The Reality of Diabetes Care
Terri Sasse, RN, CDE
Agenda
• Diabetes Overview
• Patient Monitoring of Blood Sugar
• Features and Benefits of Monitors
• Hands-on Experience with Monitors
• Case Study
Program InformationACPE # 384-000-07-017-L04
Release Date: 8-6-07Expires: 8-6-2010
STAT Educational Services, a division of National Pharmacy STAT Educational Services, a division of National Pharmacy Technician Technician Association Inc., is accredited by the Accreditation Council Association Inc., is accredited by the Accreditation Council for Pharmacy for Pharmacy Education (ACPE) as a provider of continuing pharmacy Education (ACPE) as a provider of continuing pharmacy education.education.
Objectives
Participants will be able to:
Know data of the prevalence and incidence of diabetes Describe the evolution and current technology for measuring blood
glucose levels Identify the importance of blood glucose monitoring in diabetes
management Recognize the various features and benefits of commercially
available blood glucose monitors Discuss how to assist patients in selecting a blood glucose
monitoring system Understand variables that may affect the performance of blood
glucose monitoring systems
Diabetes Prevalence
• 20.8 million people have diabetes
• 6.2 million are undiagnosed
• 41 million have pre-diabetes
Diabetes Incidence
Trends in Growth
• Aging population• Increase in overweight population
– Adults – Children
• Influx of high risk groups• Increased diagnosis
Evolution of Glucose Testing
• 1948-Urine testing strips developed using glucose oxidase as enzyme
• Limitations: qualitative only
differences in renal threshold affected by interfering substances poorly correlated to blood glucose
BG Meter Technology-1970’s
• Color Reflectance or Reflectance Photometry– Chemical reaction between glucose and an enzyme produces a color
change on test strip– Color change is proportional to amount of glucose in sample
• Electrochemical or Biosensor – An electrochemical reaction which generates an electrical current
proportional to the amount of glucose
Accuracy of Blood Glucose Measurement at www.powerpak.com. 2003
Current Technology Segmentation
75%
25%
Photometric – 25%
Lifescan Basic/Profile/Surestep
Accu-Chek Active/Compact
Prestige IQ Smart System
Biosensor – 75%
Lifescan Ultra
Therasense Freestyle
TrueTrack Smart System
Accu-Chek Advantage
Benefits of Self-Monitoring
• Benefits both Type 1 and Type 2 patients with diabetes– DCCT Type 1 – United Kingdom Prospective Diabetes
Study Type 2
ADA Standards of Medical Care in Diabetes, Diabetes Care, Vol. 27, January 2004, pg. S15-S35.
Importance of BG Monitoring
• Cornerstone of diabetes self-management
• Individualizes diabetes self-care
• Empowers the patient• Reinforces good behaviors
Frequency of Testing
• Type of Diabetes
• Overall glycemic control
• Changes in therapies
• Changes in lifecycle
ADA Standards of Medical Care in Diabetes, Diabetes Care, Vol. 27, January 2004, pg. S15-S35.
ADA Guidelines for Testing• As needed to achieve glycemic goals
• Fasting
• Preprandial/Postprandial
• 3 am
• Periodically alternate testing times
• Test when symptomatic
ADA Standards of Medical Care in Diabetes, Diabetes Care, Vol 27, January 2004, pg S15-S35.
AAFP Guidelines for Testing
• Type 1 taking insulin-test 3-4x day
• Type 2 taking insulin and orals-test 3-4x/day
• Orals only with A1C out of target range-test 2-4x/day
American Academy of Family Physicians, 2004
What are the goals?
• ADA recommendations:– Preprandial plasma glucose 90-130mg/dL– Postprandial plasma glucose <180mg/dL– A1C <7%
• All goals are individualized
• Based on certain populations
ADA Standards of Medical Care in Diabetes, Diabetes Care, Vol 27, Jan 2004, pg. S15-S35.
Measures of Glycemic Control
• Self-monitoring (SMBG)
• Glycosylated hemoglobin– Total hemoglobin
– Hemoglobin A1c
• Urine ketone testing
Advantages of Monitoring
• Immediate results• Evaluation of changes• Enhanced patient
independence
• Marker of glycemic control• Evaluation of self-monitoring• Correlation with long-term complications
SMBGGlycosylated Hemoglobin
Relationship between HbA1c and Average Blood Glucose (DCCT)*
%HbA1c
Average BG
High Risk
for
Complications
Good Control Low Risk for
Complications
Normal Range
Low Risk for Complications
330
300
270
240
210
180
150
120
90
60
13
12
11
10
9
8
7
6
5
4
Elevated Postprandial Glucose Levels
• Earliest abnormality in type 2 diabetes
• Contributes to elevations in HbA1c
• Best predictor of HbA1c
• Contributes to both microvascular and macrovascular complications
Targeting Postprandial and Fasting Glucose Levels Lowers HbA1c in Type 2 Diabetes
0%
2%
4%
6%
8%
10%
Fasting Alone
Fasting Plus Postprandial
HbA1c 9.4%9.4%
7.1%7.1%
24% Reduction
Ohkubo Y, et al. Diabetes Res Clin Pract. 1995;28:103-117.
The Reality of Diabetes Care
• <2% of American adults with diabetes receive optimal quality of care
• Majority of patients with Type 2 diabetes have only fair to poor metabolic care– Fasting glucose levels of 200mg/dL or higher– HbA1c levels of 9-10% (<7% is target)
• Postprandial glucose levels average 300mg/dL
Beckles, GL., et al. Diabetes Care, 1998:21:1432-1438; ADA, Diabetes Care, 1998:21(supple 1); Colwell JA. Ann Intern med. 1996:124 (1pt2):131-135; Abraira C, et al. Diabetes Care. 1992;15:1560-1571; Klein R, et al. Am J Epidemiol. 1987;126:415-428; CowieCC, et al. Diabetes in America. 2nd Edition
The Right Meter for the Right Patient
Customer Confusion!
•Nearly 50% of meter scripts are not brand specific
Unbranded Meter Scripts
*GfK Market Measures Therapeutic Class Studies Blood Glucose Monitoring Study V (2005) - ** GfK Market Measures Roper 2006 US Diabetes Patient Market Study
Patient’s Reasons for Selecting a BG Meter
0% 10% 20% 30% 40% 50%
Accuracy
ProfessionalRecommendation
Simplicity
Cost (net)
2006 Roper Global US Diabetes Program at GFK NOP World Health, August – September 2006
47%
13%
6%
18%
Lowest CoPay Prevalence by Test Strips – Commercial Insurance
0% 20% 40% 60%
FreeStyle
One Touch Ultra
Ascensia
Accu-Chek
TrueTrack
05/07 Top Commercial Plans by TRx Volume
19%
12%
8%
9%
51%
Features and Benefits
Meter• Size of meter
• Test time
• Calibration or coding procedure
• Data management options
• System specifications
Test Strips• Size of test strips
• Packaging of test strips
• Amount of blood required
• Blood sampling sites
Comparison of Leading BGM Systems
Test Strips Data Management
SampleSize
Required
Test Speed Test Memory
Averaging
Accu-Chek™ Aviva®
0.6 micorliters 5 seconds 500 7, 14- & 30-Day
Ascensia™ Contour®
0.6 microliters 5 seconds 480 14-Day
Freestyle® Flash®
0.3 microliters 7 seconds 250 14-Day
One Touch® Ultra 2®
1 microliter 5 seconds 500 7, 14 - & 30-Day
TrueTrack® 1 microliter 10 seconds 365 14- & 30-Day
Advanced Blood Glucose Monitoring Systems
One Touch® Ultra 2®
TrueTrack SmartSystem®
FreeStyle™ Flash™
Accu-Chek™ Aviva™
Information Blood Glucose Systems
Accu-Chek ™
Complete™ FreeStyle™
Tracker™
One Touch ®
UltraSmart®
Store Brand Offerings
TrueTrack Smart System®
ReliOn® Ultima™
Kroger®
Accuracy of Blood Glucose Monitoring Systems
• FDA Approval process involves showing substantial equivalence between the investigative device and a device that is currently on the market
• FDA requires Human Factors Studies
• International Standardization Organization
U.S. FDA –Center for Devices and Radiologic Health, 1997, Guidance Glucose Document
Industry Standards for Accuracy
• FDA recognizes National Committee for Clinical Laboratory Standards1
• ADA goal: +/- 10% at ranges 30-400mg/dL2
• Clinically acceptable is +/- 15% of the standard laboratory value3
• “Most patients with some formal training can obtain results within 20% of the lab reference”4
• Most meter result errors are user related5
\
• 1 NCCLS Method Comparison and Bias Estimation Using Patient Samples
EP9-A Vol. 15 No. 17
2
ADA Consensus Statement. Diabetes Care 1987; 1:95-99
3-5 Ibid.
Variables that can affect the Accuracy of BGM
User Variables• Poor technique
-27%-48% poor vision-25% loss of sensation-language constraints-insufficient sample size
• Soiled meter• Lack of calibration• Lack of hand-washing
System Variables• Heat or Cold • Defective Strips• HumidityPharmacological Factors• Oxygen content• Glucose content (60-
200mg/dL)• Dehydration• Interfering Substances
Accuracy of Blood Glucose Measurement. Available at http://www.powerpak.com/CE/accuracy_bgm/pharmacy /references.cfm
Promoting Accurate Testing• Review and understand manufacturers “instructions for use”
• Practice using control solution
• Assess user technique
• Understand system specifications– Proper storage and maintenance– Limitations of procedure
• Utilize manufacturer technical support
A Core Curriculum for Diabetes Education, 5th edition, AADE, Chicago, IL
Hands-on Experience with Monitors
Helping your Patients
Assess the physical needs– Visual limitations– Dexterity limitations
Assess the financial needs Cash or reimbursement
Assess the lifestyle needs Active vs. Sedentary
Assess the plan of care– Frequency of testing
Case Study
• TS is a patient with Type 2 diabetes who has been self managing with meal planning and physical activity. Her labwork showed an A1c level of 9% and her physician has referred her to a diabetes educator so that she can learn about BG monitoring and how her daily choices affect her glucose results. TS has poor vision, arthritis and is very afraid of sticking herself to get blood for a BG test.
Case Study
• In order to help TS select a monitor, what are 2 things you need to consider?
• What specific features and benefits should you look for in a monitoring system to assist TS in selecting a meter?
Conclusions
Clinical studies support the benefits of BG monitoring in helping patients achieve glycemic goals
Optimal diabetes control helps to delay or prevent complications
Manufacturers focus on designing meters that are easy to useand meet individual lifestyle needs
When used according to instructions, blood glucose monitoringprovides valuable information for managing diabetes care
Questions/Comments