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U.S. Glucose Testing Markets

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

Table of Contents

1. Overview

  • 1.1. Statement of Report
  • 1.2. About This Report
  • 1.3. Scope of the Report
  • 1.4. Methodology
  • 1.5. Executive Summary

2. Diabetes

  • 2.1. Demographics of Diabetes in the U.S.
  • 2.2. Understanding the Metabolic Conditions Underlying and Associated with Diabetes
    • 2.2.1. Pre-Diabetes Syndrome
    • 2.2.2. Metabolic Syndrome
    • 2.2.3. Progression of Diabetes
    • 2.2.4. Diabetes and Inflammation
    • 2.2.5. Risk Factors and Diabetes
      • 2.2.5.1. Obesity
      • 2.2.5.2. Stress-Induced Hyperglycemia
    • 2.2.6. Complications and Co-Morbidities in Diabetes
      • 2.2.6.1. Preventing Complications and Co-Morbidities in Diabetes
      • 2.2.6.2. Cardiovascular Disease Facts
  • 2.3. Economics of Diabetes

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

  • 3.1. U.S. Market
    • 3.1.1. U.S. Over-the-Counter (OTC) Self-Testing Glucose Market
    • 3.1.2. U.S. Professional Glucose Testing Market
    • 3.1.3. Continuous Glucose Monitoring Markets
  • 3.2. Competitive Situation
    • 3.2.1. Key Players
    • 3.2.2. Analyses of the Self-Testing Market Conditions, Competition and Product Mix
    • 3.2.3. Analyses of the Professional Blood Glucose Monitoring Market
  • 3.3. Market Drivers and Restraints
    • 3.3.1. Market Drivers
    • 3.3.2. Market Restraints
  • 3.4. Market and Product Trends
    • 3.4.1. Market Trends
    • 3.4.2. Technology Trends
  • 3.5. Strategic Recommendations
  • 3.6. Competitive Strategies
  • 3.7. New Opportunities in the Professional Blood Glucose Meter Market
  • 3.8. Adjacent Markets

4. Glucose Diagnostic and Monitoring Recommendations

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

5. Glucose Testing Technology Platforms and Consumable Products

  • 5.1. Types of Glucose Determination Technologies
  • 5.2. Enzymatic Reactions Used to Determine Glucose Concentrations
    • 5.2.1. Glucose Oxidase (GOX)
    • 5.2.2. Glucose Dehydrogenase (GDH)
      • 5.2.2.1. GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide)
      • 5.2.2.2. GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide)
      • 5.2.2.3. GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone)
    • 5.2.3. Glucose Hexokinase
  • 5.3. Development of Blood Glucose Monitors: A Historical Evaluation
    • 5.3.1. First-Generation Blood Glucose Biosensors
    • 5.3.2. Second-Generation Blood Glucose Biosensors
    • 5.3.3. Third-Generation Blood Glucose Biosensor
  • 5.4. Accuracy and Precision in Glucose Meters
    • 5.4.1. Clinical and Laboratory Standards Institute (CLSI) POCT12-A3
    • 5.4.2. International Organization for Standardization (ISO) 15197:2013
    • 5.4.3. FDA Guidelines for Blood Glucose Testing Systems
    • 5.4.4. Determining Clinical Accuracy Using the Error Grid Analysis (EGA)
    • 5.4.5. Quality Control Criteria
    • 5.4.6. Potential Variables Affecting Glucose Concentrations
  • 5.5. Key Issues for Glucose Testing Devices
    • 5.5.1. Important Elements for Glucose Testing
    • 5.5.2. Key Features to Aid Specific Patient Populations
  • 5.6. Limitations of Existing Glucose Testing
    • 5.6.1. Common User Errors in Glucose Self-Testing
    • 5.6.2. Interfering Substances and Conditions
      • 5.6.2.1. Environmental
      • 5.6.2.2. Physiologic
      • 5.6.2.3. Operational
      • 5.6.2.4. Manufacturing Variations
      • 5.6.2.5. Drugs/Medications
      • 5.6.2.6. Patient Factors
    • 5.6.3. Errors Associated with GDH-PQQ Technology
    • 5.6.4. Optimizing of Point of Care (POC) Blood Glucose Testing
  • 5.7. Potential Areas of Improvement in Blood Glucose Meter Performance
  • 5.8. Blood Glucose Reagent Test Strips
  • 5.9. Comparison of Hand-Held Blood Glucose Meters with Clinical Laboratory Glucose Measurements
  • 5.10. Continuous Glucose Monitoring Technology
    • 5.10.1. Advantages of Continuous Readings
    • 5.10.2. FDA Approval of CGM
    • 5.10.3. CGM Functions to Consider
    • 5.10.4. New Technologies for CGM
  • 5.11. Summary of Technologies Being Explored for Non-Invasive Glucose Monitoring
    • 5.11.1. GlucoTrack
    • 5.11.2. Non-Invasive Glucose Monitoring Technologies in Development
    • 5.11.3. Goals of Non-Invasive Testing
    • 5.11.4. Non-Invasive Diabetes Screening Test
  • 5.12. A1c Monitoring Technology
  • 5.13. Fructosamine Test
  • 5.14. Related Reagents and Equipment
    • 5.14.1. Lancets
      • 5.14.1.1. Types of Lancing Devices
      • 5.14.1.2. Market Size
    • 5.14.2. Control Solutions and Calibrators
    • 5.14.3. Sharps Devices
    • 5.14.4. Needle Destruction Devices
    • 5.14.5. Urine Strips
    • 5.14.6. Ketone Testing
    • 5.14.7. Long-Term Glucose Sensing Bio-Implants

6. Glucose Testing Devices on the Market

  • 6.1. Hand-held Blood Glucose Meters and Strips for Self-Testing
    • 6.1.1. LifeScan, Inc.
    • 6.1.2. Roche Diagnostics Corporation
    • 6.1.3. Bayer
    • 6.1.4. Abbott
    • 6.1.5. Agamatrix, Inc.
    • 6.1.6. Arkray, Inc.
    • 6.1.7. Bionime Corporation
    • 6.1.8. BioSense Medical Devices
    • 6.1.9. CVS/Pharmacy
    • 6.1.10. Diabetic Supply of Suncoast
    • 6.1.11. Entra Health Systems
    • 6.1.12. Fifty50 Pharmacy
    • 6.1.13. Fora Care
    • 6.1.14. Genesis Health Technologies
    • 6.1.15. GlucoCom
    • 6.1.16. Infopia
    • 6.1.17. Nipro Diagnostics, Inc.
    • 6.1.18. Nova Biomedical
    • 6.1.19. Oak Tree International Holdings, Inc.
    • 6.1.20. Omnis Health
    • 6.1.21. Phylosis
    • 6.1.22. Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.)
    • 6.1.23. Sanofi
    • 6.1.24. Target
    • 6.1.25. Telcare
    • 6.1.26. Tyson Biomedical
    • 6.1.27. US Diagnostics
    • 6.1.28. Walgreens
    • 6.1.29. Walmart
    • 6.1.30. 77 Elektronika Kft.
    • 6.1.31. A. Menarini Diagnostics
    • 6.1.32. All Medicus
    • 6.1.33. i-SENS
    • 6.1.34. Apex Biotechnology Corp.
    • 6.1.35. Glucoplus, Inc.
    • 6.1.36. Polymer Technology Systems
    • 6.1.37. Smiths Medical MD, Inc.
    • 6.1.38. TaiDoc Technology Corp.
    • 6.1.39. IN4 Technology Corporation
    • 6.1.40. ACON Laboratories, Inc.
    • 6.1.41. Pepex Biomedical
    • 6.1.42. HMD BioMedical
    • 6.1.43. BTNX, Inc.
    • 6.1.44. Shasta Technologies and Decision Diagnostics Corporation
  • 6.2. Hand-held Blood Glucose Meters for Professional Use
    • 6.2.1. Abbott
      • 6.2.1.1. Precision Xceed Pro Blood Glucose and Beta-Ketone Monitoring System
      • 6.2.1.2. i-STAT System
    • 6.2.2. ACON Laboratories
      • 6.2.2.1. On Call Platinum Blood Glucose Monitoring System
    • 6.2.3. Alere
      • 6.2.3.1. epoc Blood Analysis System
      • 6.2.3.2. Alere Cholestech LDX System
    • 6.2.4. ARKRAY, Inc.
      • 6.2.4.1. Assure Platinum, Assure Pro, and Assure 4
    • 6.2.5. EKF Diagnostics
      • 6.2.5.1. Biosen Series of Glucose and Lactate Analyzers
    • 6.2.6. HemoCue (a Quest Diagnostics Company)
      • 6.2.6.1. HemoCue Glucose 201 and Glucose 201 DM Systems
    • 6.2.7. HMD BioMedical
      • 6.2.7.1. NS100
    • 6.2.8. Medtronic
      • 6.2.8.1. iPro Continuous Glucose Monitor
    • 6.2.9. Nova Biomedical
      • 6.2.9.1. StatStrip Hospital Glucose Monitoring System
    • 6.2.10. Polymer Technology Systems, Inc.
      • 6.2.10.1. CardioChek PA Point of Care Device
    • 6.2.11. Roche
      • 6.2.11.1. Accu-Chek Inform II System
      • 6.2.11.2. Accutrend Plus System
    • 6.2.12. Techno Medica Co., Ltd.
      • 6.2.12.1. GASTAT-mini
    • 6.2.13. LifeScan
  • 6.3. Clinical Blood Chemistry Analyzers
    • 6.3.1. Abaxis, Inc.
    • 6.3.2. Alere
    • 6.3.3. ARKAY, Inc.
    • 6.3.4. Beckman Coulter
    • 6.3.5. DiaSys
    • 6.3.6. Instrumentation Laboratory
    • 6.3.7. International Techidyne Corporation (ITC)
    • 6.3.8. Nova Biomedical
    • 6.3.9. Radiometer
    • 6.3.10. Randox Laboratories
    • 6.3.11. Roche
    • 6.3.12. Siemens Healthcare Diagnostics
    • 6.3.13. Span Diagnostics
    • 6.3.14. Stanbio Laboratory
    • 6.3.15. Techno Medica Co., Ltd.
    • 6.3.16. YSI Life Sciences
  • 6.4. Continuous Glucose Patient Monitoring Systems
    • 6.4.1. Medtronic's Continuous Glucose Monitoring Systems (CGMS)
    • 6.4.2. DexCom, Inc. G4 Platinum Continuous Glucose Monitoring System
    • 6.4.3. FreeStyle Navigator-Abbott's Continuous Glucose Monitor System
    • 6.4.4. GlucoDay S Continuous Glucose Monitor
    • 6.4.5. Minimally-Invasive Continuous Glucose Monitors in Development
      • 6.4.5.1. GlySens, Inc.
      • 6.4.5.2. Senseonics (formerly Sensors for Medicine and Science)
      • 6.4.5.3. Ultradian
      • 6.4.5.4. GluMetrics
      • 6.4.5.5. GlySure Limited
  • 6.5. Non-Invasive Glucose Patient Monitoring Systems
    • 6.5.1. Cygnus GlucoWatch Biographer
    • 6.5.2. AiMedics
    • 6.5.3. BioTex, Inc.
    • 6.5.4. Echo Therapeutics, Inc.
    • 6.5.5. EyeSense GmbH
    • 6.5.6. Freedom Meditech
    • 6.5.7. Grove Instruments
    • 6.5.8. Integrity Applications Ltd.
    • 6.5.9. LighTouch Medical, Inc.
    • 6.5.10. OrSense Ltd.
    • 6.5.11. VeraLight, Inc.
    • 6.5.12. Xhale, Inc.
    • 6.5.13. Lein Applied Diagnostics
  • 6.6. A1c Testing
  • 6.7. New Product Launches
    • 6.7.1. OneTouch Verio Sync Blood Glucose Monitoring System
    • 6.7.2. Medtronic's MiniMed 530G with Enlite Sensor Technology
    • 6.7.3. Contour Next Link Meter Approved for Use with Medtronic's New MiniMed 530G with Enlite Insulin Pump System
    • 6.7.4. Roche's ACCU-CHEK Inform II System Approved by the FDA
    • 6.7.5. Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System
    • 6.7.6. Abbott Receives FDA Clearance for FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System
    • 6.7.7. LabStyle Innovations' Dario Diabetes Management System
    • 6.7.8. BlueStar by WellDoc
    • 6.7.9. FDA Approves Bayer's Contour Next EZ
    • 6.7.10. Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook App
    • 6.7.11. Sanofi-Aventis's iBGStar
    • 6.7.12. iHealth Glucose Meter Device
    • 6.7.13. MyGlucoHealth Diabetes
    • 6.7.14. gDrive
    • 6.7.15. Shasta GenStrips
    • 6.7.16. mySentry Remote Glucose Monitor
    • 6.7.17. OneTouch Verio IQ System with PatternAlert Technology
    • 6.7.18. Accu-Chek Nano SmartView
  • 6.8. Blood Glucose Meters, CGMs, and Data Management Software in Development
    • 6.8.1. Abbott's Flash Glucose Monitoring System
    • 6.8.2. Google Announces Plan to Create Contact Lens Glucose Sensors
    • 6.8.3. Socrates Health Solutions' Companion Blood Glucose Monitor
    • 6.8.4. DexCom and Johnson and Johnson's Animas Working to Develop an Artificial Pancreas
    • 6.8.5. Medtronic Enrolling Patients into Trial Testing Third-Generation, Fully-Automated Artificial Pancreas
    • 6.8.6. Boston University's Bionic Pancreas Project
  • 6.9. Recent Industry Activity
    • 6.9.1. Roche Diagnostics Corp. Cutting Jobs in Diabetes Division
    • 6.9.2. AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership
    • 6.9.3. LifeScan, Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed
    • 6.9.4. Kroger Selects WaveSense Diabetes Testing Products
    • 6.9.5. Medtronic and Bayer Healthcare Expand International Alliance
    • 6.9.6. PositiveID Corporation and IDEAL LIFE Partner to Bring iglucose to Market for Wireless Diabetes Management
    • 6.9.7. Roche Diagnostics U.S. and DexCom, Inc. Announce Research and Development Agreement
    • 6.9.8. BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for Both CGM and Pump
    • 6.9.9. Court Sides with Decision Diagnostics in Patent Infringment Case
    • 6.9.10. iBGStar Blood Glucose Monitoring System Receives U.S. FDA 510(k) Clearance
    • 6.9.11. Infopia America Partners with Walgreens Drugstores
    • 6.9.12. Qualcomm Forms Qualcomm Life Subsidiary
    • 6.9.13. Perrigo and AgaMatrix Enter into an Exclusive Sales and Distribution Agreement
    • 6.9.14. Pepex Biomedical Signs Seven Year Deal to Manufacture Trio
    • 6.9.15. DexCom and Tandem Diabetes Care Team Up for CGM Development and Commercialization
    • 6.9.16. Insulet Corporation Signs Worldwide Agreement with LifeScan
  • 6.10. M&A Activity
    • 6.10.1. Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to Become Nipro Diagnostics, Inc.
    • 6.10.2. Medtronic, Inc. (MDT) Acquires New Diabetes Technology from PreciSense AS
    • 6.10.3. Geonostics Acquires FlexSite's Consumer Diabetes Tests
    • 6.10.4. Radiometer Medical Acquires Hemocue
    • 6.10.5. Additional M&A
    • 6.10.6. Important Deals in BGM market

7. Business Trends in Glucose Testing

  • 7.1. Drivers of Clinical Glucose Testing
  • 7.2. Competition for Services
  • 7.3. Healthcare Cost Controls
  • 7.4. Changes in Patient Management
  • 7.5. Regionalization of Laboratory Care
  • 7.6. Satellite Facilities
  • 7.7. Professional Point of Care Testing
  • 7.8. Factors Affecting OTC Medical Product Distribution
  • 7.9. Drugstores Critical to the Diabetic Care Category
  • 7.10. Drivers of OTC and Self-Testing Markets
    • 7.10.1. Brand Loyalty
  • 7.11. Cost Elements of Glucose Self-Testing
  • 7.12. Blood Glucose Self-Testing Insurance Coverage and Reimbursement
  • 7.13. Reimbursement Challenges
    • 7.13.1. New Medicare Part B
  • 7.14. Managed Care
  • 7.15. Government Regulation of Medical Devices
  • 7.16. Clinical Laboratory Improvement Act (CLIA)
  • 7.17. FDA Labeling Requirements
  • 7.18. Legal Liability for Glucose Meters
  • 7.19. FDA's Artificial Pancreas Guidance Document

8. Technology Trends

  • 8.1. Improving Today's OTC Blood Glucose Meters
  • 8.2. Biosensor Technology
  • 8.3. Fructosamine Test
  • 8.4. Telemedicine Devices
    • 8.4.1. Remote Patient Monitoring
      • 8.4.1.1. Infopia Eocene System
      • 8.4.1.2. Health Buddy Systems Monitoring Technologies
      • 8.4.1.3. GlucoCom Glucose Monitoring System
      • 8.4.1.4. Alere's DayLink Monitor
      • 8.4.1.5. Alere HomeLink Receives FDA Approval for Over-the-Counter Use
  • 8.5. Non-Traditional Methods for Sample Collection
  • 8.6. Data Management
    • 8.6.1. Medical Device Radiocommunications Service (MedRadio)
    • 8.6.2. Connectivity
    • 8.6.3. Advantages of Connectivity
    • 8.6.4. Connectivity Platforms
    • 8.6.5. DataLink Data Management System
    • 8.6.6. RALS-Plus
    • 8.6.7. FDA Required Software Verification
    • 8.6.8. Information Management Advances
    • 8.6.9. POL Laboratory Data Management
      • 8.6.9.1. Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software
      • 8.6.9.2. Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System
      • 8.6.9.3. Technical Problems of Connectivity
      • 8.6.9.4. Web-Based Data Interface
    • 8.6.10. HIT Competition

9. Company Profiles

  • 9.1. Abaxis, Inc.
  • 9.2. Abbott Laboratories
  • 9.3. ACON Laboratories
  • 9.4. AgaMatrix
  • 9.5. Alere, Inc.
  • 9.6. All Medicus, Co., Ltd.
  • 9.7. Amedica Biotech
  • 9.8. A. Menarini Diagnostics
  • 9.9. Apex Biotechnology Corporation
  • 9.10. ARKRAY USA, Inc.
  • 9.11. Bayer AG
  • 9.12. B. Braun Melsungen
  • 9.13. Beckman Coulter
  • 9.14. Bionime
  • 9.15. Bio-Rad Laboratories, Inc.
  • 9.16. BioTex, Inc.
  • 9.17. Calisto Medical, Inc.
  • 9.18. Cambridge Sensors
  • 9.19. DexCom
  • 9.20. Diagnostic Devices/Prodigy Diabetes Care
  • 9.21. DiaSys
  • 9.22. Echo Therapeutics, Inc.
  • 9.23. Entra Health Systems
  • 9.24. Fora Care
  • 9.25. FIFTY50 Medical, Inc.
  • 9.26. Freedom Meditech
  • 9.27. Genesis Health Technologies
  • 9.28. GenExel-Sein, Inc.
  • 9.29. GlucoPlus
  • 9.30. GlySens, Inc.
  • 9.31. GlySure Limited
  • 9.32. Grove Instruments
  • 9.33. Hainice Medical
  • 9.34. HemoCue (a Quest Diagnostics company)
  • 9.35. Home Diagnostics
  • 9.36. Infopia Co., Ltd.
  • 9.37. IN4 Technology
  • 9.38. International Techidyne Corporation (ITC)
  • 9.39. Instrumentation Laboratory Company
  • 9.40. i-Sens
  • 9.41. Johnson & Johnson
  • 9.42. LabStyle Innovations Corporation
  • 9.43. Medtronic
  • 9.44. Nipro Diagnostics
  • 9.45. Nova Biomedical
  • 9.46. OrSense Ltd.
  • 9.47. Polymer Technology Systems
  • 9.48. Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.)
  • 9.49. Radiometer Medical
  • 9.50. Roche Diagnostics
  • 9.51. 77 Elektronika Kft.
  • 9.52. Siemens AG
  • 9.53. Smiths Group
  • 9.54. Stanbio Laboratory
  • 9.55. TaiDoc Technology
  • 9.56. Techno Medica Co., Ltd.
  • 9.57. Telcare
  • 9.58. US Diagnostics
  • 9.59. VeraLight
  • 9.60. Ypsomed Holding
  • 9.61. YSI Life Sciences

INDEX OF FIGURES

  • Figure 2.1: Annual Number of New Cases of Diagnosed Diabetes Among U.S. Adults Aged 18-79 Years, 1980-2011
  • Figure 2.2: Diagnosed Diabetes by Age in the U.S., 2013
  • Figure 2.3: Number of Deaths from Diabetes by Age in the U.S., 2010
  • Figure 2.4: Number of Diabetes Deaths by Race and Sex in the U.S., 2010
  • Figure 2.5: Maintenance of Normal Blood Sugar Levels
  • Figure 2.6: Prevalence of Self-Reported Obesity (BMI ≥30) Among U.S. Adults, 2012
  • Figure 2.7: Prevalence of Obesity Among Adults in the U.S., 2009-2010
  • Figure 2.8: Trends in Obesity Among Children and Adolescents in the U.S., 1988-2010
  • 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
  • Figure 2.10: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, in the U.S., 1997-2011
  • 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
  • Figure 2.12: How Diabetes Dollars are Spent in the U.S., 2012
  • Figure 2.13: Percent of Medical Condition-Specific Expenditures Associated with Diabetes, 2012
  • Figure 3.1: Forecasted Test Strip Usage by Different Diabetic Populations
  • Figure 4.1: Approach to Management of Hypoglycemia
  • Figure 4.2: Glycemic Status-Ranges and Health Implications
  • Figure 5.1: EGA Zones of Clinical Accuracy
  • Figure 5.2: Single-Day Continuous Blood Glucose Data
  • Figure 5.3: Factors that may Adversely Affect Glucose Testing
  • Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2013
  • Figure 6.1: Medtronic's Threshold Suspend Feature

INDEX OF TABLES

  • Table 2.1: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013
  • Table 2.2: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2010
  • Table 2.3: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S.
  • Table 2.4: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes
  • Table 2.5: Prevalence of Complications Among Patients with Diabetes
  • Table 2.6: Major Causes of End-Stage Renal Disease
  • Table 2.7: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus
  • Table 2.8: Clinical Recommendations for Adults with Diabetes
  • Table 2.9: Laboratory Assessment of Diabetic Vascular Disease
  • Table 2.10: Average Years Gained Free of Diabetes-Related Disease with Intensive Management
  • Table 2.11: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2010
  • Table 2.12: Cost of Diagnosed Diabetes in the U.S., 2012
  • Table 2.13: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009
  • Table 2.14: Healthcare Utilization by Diabetic Patients, 2012
  • Table 3.1: Comprehensive Glucose Testing Market in the U.S. (Includes Reagents and Supplies in the Self-Testing and Professional Markets), 2012-2018
  • Table 3.2: U.S. Blood Glucose Reagent Strip Market (Includes Both Self-Testing and Professional Markets), 2012-2018
  • Table 3.3: Market for Glucose Self-Testing in the U.S. (Includes Meters, Strips and Lancets), 2012-2018
  • Table 3.4: Market Share of U.S. Blood Glucose Self-Testing, 2013
  • Table 3.5: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages
  • Table 3.6: OTC Blood Glucose Instrument Reagents by Manufacturer Retail
  • Table 3.7: Demographic Characteristics Glucose Self-Testing Kit Buyers
  • Table 3.8: Top Brand Preferences for Glucose Self-Testing Kits
  • Table 3.9: Instances when Patients Prefer Professional's Glucose Testing
  • Table 3.10: Advantages of a Glucose Self-Testing Kit
  • Table 3.11: Disadvantages of Using a Glucose Self-Testing Kit
  • Table 3.12: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing Kits
  • Table 3.13: Customer Priorities-Glucose Meter Self-Testing Market, 2001, 2006 and 2013
  • Table 3.14: Market for Total Professional Glucose Testing (Central Laboratory and Hospital POC & POL) in the U.S., 2012-2018
  • Table 3.15: U.S. Revenues for Professional POC Blood Glucose Monitoring (Hospital & POL), 2012-2018
  • Table 3.16: U.S. Continuous Glucose Monitoring Market, 2012-2018
  • Table 3.17: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market
  • Table 3.18: Key Market Drivers for Glucose Testing
  • Table 3.19: Point of Care Glucose Testing Market: Market Drivers Ranked in Order of Impact
  • Table 3.20: Market Drivers for Continuous Glucose Monitoring
  • Table 3.21: Key Market Restraints for Glucose Testing
  • Table 3.22: Market Restraints for Continuous Glucose Monitoring
  • Table 3.23: Point of Care Glucose Testing Market: Market Restraints Ranked in Order of Impact
  • Table 4.1: Criteria for the Diagnosis of Diabetes
  • Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes)
  • Table 4.3: Normal Glucose Values-Fasting State
  • Table 4.4: Criteria for Testing for Diabetes in Asymptomatic Adults
  • Table 4.5: Criteria for Type 2 Diabetes in Asymptomatic Children
  • Table 4.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM)
  • Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes
  • Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes
  • Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-Existing Diabetes
  • Table 4.10: Plasma Blood Glucose and A1c Goals for Type 1 Diabetes by Age-Group
  • Table 4.11: Glucose Monitoring Recommendations
  • Table 4.12: Key Issues for SMBG in Insulin-Independent Type 2 Diabetics
  • Table 4.13: A1c Testing Recommendations
  • Table 4.14: Correlation of A1c with Mean Blood Glucose
  • Table 4.15: Glucose Monitoring Recommendations for Hospital Settings
  • Table 4.16: Glycemic Goals for Hospital Patients
  • Table 5.1: Analytic Performance Criteria for Glucose Meters
  • Table 5.2: Potential Variables Affecting Glucose Concentrations
  • Table 5.3: Key Features Considered for Glucose Testing Devices
  • Table 5.4: Common User Errors Made While Self-Testing for Blood Glucose
  • Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin PD Solution
  • Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters
  • Table 5.7: Features Required for Safe and Effective Meters for Hospital Settings
  • Table 5.8: Key Features Considered for Reagent Test Strips
  • Table 5.9: Differences between Laboratory Instruments for Glucose Analysis and Hand-Held Blood Glucose Meters
  • Table 5.10: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels
  • Table 5.11: Unit Sales of Homecare Lancets in the U.S., 2012-2017
  • Table 5.12: Unit Sales of Homecare Lancets in the E.U., 2012-2017
  • Table 5.13: Dollar Sales of Homecare Lancets in the U.S., 2012-2017
  • Table 5.14: Dollar Sales of Homecare Lancets in the E.U., 2012-2017
  • Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2012-2017
  • Table 5.16: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2012-2017
  • Table 5.17: Competition in the Lancet Market Segment
  • Table 5.18: Limitations of Urine Glucose Monitoring
  • Table 5.19: Advantages of Urine Glucose Monitoring
  • Table 5.20: Blood Ketone Reading Indications
  • Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time, and Other Features
  • Table 6.2: Point of Care Blood Glucose or Blood Gas Meters Marketed for Professional Use
  • Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays
  • Table 6.4: Detailed Features of Selected CGM Systems Currently Available
  • Table 6.5: Non-Invasive Glucose Monitoring Systems in Development
  • Table 7.1: POC Procedural Advantages for Hospital Testing
  • Table 7.2: Financial Comparison for Moderate and Waived CLIA Labs
  • Table 8.1: Data Entry and Data Management Features to Include in Future Meters
  • Table 8.2: Leading Companies for Patient Monitoring Products
  • Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements
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