U.S. Glucose Testing Markets

Publisher Name :
Date:1-Jul-2014
No. of pages: 268

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, doctor’s 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 company’s market position. Detailed tables and charts with sales forecasts and market data are also included.

U.S. Glucose Testing Markets

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
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
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 4(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
54.6.2.5 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
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
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
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
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 Medtronic’s Continuous Glucose Monitoring Systems (CGMS) 173
6.4.2 DexCom, Inc. G4 Platinum Continuous Glucose Monitoring System 176
6.4.3 FreeStyle Navigator—Abbott’s 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
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 Medtronic’s MiniMed 530G with Enlite Sensor Technology 186
6.7.3 Contour Next Link Meter Approved for Use with Medtronic’s New MiniMed 530G with Enlite Insulin Pump System 187
6.7.4 Roche’s 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 β-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 Bayer’s Contour Next EZ 188
6.7.10 Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook App 188
6.7.11 Sanofi-Aventis’s 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 Abbott’s 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 Johnson’s 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 University’s Bionic Pancreas Project  191
6.9 Recent Industry Activity  191
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 FlexSite’s 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
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 FDA’s Artificial Pancreas Guidance Document 215

8. Technology Trends 216
8.1 Improving Today’s 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 Alere’s 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
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
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
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), 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 Professional’s 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 Priorities—Glucose 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 Values—Fasting 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
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
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 Status—Ranges and Health Implications  79
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: Medtronic’s Threshold Suspend Feature  175

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    Published: 1-Mar-2014        Price: US $2400 Onwards        Pages: 150
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