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Practical Ways to Achieve Targets in Diabetes Care

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									DAVID C KLONOFF, MD
Medical Director Dorothy L. and James E. Frank Diabetes Research Institute of Mills-Peninsula Health Services Clinical Professor of Medicine, UCSF

GLUCOSE SENSORS IN ACHIEVING TARGET A1C

AUGUST 13, 2005 KEYSTONE RESORT

San Francisco

Mills Health Center San Mateo, California

Spring, 1999 Vol. 1, No. 1 ISSN 1520-9156

A SENSOR IS A DEVICE THAT DETECTS OR SENSES A SIGNAL AND CAN MEASURE GLUCOSE INTERMITTENTLY IN BLOOD OR CONTINUOUSLY IN ISF

Three Waves of Technology in Diabetes Monitoring

(1) Urine Testing

(2) Intermittent Blood Glucose Testing

(3) Continuous Glucose Monitoring

INTERMITTENT BLOOD GLUCOSE SENSORS IN ACHIEVING TARGET A1C
CURRENT STATUS

 Improves control in T1DM and insulin-treated T2DM  Generally does not improve control in T2DM on diet or OHAs  Prevents severe hypos in all pts  Works best if pts know to respond

ASSOCIATION BETWEEN FREQUENCY OF SMBG TESTING AND A1c IN T1DM
10 9.5 9 8.5 8 7.5 7 6.5 6 5.5 5
A1c = 5.99 + 5.32 / ([number of glucose tests per day] + 1.39)

A1c (%)

n=378

0

2

4

6

8

10

12

SMBG Tests per Day
378 T1DM INSULIN PUMP USERS Davidson et al. Diabetes 2004; 53 (Suppl 2): A101

SMBG FREQUENCY CORRELATES WITH A1C ADJUSTED FOR DEMOGRAPHIC VARIABLES

A1c (%)

For full adherence D A1C = 1.0% in T1 DM 0.6% in T2 DM P < .0001
No r values calculated 24,312 Kaiser Northern Calif adults (95% T2 / 5% T1) Karter et al. Am J Med 2001: 111:1-9

SMBG FREQUENCY CORRELATES WITH A1C ADJUSTED FOR DEMOGRAPHIC VARIABLES
For each additional SMBG per day - A1c fell by 0.3%

A1c (%)

For full adherence D A1C = 1.0% in T1 DM 0.6% in T2 DM P < .0001
No r values calculated 24,312 Kaiser Northern Calif adults (95% T2 / 5% T1) Karter et al. Am J Med 2001: 111:1-9

July 2005

● Volume 22

● Pages 200-206

SELFMONITORING OF BLOOD GLUCOSE IN NON-INSULIN-TREATED DIABETIC PATIENTS: A LONGITUDINAL EVALUATION OF ITS IMPACT ON METABOLIC CONTROL
M. Franciosi, F. Pellegrini, G. De Berardis, M. Belfiglio, B. Di Nardo, S. Greenfield, S. H. Kaplan, M. C. E. Rossi, M. Sacco, G. Tognoni, M. Valentini and A. Nicolucci for The QuED Study Group quality of care and outcomes in Type 2 diabetes

1896 T2DM non-insulin-treated patients followed for 3 years

Freq of SMBG did not predict better control but did predict fewer hypoglycemic episodes

THE DiGEMtrial PROTOCOL
A 12-MONTH RCT IN T2DM TO DETERMINE THE EFFECT OF 3 STRATEGIES OF SMBG ON CONTROL

450 T2DM PATIENTS ON OHAs OR DIET

1

CONTROL Rx: Q 3 MO A1c WITH NP INTERPRETATION

2 3

SMBG WITH ADJUSTMENTS IN Rx PER NP ONLY

STUDY TO REPORT IN 2007

SMBG WITH ADJUSTMENTS IN Rx PER SUBJECT OR NP

BMC Fam Pract 6: 25; 2005

CONTINUOUS GLUCOSE SENSORS IN ACHIEVING TARGET A1C
CURRENT STATUS

 Provides around-the-clock info on absolute BG values and trends  Five products now approved and two are being evaluated by the FDA  Greater accuracy needed  Reimbursement is inconsistent

CONTINUOUS GLUCOSE MONITORING
OUTLINE
 Purpose  Technologies  Target Populations  Accuracy  Clinical Indications  Outcomes  Future Trends

CONTINUOUS GLUCOSE MONITORING
OUTLINE
 Purpose  Technologies  Target Populations  Accuracy  Clinical Indications  Outcomes  Future Trends

PURPOSE OF CONTINUOUS GLUCOSE MONITORING
To obtain maximal information about shifting blood glucose levels throughout the day to make the best treatment decisions

CONTINUOUS GLUCOSE MONITORING
OUTLINE
 Purpose  Technologies  Target Populations  Accuracy  Clinical Indications  Outcomes  Future Trends

CONTINUOUS GLUCOSE MEASUREMENT DEVICES
APPROVED PRODUCTS IN US & EUROPE

 Continuous Glucose Monitoring

System Gold (CGMS Gold)  Guardian  Guardian RT * (Europe only)
 GlucoWatch® G2 Biographer  GlucoDay * (Europe only)

CONTINUOUS GLUCOSE MONITORING SYSTEM GOLD (CGMS GOLD)

CGMS GOLD - CONTINUOUS GLUCOSE MONITORING SYSTEM

GLUCOSE SENSOR MONITOR COM-STATION TO DOWNLOAD DATA SENSERTER

MEDTRONIC
MINIMED

GUARDIAN AND GUARDIAN RT

MEDTRONIC MINIMED GUARDIAN
COMPONENTS

Sensor Transmitter

Monitor
Alarm (50 db)

® GLUCOWATCH

G2 BIOGRAPHER

TIME GLUCOSE TREND

MENARINI GLUCODAY

CONTINUOUS GLUCOSE MONITOR

GLUCODAY

ITALY

ABBOTT
LABORATORIES

FREESTYLE NAVIGATOR

Abbott Laboratories FreeStyle Navigator™ Continuous Glucose Monitor
FEATURES 1 Enzyme-tipped SC catheter 2 Wireless transmission to monitor up to 10 ft away 3 Reads Q 1 min in real time 4 Sensor lasts 3 days

DEPLOYMENT OF THE NAVIGATOR 1
Attach Sensor Mount to Skin

2
Press to Insert Sensor

3

4

Attach Transmitter to Sensor Mount

Data is Transmitted to Receiver

DEXCOM SHORT-TERM CONTINUOUS GLUCOSE MONITORING SYSTEM (STS)

CONTINUOUS GLUCOSE MONITORING
OUTLINE
 Purpose  Technologies  Target Populations  Accuracy  Clinical Indications  Outcomes  Problems

A TOOL FOR DETERMINING ACCURACY IN AN EXPERIMENTAL BLOOD GLUCOSE MONITOR
RELATIVE ABSOLUTE DIFFERENCE (RAD) =

I EXPERIMENTAL BG – REFERENCE BG I x REFERENCE BG
RAD IS EXPRESSED AS A PERCENTAGE

1 100

CONTINUOUS GLUCOSE MONITORING
ACCURACY STUDIES BY DIRECNET
 RAD of CGMS 19%  RAD of CGMS Gold 11% & 12%  RAD of GW2B 16%
91 and 89 children with T1DM in a CRC setting DirecNet: Diabetes Technol Ther 2003; 5: 781-789 and 791-800 200 children with T1DM in an outpatient setting DirecNet: Diabetes Technol Ther 2005; 7:109-114

A TOOL FOR DETERMINING ACCURACY IN AN EXPERIMENTAL BLOOD GLUCOSE MONITOR
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO) CRITERIA
 Ref BG > 75 mg/dl: Sensor BG +/- 20%  Ref BG < 75 mg/dl: Sensor BG +/- 15 mg/dl  Data expressed as % of pairs meeting above criteria

ISO ACCURACY OF CONTINUOUS BG MONITORS

% of Values Meeting ISO Criteria

One Touch Ultra

CGMS Gold GW2B

Reference Glucose Values (mg/dl)
DirecNet: Diabetes Technol Ther 2003; 5: 781-789 and 791-800

EIGHT-POINT TESTING VS CGMS TO EVALUATE CONTROL IN T1DM
EIGHT-POINT TESTING ADVANTAGES CGMS MONITOR ADVANTAGES
Children with T1DM n = 200 JCEM 2005; 90: 3387-3391

 Similar Mean BGs:    

188 mg/dl 183 mg/dl Mean noc BG: 199 mg/dl 174 mg/dl ? ↑ specificity low BG ? ↓ specificity low BG Similar BG / A1c ratios: 23 mg/dl per 1% A1c 19/mg/dl per 1% A1c 2-hr PP ∆BG PM: 2-hr PP ∆BG PM: + Compliance (72h): 10% Compliance Median: 70h

CONTINUOUS GLUCOSE MONITORING
OUTLINE
 Purpose  Technologies  Target Populations  Accuracy  Clinical Indications  Outcomes  Future Trends

SITUATIONS REQUIRING DETAILED INFO ABOUT GLUCOSE FLUCTUATIONS
CLINICAL INDICATIONS TO USE CGM

 Assess impact of an adjustment in

therapy to improve control
 Achieve tighter control without causing

hypoglycemia (e.g. peds DM, GDM, ICU)
 Diagnose / prevent hypoglycemia during

sleep or hypoglycemia unawareness
 Quantify the response in clinical trials

ELEMENTS OF THERAPY THAT CAN BE ADJUSTED WITH CGM
 Type or dose of mealtime insulin  Type or dose of basal insulin  Treatment of High or Low BG  Insulin: Glucose ratio for High BGs  Insulin: CH2O ratio at mealtime  Carbohydrate composition of diet  Discount in short-acting ins for exercise  HS regimen because of dawn phenom  Target pre- or post- prandial BG  Refer to Ψ to improve adherence

ELEMENTS OF THERAPY THAT CAN BE ADJUSTED WITH CGM
 Increase dose of mealtime insulin (#1 of 8) I  Type of basal insulin . (#1 of 9)  Treatment of High or Low BG  Insulin: Glucose ratio for High BGs  Insulin: CH2O ratio at mealtime  Carbohydrate composition of diet  Discount in short-acting ins for exercise  HS regimen because of dawn phenom  Target pre- or post- prandial BG Sabbah et al: Diabetes 2000; 49 (Suppl  Refer to Ψ to improve adherence 1): A393 Kaufman et al: Diabetes Care 2001; 24: 2430-2434

CONTINUOUS GLUCOSE MONITORING
OUTLINE
 Purpose  Technologies  Target Populations  Accuracy  Clinical Indications  Outcomes  Future Trends

OUTCOMES TRIALS OF CGM: STUDY DESIGNS AND ENDPOINTS
 Six RCT’s: two showed SS ↓ in A1c,

three showed NSS ↓ in A1c and one showed no ↓ in A1c but did show a SS ↓ in duration of hypo episodes  Five nonrandomized uncontrolled trials: all five showed a SS ↓ in A1c  One nonrandomized uncontrolled trial using ↓ and ↑ excursions as an endpoint showed reduced excursions of both

IMPROVED BG CONTROL WITH REAL TIME CONTINUOUS GLUCOSE MONITORING USING AN IMPLANTED SENSOR
10

BLINDED TESTING vs REAL TIME ACCESS

Time Spent (hrs/day)

8
6

BLINDED TESTING REAL TIME ACCESS

Time spent Hypoglycemic (< 55 mg/dl) Decreased 47% Time spent Hyperglycemic (> 241 mg/dl ) Decreased 25%

4
2 0

40 - 55

56 - 80

81 – 140

141 – 240

241 - 400
Diabetes Care. 2004;27:734-8

Glucose Range (mg/dl)

SUMMARY

20 T1DM subjects at Stanford and Barbara Davis Center wore 1-2 GlucoWatch GW2Bs
240 total alarms in 24 hours (180 during sleep) for: a) BG ≤ 70 mg/dl b) expected hypo within 20 min c) BG ≥ 300 mg/dl Subjects awoke to: 29% of individual alarms 66% of alarm events 100% of true hypo events
DirecNet: Diabetes Technol Ther June 2005; 7:440-447

SUMMARY

20 T1DM subjects at Stanford and Barbara Davis Center wore 1-2 GlucoWatch GW2Bs
240 total alarms in 24 hours (180 during sleep) for: a) BG ≤ 70 mg/dl b) expected hypo within 20 min c) BG ≥ 300 mg/dl Subjects awoke to: 29% of individual alarms 66% of alarm events 100% of true hypo events
DirecNet: Diabetes Technol Ther June 2005; 7:440-447

CONTINUOUS GLUCOSE MONITORING
OUTLINE
 Purpose  Technologies  Target Populations  Accuracy  Clinical Indications  Outcomes  Future Trends

MEDTRONIC MINIMED PARADIGM SENSOR AUGMENTED SYSTEM
CONTINUOUS REAL TIME SENSOR
TRANSMITTER COMBINED MONITOR AND INSULIN PUMP

MONITOR SENSOR SUTURES

CABLE
Diabetes Technol Ther 2002; 4: 305-312

J Feline Med Surg 2005; 7: 53-62

J Feline Med Surg 2005; 7: 53-62

J Feline Med Surg 2005; 7: 53-62

J Feline Med Surg 2005; 7: 53-62

J Feline Med Surg 2005; 7: 53-62

J Feline Med Surg 2005; 7: 53-62

CONTINUOUS
GLUCOSE MONITORING MEANS MORE BLOOD GLUCOSE DATA

CONTINUOUS GLUCOSE SENSORS IN ACHIEVING TARGET A1C
CONCLUSIONS

 Provides maximal information for making treatment decisions  Multiple methods are effective  Technology will be a routine part of intensive treatment regimens  In the future a continuous sensor will control an artificial pancreas


								
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