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1 INTRODUCTION TO CONTINUOUS GLUCOSE MONITORS H. Peter Chase, MD Professor of Pediatrics Barbara Davis Center Aurora, CO Keystone Conference Wednesday,

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Presentation on theme: "1 INTRODUCTION TO CONTINUOUS GLUCOSE MONITORS H. Peter Chase, MD Professor of Pediatrics Barbara Davis Center Aurora, CO Keystone Conference Wednesday,"— Presentation transcript:

1 1 INTRODUCTION TO CONTINUOUS GLUCOSE MONITORS H. Peter Chase, MD Professor of Pediatrics Barbara Davis Center Aurora, CO Keystone Conference Wednesday, July 16, 2008 Barbara Davis Center for Childhood Diabetes May 2008

2 2 CGM Introduction Class The slides from our course for families interested in starting CGM are available for use in your centers. They are on our website: The slides can then be accessed by any of the following methods:www.barbaradaviscenter.org 1. Click on the “CGM Slideset” tab 2. In the “Online Books and Teaching Slides” page: 3. In the Clinical Resources section (last entry):

3 3 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 1-5 minutes (10-15 minute delay) Provides alarms for high and low glucose levels and trend information The 3rd era in diabetes management Barbara Davis Center for Childhood Diabetes May 2008

4 4 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 May 2008

5 5 Continuous Glucose Monitoring (CGM) WHY? 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 May 2008

6 6 How common are glucose levels <60mg/dl during the night in children with T1D? –French (i) and Australian (ii) data showed approximately 50% of children with low BG (<60mg/dl) during the night (on NPH bid) –DirecNet data (one night in hospital with blood sugars every 30 min.) A) : 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) i)Beregszaszi M, et al. J Pediatr. 131, 27, 1997 ii)Porter PA, et al. J. Pediatr. 13, 366, 1997 Barbara Davis Center May 2008

7 7 Continuous Glucose Monitoring (CGM) WHY? 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 May 2008

8 8 “Snapshot of BG levels” Barbara Davis Center for Childhood Diabetes May 2008

9 9 Continuous Glucose Monitoring Barbara Davis Center for Childhood Diabetes May 2008

10 10 Hyperglycemia is common, especially after meals 0% 10% 20% 30% 40% 50% < > 300 Breakfast Lunch Dinner Boland et al, Diabetes Care 24:1858, 2001 Barbara Davis Center May 2008

11 11 Continuous Glucose Monitoring (CGM) WHY? 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 May 2008

12 12 Three Parts to All CGMs:* A.Sensor B.Transmitter C.Receiver/Monitor *(Understanding Pumps and CGMs, p.103) Barbara Davis Center for Childhood Diabetes May 2008

13 13 A)Sensor (p.103) Barbara Davis Center for Childhood Diabetes May 2008

14 14 B)Transmitter (p.103) Barbara Davis Center for Childhood Diabetes May 2008

15 15 C)Receiver or Monitor (p.103) Barbara Davis Center for Childhood Diabetes May 2008

16 16 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 May 2008

17 17 What type of data will we get? 1) “Real-time” (Immediate) i. Trend graphs (p.109)* ii. Alarms (p.110)* iii. Trend arrows (p.113)* *(Understanding Pumps and CGMs) Barbara Davis Center May 2008

18 Trend graphs – Knowing a glucose level is 240 mg/dl may not be as important as knowing the “trend.” i) TREND GRAPHS* *(Understanding Pumps and CGMs, p.103) Barbara Davis Center for Childhood Diabetes May 2008

19 ii) ALARMS (p.109) Can warn patients of current or projected high and low blood sugar Projected alarms: 10, 20, or 30 minute warning of impending hypo- or hyperglycemia (Navigator and Guardian devices) Threshold alarms: warning when glucose is below or above a set value (all devices) Barbara Davis Center for Childhood Diabetes May 2008

20 iii) TREND ARROWS (p.110) Rate of Change Arrows Gives the up-to-the-minute glucose value and a rate of change arrow Glucose going down -1 to -2 (mg/dL)/min Glucose going up 1 to 2 (mg/dL)/min Glucose falling quickly >-2 (mg/dL)/min Fairly stable glucose -1 to 1 (mg/dL)/min Glucose rising quickly >2 (mg/dL)/min Barbara Davis Center for Childhood Diabetes May 2008

21 21 Second type of data: (Retrospective, must download) 2) Retrospective A.Modal Day Graphs (p.113) B.Pie Chart (p.114) C.Statistics (p.113) *(Understanding Pumps and CGMs, Chapter 17, p.109) Barbara Davis Center for Childhood Diabetes May 2008

22 22 A) Case Study: Modal Day Graphs* A) Case Study: Modal Day Graphs* Teenager with T1D for 9.5 years Started Navigator: Sept Starting HbA1c: 7.1% Most recent HbA1c: 6.0% Current number of low BGs per week (<60 mg/dL or <3.3 mmol/L): 1/week Three “modal-day” graphs: *(Understanding Pumps and CGMs, p.113) Barbara Davis Center for Childhood Diabetes May 2008

23 23 A) BASELINE GLUCOSE MODAL DAY: i) Prior to Navigator Use Barbara Davis Center for Childhood Diabetes May 2008

24 24 ii) After three months of use A) GLUCOSE MODAL DAY Breakfast/Lunch Improvements ii) After three months of use Barbara Davis Center for Childhood Diabetes May 2008

25 25 iii) Most recent report A) GLUCOSE MODAL DAY iii) Most recent report Barbara Davis Center for Childhood Diabetes May 2008

26 26 B) PIE CHARTS (p.114) Barbara Davis Center for Childhood Diabetes May 2008

27 27 C) STATISTICS (p.113) Barbara Davis Center for Childhood Diabetes May 2008

28 28 USE OF CGM RESULTS: (To “fine-tune” insulin and diabetes management) i)Important not to overwhelm families *** One change at a time *** ii)Look for patterns 2 out of 3 days iii)A behavior modification device  Missed boluses, snacking, low BGs on CGM iv) Good initial communication with HCP Barbara Davis Center for Childhood Diabetes May 2008

29 29 Questions? The presentation by the nurses will be next. You will then examine the CGMs from 3 companies. Barbara Davis Center for Childhood Diabetes May 2008

30 30 Part 2: CLINICAL STUDIES Use of CGM (The Navigator) in Clinical Studies of Children: A) Insulin Pump Study (JPediatr 151:388,2007) B) Lantus Study (DiabetesCare 31:525,2008)

31 31 CGM can help with glycemic control N30 Mean Age T1D duration 11.2 yr 5.8 years Female40% HbA1cInitial 13 wks 7.1±0.6% 6.8±0.7% (p=0.02) A) 30 Pump Patients Using Navigator x 13 weeks* *DirecNet J Pediatri 151,388,2007

32 32 HbA1c HbA1c (%) Baseline Week 7Week 13Week 26 Baseline A1c  7.0% Baseline A1c >7.0% Black dots denote mean values and boxes denote median, 25 th and 75 th percentiles. N=15 N=13 N=15 N=13 N=12 * p=0.004 vs. baseline; § p=0.002 vs. wks § *

33 33 Percentage of Navigator Glucose Values in Target Range 30% 40% 50% 60% 70% 80% 90% BaselineWks 1-4 Wks 5-8 Wks 9-13 Wks Wks Wks Percent in target range (71-180) Baseline A1c  7.0% Baseline A1c >7.0% N=14 N=15 N=11 N=9 N=11 N=13 N=15 N=13

34 34 Percentage of Navigator Glucose Values Below 70 mg/dL Percent below 70 mg/dL 0% 2% 4% 6% 8% 10% 12% 14% BaselineWks 1-4 Wks 5-8 Wks 9-13 Wks Wks Wks Baseline A1c  7.0% Baseline A1c >7.0% N=11 N=13 N=15 N=13 N=14 N=15 N=11 N=9 N=11

35 35 N27 (23 completed) Age11.0 ± 3.9 yr Female14 (52%) Caucasian25 (93%) HbA1c7.9 ± 1.0% T1D duration4.0 ± 3.1 yr MDI Regimen Glargine + RAIA* Glargine + RAIA* + NPH Other 21 (78%) 5 (16%) 1 ( 4%) * DirecNet: Diabetes Care 31:525, 2008 B) Lantus Subjects using CGM*

36 36 Lantus Subjects using CGM Results – Glycemic Control HbA1c (%) Baseline A1c ≤ 7.5% Baseline A1c > 7.5% BaselineWeek 7Week 13 ** p = 0.03 * p = 0.02 * **

37 37 Lantus Subjects using CGM Results – Glycemic Variability Mean Amplitude of Glycemic Excursion (MAGE, mg/dL) BaselineWks 1-4Wks 5-8Wks 9-13 Baseline A1c ≤ 7.5% Baseline A1c > 7.5% * ** ** p = 0.17 * p = 0.004

38 38 Use of the Navigator CGM was associated with an improvement in glycemic control without an accompanying rise in hypoglycemia Glycemic variability decreased with use of the Navigator Subjects and parents reported high overall satisfaction with the Navigator and did not demonstrate deterioration in quality of life during 3- month use CGM are tolerable and effective in children using MDI regimens Lantus Subjects using CGM Conclusions

39 39 CGM Influences on Glucose Levels Blinded vs Non-Blinded CGM Tracings: p-value 21% less time <55 mg/dl< % less time >240 mg/dl< % more time in target<0.001 (81 – 140 mg/dl) (Garg et al, Diabetes Care 27:1922,2004)

40 40 COMMON MISCONCEPTIONS OF CGM (QUIZ) 1) “If I use CGM, I do not have to do BG checks anymore.” Barbara Davis Center for Childhood Diabetes May 2008

41 41 2) “The starting of CGM will make diabetes management a breeze – so simple!” COMMON MISCONCEPTIONS OF CGM Barbara Davis Center for Childhood Diabetes May 2008

42 42 3) “The use of CGM will fix the diabetes – all blood sugars will be perfect.” COMMON MISCONCEPTIONS OF CGM Barbara Davis Center for Childhood Diabetes May 2008

43 43 4) “My CGM values should match my BG values.” COMMON MISCONCEPTIONS OF CGM Barbara Davis Center for Childhood Diabetes May 2008

44 44 5) “The alarms will catch every low or pending low so I don’t need to worry about lows anymore.” COMMON MISCONCEPTIONS OF CGM Barbara Davis Center for Childhood Diabetes May 2008

45 45 CLOSED LOOP (BIONIC) PANCREAS “The Future” i)Will probably come in parts ii)JDRF supporting algorithm development iii)Should reduce glucose highs, lows, and fluctuations iv)Will probably be more realistic than islet cell transplant v)FDA and medical insurance approvals (as with CGM) will be critical

46 46 Q. Why combine insulin pumps (CSII) and Continuous Glucose Monitors (CGM)? (p121) A: “They complement each other tremendously and provide the most ‘state of the art’ diabetes care available.” The CGM helps with: Cannulas dislodging Missed food boluses Hypoglycemia Corrections

47 47 Our Initial Data: 1.Two oral presentations at ADA in June, 2008 (Abstract # 230-OR and 42-OR). 2.Our emphasis: Preventing severe hypoglycemia at night. 3.This may be the first part of a closed loop system acceptable to the FDA. 4.We have shown that 80% of pending lows can be predicted. 5.Safety remains the primary goal.

48 48 “Now let me get this right, Dr. Chase… You want the elves to make an artificial pancreas?” THANK YOU


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