications (? ) Barbara Davis Center for Childhood Diabetes April 2010 5

How common are glucose levels <60 mg/dl during the night in children with T 1 D? – French (i) and Australian (ii) data showed approximately 50% of children with low BG (<60 mg/dl) during the night (on NPH bid) – Direc. Net data (one night in hospital with blood sugars every 30 min. ) A) 2001 -2002: 39 of 91 (43%) low BG (44% of children on insulin pumps/56% on NPH) B) 2004: 14 of 50 (28%) with low BG (all on insulin pumps or Lantus) 1. Barbara Davis Center for Childhood Diabetes April 2010 2. (i) Beregszaszi M, et al. J Pediatr. 131, 27, 1 6 (ii) Porter PA, et al. J. Pediatr. 13, 366, 1997

WHY Use CGM? A. Prevention of low blood sugars (alarms) B. Prevention of high blood sugars (ketones) C. Minimize wide glucose fluctuations D. Behavior Modification E. Prevention of Complications (? ) Barbara Davis Center for Childhood Diabetes April 2010 7

“Snapshot of BG levels” Barbara Davis Center for Childhood Diabetes April 2010 8

Continuous Glucose Monitoring Barbara Davis Center for Childhood Diabetes April 2010 9

Hyperglycemia is common, especially after meals 50% 40% 30% Breakfast Lunch Dinner 20% 10% 0% < 180 181 - 240 241 - 300 Barbara Davis Center for Childhood Diabetes April 2010 > 300 10 Boland et al, Diabetes Care 24: 1858, 2001

WHY Use CGM? A. Prevention of low blood sugars (alarms) B. Prevention of high blood sugars (ketones) C. Minimize wide glucose fluctuations D. Behavior Modification E. Prevention of Complications? Barbara Davis Center for Childhood Diabetes April 2010 11

Three Parts to CGMs: A. Sensor B. Transmitter C. Receiver/Monitor Understanding Pumps and CGMs, p. 103 Barbara Davis Center for Childhood Diabetes April 2010 12

A) Sensor B) (p. 103) Barbara Davis Center for Childhood Diabetes April 2010 13

B) Transmitter (p. 103) Barbara Davis Center for Childhood Diabetes April 2010 14

C) Receiver or Monitor (p. 103) Barbara Davis Center for Childhood Diabetes April 2010 15

What does “Calibration” mean and why do I need to do it? • Calibration is a process that gives a fingerstick BG value to the CGM system so the values will align with each other • Number of Calibrations vary by device • Best times to calibrate are when the BG values are stable: before meals and before bed • Do not calibrate when arrows are present Barbara Davis Center for Childhood Diabetes April 2010 16

What type of data will we get? Two types of CGM data: • Real Time data: seen on CGM • Retrospective data: download to a computer Barbara Davis Center for Childhood Diabetes April 2010 17

Real Time Data Three types of Real Time Data: A) Trend graphs B) Alarms C) Trend Arrows Understanding Pumps and CGM: pages 109 -113 Barbara Davis Center for Childhood Diabetes April 2010 18

Real Time data TREND GRAPHS Trend graphs – Knowing a glucose level is 240 mg/dl may not be as important as knowing the “trend. ” Understanding Pumps and CGM: p. 103 Barbara Davis Center for Childhood Diabetes April 2010 19

Real Time data ALARMS Warn patients of current or projected high and low blood sugar Barbara Davis Center for Childhood Diabetes April 2010 20

Real Time data Alarms continued Threshold alarm: Warning when glucose is above or below a set value --all devices have this Projected Alarms: 10, 20 or 30 minute warning of Impending hypo- or hyperglycemia Real-Time Revel System, Guardian Real-Time and the Navigator have these Barbara Davis Center for Childhood Diabetes April 2010 21

Real Time data TREND ARROWS Arrows that indicate the rate and direction of change Glucose rising quickly >2 (mg/d. L)/min Glucose going up 1 to 2 (mg/d. L)/min Fairly stable glucose -1 to 1 (mg/d. L)/min Glucose going down -1 to -2 (mg/d. L)/min Glucose falling quickly >-2 (mg/d. L)/min Barbara Davis Center for Childhood Diabetes April 2010 22

Retrospective Data Three types of Retrospective data (viewed on computer download) A) Trend graphs B) Pie charts C) Data tables Understanding Pumps and CGMs, Chapter 17 Barbara Davis Center for Childhood Diabetes April 2010 23

Retrospective data A) Trend Graphs Reports that show one or more days of CGM data– also called sensor overlay Barbara Davis Center for Childhood Diabetes August 2009 Barbara Davis Center for Childhood Diabetes April 2010 24

Retrospective data Case Study: Using Trend Graphs • Three Trend Graphs showing change over time: – – – Teenager with T 1 D for 9. 5 years Started Navigator: Sept. 2005 Starting Hb. A 1 c: 7. 1% Most recent Hb. A 1 c: 6. 0% Current number of low BGs per week (<60 mg/d. L or <3. 3 mmol/L): 1/week Barbara Davis Center for Childhood Diabetes April 2010 25

Retrospective data BASELINE GLUCOSE Trend Graph #1 Prior to CGM Use Barbara Davis Center for Childhood Diabetes April 2010 26

Retrospective data Glucose Trend Graph #2 After three months of CGM use Barbara Davis Center for Childhood Diabetes April 2010 27

Retrospective data GLUCOSE Trend Graph #3 Most recent CGM report Barbara Davis Center for Childhood Diabetes April 2010 28

Retrospective data B) PIE CHARTS Show percentage of time glucose is above, below and in target range Barbara Davis Center for Childhood Diabetes April 2010 29

Retrospective data C) Data Tables Show statistical information about different periods of the day Barbara Davis Center for Childhood Diabetes April 2010 30

USING CGM RESULTS: (To make insulin adjustments) • Important not to get overwhelmed by data ** Make One Change At A Time • Look for patterns 2 out of 3 days • A behavior modification device Missed boluses, snacking, low BGs on CGM • Good initial communication with HCP Barbara Davis Center for Childhood Diabetes April 2010 31

Interpreting CGM data Barbara Davis Center for Childhood Diabetes April 2010 32

Interpreting CGM data Barbara Davis Center for Childhood Diabetes April 2010 33

Realistic Expectations of CGM • You will still need to test your blood sugar levels • Using CGM does not make Diabetes Management a “Breeze” • You will still experience low and high blood sugar values • Sensor values will not always “MATCH” the blood sugar values • The most significant improvements will be seen with consistent CGM wear Barbara Davis Center for Childhood Diabetes April 2010 34

Realistic Expectations of CGM You will still need to test your blood sugar levels for: • Calibrations • Insulin dosing • Treating high and low blood sugar levels • Questioning the accuracy of the CGM values • Times when you do not feel right Barbara Davis Center for Childhood Diabetes April 2010 35

Realistic Expectations of CGM Using CGM does not make Diabetes Management a “Breeze” • Initially, people are overwhelmed from all the data • Subjects will follow an algorithm early on in the use of CGM • Family weekly downloads of CGM data are important • CGM works as a behavior modification device Barbara Davis Center for Childhood Diabetes April 2010 36

Realistic Expectations of CGM You will still experience low and high blood sugar levels • There will ALWAYS be some lows and highs • Alarms may NOT be sensitive to slowly falling blood sugar values • The time spent in hypoglycemia and hyperglycemia can be reduced • CGM is an additional tool to help make decisions • CGM values are not very helpful in treating lows Barbara Davis Center for Childhood Diabetes April 2010 37

Realistic Expectations of CGM Sensor values will not always “MATCH” the blood sugar values • CGM values are about 10 minutes behind blood sugar values • Values are less accurate early after insertion • Values are furthest off when blood sugars are rapidly rising or falling • Calibrations are important determinants of accuracy of the CGM Barbara Davis Center for Childhood Diabetes April 2010 38

Realistic Expectations of CGM The most significant improvements will be seen with consistent CGM wear ( >6 days/week) • Good initial education helps patients and families to learn what to expect • Regular use of Real-time and Retrospective data is necessary for optimal benefits • Follow up with Diabetes Team is important to continue to make adjustments Barbara Davis Center for Childhood Diabetes April 2010 39

Questions? • Next: Device Information from the nurses • Hands on with CGM devices Barbara Davis Center for Childhood Diabetes April 2010 40

CGMs available April 2010 Barbara Davis Center for Childhood Diabetes April 2010 41

Paradigm Real Time systems (Paradigm pump and Revel pump) • A: Insulin pump and CGM receiver • B: Infusion set • C: Sensor • D: Transmitter Barbara Davis Center for Childhood Diabetes April 2010 42

Paradigm Real-Time system (Paradigm pump and Revel pump) • • Pump is not controlled by CGM readings No extra receiver to carry Has high and low alarms Revel has predictive alarms Sensors last 3 days (6 days) Calibrations every 12 hours Great online download Barbara Davis Center for Childhood Diabetes April 2010 43

Guardian Real Time • • • For people not using a pump Has high and low alarms Has predictive alarms Sensor lasts 3 days (6 days) Calibrations every 12 hours Why not buy a pump? Barbara Davis Center for Childhood Diabetes April 2010 44

Navigator CGM Barbara Davis Center for Childhood Diabetes April 2010 45

Navigator CGM • • Has built in Freestyle BG meter Larger transmitter Has high and low alarms Has predictive alarms Sensors last 5 days Calibrations at 10, 12, 24 and 72 hours Well studied and highly accurate Barbara Davis Center for Childhood Diabetes April 2010 46

Dex. Com 7 Plus Barbara Davis Center for Childhood Diabetes April 2010 47

Dex. Com 7 Plus • • Most simple system to use Smallest transmitter Has high and low alarms Has rate of change alarms Sensor lasts 7 days Calibrations every 12 hours Basic download software Barbara Davis Center for Childhood Diabetes April 2010 48

Mini. Med Guardian Mini. Med Paradigm 522/722 Freestyle Navigator Dexcom Seven Plus Sensor life 3 days 5 days 7 days Initial calibration period 2 hours 10 hours 2 hours Number of 2 -4 per day calibrations 4 in 5 days 2 -4 per day Trend arrows Yes Yes High/low alarms Yes Yes Predictive high/low alarms Yes No-Paradigm Real-time Yes-Revel pump Yes Rate of change alarms Cost ~$1300 system $35/sensor $1000 system + 722/522 insulin pump $35/sensor ~$1000 system ~$35 -50/sensor ~$400 -800 system ~$60/sensor Barbara Davis Center for Childhood Diabetes April 2010 49

CGM Reimbursement • Family will fill out an Authorization to release insurance information • Physician will write prescription (Letter of Medical Necessity) • BDC will provide any other paperwork requested by the insurance company • Call Mireya at BDC to get started phone: 303 -724 -6763, fax: 303 -724 -6779 Barbara Davis Center for Childhood Diabetes April 2010 50

Websites • Paradigm REAL-Time, Paradigm REAL-time Revel and Guardian REAL-time: www. minimed. com 1 -866 -948 -6633 • Navigator: www. abbottdiabetescare. com 1 -888 -5226 • Dexcom: www. dexcom. com 1 -877 -339 -2664 Barbara Davis Center for Childhood Diabetes April 2010 51

CGM Start and Follow up Medtronic Device Training— Contact Mireya at 303 -724 -6763 to schedule Navigator Training— Trainer will contact you when your device ships Dexcom Training— Contact Michelle Perrot at 720 -878 -4099 Follow up CGM with Stephanie Kassels, FNP– call Dahlia at 303 -724 -6748 to schedule Barbara Davis Center for Childhood Diabetes April 2010 52