Blood Glucose Testing and Diabetes Management

Publisher Name :
Date: 01-May-2014
No. of pages: 311

There has been a dramatic increase in the incidence of diabetes worldwide, which has been exacerbated by the growing obesity problem across the globe. Once thought of as primarily a childhood disease--sometimes referred to as juvenile diabetes, now mostly Type 1 diabetes--the obesity crisis linked to the adoption of a high-fat, high-carbohydrate, high-calorie American diet has resulted in skyrocketing rates of diabetes, particularly Type 2 diabetes, among adults across the world. As such, the global market for blood glucose testing products is undergoing a significant transition driven by the advent of new analytical technologies and developments in diabetes treatment. Although the blood glucose testing segment of the in vitro diagnostics (IVD) industry is mature, certain segments of the market, such as home testing devices for diabetes management, will exhibit strong growth. What’s more, non-invasive testing now represents a major new area for the application of IVD testing. Additionally, direct access testing--or over-the-counter testing, which allows consumers to order tests themselves without visiting a doctor--has emerged as a strong force in the blood glucose testing segment. The purpose of this TriMark Publications report is to describe the specific market segments for blood glucose testing and diabetes management. This study reviews all of the generally-accepted clinical analytical methods that are currently in use today for measuring serum or plasma or whole-blood glucose concentrations. Moreover, it examines clinical measurement devices, reagents and supplies as utilized in hospitals, clinics, doctor’s offices and at-home care locations. The report has made a survey of selected companies marketing, manufacturing or developing various blood glucose testing and diabetes management supplies throughout the world. 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 share data are also included.

Blood Glucose Testing and Diabetes Management

Table of Contents

1. Overview 15
1.1 Statement of Report 15
1.2 About this Report 15
1.3 Scope of the Report 16
1.4 Methodology 17
1.5 Executive Summary 18

2. Diabetes 21
2.1 Demographics of Diabetes 22
2.1.1 Worldwide Diabetes Incidence 22
2.1.2 Diabetes in the U.S. 26
2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 31
2.2.1 Pre-Diabetes Syndrome 32
2.2.2 Metabolic Syndrome 32
2.2.3 Progression of Diabetes 32
2.2.4 Diabetes and Inflammation 33
2.2.5 Risk Factors and Diabetes 33
2.2.5.1 Obesity 34
2.2.5.2 Stress-Induced Hyperglycemia 36
2.2.6 Complications and Co-Morbidities in Diabetes 37
2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes 41
2.2.6.2 Cardiovascular Disease Facts 42
2.3 Economics of Diabetes 45
2.3.1 Worldwide Costs of Diabetes 46
2.3.2 Costs of Diabetes in the U.S. 46

3. Market Analysis: Size, Growth, Share and Competitors 51
3.1 Worldwide Glucose Testing Market 52
3.1.1 Global Blood Glucose Self-Testing Market 54
3.1.2 Worldwide Professional Blood Glucose Testing Market 57
3.1.3 Continuous Glucose Monitoring Markets 58
3.2 U.S. Market 59
3.2.1 U.S. Over-the-Counter (OTC) Self-Testing Glucose Market 60
3.2.2 U.S. Professional Glucose Testing Market 64
3.3 European Market 65
3.4 Asian Market 66
3.4.1 Japanese Market 68
3.4.2 Chinese Market 69
3.4.3 Indian Market 71
3.4.4 Korean Market 72
3.4.5 Southeast Asian Market 73
3.4.6 ROW Markets 74
3.5 Competitive Situation 74
3.5.1 Key Players in the Self-testing Market 74
3.5.2 Analyses of the Self-testing Market Conditions, Competition and Product Mix 75
3.5.3 Analyses of the Professional Blood Glucose Monitoring Market 78
3.6 Market Drivers and Restraints 80
3.6.1 Market Drivers 80
3.6.2 Market Restraints 82
3.7 Market and Product Trends 84
3.7.1 Market Trends 85
3.7.2 Technology Trends 86
3.8 Strategic Recommendations 87
3.9 Competitive Strategies 89
3.10 New Opportunities in the Professional Blood Glucose Meter Market 90
3.11 Adjacent Markets 91

4. Glucose Diagnostic and Monitoring Recommendations 92
4.1 Diagnosis of Diabetes Mellitus 92
4.2 Tight Glucose Control in Treating Diabetes 95
4.2.1 Tight Glucose Control Lowers Cardiovascular Complications 96
4.3 Recommendations for Glucose Control in Diabetic Patients 96
4.3.1 New Plasma Blood Sugar and HbA1c Target Recommendation for Children with Type 1 Diabetes 97
4.3.2 Recommended Frequency of Blood Glucose Testing 99
4.3.3 Using Blood Glucose Data to Monitor and Modify Patient Therapy 99
4.3.4 Testing in Individuals with Type 2 Diabetes 100
4.3.5 Continuous Glucose Monitoring (CGM) 101
4.3.6 A1c Testing Recommendations 102
4.3.7 Blood Glucose Testing for All Hospitalized Patients According to Guidelines by The Endocrine Society 103
4.4 Hypoglycemia and Treatment 104

5. Glucose Testing Technology Platforms and Consumable Products 106
5.1 Types of Glucose Determination Technologies 106
5.2 Enzymatic Reactions Used to Determine Glucose Concentrations 107
5.2.1 Glucose Oxidase (GOX) 107
5.2.2 Glucose Dehydrogenase (GDH) 108
5.2.2.1 GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide) 108
5.2.2.2 GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide) 108
5.2.2.3 GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone) 108
5.2.3 Glucose Hexokinase 109
5.3 Development of Blood Glucose Monitors: A Historical Evaluation 109
5.3.1 First Generation Blood Glucose Biosensors 109
5.3.2 Second Generation Blood Glucose Biosensors 109
5.3.3 Third Generation Blood Glucose Biosensor 110
5.4 Accuracy and Precision in Glucose Meters 110
5.4.1 Clinical and Laboratory Standards Institute (CLSI) POCT12–A3 111
5.4.2 International Organization for Standardization (ISO) 15197:2013 112
5.4.3 FDA Guidelines for Blood Glucose Testing Systems 112
5.4.4 Determining Clinical Accuracy Using the Error Grid Analysis (EGA) 115
5.4.5 Quality Control Criteria 116
5.4.6 Potential Variables Affecting Glucose Concentrations 117
5.5 Key Issues for Glucose Testing Devices 117
5.5.1 Important Elements for Glucose Testing 118
5.5.2 Key Features to Aid Specific Patient Populations 119
5.6 Limitations of Existing Glucose Testing 120
5.6.1 Common User Errors in Glucose Self-Testing 121
5.6.2 Interfering Substances and Conditions 122
5.6.2.1 Environmental 122
5.6.2.2 Physiologic 122
5.6.2.3 Operational 122
5.6.2.4 Manufacturing Variations 122
5.6.2.5 Drugs/Medications 122
5.6.2.6 Patient Factors 122
5.6.3 Errors Associated with GDH-PQQ Technology 123
5.6.4 Optimizing of Point-of-Care (POC) Blood Glucose Testing 126
5.7 Potential Areas of Improvement in Blood Glucose Meter Performance 126
5.7.1 Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems 128
5.8 Blood Glucose Reagent Test Strips 129
5.9 Comparison of Hand-Held Blood Glucose Meters with Clinical Laboratory Glucose Measurements 130
5.10 Continuous Glucose Monitoring Technology 130
5.10.1 Advantages of Continuous Readings 130
5.10.2 FDA Approval of CGM 131
5.10.3 CGM Functions to Consider 131
5.10.4 New Technologies for CGM 132
5.11 Summary of Technologies Being Explored for Non-invasive Glucose Monitoring 133
5.11.1 GlucoTrack 133
5.11.2 Non-invasive Glucose Monitoring Technologies in Development 133
5.11.3 Goals of Non-Invasive Testing 134
5.11.4 Non-Invasive Diabetes Screening Test 135
5.12 A1c Monitoring Technology 135
5.12.1 PTS Diagnostics’ (Chek Diagnostics’) A1c Home Test 136
5.13 Fructosamine Test 137
5.14 Related Reagents and Equipment 138
5.14.1 Lancets 138
5.14.1.1 Types of Lancing Devices 138
5.14.1.2 Market Size 139
5.14.2 Control Solutions and Calibrators 144
5.14.3 Sharps Devices 144
5.14.4 Needle Destruction Devices 145
5.14.5 Urine Strips 145
5.14.6 Ketone Testing 147
5.14.7 Long-term Glucose Sensing Bio-implants 148

6. Glucose Testing Devices on the Market 149
6.1 Hand-Held Blood Glucose Meters and Strips for Self-testing 149
6.1.1 LifeScan 153
6.1.2 Roche Diagnostics Corporation 155
6.1.3 Bayer 157
6.1.4 Abbott (MediSense) 159
6.1.5 AgaMatrix, Inc. 161
6.1.6 ARKRAY, Inc. 162
6.1.7 Bionime Corporation 163
6.1.8 BioSense Medical Devices 165
6.1.9 CVS/pharmacy 165
6.1.10 Diabetic Supply of Suncoast 166
6.1.11 Entra Health Systems 166
6.1.12 Fifty50 Pharmacy 166
6.1.13 Fora Care 167
6.1.14 Genesis Health Technologies 167
6.1.15 GlucoCom 167
6.1.16 iHealth 168
6.1.17 Infopia 168
6.1.18 Livongo Health 169
6.1.19 Nipro Diagnostics, Inc. 169
6.1.20 Nova Biomedical 170
6.1.21 Oak Tree International Holdings, Inc. 171
6.1.22 Omnis Health 171
6.1.23 Phylosis 172
6.1.24 Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.) 172
6.1.25 Sanofi 173
6.1.26 Target 173
6.1.27 Telcare 173
6.1.28 Tyson Biomedical 174
6.1.29 US Diagnostics 174
6.1.30 Walgreens 175
6.1.31 Walmart 175
6.1.32 77 Elektronika Kft. 175
6.1.33 A. Menarini Diagnostics 176
6.1.34 All Medicus 176
6.1.35 i-SENS 176
6.1.36 Apex Biotechnology Corp. 177
6.1.37 Glucoplus, Inc. 177
6.1.38 Polymer Technology Systems 177
6.1.39 Smiths Medical MD, Inc. 177
6.1.40 TaiDoc Technology Corp. 178
6.1.41 IN4 Technology Corporation 178
6.1.42 ACON Laboratories 178
6.1.43 Pepex Biomedical 179
6.1.44 HMD BioMedical 179
6.1.45 BTNX 179
6.1.46 Decision Diagnostics Corporation and Pharma Tech Solutions 179
6.2 Point of Care Blood Glucose Meters for Professional Use 180
6.2.1 Abbott 183
6.2.1.1 Precision Xceed ProÒ Blood Glucose and Beta-Ketone Monitoring System 183
6.2.1.2 i-STATÒ System 183
6.2.2 Alere 184
6.2.2.1 epoc® Blood Analysis System 184
6.2.2.2 Alere Cholestech LDX System 184
6.2.3 Apex Biotechnology 184
6.2.4 ARKRAY 185
6.2.4.1 AssureÒ Platinum and Assure Prism Multi 185
6.2.5 EKF Diagnostics 185
6.2.5.1 Biosen Series of Glucose and Lactate Analyzers 185
6.2.6 Fora Care 185
6.2.6.1 VSM100 Pro Vital Sign Monitor 185
6.2.7 HemoCue (part of Radiometer) 186
6.2.7.1 HemoCueÒ Glucose 201+, Glucose 201 RT, Glucose 201 DM, and Glucose DM RT Systems 186
6.2.8 HMD BioMedical 186
6.2.8.1 NS101 186
6.2.9 Infopia 186
6.2.9.1 Lipid Pro 186
6.2.10 Jant Pharmacal 187
6.2.10.1 LipidPlus® Lipid Profile and Glucose Measuring System 187
6.2.11 Medtronic 187
6.2.11.1 iPro™ Continuous Glucose Monitor 187
6.2.12 Nova Biomedical 188
6.2.12.1 StatStripÒ Hospital Glucose Monitoring System 188
6.2.13 Polymer Technology Systems 188
6.2.13.1 CardioChek® PA Point-of-Care Device 188
6.2.14 Roche 188
6.2.14.1 Accu-ChekÒ Inform II System 188
6.2.14.2 AccutrendÒ Plus System 188
6.2.15 Techno Medica Co., Ltd 189
6.2.15.1 GASTAT-mini 189
6.2.16 LifeScan 189
6.3 Clinical Blood Chemistry Analyzers 189
6.3.1 Abaxis, Inc. 191
6.3.1.1 Piccolo® Xpress Blood Chemistry Analyzers 191
6.3.2 Abbott 192
6.3.2.1 ARCHITECT 192
6.3.3 Alere 192
6.3.3.1 Cholestech LDX® System 192
6.3.4 AMS 192
6.3.4.1 SAT 600 192
6.3.4.2 SAT 450 192
6.3.4.3 LIASYS 192
6.3.4.4 ELLIPSE 193
6.3.4.5 NEPHYS 193
6.3.4.6 VEGASYS 193
6.3.5 ARKRAY, Inc. 193
6.3.5.1 SPOTCHEM™ EZ 193
6.3.5.2 SPOTCHEM D-02 (SD-4810) & SPOTCHEM D-03 (SD-4820) 193
6.3.6 Beckman Coulter 193
6.3.6.1 AU chemistry systems 193
6.3.6.2 UniCel® DxC chemistry systems 193
6.3.7 DiaSys 194
6.3.7.1 InnovaStar® 194
6.3.7.2 SensoStar GL30 touch and SensoStar GLHsix 194
6.3.7.3 respons® 910 and 920 194
6.3.7.4 BioMajesty® JCA-BM6010/C 194
6.3.8 Diatron 194
6.3.8.1 Pictus 500 194
6.3.8.2 Pictus 700 194
6.3.8.3 Pictus 400 194
6.3.8.4 Pictus 200 195
6.3.8.5 Pictus B 195
6.3.9 Instrumentation Laboratory 195
6.3.9.1 IL GEM Premier 4000, 3500 and 3000 195
6.3.10 LifeHealth (formerly International Techidyne Corporation) 195
6.3.10.1 IRMA TruPoint® 195
6.3.11 Nova Biomedical 196
6.3.11.1 Nova Electrolyte/Chemistry Analyzers 196
6.3.11.2 Stat Profile® Critical Care Xpress 196
6.3.11.3 Stat Profile® pHOx® Plus 196
6.3.11.5 Stat Profile® pHOx® Ultra 196
6.3.12 Radiometer™ 196
6.3.12.1 ABL™80 FLEX 196
6.3.12.2 ABL™90 FLEX 197
6.3.12.3 ABL™800 FLEX 197
6.3.13 Randox Laboratories 197
6.3.13.1 RX Series of clinical chemistry analyzers 197
6.3.14 Roche 198
6.3.14.1 cobas® 4000, cobas® 6000, and cobas® 8000 modular Analyzer Series 198
6.3.14.2 cobas® c 111 Analyzer 198
6.3.14.3 cobas® b 221 System 198
6.3.14.4 Reflotron® Systems 198
6.3.15 Siemens Healthcare Diagnostics 198
6.3.15.1 Point-of-care Blood Gas Analyzers 199
6.3.15.2 Central (Core) Laboratory Clinical Chemistry Systems 199
6.3.16 Span Diagnostics 201
6.3.16.1 Autochem Xact 201
6.3.16.2 BT 1500 201
6.3.17 Stanbio Laboratory 201
6.3.17.1 Excel Semi-Automated Clinical Chemistry Analyzer 201
6.3.17.2 Sirrus® Clinical Chemistry Analyzer 201
6.3.18 Techno Medica Co., Ltd 202
6.3.19 Thermo Fisher Scientific 202
6.3.19.1 Indiko™ Clinical and Specialty Chemistry System 202
6.3.19.2 Indiko™ Plus Clinical and Specialty Chemistry System 202
6.3.19.3 Konelab™ 20XT Clinical Chemistry Analyzer 202
6.3.19.4 Konelab™ PRIME 60 Clinical Chemistry Analyzer 202
6.3.19.5 MGC 240 Benchtop Analyzer 202
6.3.20 Tokyo Boeki Medisys 202
6.3.20.1 BiOLis family of analyzers 202
6.3.21 YSI Life Sciences 202
6.3.21.1 YSI 2300 STAT Plus™ Glucose & Lactate Analyzer 202
6.4 Continuous Glucose Patient Monitoring Systems 203
6.4.1 Medtronic’s Continuous Glucose Monitoring Systems (CGMS) 205
6.4.1.1 MiniMed Paradigm REAL-Time Revel System 205
6.4.1.2 Guardian REAL-Time 206
6.4.1.3 MiniMed 530G with Enlite 207
6.4.1.4 iPro®2 Professional CGM 208
6.4.2 Dexcom, Inc.’s Continuous Glucose Monitoring System 208
6.4.2.1 G4 Platinum Continuous Glucose Monitoring System 208
6.4.2.2 Dexcom G4 Platinum Continuous Glucose Monitoring System with Share 209
6.4.2.3 Dexcom G5 Mobile Continuous Glucose Monitoring System 209
6.4.3 Animas Vibe System 209
6.4.4 Abbott’s Continuous Glucose Monitor System 210
6.4.4.1 FreeStyle Libre 210
6.4.4.2 FreeStyle Navigator (discontinued) 210
6.4.5 GlucoDay® S Continuous Glucose Monitor 211
6.4.6 Minimally-Invasive Continuous Glucose Monitors in Development 211
6.4.6.1 GlySens Inc. 211
6.4.6.2 Senseonics (formerly Sensors for Medicine and Science) 212
6.4.6.3 Ultradian 213
6.5 Non-Invasive Glucose Patient Monitoring Systems 213
6.5.1 Cygnus GlucoWatch Biographer 214
6.5.2 AiMedics 214
6.5.3 Echo Therapeutics 214
6.5.4 EyeSense GmbH 215
6.5.5 Freedom Meditech 216
6.5.6 Google and Novartis 216
6.5.7 Integrity Applications Ltd. 216
6.5.8 Lein Applied Diagnostics 217
6.5.9 LighTouch Medical 217
6.3.10 Miraculins, Inc. 217
6.5.11 Xhale Inc. 218
6.6 A1c Testing 218
6.7 New Product Launches 219
6.7.1 OneTouch® Verio®Sync Blood Glucose Monitoring System 219
6.7.2 Medtronic's MiniMed 530G with Enlite Sensor Technology 219
6.7.3 Contour Next Link Meter Approved for Use with Medtronic’s New MiniMed 530G with Enlite Insulin Pump System 219
6.7.4 Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System 220
6.7.5 Abbott Receives FDA Clearance for FreeStyle Precision Pro Blood Glucose and ß–Ketone Monitoring System 220
6.7.6 LabStyle Innovations’ Dario Diabetes Management System 220
6.7.7 BlueStar by WellDoc 220
6.7.8 FDA Approves Bayer’s Contour Next EZ 221
6.7.9 Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook App 221
6.7.10 Sanofi-Aventis’s iBGStar 221
6.7.11 iHealth Glucose Meter Device 222
6.7.12 MyGlucoHealth® Diabetes 222
6.7.13 Enlite™ Sensor 222
6.7.14 Medtronic Gains Approval of First Artificial Pancreas Device System, the MiniMed® 530G with Enlite® 223
6.7.15 Nipro Diagnostics TrueMetrix Air 223
6.7.16 Animas Vibe System 223
6.7.17 Abbott’s FreeStyle Libre and FreeStyle Libre Pro 223
6.7.18 Abbott’s FreeStyle Precision Neo Blood Glucose Monitoring System 224
6.7.19 Dexcom G4 Platinum Continuous Glucose Monitoring System with Share 224
6.7.20 Medtronic’s MiniMed Connect 224
6.7.21 Dexcom G5 Mobile CGM System 224
6.8 Blood Glucose Meters, CGMs, and Data Management Software in Development 225
6.8.1 Abbott’s Flash Glucose Monitoring System 225
6.8.2 Google Announces Plan to Create Contact Lens Glucose Sensors 225
6.8.3 Socrates Health Solutions’ Companion Blood Glucose Monitor 225
6.8.4 Boston University’s Bionic Pancreas Project 225
6.8.5 IGI Stat’s Test to Identify Type 1 Diabetes 226
6.8.6 Medtronic’s Next-generation Combination Pump and CGM 226
6.8.7 Medtronic and IBM’s Watson Health to Develop Data Management Solutions 226
6.9 Recent Industry Activity 227
6.9.1 Roche Diagnostics Corp. Cutting Jobs in Diabetes Division 227
6.9.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 227
6.9.3 LifeScan Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed 227
6.9.4 Medtronic and Bayer Healthcare Expand International Alliance 227
6.9.5 PositiveID Corporation Licenses iglucose Technology to Smart Glucose Meter Corp 227
6.9.6 BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for Both CGM and Pump 228
6.9.7 Court Sides with Decision Diagnostics in Patent Infringment Case 228
6.9.8 Senseonics Partners with Rubin Medical to Commercialize New CGM 228
6.9.9 Abbott re-entering Continuous Glucose Monitoring Market in Europe with FreeStyle Libre 228
6.9.10 Medtronic and IBM’s Watson Health Partnering to Develop Personalized Diabetes Management Solutions 228
6.10 M&A Activity 229
6.10.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to Become Nipro Diagnostics, Inc. 229
6.10.2 Medtronic, Inc. Acquires New Diabetes Technology from PreciSense AS 229
6.10.3 Geonostics Acquires FlexSite's Consumer Diabetes Tests 230
6.10.4 Radiometer Medical Acquires Hemocue 230
6.10.5 Additional M&A 230
6.10.6 Important Deals in BGM market 231

7. Business Trends in Glucose Testing 233
7.1 Drivers of Clinical Glucose Testing 233
7.2 Competition for Professional POC Glucose Testing 233
7.3 Healthcare Cost Controls 233
7.4 Changes in Patient Management 234
7.5 Regionalization of Laboratory Care 234
7.6 Satellite Facilities 235
7.7 Professional Point-of-Care Testing 235
7.8 Factors Affecting OTC Medical Product Distribution 236
7.9 Drug Stores Critical to the Diabetic Care Category 238
7.10 Drivers of OTC and Self-Testing Markets 238
7.10.1 Brand Loyalty 238
7.11 Cost Elements of Glucose Self-Testing 239
7.12 Costs of Doing Business in Europe 239
7.13 Drivers of European Diagnostics Testing 240
7.14 Cost Containment in Europe 240
7.15 Blood Glucose Self-Testing Insurance Coverage and Reimbursement 240
7.15.1 American OTC Testing and Self-Testing Reimbursement 240
7.15.2 European Reimbursement 243
7.16 Reimbursement Challenges 244
7.16.1 New Medicare Part B 244
7.17 Managed Care 244
7.18 Government Regulation of Medical Devices 245
7.18.1 U.S. Regulations 245
7.18.2 E.U. Regulations 248
7.18.3 U.K. Regulations 253
7.19 Clinical Laboratory Improvement Act (CLIA) 254
7.19.1 Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems 256
7.20 FDA Labeling Requirements 256
7.21 Legal Liability for Glucose Meters 258
7.22 FDA’s Artificial Pancreas Guidance Document 258

8. Technology Trends 259
8.1 Improving Today’s Over-The-Counter (OTC) Blood Glucose Meters 259
8.2 Biosensor Technology 260
8.3 Artificial Pancreas 262
8.4 Telemedicine 263
8.4.1 Remote Patient Monitoring 266
8.4.1.1 Infopia Eocene System 268
8.4.1.2 Health Buddy Systems Monitoring Technologies 269
8.4.1.3 GlucoCom Glucose Monitoring System 269
8.4.1.4 Alere’s DayLink® Monitor 269
8.4.1.5 Alere HomeLink Receives FDA Approval for Over-the-Counter Use 269
8.4.1.6 iGlucose System 270
8.5 Non-Traditional Methods for Sample Collection 270
8.6 Data Management 271
8.6.1 Medical Device Radiocommunications Service (MedRadio) 271
8.6.2 Connectivity 271
8.6.3 Advantages of Connectivity 273
8.6.4 Connectivity Platforms 273
8.6.5 DataLink Data Management System 274
8.6.6 RALS-Plus 275
8.6.7 FDA Required Software Verification 275
8.6.8 Information Management Advances 276
8.6.9 POL Laboratory Data Management 277
8.6.9.1 Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software 278
8.6.9.2 Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System 279
8.6.9.3 Technical Problems of Connectivity 280
8.6.9.4 Web-Based Data Interface 280
8.6.10 HIT Competition 280

9. Company Profiles 282
9.1 A. Menarini Diagnostics 282
9.2 Abaxis, Inc. 282
9.3 Abbott Laboratories 283
9.4 ACON Laboratories 286
9.5 AgaMatrix 287
9.6 Alere 287
9.7 All Medicus 287
9.8 AMS Alliance 287
9.9 Apex Biotechnology Corporation 288
9.10 ARKRAY USA 288
9.11 Bayer 288
9.12 B. Braun Melsungen 290
9.13 Beckman Coulter 290
9.14 Bionime 295
9.15 Bio-Rad Laboratories, Inc. 295
9.16 Cambridge Sensors 296
9.17 Cardiocom 296
9.18 DexCom 296
9.19 Diagnostic Devices/Prodigy Diabetes Care 297
9.20 DiaSys 297
9.21 Diatron 297
9.22 Echo Therapeutics 297
9.23 Entra Health Systems 298
9.24 Fora Care 299
9.25 FIFTY50 Medical, Inc. 299
9.26 Genesis Health Technologies 299
9.27 GenExel-Sein 299
9.28 GlucoPlus 299
9.29 GlySens 299
9.30 Hainice Medical 300
9.31 HemoCue (a Quest Diagnostics company) 300
9.32 Home Diagnostics 300
9.33 Infopia 300
9.34 IN4 Technology 301
9.35 Integrity Applications 301
9.36 International Techidyne Corporation (ITC) 301
9.37 Instrumentation Laboratory Company 301
9.38 i-Sens 301
9.39 Jant Pharmacal 302
9.40 Johnson & Johnson 302
9.41 LabStyle Innovations Corporation 303
9.42 LifeHealth, LLC 304
9.43 Medtronic 304
9.44 Miraculins 305
9.45 Nipro Diagnostics 305
9.46 Nova Biomedical 305
9.47 Polymer Technology Systems 306
9.48 Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.) 306
9.49 Radiometer Medical 307
9.50 Roche Diagnostics 307
9.51 Senseonics 309
9.52 77 Elektronika Kft. 309
9.53 Siemens AG 310
9.54 Smiths Group 310
9.55 TaiDoc Technology 311
9.56 Techno Medica Co., Ltd. 311
9.57 Telcare 311
9.58 Tokyo Boeki Medisys 311
9.59 US Diagnostics 312
9.60 Ypsomed Holding 312
9.61 YSI Life Sciences 312

List of Tables

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions 23
Table 2.2: Countries with the Largest Numbers of Diabetics 24
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics 24
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group 25
Table 2.5: Countries with the Largest Number of Deaths Attributable to Diabetes 25
Table 2.6: U.S. Population of Diagnosed Diabetics Aged 20 - 79 Years 27
Table 2.7: Percentage of U.S. Adults with Diagnosed Diabetes by State 28
Table 2.8: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 37
Table 2.9: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 39
Table 2.10: Prevalence of Complications Among Patients with Diabetes 39
Table 2.11: Major Causes of End-stage Renal Disease 39
Table 2.12: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 40
Table 2.13: Clinical Recommendations for Adults with Diabetes 41
Table 2.14: Laboratory Assessment of Diabetic Vascular Disease 42
Table 2.15: Average Years Gained Free of Diabetes-related Disease with Intensive Management 42
Table 2.16: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S. 44
Table 2.17: Cost of Diagnosed Diabetes in the U.S. 47
Table 2.18: Annual Cost of Care of United Healthcare Adult Members with Diabetes 48
Table 2.19: Healthcare Utilization by Diabetic Patients 49
Table 3.1: Worldwide Comprehensive Glucose Testing Market (includes reagents and supplies in both the Self-testing and Professional Markets in $ Billions), 2013-2019 53
Table 3.2: Total Global Unit Demand for Glucose Testing Reagent Strips 54
Table 3.3: Global Dollar Sales of Glucose Testing Reagent Strips 54
Table 3.4: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, and Lancets) 55
Table 3.5: World Market Share of Glucose Self-testing Marketers 57
Table 3.6: Global Revenues for Total Professional Blood Glucose Monitoring (Central Laboratory Testing and Hospital POC & POL) 57
Table 3.7: Global Revenues for Professional Point-of-Care Blood Glucose Monitoring Systems (within Hospitals and Physician’s Offices) 58
Table 3.8: Global Revenues for Continuous Glucose Monitoring Systems 58
Table 3.9: Comprehensive Glucose Testing Market in the U.S. (includes reagents and supplies in the Self-testing and Professional Markets) 59
Table 3.10: U.S. Blood Glucose Reagent Strip Market (includes both Self-testing and Professional Markets) 60
Table 3.11: Market for Glucose Self-Testing in the U.S. (includes Meters, Strips, and Lancets) 60
Table 3.12: Market Share of U.S. Blood Glucose Self-Testing 61
Table 3.13: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages 61
Table 3.14: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 62
Table 3.15: Demographic Characteristics Glucose Self-Testing Kit Buyers 63
Table 3.16: Top Brand Preferences for Glucose Self-Testing Kits 63
Table 3.17: Instances when Patients Prefer Professional’s Glucose Testing 63
Table 3.18: Advantages of a Glucose Self-Testing Kit 63
Table 3.19: Disadvantages of Using a Glucose Self-Testing Kit 64
Table 3.20: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing Kits 64
Table 3.21: Customer Priorities—Glucose Meter Self-Testing Market, 2001, 2006 and 2014 64
Table 3.22: Market for Total Professional Glucose Testing (Central Laboratory and Hospital POC & POL) in the U.S., 2013-2019 64
Table 3.23: U.S. Revenues for Professional POC Blood Glucose Monitoring (Hospital & POL) 65
Table 3.24: European Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets) 66
Table 3.25: European Market for Glucose Self-Testing (includes Meters, Strips, and Lancets) 66
Table 3.26: Asian Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets) 67
Table 3.27: Asian Market for Glucose Self-Testing (includes Meters, Strips, and Lancets) 67
Table 3.28: Japanese Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets) 68
Table 3.29: Japanese Market for Glucose Self-Testing (includes Meters, Strips, and Lancets) 69
Table 3.30: Chinese Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets) 70
Table 3.31: Chinese Market for Glucose Self-Testing (includes Meters, Strips, and Lancets) 70
Table 3.32: Indian Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets) 72
Table 3.33: Indian Market for Glucose Self-Testing (includes Meters, Strips, and Lancets) 72
Table 3.34: Southeast Asian Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets 73
Table 3.35: Southeast Asian Market for Glucose Self-Testing (includes Meters, Strips, and Lancets) 73
Table 3.36: Southeast Asian Comprehensive Glucose Testing Market by Country 73
Table 3.37: Southeast Asian Market for Glucose Self-Testing by Country (includes Meters, Strips, and Lancets) 74
Table 3.38: ROW Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets) 74
Table 3.39: ROW Market for Glucose Self-Testing (includes Meters, Strips, and Lancets) 74
Professional POC 78
Table 3.40: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point-of-Care Market 80
Table 3.41: Key Market Drivers for Glucose Testing 81
Table 3.42: Market Drivers for Continuous Glucose Monitoring 81
Table 3.43: Point-of-Care Glucose Testing Market: Market Drivers Ranked in Order of Impact 82
Table 3.44: Key Market Restraints for Glucose Testing 83
Table 3.45: Market Restraints for Continuous Glucose Monitoring 83
Table 3.46: Point-of-Care Glucose Testing Market: Market Restraints Ranked in Order of Impact 83
Table 4.1: Criteria for the Diagnosis of Diabetes 92
Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 92
Table 4.3: Normal Glucose Values—Fasting State 93
Table 4.4: Criteria for Testing for Diabetes in Asymptomatic Adults 93
Table 4.5: Criteria for Type 2 Diabetes in Asymptomatic Children 94
Table 4.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM) 95
Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 97
Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes 97
Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes 97
Table 4.10: Plasma Blood Glucose and A1c Goals for Type 1 Diabetes by Age-group 98
Table 4.11: Glucose Monitoring Recommendations 99
Table 4.12: Key Issues for SMBG in Insulin-independent Type 2 Diabetics 101
Table 4.13: A1c Testing Recommendations 102
Table 4.14: Correlation of A1c with Mean Blood Glucose 102
Table 5.1: Analytic Performance Criteria for Glucose Meters 111
Table 5.2: Potential Variables Affecting Glucose Concentrations 117
Table 5.3: Key Features Considered for Glucose Testing Devices 119
Table 5.4: Common User Errors Made While Self-Testing for Blood Glucose 121
Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin Peritoneal Dialysis (PD) Solution 124
Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters 126
Table 5.7: Features Required For Safe and Effective Meters for Hospital Settings 127
Table 5.8: Key Features Considered for Reagent Test Strips 129
Table 5.9: Differences between Laboratory Instruments for Glucose Analysis and Hand-Held Blood Glucose Meters 130
Table 5.10: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels 135
Table 5.10: Unit Sales of Homecare Lancets in the U.S. 139
Table 5.11: Unit Sales of Homecare Lancets in the E.U. 140
Table 5.12: Dollar Sales of Homecare Lancets in the U.S. 140
Table 5.13: Dollar Sales of Homecare Lancets in the E.U. 140
Table 5.14: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S. 140
Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U. 141
Table 5.17: Competition in the Lancet Market Segment 142
Table 5.18: Limitations of Urine Glucose Monitoring 146
Table 5.19: Advantages of Urine Glucose Monitoring 147
Table 5.20: Blood Ketone Reading Indications 147
Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time, and Other Features 149
Table 6.2: Point of Care Blood Glucose or Blood Gas Meters Marketed for Professional Use 182
Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays 190
Table 6.2: Detailed Features of Selected CGM Systems Currently Available 204
Table 6.5: Non-Invasive Glucose Monitoring Systems in Development 213
Table 7.1: POC Procedural Advantages for Hospital Testing 233
Table 7.2: Financial Comparison for Moderate and Waived CLIA Labs 255
Table 8.1: Data Entry and Data Management Features to Include in Future Meters 260
Table 8.2: Leading Companies for Patient Monitoring Products 268
Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements 275

List of Figures

Figure 2.1: Worldwide Diabetes Cases, 2014 and 2035 22
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years) 23
Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age 27
Figure 2.4: Prevalence of Diabetes by Age in the U.S. 27
Figure 2.5: Diagnosed Diabetes by Age in the U.S. 28
Figure 2.6: Percentage of U.S. Adults Diagnosed Diabetes by State 29
Figure 2.7: Number of Deaths from Diabetes by Age in the U.S. 30
Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S. 30
Figure 2.9: Maintenance of Normal Blood Sugar Levels 31
Figure 2.10: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or
Older Reporting Heart Disease or Stroke, by Sex, in the U.S. 38
Figure 2.11: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, United States 40
Figure 2.12: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment, United States 41
Figure 2.13: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (USD) 46
Figure 2.14: How Diabetes Dollars are Spent in the U.S. 48
Figure 2.15: Percent of Medical Condition–specific Expenditures Associated with Diabetes 49
Figure 3.1: Global Unit Sales of Glucose Testing Reagent Strips 54
Figure 3.2: Geographic Segments of the Worldwide Glucose Self-testing Market, 2013 and 2019 55
Figure 3.3: Worldwide Glucose Self-Testing Market by Region 55
Figure 4.1: Approach to Management of Hypoglycemia 98
Figure 4.2: Glycemic Status—Ranges and Health Implications 105
Figure 5.1: EGA Zones of Clinical Accuracy 116
Figure 5.2: Single-Day Continuous Blood Glucose Data 121
Figure 5.3: Factors that May Adversely Affect Glucose Testing 123
Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region 141
Figure 6.1: Medtronic’s Threshold Suspend Feature 207

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