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World Glucose Self-Testing Markets

  • September 2015
  • -
  • TriMark Publications
  • -
  • 276 pages

The worldwide incidence of diabetes is dramatically increasing, and it is estimated that 439 million people will have developed the disease by 2030. As such, the global market for blood glucose self-testing products is undergoing a significant transition driven by the advent of new analytical technologies and new recommendations for tight glucose control for monitoring diabetes. In addition, the proliferation of the middle class within developing nations, particularly China and India, has resulted in both a substantial rise in Type 2 diabetes and the financial means to manage the disease. The purpose of this TriMark Publications report is to provide a comprehensive analysis of the specific segment of the over-the-counter diagnostics sector known as the glucose self-testing market. The term "self-testing" is used to distinguish it from in vitro diagnostics testing for blood glucose in hospitals, commercial labs and doctor's offices, the so-called "professional" component of the glucose testing market. This study reviews the viable technology drivers and assesses the market dynamics of the glucose self-testing market worldwide. This report also looks at the industry challenges and potential threats, and it makes strategic recommendations for boosting market share. Detailed tables and charts with sales forecasts and market share data are also included.

Table Of Contents

World Glucose Self-Testing Markets












TABLE OF CONTENTS



1. Overview 13

1.1 Statement of Report 13

1.2 About This Report 13

1.3 Scope of the Report 14

1.4 Objectives 15

1.5 Methodology 16

1.6 Executive Summary 17

2. Diabetes 20

2.1 Demographics of Diabetes 21

2.1.1 Worldwide Diabetes Incidence 21

2.1.2 Diabetes in the U.S. 25

2.2 Understanding the Metabolic Conditions Underlying and Associated with
Diabetes 30

2.2.1 Pre-Diabetes Syndrome 31

2.2.2 Metabolic Syndrome 31

2.2.3 Progression of Diabetes 31

2.2.4 Diabetes and Inflammation 32

2.2.5 Risk Factors and Diabetes 32

2.2.5.1 Obesity 33

2.2.5.2 Stress-Induced Hyperglycemia 35

2.2.6 Complications and Co-Morbidities in Diabetes 36

2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes 40

2.3 Economics of Diabetes 41

2.3.1 Worldwide Costs of Diabetes 42

2.3.2 Costs of Diabetes in the U.S. 42

3. Market Analysis: Size, Growth, Share and Competitors 47

3.1 Worldwide Glucose Testing Market 47

3.2 Global Glucose Self-Testing Market 49

3.2.1 Continuous Glucose Monitoring Markets 52

3.3 U.S. Market 53

3.4 European Market 57

3.5 Asian Market 58

3.5.1 Japanese Market 59

3.5.2 Chinese Market 60

3.5.3 Indian Market 62

3.5.4 Korean Market 63

3.5.5 Southeast Asian Market 63

3.5.6 ROW Markets 64

3.6 Competitive Situation 64

3.6.1 Key Players 64

3.6.2 Analyses of the Current Market Conditions, Competition and Product Mix 65

3.6.2 Abbott re-entering Continuous Glucose Monitoring Market in Europe 66

3.6.3 A Range of Products 66

3.7 Market Drivers and Restraints 68

3.7.1 Market Drivers 68

3.7.2 Market Restraints 69

3.8 Market and Product Trends 71

3.8.1 Market Trends 72

3.8.2 Technology Trends 73

3.9 Strategic Recommendations 74

3.10 Competitive Strategies 76

3.11 Adjacent Markets 76

4. Glucose Diagnostic and Monitoring Recommendations 78

4.1 Diagnosis of Diabetes Mellitus 78

4.2 Tight Glucose Control in Treating Diabetes 81

4.2.1 Tight Glucose Control Lowers Cardiovascular Complications 82

4.3 Recommendations for Glucose Control in Diabetic Patients 82

4.3.1 New Plasma Blood Sugar and HbA1c Target Recommendation for Children with
Type 1 Diabetes 83

4.3.1 Recommended Frequency of Blood Glucose Testing 85

4.3.2 Using Blood Glucose Data to Monitor and Modify Patient Therapy 85

4.3.3 Testing in Individuals with Type 2 Diabetes 86

4.3.4 Continuous Glucose Monitoring (CGM) 87

4.3.5 A1c Testing Recommendations 88

4.4 Hypoglycemia and Treatment 89

5. Glucose Self-Testing Technology Platforms and Consumable Products 91

5.1 Types of Glucose Self-Testing Devices 91

5.2 Enzymatic Reactions Used in Glucose Self-Testing Devices 92

5.2.1 Glucose Oxidase (GOX) 92

5.2.2 Glucose Dehydrogenase (GDH) 93

5.2.2.1 GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide) 93

5.2.2.2 GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide) 93

5.2.2.3 GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone) 93

5.2.3 Glucose Hexokinase 94

5.3 Development of Blood Glucose Monitors: A Historical Evaluation 94

5.3.1 First-Generation Blood Glucose Biosensors 94

5.3.2 Second-Generation Blood Glucose Biosensors 94

5.3.3 Third-Generation Blood Glucose Biosensor 95

5.4 Accuracy and Precision in Glucose Meters 95

5.4.1 International Organization for Standardization (ISO) 15197:2013 96

5.4.2 FDA Guidelines for Blood Glucose Testing Systems 97

5.4.3 Determining Clinical Accuracy Using the Error Grid Analysis (EGA) 100

5.4.4 Quality Control Criteria 101

5.4.5 Potential Variables Affecting Glucose Concentrations 101

5.4.6 Calibration Methods 101

5.4.7 Common User Errors 102

5.5 Key Issues for Glucose Self-Testing Devices 102

5.5.1 Important Elements for Glucose Self-Testing 104

5.5.2 Key Features to Aid Specific Patient Populations 105

5.6 Limitations of Existing Glucose Self-Testing Products 106

5.7 Interfering Substances and Conditions 107

5.7.1 Environmental 107

5.7.2 Physiologic 107

5.7.3 Operational 107

5.7.4 Manufacturing Variations 108

5.7.5 Drugs 108

5.7.6 Patient Factors 108

5.7.6.1 Errors Associated with GDH-PQQ Technology 108

5.8 Potential Areas of Improvement in Blood Glucose Monitor Performance 111

5.8.1 Blood Glucose Reagent Test Strips 112

5.9 Continuous Glucose Monitoring Technology 113

5.9.1 Advantages of Continuous Readings 114

5.9.2 FDA Approval of CGM 114

5.9.3 CGM Functions to Consider 115

5.9.4 New Technologies for CGM 115

5.10 Summary of Technologies being Explored for Non-Invasive Glucose Monitoring
116

5.10.1 GlucoTrack 116

5.10.2 Non-Invasive Glucose Monitoring Technologies in Development 116

5.10.3 Goals of Non-Invasive Testing 117

5.10.4 Non-Invasive Diabetes Screening Test 118

5.11 A1c Monitoring Technology 118

5.11.1 PTS Diagnostics' (Chek Diagnostics') A1c Home Test 120

5.12 Fructosamine Test 120

5.13 Related Reagents and Equipment 121

5.13.1 Lancets 121

5.13.1.1 Types of Lancing Devices 121

5.13.1.2 Market Size 122

5.13.2 Control Solutions and Calibrators 127

5.13.3 Sharps Devices 127

5.13.4 Needle Destruction Devices 128

5.13.5 Ketone Testing 128

5.14 New Developments in Glucose Self-Testing Systems 129

5.14.1 Voice Operated Glucose Self-Testing Meters 129

5.14.2 Bluetooth-Enabled Glucose Self-Testing Meters 132

5.14.2.1 MyGlucoHealth Wireless Meter 132

5.14.2.2 Fora D40, Fora Test N'Go, and Fora Test N'Go Voice Meters 133

5.14.2.3 OneTouch VerioSync Blood Glucose Monitoring System 133

5.14.2.4 Genesis Health Technologies (GHT) Meter 133

5.14.2.5 iHealth Wireless Smart Gluco-Monitoring System 133

5.14.2.6 Accu-chek Aviva Connect 133

5.14.3 Cellular-enabled Glucose Self-Testing Meters 134

5.14.3.1 Telcare BGM 134

5.14.3.2 Solus Mobile 134

5.14.3.3 Livongo Health's In Touch 134

5.14.3.4 iGlucose meter 134

5.14.4 Glucose Self-Testing Meters with Computer Connectivity 135

5.14.5 Data Management 135

5.14.5.1 Log Sheets/Spreadsheets 135

5.14.5.2 Glucose Self-Testing Software 135

5.14.5.3 External Servers and Cloud-based Data Collection Systems 137

5.14.5.4 Smart Phone and iPad/iPod Touch Applications 137

5.14.6 Remote Patient Monitoring 139

5.14.6.1 Infopia Eocene System 142

5.14.6.2 Health Buddy Systems Monitoring Technologies 142

5.14.6.3 GlucoCom Glucose Monitoring System 143

5.14.6.4 Alere's DayLink Monitor 143

5.14.6.5 Alere HomeLink Receives FDA Approval for Over-the-Counter Use 144

5.14.6.6 iGlucose System 144

5.14.7 Integrated Testing: Glucose Meter, Test Strips and Lancet 144

5.14.8 Long-Term Glucose Sensing Bio-Implants 145

5.14.9 Glucose Self-Testing Meters that Wirelessly Communicate with Insulin
Pumps 145

5.14.9.1 Medtronic's MiniMed Paradigm Revel 146

5.14.9.2 MiniMed 530G with Enlite 146

5.14.9.3 Nova Max Link 146

5.14.9.4 Contour Next Link 146

5.14.9.5 One Touch Ping 146

5.14.9.6 Accu-Chek Combo System 147

6. Glucose Self-Testing Meters on the Market: Description of Test Meters 148

6.1 Blood Glucose Self-Testing Meters and Strips 148

6.1.1 LifeScan, Inc. 152

6.1.2 Roche Diagnostics Corporation 154

6.1.3 Bayer 156

6.1.4 Abbott (MediSense) 158

6.1.5 Agamatrix, Inc. 160

6.1.6 ARKRAY, Inc. 161

6.1.7 Bionime Corporation 162

6.1.8 BioSense Medical Devices 164

6.1.9 CVS/Pharmacy 165

6.1.10 Diabetic Supply of Suncoast 165

6.1.11 Entra Health Systems 165

6.1.12 Fifty50 Pharmacy 165

6.1.13 Fora Care 166

6.1.14 Genesis Health Technologies 166

6.1.15 GlucoCom 167

6.1.16 iHealth 167

6.1.17 Infopia 167

6.1.18 Livongo Health 168

6.1.19 Nipro Diagnostics, Inc. 168

6.1.20 Nova Biomedical 169

6.1.21 Oak Tree International Holdings, Inc. 170

6.1.22 Omnis Health 170

6.1.23 Phylosis 171

6.1.24 Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.) 171

6.1.25 Sanofi 172

6.1.26 Target 172

6.1.27 Telcare 172

6.1.28 Tyson Biomedical 173

6.1.29 US Diagnostics 173

6.1.30 Walgreens 174

6.1.31 Walmart 174

6.1.32 77 Elektronika Kft. 174

6.1.33 A. Menarini Diagnostics 175

6.1.34 All Medicus 175

6.1.35 i-SENS 175

6.1.36 Apex Biotechnology Corp. 176

6.1.37 Glucoplus, Inc. 176

6.1.38 Polymer Technology Systems 176

6.1.39 Smiths Medical MD, Inc. 176

6.1.40 TaiDoc Technology Corp. 177

6.1.41 IN4 Technology Corporation 177

6.1.42 ACON Laboratories 177

6.1.43 Pepex Biomedical 178

6.1.44 HMD BioMedical 178

6.1.45 BTNX, Inc. 178

6.1.46 Decision Diagnostics Corporation and Pharma Tech Solutions 178

6.2 Continuous Glucose Patient Monitoring Systems 179

6.2.1 Medtronic's Continuous Glucose Monitoring Systems (CGMS) 181

6.2.1.1 MiniMed Paradigm Revel System 181

6.2.1.2 Guardian REAL-Time 182

6.2.1.3 MiniMed 530G with Enlite 182

6.2.1.4 iPro®2 Professional CGM 183

6.2.2 Dexcom, Inc.'s Continuous Glucose Monitoring Systems 184

6.2.2.1 Dexcom G4 Platinum Continuous Glucose Monitoring System 184

6.2.2.2 Dexcom G4 Platinum Continuous Glucose Monitoring System with Share 184

6.2.2.3 Dexcom G5 Mobile Continuous Glucose Monitoring System 185

6.2.3 Animas Vibe System 185

6.2.4 Abbott's Continuous Glucose Monitor System 185

6.2.4.1 FreeStyle Libre 185

6.2.4.2 FreeStyle Navigator (discontinued) 186

6.2.5 GlucoDay S Continuous Glucose Monitor 187

6.2.6 Minimally-Invasive Continuous Glucose Monitors in Development 187

6.2.6.1 GlySens, Inc. 187

6.2.6.2 Senseonics (formerly Sensors for Medicine and Science) 188

6.2.6.3 Ultradian Diagnostics 188

6.3 Non-Invasive Glucose Patient Monitoring Systems in Development 189

6.3.1 Cygnus GlucoWatch Biographer 189

6.3.2 AiMedics 190

6.3.3 Echo Therapeutics, Inc. 190

6.3.4 EyeSense GmbH 191

6.3.5 Freedom Meditech 192

6.3.6 Google and Novartis 192

6.3.7 Integrity Applications Ltd. 192

6.3.8 Lein Applied Diagnostics 193

6.3.9 LighTouch Medical, Inc. 193

6.3.10 Miraculins, Inc. 193

6.3.11 Xhale, Inc. 194

6.4 A1c Self-Testing 194

6.4.1 A1CNow SELFCHECK 194

6.4.2 DTI Laboratories 195

6.4.3 Polymer Technology Systems' A1C Tests 195

6.4.4 Walmart's ReliOn A1c Test (Mail-in) 195

6.5 New Product Launches 196

6.5.1 OneTouch VerioSync Blood Glucose Monitoring System 196

6.5.2 Medtronic's MiniMed 530G with Enlite Sensor Technology, the First
Artificial Pancreas Device System 196

6.5.3 Contour Next Link Meter Approved for Use with Medtronic's New MiniMed 530G
with Enlite Insulin Pump System 196

6.5.4 Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone
Monitoring System 196

6.5.5 LabStyle Innovations' Dario Diabetes Management System 196

6.5.6 BlueStar by WellDoc 197

6.5.7 FDA Approves Bayer's Contour Next EZ 197

6.5.8 Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook
App 198

6.5.9 Sanofi-Aventis's iBGStar 198

6.5.10 iHealth Glucose Meter Device 198

6.5.11 Nipro Diagnostics TrueMetrix Air 199

6.5.12 Animas Vibe System 199

6.5.13 Abbott's FreeStyle Libre and FreeStyle Libre Pro 199

6.5.14 Abbott's FreeStyle Precision Neo Blood Glucose Monitoring System 199

6.5.15 Dexcom G4 Platinum Continuous Glucose Monitoring System with Share 199

6.5.16 Medtronic's MiniMed Connect 200

6.5.17 Dexcom G5 Mobile CGM System 200

6.6 Blood Glucose Meters, CGMs, and Data Management Software in Development 201

6.6.1 Abbott's Flash Glucose Monitoring System 201

6.6.2 Google Announces Plan to Create Contact Lens Glucose Sensors 201

6.6.3 Socrates Health Solutions' Companion Blood Glucose Monitor 201

6.6.4 Boston University's Bionic Pancreas Project 201

6.6.5 IGI Stat's Test to Identify Type 1 Diabetes 201

6.6.6 Medtronic's Next-generation Combination Pump and CGM 202

6.6.7 Medtronic and IBM's Watson Health to Develop Data Management Solutions 202

6.7 Recent Industry Activity 203

6.7.1 Roche Diagnostics Corp. Cutting Jobs in Diabetes Division 203

6.7.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 203

6.7.3 LifeScan, Inc. Terminates Exclusive Supply Agreement with Medtronic
MiniMed 203

6.7.4 Medtronic and Bayer Healthcare Expand International Alliance 203

6.7.5 PositiveID Corporation Licenses iglucose Technology to Smart Glucose Meter
Corp 203

6.7.6 BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for
Both CGM and Pump 203

6.7.7 Court Sides with Decision Diagnostics in Patent Infringement Case 204

6.7.8 Senseonics Partners with Rubin Medical to Commercialize New CGM 204

6.7.9 Abbott re-entering Continuous Glucose Monitoring Market in Europe with
FreeStyle Libre 204

6.7.10 Medtronic and IBM's Watson Health Partnering to Develop Personalized
Diabetes Management Solutions 204

6.8 Mandamp;A Activity 205

6.8.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to become
Nipro Diagnostics, Inc. 205

6.8.2 Medtronic, Inc. (MDT) Acquires New Diabetes Technology from PreciSense AS
205

6.8.3 Geonostics Acquires FlexSite's Consumer Diabetes Tests 205

6.8.4 Additional Mandamp;A 206

6.8.5 Important Deals in BGM Market 206

7. Business Trends in the Industry 208

7.1 Wholesale Distribution Overview 208

7.2 Factors Affecting OTC Medical Product Distribution 209

7.3 Drugstores Critical to the Diabetic Care Category 211

7.4 Drivers of OTC and Self-Testing Markets 211

7.4.1 Brand Loyalty 211

7.5 Cost Elements of Glucose Self-Testing 212

7.6 Important Elements of OTC Testing 212

7.7 Growth of Home Care and Self-Testing 213

7.8 Blood Glucose Self-Testing Insurance Coverage and Reimbursement 213

7.8.1 American OTC Testing and Self-Testing Reimbursement 213

7.8.2 European Reimbursement 215

7.8.3 Reimbursement Challenges 216

7.8.4 New Medicare Part B 216

7.9 Government Regulation of Medical Devices 217

7.9.1 U.S. Regulations 217

7.9.2 E.U. Regulations 219

7.9.3 U.K. Regulations 225

7.10 Clinical Laboratory Improvement Act (CLIA) 226

7.10.1 Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems 228

7.11 FDA Labeling Requirements 228

7.12 Legal Liability for Glucose Meters 230

7.13 FDA's Artificial Pancreas Guidance Document 230

8. Technology Trends 231

8.1 Improving Today's Over-the-Counter (OTC) Blood Glucose Meters 231

8.2 Biosensor Technology 232

8.3 Artificial Pancreas 234

8.4 Fructosamine Test 235

8.5 Telemedicine 236

8.5.1 Remote Patient Monitoring 238

8.5.1.1 Infopia Eocene System 242

8.5.1.2 Health Buddy Systems Monitoring Technologies 242

8.5.1.3 GlucoCom Glucose Monitoring System 242

8.5.1.4 Alere's DayLink Monitor 243

8.5.1.5 Alere HomeLink Receives FDA Approval for Over-the-Counter Use 243

8.5.1.6 iGlucose System 243

8.6 Non-Traditional Methods for Sample Collection 244

8.7 Data Management 244

8.7.1 Medical Device Radiocommunications Service (MedRadio) 244

8.7.2 FDA Required Software Verification 244

9. OTC Testing: Critical Issues 246

9.1 Moderators of Growth for OTC Testing 246

9.2 Attitudes of Critical Care Nurses and Physicians 246

9.3 Personnel Impact for OTC Testing 247

9.4 Data Management Issues 247

10. Current Issues for OTC and Diagnostic Self-Testing 248

10.1 New Markets for OTC and Diagnostic Self-Testing 248

10.2 Utility of OTC and Self-Testing 249

10.3 Generational Drivers of Home Testing 250

10.4 Move Away from Central Laboratories 251

10.5 Healthcare Cost Controls 252

10.6 Mergers of Diagnostic Companies 252

10.7 Home Healthcare Trends 252

10.8 Home Healthcare Providers versus Mass Market Retailers 252

10.9 Demographic Merchandising 253

10.10 Marketing Strategies 253

10.11 Third-Party Pharmacy Networks 254

10.12 Which Customer Segments Purchase Home Healthcare? Which Products Fit Their
Needs? 254

10.13 Future of Patient Self-Testing 256

11. SWOT Analysis 257

11.1 Roche 257

11.2 LifeScan 257

12. Company Profiles 260

12.1 A. Menarini Diagnostics 260

12.2 Abbott Laboratories 260

12.3 ACON Laboratories 264

12.4 AgaMatrix 264

12.5 Allmedicus Co., Ltd. 264

12.6 Apex Biotechnology Corporation 264

12.7 ARKRAY USA, Inc. 264

12.8 Bayer 265

12.9 B. Braun Melsungen 266

12.10 Bionime 267

12.11 Cambridge Sensors 267

12.12 Cardiocom 267

12.13 DexCom 267

12.14 Diagnostic Devices/Prodigy Diabetes Care 268

12.15 Echo Therapeutics, Inc. 268

12.16 Entra Health Systems 269

12.17 Fora Care 269

12.18 FIFTY50 Medical, Inc. 269

12.19 Genesis Health Technologies 270

12.20 GlucoPlus 270

12.21 GlySens, Inc. 270

12.22 Google 270

12.23 Hainice Medical 271

12.24 Home Diagnostics 271

12.25 Infopia 271

12.26 IN4 Technology 271

12.27 Integrity Applications 271

12.28 i-Sens 271

12.29 Johnson andamp; Johnson 271

12.30 LabStyle Innovations Corporation 272

12.31 Livongo Health 272

12.32 Medtronic 272

12.33 Miraculins 273

12.34 Nipro Corporation 273

12.35 Nova Biomedical 273

12.36 Novartis 274

12.37 PTS Diagnostics 274

12.38 Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.) 274

12.39 Roche 275

12.40 77 Elektronika Kft. 276

12.41 Senseonics 276

12.42 Smart Meter Corporation 276

12.43 Smiths Group 276

12.44 TaiDoc Technology 277

12.45 Telcare 277

12.46 US Diagnostics 277





INDEX OF FIGURES



Figure 2.1: Worldwide Diabetes Cases, 2014 and 2035 21

Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years) 22

Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age
26

Figure 2.4: Prevalence of Diabetes by Age in the U.S. 26

Figure 2.5: Diagnosed Diabetes by Age in the U.S. 27

Figure 2.6: Percentage of U.S. Adults Diagnosed Diabetes by State 28

Figure 2.7: Number of Deaths from Diabetes by Age in the U.S. 29

Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S. 29

Figure 2.9: Maintenance of Normal Blood Sugar Levels 30

Figure 2.10: Prevalence of Self-Reported Obesity (BMI ³30) Among U.S. Adults 34

Figure 2.11: Prevalence of Obesity (BMI =30) Among Adults in the U.S. 34

Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S. 35

Figure 2.13: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or
Older Reporting Heart Disease or Stroke, by Sex, in the U.S. 37

Figure 2.14: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility
Limitation, by Age, in the U.S. 39

Figure 2.15: Number (in Millions) of Adults Aged 18 Years or Older with
Diagnosed Diabetes Reporting Visual Impairment in the U.S. 40

Figure 2.16: Mean Diabetes Healthcare-Related Expenditures Per Adult (20-79
Years) with Diabetes 42

Figure 2.17: How Diabetes Dollars are Spent in the U.S. 44

Figure 3.1: Geographic Segments of the Worldwide Glucose Self-Testing Market 50

Figure 3.2: Worldwide Glucose Self-Testing Market by Region 50

Figure 3.3: Worldwide Glucose Self-Testing Market Segments 51

Figure 4.1: Approach to Management of Hypoglycemia 84

Figure 4.2: Glycemic Status—Ranges and Health Implications 90

Figure 5.1: EGA Zones of Clinical Accuracy 100

Figure 5.2: Single-Day Continuous Blood Glucose Data 107

Figure 5.3: Factors that may Adversely Affect Glucose Testing 108

Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2014
124

Figure 6.1: Medtronic's Threshold Suspend Feature 183





INDEX OF TABLES



Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in
Millions 22

Table 2.2: Countries with the Largest Numbers of Diabetics 23

Table 2.3: Countries with the Largest Estimated Numbers of Diabetics 23

Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and
Income Group 24

Table 2.5: Countries with the Largest Number of Deaths Attributable to Diabetes
24

Table 2.6: New Cases of Diagnosed Diabetes Among U.S. Adults Aged 20 Years or
Older 25

Table 2.7: U.S. Population of Diagnosed Diabetics Aged 20-79 Years 26

Table 2.8: Percentage of U.S. Adults with Diagnosed Diabetes by State 27

Table 2.9: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 36

Table 2.10: Odds Ratio of Progression to Complications Associated with Type 2
Diabetes 38

Table 2.11: Prevalence of Complications Among Patients with Diabetes 38

Table 2.12: Major Causes of End-Stage Renal Disease 38

Table 2.13: Novel Risk Factors and Possible Mechanisms of the Excess Risk of
Coronary Heart Disease in Type 2 Diabetes Mellitus 39

Table 2.14: Clinical Recommendations for Adults with Diabetes 40

Table 2.15: Laboratory Assessment of Diabetic Vascular Disease 41

Table 2.16: Average Years Gained Free of Diabetes-Related Disease with Intensive
Management 41

Table 2.17: Cost of Diagnosed Diabetes in the U.S. 43

Table 2.18: Annual Cost of Care of United Healthcare Adult Members with Diabetes
44

Table 2.19: Healthcare Utilization by Diabetic Patients 45

Table 3.1: Total Global Unit Demand for Glucose Testing Reagent Strips 48

Table 3.2: Global Dollar Sales of Glucose Testing Reagent Strips 49

Table 3.3: Worldwide Glucose Self-Testing Market Sales (Meters, Strips and
Lancets) 50

Table 3.4: World Market Share of Glucose Self-Testing Marketers 51

Table 3.5: Global Revenues for Continuous Glucose Monitoring Systems 52

Table 3.6: Market for Glucose Self-Testing in the U.S. (Includes Meters, Strips
and Lancets) 53

Table 3.7: Market Share of U.S. Blood Glucose Self-Testing 54

Table 3.8: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales
Percentages 54

Table 3.9: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 55

Table 3.10: Demographic Characteristics Glucose Self-Testing Kit Buyers 56

Table 3.11: Top Brand Preferences for Glucose Self-Testing Kits 56

Table 3.12: Instances when Patients Prefer Professional's Glucose Testing 56

Table 3.13: Advantages of a Glucose Self-Testing Kit 56

Table 3.14: Disadvantages of Using a Glucose Self-Testing Kit 57

Table 3.15: Popular Shopping Destinations for Buying or Seeking Information on
Glucose Self-Testing Kits 57

Table 3.16: Customer Priorities—Glucose Meter Self-Testing Market, 2001, 2006
and 2014 57

Table 3.17: European Market for Glucose Self-Testing (Includes Meters, Strips
and Lancets) 58

Table 3.18: Asian Market for Glucose Self-Testing (Includes Meters, Strips and
Lancets) 59

Table 3.19: Japanese Market for Glucose Self-Testing (Includes Meters, Strips
and Lancets) 60

Table 3.20: Chinese Market for Glucose Self-Testing (Includes Meters, Strips and
Lancets) 61

Table 3.21: Southeast Asian Market for Glucose Self-Testing (Includes Meters,
Strips and Lancets) 63

Table 3.22: Southeast Asian Market for Glucose Self-Testing by Country (Includes
Meters, Strips and Lancets) 64

Table 3.23: ROW Market for Glucose Self-Testing (Includes Meters, Strips and
Lancets) 64

Table 3.24: Key Market Drivers for Glucose Self-Testing 69

Table 3.25: Market Drivers for Continuous Glucose Monitoring 69

Table 3.26: Key Market Restraints for Glucose Self-Testing 70

Table 3.27: Market Restraints for Continuous Glucose Monitoring 70

Table 4.1: Criteria for the Diagnosis of Diabetes 78

Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 78

Table 4.3: Normal Glucose Values—Fasting State 79

Table 4.4: Criteria for Testing for Diabetes in Asymptomatic Adults 79

Table 4.5: Criteria for Type 2 Diabetes in Asymptomatic Children 80

Table 4.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM) 81

Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 83

Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes 83

Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-Existing
Diabetes 83

Table 4.10: Plasma Blood Glucose and A1c Goals for Type 1 Diabetes by Age-group
84

Table 4.11: Glucose Monitoring Recommendations 85

Table 4.12: Key Issues for SMBG in Insulin-Independent Type 2 Diabetics 87

Table 4.13: A1c Testing Recommendations 88

Table 4.14: Correlation of A1c with Mean Blood Glucose 88

Table 5.1: Analytic Performance Criteria for Glucose Meters 96

Table 5.2: Potential Variables Affecting Glucose Concentrations 101

Table 5.3: Common User Errors Made while Self-Testing for Blood Glucose 102

Table 5.4: Key Features Considered for Glucose Self-Testing Devices 105

Table 5.5: Key Features Considered for Reagent Test Strips 105

Table 5.6: Compatibility of Various Blood Glucose Meters with Icodextrin PD
Solution 109

Table 5.7: Ten Factors Needed to Improve the Performance of Blood Glucose
Monitors 111

Table 5.8: Key Features Considered for Reagent Test Strips 113

Table 5.9: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels
119

Table 5.10: Unit Sales of Homecare Lancets in the U.S. 123

Table 5.11: Unit Sales of Homecare Lancets in the E.U. 123

Table 5.12: Dollar Sales of Homecare Lancets in the U.S. 123

Table 5.13: Dollar Sales of Homecare Lancets in the E.U. 123

Table 5.14: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S. 124

Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U. 124

Table 5.16: Competition in the Lancet Market Segment 125

Table 5.17: Blood Ketone Reading Indications 129

Table 5.18: Leading Companies for Patient Monitoring Products 141

Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time,
and Other Features 148

Table 6.2: Detailed Features of Selected CGM Systems Currently Available 179

Table 6.3: Non-Invasive Glucose Monitoring Systems in Development 189

Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs 227

Table 8.1: Data Entry and Data Management Features to Include in Future Meters
232

Table 8.2: Leading Companies for Patient Monitoring Products 241






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