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U.S. Glucose Testing Markets

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Publication Date:
July 2014; Pages: 268
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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.

 

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 (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
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


INDEX 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


INDEX 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

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