Aarkstore Enterprise

Aarkstore - U.S. Glucose Testing Markets

U.S. glucose testing is undergoing a significant transition, driven by new analytical technologies
and developments in diabetes treatment. Although the blood glucose testing segment of the in vitro
diagnostics (IVD) industry is mature, several segments of the market, such as home testing devices
for diabetes management and point of care (POC) instruments for use in professional settings, will
exhibit strong growth. Direct access testing has emerged as a strong force in the blood glucose
testing segment, and non-invasive and minimally-invasive testing now represent major new areas
for the application of IVD testing. This TriMark Publications report describes the specific market
segments for blood glucose testing and diabetes management in the U.S. market. It reviews all of
the generally-accepted clinical analytical methods that are currently in use today for measuring
serum, plasma or whole-blood glucose concentrations. Additionally, this study examines clinical
measurement devices, reagents and supplies as utilized in hospitals, clinics, doctors offices and at-
home care locations. Moreover, it analyzes almost all of the companies known to be marketing,
manufacturing or developing glucose testing products for the U.S. market. Each company is
discussed in extensive depth with a section on its history, product line, business and marketing
analysis, and a subjective commentary of the companys market position. Detailed tables and charts
with sales forecasts and market data are also included.

19
th
September 2014


Browse Full Report @
http://www.aarkstore.com/healthcare/35987/US-Glucose-
Testing-Markets
Published: Jul 2014 | No. Of Pages: 268 Pages
PDF: $3400 | Site Licence: 6800 | Enterprise Wide Licence: $10200

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Table of Contents:

1. Overview 11
1.1 Statement of Report 11
1.2 About This Report 11
1.3 Scope of the Report 12
1.4 Methodology 13
1.5 Executive Summary 14

2. Diabetes 17
2.1 Demographics of Diabetes in the U.S. 18
2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 23
2.2.1 Pre-Diabetes Syndrome 24
2.2.2 Metabolic Syndrome 24
2.2.3 Progression of Diabetes 24
2.2.4 Diabetes and Inflammation 25
2.2.5 Risk Factors and Diabetes 25
2.2.5.1 Obesity 26
2.2.5.2 Stress-Induced Hyperglycemia 28
2.2.6 Complications and Co-Morbidities in Diabetes 29
2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes 33
2.2.6.2 Cardiovascular Disease Facts 34
2.3 Economics of Diabetes 37

3. Market Analysis: Size, Growth, Share and Competitors 43
3.1 U.S. Market 44
3.1.1 U.S. Over-the-Counter (OTC) Self-Testing Glucose Market 45
3.1.2 U.S. Professional Glucose Testing Market 50
3.1.3 Continuous Glucose Monitoring Markets 51
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3.2 Competitive Situation 52
3.2.1 Key Players 52
3.2.2 Analyses of the Self-Testing Market Conditions, Competition and Product Mix 52
3.2.3 Analyses of the Professional Blood Glucose Monitoring Market 55
3.3 Market Drivers and Restraints 57
3.3.1 Market Drivers 57
3.3.2 Market Restraints 59
3.4 Market and Product Trends 61
3.4.1 Market Trends 61
3.4.2 Technology Trends 62
3.5 Strategic Recommendations 63
3.6 Competitive Strategies 65
3.7 New Opportunities in the Professional Blood Glucose Meter Market 66
3.8 Adjacent Markets 67

4. Glucose Diagnostic and Monitoring Recommendations 68
4.1 Diagnosis of Diabetes Mellitus 68
4.2 Tight Glucose Control in Treating Diabetes 71
4.2.1 Tight Glucose Control Lowers Cardiovascular Complications 72
4.3 Recommendations for Glucose Control in Diabetics 72
4.3.1 Recommended Frequency of Blood Glucose Self-Testing 74
4.3.2 Using Blood Glucose Data to Monitor and Modify Patient Therapy 75
4.3.3 Testing in Individuals with Type 2 Diabetes 76
4.3.4 Continuous Glucose Monitoring (CGM) 77
4.3.5 A1c Testing Recommendations 78
4.3.6 Recommendations for Diabetes Care and Glucose Testing in the Hospital Setting 78
4.4 Hypoglycemia and Treatment 82

5. Glucose Testing Technology Platforms and Consumable Products 84
5.1 Types of Glucose Determination Technologies 84
5.2 Enzymatic Reactions Used to Determine Glucose Concentrations 85
5.2.1 Glucose Oxidase (GOX) 85
5.2.2 Glucose Dehydrogenase (GDH) 86
5.2.2.1 GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide) 86

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5.2.2.2 GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide) 86
5.2.2.3 GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone) 86
5.2.3 Glucose Hexokinase 86
5.3 Development of Blood Glucose Monitors: A Historical Evaluation 87
5.3.1 First-Generation Blood Glucose Biosensors 87
5.3.2 Second-Generation Blood Glucose Biosensors 87
5.3.3 Third-Generation Blood Glucose Biosensor 87
5.4 Accuracy and Precision in Glucose Meters 88
5.4.1 Clinical and Laboratory Standards Institute (CLSI) POCT12-A3 89
5.4.2 International Organization for Standardization (ISO) 15197:2013 90
5.4.3 FDA Guidelines for Blood Glucose Testing Systems 90
5.4.4 Determining Clinical Accuracy Using the Error Grid Analysis (EGA) 93
5.4.5 Quality Control Criteria 94
5.4.6 Potential Variables Affecting Glucose Concentrations 95
5.5 Key Issues for Glucose Testing Devices 95
5.5.1 Important Elements for Glucose Testing 96
5.5.2 Key Features to Aid Specific Patient Populations 97
5.6 Limitations of Existing Glucose Testing 98
5.6.1 Common User Errors in Glucose Self-Testing 99
5.6.2 Interfering Substances and Conditions 100
5.6.2.1 Environmental 100
5.6.2.2 Physiologic 100
5.6.2.3 Operational 100
5.6.2.4 Manufacturing Variations 100
5.6.2.5 Drugs/Medications 100
5.6.2.6 Patient Factors 100
5.6.3 Errors Associated with GDH-PQQ Technology 101
5.6.4 Optimizing of Point of Care (POC) Blood Glucose Testing 104
5.7 Potential Areas of Improvement in Blood Glucose Meter Performance 104
5.8 Blood Glucose Reagent Test Strips 106
5.9 Comparison of Hand-Held Blood Glucose Meters with Clinical Laboratory Glucose
Measurements 107
5.10 Continuous Glucose Monitoring Technology 108
5.10.1 Advantages of Continuous Readings 108

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5.10.2 FDA Approval of CGM 108
5.10.3 CGM Functions to Consider 109
5.10.4 New Technologies for CGM 110
5.11 Summary of Technologies Being Explored for Non-Invasive Glucose Monitoring 110
5.11.1 GlucoTrack 110
5.11.2 Non-Invasive Glucose Monitoring Technologies in Development 111
5.11.3 Goals of Non-Invasive Testing 112
5.11.4 Non-Invasive Diabetes Screening Test 112
5.12 A1c Monitoring Technology 113
5.13 Fructosamine Test 114
5.14 Related Reagents and Equipment 115
5.14.1 Lancets 115
5.14.1.1 Types of Lancing Devices 116
5.14.1.2 Market Size 116
5.14.2 Control Solutions and Calibrators 121
5.14.3 Sharps Devices 121
5.14.4 Needle Destruction Devices 122
5.14.5 Urine Strips 122
5.14.6 Ketone Testing 124
5.14.7 Long-Term Glucose Sensing Bio-Implants 125

6. Glucose Testing Devices on the Market 126
6.1 Hand-held Blood Glucose Meters and Strips for Self-Testing 126
6.1.1 LifeScan, Inc. 129
6.1.2 Roche Diagnostics Corporation 132
6.1.3 Bayer 133
6.1.4 Abbott 135
6.1.5 Agamatrix, Inc. 137
6.1.6 Arkray, Inc. 138
6.1.7 Bionime Corporation 139
6.1.8 BioSense Medical Devices 141
6.1.9 CVS/Pharmacy 141
6.1.10 Diabetic Supply of Suncoast 141
6.1.11 Entra Health Systems 142

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6.1.12 Fifty50 Pharmacy 142
6.1.13 Fora Care 142
6.1.14 Genesis Health Technologies 143
6.1.15 GlucoCom 143
6.1.16 Infopia 144
6.1.17 Nipro Diagnostics, Inc. 144
6.1.18 Nova Biomedical 146
6.1.19 Oak Tree International Holdings, Inc. 146
6.1.20 Omnis Health 146
6.1.21 Phylosis 147
6.1.22 Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.) 147
6.1.23 Sanofi 148
6.1.24 Target 148
6.1.25 Telcare 148
6.1.26 Tyson Biomedical 148
6.1.27 US Diagnostics 149
6.1.28 Walgreens 150
6.1.29 Walmart 150
6.1.30 77 Elektronika Kft. 150
6.1.31 A. Menarini Diagnostics 150
6.1.32 All Medicus 151
6.1.33 i-SENS 151
6.1.34 Apex Biotechnology Corp. 151
6.1.35 Glucoplus, Inc. 152
6.1.36 Polymer Technology Systems 152
6.1.37 Smiths Medical MD, Inc. 152
6.1.38 TaiDoc Technology Corp. 152
6.1.39 IN4 Technology Corporation 152
6.1.40 ACON Laboratories, Inc. 152
6.1.41 Pepex Biomedical 153
6.1.42 HMD BioMedical 153
6.1.43 BTNX, Inc. 154
6.1.44 Shasta Technologies and Decision Diagnostics Corporation 154
6.2 Hand-held Blood Glucose Meters for Professional Use 154

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6.2.1 Abbott 156
6.2.1.1 Precision Xceed Pro Blood Glucose and Beta-Ketone Monitoring System 156
6.2.1.2 i-STAT System 157
6.2.2 ACON Laboratories 157
6.2.2.1 On Call Platinum Blood Glucose Monitoring System 157
6.2.3 Alere 157
6.2.3.1 epoc Blood Analysis System 157
6.2.3.2 Alere Cholestech LDX System 158
6.2.4 ARKRAY, Inc. 158
6.2.4.1 Assure Platinum, Assure Pro, and Assure 4 158
6.2.5 EKF Diagnostics 158
6.2.5.1 Biosen Series of Glucose and Lactate Analyzers 158
6.2.6 HemoCue (a Quest Diagnostics Company) 158
6.2.6.1 HemoCue Glucose 201 and Glucose 201 DM Systems 159
6.2.7 HMD BioMedical 159
6.2.7.1 NS100 159
6.2.8 Medtronic 159
6.2.8.1 iPro Continuous Glucose Monitor 159
6.2.9 Nova Biomedical 159
6.2.9.1 StatStrip Hospital Glucose Monitoring System 159
6.2.10 Polymer Technology Systems, Inc. 160
6.2.10.1 CardioChek PA Point of Care Device 160
6.2.11 Roche 160
6.2.11.1 Accu-Chek Inform II System 160
6.2.11.2 Accutrend Plus System 160
6.2.12 Techno Medica Co., Ltd. 161
6.2.12.1 GASTAT-mini 161
6.2.13 LifeScan 161
6.3 Clinical Blood Chemistry Analyzers 161
6.3.1 Abaxis, Inc. 163
6.3.2 Alere 163
6.3.3 ARKAY, Inc. 164
6.3.4 Beckman Coulter 164
6.3.5 DiaSys 164

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6.3.6 Instrumentation Laboratory 165
6.3.7 International Techidyne Corporation (ITC) 165
6.3.8 Nova Biomedical 165
6.3.9 Radiometer 166
6.3.10 Randox Laboratories 167
6.3.11 Roche 168
6.3.12 Siemens Healthcare Diagnostics 168
6.3.13 Span Diagnostics 171
6.3.14 Stanbio Laboratory 171
6.3.15 Techno Medica Co., Ltd. 171
6.3.16 YSI Life Sciences 171
6.4 Continuous Glucose Patient Monitoring Systems 172
6.4.1 Medtronics Continuous Glucose Monitoring Systems (CGMS) 173
6.4.2 DexCom, Inc. G4 Platinum Continuous Glucose Monitoring System 176
6.4.3 FreeStyle NavigatorAbbotts Continuous Glucose Monitor System 177
6.4.4 GlucoDay S Continuous Glucose Monitor 178
6.4.5 Minimally-Invasive Continuous Glucose Monitors in Development 178
6.4.5.1 GlySens, Inc. 178
6.4.5.2 Senseonics (formerly Sensors for Medicine and Science) 179
6.4.5.3 Ultradian 179
6.4.5.4 GluMetrics 179
6.4.5.5 GlySure Limited 180
6.5 Non-Invasive Glucose Patient Monitoring Systems 180
6.5.1 Cygnus GlucoWatch Biographer 181
6.5.2 AiMedics 181
6.5.3 BioTex, Inc. 182
6.5.4 Echo Therapeutics, Inc. 182
6.5.5 EyeSense GmbH 183
6.5.6 Freedom Meditech 183
6.5.7 Grove Instruments 183
6.5.8 Integrity Applications Ltd. 183
6.5.9 LighTouch Medical, Inc. 184
6.5.10 OrSense Ltd. 184
6.5.11 VeraLight, Inc. 185

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6.5.12 Xhale, Inc. 185
6.5.13 Lein Applied Diagnostics 185
6.6 A1c Testing 185
6.7 New Product Launches 186
6.7.1 OneTouch Verio Sync Blood Glucose Monitoring System 186
6.7.2 Medtronics MiniMed 530G with Enlite Sensor Technology 186
6.7.3 Contour Next Link Meter Approved for Use with Medtronics New MiniMed 530G with
Enlite Insulin Pump System 187
6.7.4 Roches ACCU-CHEK Inform II System Approved by the FDA 187
6.7.5 Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone Monitoring
System 187
6.7.6 Abbott Receives FDA Clearance for FreeStyle Precision Pro Blood Glucose and -Ketone
Monitoring System 187
6.7.7 LabStyle Innovations Dario Diabetes Management System 187
6.7.8 BlueStar by WellDoc 188
6.7.9 FDA Approves Bayers Contour Next EZ 188
6.7.10 Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook App 188
6.7.11 Sanofi-Aventiss iBGStar 189
6.7.12 iHealth Glucose Meter Device 189
6.7.13 MyGlucoHealth Diabetes 189
6.7.14 gDrive 190
6.7.15 Shasta GenStrips 190
6.7.16 mySentry Remote Glucose Monitor 190
6.7.17 OneTouch Verio IQ System with PatternAlert Technology 190
6.7.18 Accu-Chek Nano SmartView 190
6.8 Blood Glucose Meters, CGMs, and Data Management Software in Development 190
6.8.1 Abbotts Flash Glucose Monitoring System 190
6.8.2 Google Announces Plan to Create Contact Lens Glucose Sensors 191
6.8.3 Socrates Health Solutions Companion Blood Glucose Monitor 191
6.8.4 DexCom and Johnson and Johnsons Animas Working to Develop an Artificial Pancreas 191
6.8.5 Medtronic Enrolling Patients into Trial Testing Third-Generation, Fully-Automated Artificial
Pancreas 191
6.8.6 Boston Universitys Bionic Pancreas Project 191
6.9 Recent Industry Activity 191

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6.9.1 Roche Diagnostics Corp. Cutting Jobs in Diabetes Division 191
6.9.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 191
6.9.3 LifeScan, Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed 192
6.9.4 Kroger Selects WaveSense Diabetes Testing Products 192
6.9.5 Medtronic and Bayer Healthcare Expand International Alliance 192
6.9.6 PositiveID Corporation and IDEAL LIFE Partner to Bring iglucose to Market for Wireless
Diabetes Management 192
6.9.7 Roche Diagnostics U.S. and DexCom, Inc. Announce Research and Development Agreement
192
6.9.8 BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for Both
CGM and Pump 193
6.9.9 Court Sides with Decision Diagnostics in Patent Infringment Case 193
6.9.10 iBGStar Blood Glucose Monitoring System Receives U.S. FDA 510(k) Clearance 193
6.9.11 Infopia America Partners with Walgreens Drugstores 193
6.9.12 Qualcomm Forms Qualcomm Life Subsidiary 193
6.9.13 Perrigo and AgaMatrix Enter into an Exclusive Sales and Distribution Agreement 194
6.9.14 Pepex Biomedical Signs Seven Year Deal to Manufacture Trio 194
6.9.15 DexCom and Tandem Diabetes Care Team Up for CGM Development and
Commercialization 194
6.9.16 Insulet Corporation Signs Worldwide Agreement with LifeScan 194
6.10 M&A Activity 194
6.10.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to Become Nipro
Diagnostics, Inc. 194
6.10.2 Medtronic, Inc. (MDT) Acquires New Diabetes Technology from PreciSense AS 195
6.10.3 Geonostics Acquires FlexSites Consumer Diabetes Tests 195
6.10.4 Radiometer Medical Acquires Hemocue 195
6.10.5 Additional M&A 195
6.10.6 Important Deals in BGM market 196

7. Business Trends in Glucose Testing 198
7.1 Drivers of Clinical Glucose Testing 198
7.2 Competition for Services 198
7.3 Healthcare Cost Controls 198
7.4 Changes in Patient Management 199

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7.5 Regionalization of Laboratory Care 199
7.6 Satellite Facilities 200
7.7 Professional Point of Care Testing 200
7.8 Factors Affecting OTC Medical Product Distribution 201
7.9 Drugstores Critical to the Diabetic Care Category 203
7.10 Drivers of OTC and Self-Testing Markets 203
7.10.1 Brand Loyalty 203
7.11 Cost Elements of Glucose Self-Testing 204
7.12 Blood Glucose Self-Testing Insurance Coverage and Reimbursement 204
7.13 Reimbursement Challenges 207
7.13.1 New Medicare Part B 208
7.14 Managed Care 208
7.15 Government Regulation of Medical Devices 208
7.16 Clinical Laboratory Improvement Act (CLIA) 211
7.17 FDA Labeling Requirements 213
7.18 Legal Liability for Glucose Meters 214
7.19 FDAs Artificial Pancreas Guidance Document 215

8. Technology Trends 216
8.1 Improving Todays OTC Blood Glucose Meters 216
8.2 Biosensor Technology 217
8.3 Fructosamine Test 219
8.4 Telemedicine Devices 219
8.4.1 Remote Patient Monitoring 222
8.4.1.1 Infopia Eocene System 225
8.4.1.2 Health Buddy Systems Monitoring Technologies 226
8.4.1.3 GlucoCom Glucose Monitoring System 226
8.4.1.4 Aleres DayLink Monitor 226
8.4.1.5 Alere HomeLink Receives FDA Approval for Over-the-Counter Use 226
8.5 Non-Traditional Methods for Sample Collection 227
8.6 Data Management 227
8.6.1 Medical Device Radiocommunications Service (MedRadio) 227
8.6.2 Connectivity 228
8.6.3 Advantages of Connectivity 229

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8.6.4 Connectivity Platforms 230
8.6.5 DataLink Data Management System 230
8.6.6 RALS-Plus 232
8.6.7 FDA Required Software Verification 232
8.6.8 Information Management Advances 232
8.6.9 POL Laboratory Data Management 234
8.6.9.1 Electronic Medical Record Systems and Physician Office Laboratory Data Linking
Software 234
8.6.9.2 Physician Office Laboratory Data Linking Software and Interface to the Laboratory
Information System 236
8.6.9.3 Technical Problems of Connectivity 236
8.6.9.4 Web-Based Data Interface 237
8.6.10 HIT Competition 237

9. Company Profiles 238
9.1 Abaxis, Inc. 238
9.2 Abbott Laboratories 240
9.3 ACON Laboratories 243
9.4 AgaMatrix 244
9.5 Alere, Inc. 244
9.6 All Medicus, Co., Ltd. 244
9.7 Amedica Biotech 244
9.8 A. Menarini Diagnostics 245
9.9 Apex Biotechnology Corporation 245
9.10 ARKRAY USA, Inc. 245
9.11 Bayer AG 245
9.12 B. Braun Melsungen 247
9.13 Beckman Coulter 247
9.14 Bionime 252
9.15 Bio-Rad Laboratories, Inc. 252
9.16 BioTex, Inc. 253
9.17 Calisto Medical, Inc. 253
9.18 Cambridge Sensors 253
9.19 DexCom 253

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9.20 Diagnostic Devices/Prodigy Diabetes Care 255
9.21 DiaSys 255
9.22 Echo Therapeutics, Inc. 255
9.23 Entra Health Systems 257
9.24 Fora Care 257
9.25 FIFTY50 Medical, Inc. 257
9.26 Freedom Meditech 257
9.27 Genesis Health Technologies 257
9.28 GenExel-Sein, Inc. 257
9.29 GlucoPlus 257
9.30 GlySens, Inc. 258
9.31 GlySure Limited 258
9.32 Grove Instruments 258
9.33 Hainice Medical 258
9.34 HemoCue (a Quest Diagnostics company) 258
9.35 Home Diagnostics 259
9.36 Infopia Co., Ltd. 259
9.37 IN4 Technology 259
9.38 International Techidyne Corporation (ITC) 259
9.39 Instrumentation Laboratory Company 260
9.40 i-Sens 260
9.41 Johnson & Johnson 260
9.42 LabStyle Innovations Corporation 261
9.43 Medtronic 262
9.44 Nipro Diagnostics 263
9.45 Nova Biomedical 263
9.46 OrSense Ltd. 263
9.47 Polymer Technology Systems 263
9.48 Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.) 264
9.49 Radiometer Medical 264
9.50 Roche Diagnostics 265
9.51 77 Elektronika Kft. 266
9.52 Siemens AG 266
9.53 Smiths Group 266

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9.54 Stanbio Laboratory 267
9.55 TaiDoc Technology 267
9.56 Techno Medica Co., Ltd. 268
9.57 Telcare 268
9.58 US Diagnostics 268
9.59 VeraLight 268
9.60 Ypsomed Holding 268
9.61 YSI Life Sciences 269


List of Tables

Table 2.1: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013 20
Table 2.2: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2010 20
Table 2.3: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 29
Table 2.4: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 31
Table 2.5: Prevalence of Complications Among Patients with Diabetes 31
Table 2.6: Major Causes of End-Stage Renal Disease 31
Table 2.7: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart
Disease in Type 2 Diabetes Mellitus 32
Table 2.8: Clinical Recommendations for Adults with Diabetes 34
Table 2.9: Laboratory Assessment of Diabetic Vascular Disease 34
Table 2.10: Average Years Gained Free of Diabetes-Related Disease with Intensive Management
34
Table 2.11: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the
U.S.,
2010 36
Table 2.12: Cost of Diagnosed Diabetes in the U.S., 2012 38
Table 2.13: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 40
Table 2.14: Healthcare Utilization by Diabetic Patients, 2012 40
Table 3.1: Comprehensive Glucose Testing Market in the U.S. (Includes Reagents and Supplies in
the Self-Testing and Professional Markets), 2012-2018 45
Table 3.2: U.S. Blood Glucose Reagent Strip Market (Includes Both Self-Testing and Professional
Markets),

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2012-2018 45
Table 3.3: Market for Glucose Self-Testing in the U.S. (Includes Meters, Strips and Lancets), 2012-
2018 46
Table 3.4: Market Share of U.S. Blood Glucose Self-Testing, 2013 47
Table 3.5: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages 47
Table 3.6: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 48
Table 3.7: Demographic Characteristics Glucose Self-Testing Kit Buyers 49
Table 3.8: Top Brand Preferences for Glucose Self-Testing Kits 49
Table 3.9: Instances when Patients Prefer Professionals Glucose Testing 49
Table 3.10: Advantages of a Glucose Self-Testing Kit 49
Table 3.11: Disadvantages of Using a Glucose Self-Testing Kit 50
Table 3.12: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-
Testing
Kits 50
Table 3.13: Customer PrioritiesGlucose Meter Self-Testing Market, 2001, 2006 and 2013 50
Table 3.14: Market for Total Professional Glucose Testing (Central Laboratory and Hospital POC
& POL) in the U.S., 2012-2018 51
Table 3.15: U.S. Revenues for Professional POC Blood Glucose Monitoring (Hospital & POL),
2012-2018 51
Table 3.16: U.S. Continuous Glucose Monitoring Market, 2012-2018 51
Table 3.17: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Glucose Point of Care Market 57
Table 3.18: Key Market Drivers for Glucose Testing 58
Table 3.19: Point of Care Glucose Testing Market: Market Drivers Ranked in Order of Impact 58
Table 3.20: Market Drivers for Continuous Glucose Monitoring 59
Table 3.21: Key Market Restraints for Glucose Testing 60
Table 3.22: Market Restraints for Continuous Glucose Monitoring 60
Table 3.23: Point of Care Glucose Testing Market: Market Restraints Ranked in Order of Impact 60
Table 4.1: Criteria for the Diagnosis of Diabetes 68
Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 68
Table 4.3: Normal Glucose ValuesFasting State 69
Table 4.4: Criteria for Testing for Diabetes in Asymptomatic Adults 69
Table 4.5: Criteria for Type 2 Diabetes in Asymptomatic Children 70
Table 4.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM) 71

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Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 73
Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes 73
Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-Existing Diabetes 73
Table 4.10: Plasma Blood Glucose and A1c Goals for Type 1 Diabetes by Age-Group 73
Table 4.11: Glucose Monitoring Recommendations 75
Table 4.12: Key Issues for SMBG in Insulin-Independent Type 2 Diabetics 76
Table 4.13: A1c Testing Recommendations 78
Table 4.14: Correlation of A1c with Mean Blood Glucose 78
Table 4.15: Glucose Monitoring Recommendations for Hospital Settings 80
Table 4.16: Glycemic Goals for Hospital Patients 81
Table 5.1: Analytic Performance Criteria for Glucose Meters 89
Table 5.2: Potential Variables Affecting Glucose Concentrations 95
Table 5.3: Key Features Considered for Glucose Testing Devices 97
Table 5.4: Common User Errors Made While Self-Testing for Blood Glucose 99
Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin PD Solution 102
Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters 104
Table 5.7: Features Required for Safe and Effective Meters for Hospital Settings 105
Table 5.8: Key Features Considered for Reagent Test Strips 107
Table 5.9: Differences between Laboratory Instruments for Glucose Analysis and Hand-Held Blood
Glucose Meters 107
Table 5.10: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels 113
Table 5.11: Unit Sales of Homecare Lancets in the U.S., 2012-2017 117
Table 5.12: Unit Sales of Homecare Lancets in the E.U., 2012-2017 117
Table 5.13: Dollar Sales of Homecare Lancets in the U.S., 2012-2017 117
Table 5.14: Dollar Sales of Homecare Lancets in the E.U., 2012-2017 118
Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2012-2017 118
Table 5.16: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2012-2017 118
Table 5.17: Competition in the Lancet Market Segment 119
Table 5.18: Limitations of Urine Glucose Monitoring 123
Table 5.19: Advantages of Urine Glucose Monitoring 123
Table 5.20: Blood Ketone Reading Indications 124
Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time, and Other Features
126
Table 6.2: Point of Care Blood Glucose or Blood Gas Meters Marketed for Professional Use 155

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Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays 162
Table 6.4: Detailed Features of Selected CGM Systems Currently Available 173
Table 6.5: Non-Invasive Glucose Monitoring Systems in Development 181
Table 7.1: POC Procedural Advantages for Hospital Testing 198
Table 7.2: Financial Comparison for Moderate and Waived CLIA Labs 212
Table 8.1: Data Entry and Data Management Features to Include in Future Meters 217
Table 8.2: Leading Companies for Patient Monitoring Products 225
Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements 232


List of Figures

Figure 2.1: Annual Number of New Cases of Diagnosed Diabetes Among U.S. Adults Aged 18-79
Years,
1980-2011 19
Figure 2.2: Diagnosed Diabetes by Age in the U.S., 2013 19
Figure 2.3: Number of Deaths from Diabetes by Age in the U.S., 2010 22
Figure 2.4: Number of Diabetes Deaths by Race and Sex in the U.S., 2010 22
Figure 2.5: Maintenance of Normal Blood Sugar Levels 23
Figure 2.6: Prevalence of Self-Reported Obesity (BMI 30) Among U.S. Adults, 2012 27
Figure 2.7: Prevalence of Obesity Among Adults in the U.S., 2009-2010 27
Figure 2.8: Trends in Obesity Among Children and Adolescents in the U.S., 1988-2010 28
Figure 2.9: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or Older Reporting
Heart Disease or Stroke, by Sex, in the U.S., 1997-2011 30
Figure 2.10: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation,
by Age, in the U.S., 1997-2011 32
Figure 2.11: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes
Reporting Visual Impairment, in the U.S., 1997-2011 33
Figure 2.12: How Diabetes Dollars are Spent in the U.S., 2012 39
Figure 2.13: Percent of Medical Condition-Specific Expenditures Associated with Diabetes, 2012
41
Figure 3.1: Forecasted Test Strip Usage by Different Diabetic Populations 46
Figure 4.1: Approach to Management of Hypoglycemia 74
Figure 4.2: Glycemic StatusRanges and Health Implications 79

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Figure 5.1: EGA Zones of Clinical Accuracy 94
Figure 5.2: Single-Day Continuous Blood Glucose Data 99
Figure 5.3: Factors that may Adversely Affect Glucose Testing 101
Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2013 118
Figure 6.1: Medtronics Threshold Suspend Feature 175


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