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