Continuous Glucose Monitoring: The Current State of the Art
REPORT SCOPE:
The scope of this study includes what a CGM is, how it works and how a PWD wears the device. This study also includes advances in the technology—both those advances being seen in the market today and advances for which CE mark or FDA approval is pending. There is a section covering the pancreas and diabetes, including the continued growth in the number of diabetics and prediabetics in the U.S. and elsewhere. It covers selected clinical trials pertinent to the evolution and proliferation of CGMs. The scope of this report includes novel CGMs and components in development. These may or may not ever see market launch but should nonetheless be of interest to industry managers.
Also covered here are selected regulatory and reimbursement affairs. Regulatory guidelines need to keep abreast of the technological developments so that safe, effective devices may enter the market. Without sufficient, carefully crafted reimbursement or payer coverage, the devices will never get off the ground. Both favorable regulatory and reimbursement guidelines are needed if manufacturers are to continue to develop and commercialize the best equipment for managing diabetes.
Selected companies are profiled in this report. These include not only the market leaders—Dexcom, Medtronic, Abbott, Tandem and Insulet—but also smaller companies working on promising technology.
Not covered in the scope of this report is in-depth analysis of market values and growth rates. These are available in other BCC Research reports. Also not covered is the ultimate in artificial pancreas: the cell-based implant. While these are under development, for practical purposes implants seem to be some distance down the road.
REPORT INCLUDES:
The scope of this study includes what a CGM is, how it works and how a PWD wears the device. This study also includes advances in the technology—both those advances being seen in the market today and advances for which CE mark or FDA approval is pending. There is a section covering the pancreas and diabetes, including the continued growth in the number of diabetics and prediabetics in the U.S. and elsewhere. It covers selected clinical trials pertinent to the evolution and proliferation of CGMs. The scope of this report includes novel CGMs and components in development. These may or may not ever see market launch but should nonetheless be of interest to industry managers.
Also covered here are selected regulatory and reimbursement affairs. Regulatory guidelines need to keep abreast of the technological developments so that safe, effective devices may enter the market. Without sufficient, carefully crafted reimbursement or payer coverage, the devices will never get off the ground. Both favorable regulatory and reimbursement guidelines are needed if manufacturers are to continue to develop and commercialize the best equipment for managing diabetes.
Selected companies are profiled in this report. These include not only the market leaders—Dexcom, Medtronic, Abbott, Tandem and Insulet—but also smaller companies working on promising technology.
Not covered in the scope of this report is in-depth analysis of market values and growth rates. These are available in other BCC Research reports. Also not covered is the ultimate in artificial pancreas: the cell-based implant. While these are under development, for practical purposes implants seem to be some distance down the road.
REPORT INCLUDES:
- An overview of the current state of the art for Continuous Glucose Monitoring (CGM) for diabetes
- Analyses of global market trends with data from 2018, 2019, and projections of compound annual growth rates (CAGRs) through 2024
- Encompassing details of CGM functionalities like how they work, who can use one, and when a CGM could help to better manage the disease
- Examination of the critical issues within the CGM market, including technological developments, geographic trends, market dynamics, adoption trends and clinical trials
- Evaluation of current market size, market forecast and future of the CGM device industry
- Market share analysis of the leading players of the industry and their comprehensive company profiles
CHAPTER 1 INTRODUCTION
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports
CHAPTER 2 EXECUTIVE SUMMARY
Overview of the Pancreas
T1D and T2D
Tight Glycemic Control and the Importance of Time in Range
CGMs on the U.S. Market
The iCGM Trend
Timeline of Recent Device and Software Approvals
Increasing Patient Choice and Device Interoperability
Advances in the Closed-Loop Insulin Delivery System
Tandem's Control-IQ Technology
WaveForm Technologies' Cascade CGM
Novel Device Developments
Smartwatches and Wristbands
Implantable CGM Sensors
Regulatory and Reimbursement Events
FDA Approves New Interoperable Insulin Dosing 'Controller'
FDA's 'Breakthrough Device Designation' for Diabetes Management Devices
CGM for T2Ds
CGM Usage for T2Ds in the European Union
Selected Clinical Trials
CHAPTER 3 DEFINITIONS
What Does the Pancreas Do?
T1D
T2D
A Few Statistics
Improving Hemoglobin A1c (HbA1c) Control
Tight Glycemic Control and the Importance of Time in Range
Daily Diabetes-Oriented Tasks of a Person with T1D
Advantages of CGM for Managing Glucose Levels
How a Diabetic Uses a CGM
CGMs Currently on the Market in the EU and U.S.
The FDA and ACE Pumps
CHAPTER 4 INCREASING PATIENT CHOICE AND DEVICE INTEROPERABILITY
Advances in the Closed-Loop Insulin Delivery System
Barriers to a Fully Automated Closed-Loop System
Tandem's Control-IQ Technology
Tidepool Loop and Interoperable Insulin Pumps
Medtronic's Next-Gen Advanced Hybrid Closed Loop System
Medtronic's European Envision Pro CGM
Biolinq's New CGM Sensor
Insulet's Omnipod
Dexcom CGM
Senseonics and Its Eversense Implantable CGM
Lilly: Connected Pens, Dexcom and Hybrid Closed-Loop System
WaveForm Cascade CGM
Timeline of Recent Device and Software Approvals
CHAPTER 5 NOVEL CGMS AND COMPONENTS IN DEVELOPMENT
Smartwatches and Wristbands
Apple
Alertgy
Know Labs
PKvitality
Prediktor Medical
Traditional Wearable Sensors
I-SENS Inc.
Pacific Diabetes Technologies
Medtrum Technologies Inc.
SanVita Medical, LLC
Infinovo
GlucoRx
Implantable CGM Sensors
Integrated Medical Sensors Inc.
Profusa
GlySens
PercuSense
Patch/Microneedle Sensors
Nemaura Medical
Sano
University of California, San Diego
Other Potential Noninvasive CGMs
CHAPTER 6 TECHNOLOGICAL PROMISES OR HYPE?
MIT and Noninvasive Blood Glucose Monitoring
How Raman Spectroscopy Works
The Future of Raman Spectroscopy for Measuring Blood Glucose
Optogenetics: Ready to Revolutionize Diabetes Treatment?
NASA, Mars and Diabetes
Cam Med's Bandage-Like, Flexible 'Patch' Insulin Pump
CHAPTER 7 SELECTED REGULATORY AND REIMBURSEMENT AFFAIRS
The iCGM Trend
iCGM Development 'Helped' Along by Hackers
iCGM: The Most Important Trend in CGMs
FDA Approves New Interoperable Insulin Dosing 'Controller'
FDA's 'Breakthrough Device Designation' for Diabetes Management Devices
Medicare Supports CGM Smartphone App Use for Diabetes
CGM for T2Ds
CGMs Have Come Far Since 1999
Data Show Improved Glycemic Control in T2Ds
CGMs Advanced to the Point of Cost Savings, Even for T2Ds
CGM Usage for T2Ds in the European Union
Dexcom Granted CE mark for CGM Use by Pregnant Women
February 2019: FDA Approves Tandem's and Insulet's ACE Pumps
CHAPTER 8 SELECTED CLINICAL TRIALS
The International Diabetes Closed Loop Trial: Clinical Acceptance of the Artificial Pancreas
Description
Method
Conclusions
The VRIF Trial: Hypoglycemia Reduction with Automated-Insulin Delivery System
Description
Method
Conclusions
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas in Pediatrics: A Study of t:Slim X2 With Control-IQ Technology
Description
Method
Conclusions
Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24 hr Closed Loop Control
Description
Method
Conclusions
PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days
Description
Method
Conclusions
Evaluation of Two Different Glucose Monitoring Treatments and Their Impact on Time in Target, Sleep and Quality of Life in Children with Type 1 Diabetes and Primary Caregivers: The QUEST Study
Description
Method
Conclusions
Continuous Glucose Monitoring and Management In Type 2 Diabetes (T2D) (COMMITTED)
Description
Method
Conclusions
CHAPTER 9 COMPANY PROFILES
ABBOTT LABORATORIES
ALERTGY
BETA BIONICS
BETA-O2 TECHNOLOGIES
BIGFOOT BIOMEDICAL
BIOLINQ
CAM MED INC.
DEXCOM
DIABELOOP SA
ELI LILLY & CO.
EOFLOW INC.
INSULET CORP.
LIFESCAN
MEDTRONIC DIABETES
NEMAURA MEDICAL INC.
PACIFIC DIABETES TECHNOLOGIES
PREDIKTOR MEDICAL
ROCHE DIABETES CARE
SENSEONICS
TANDEM DIABETES CARE INC.
TIDEPOOL
WAVEFORM TECHNOLOGIES
CHAPTER 10 APPENDIX: TERMS AND ABBREVIATIONS
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports
CHAPTER 2 EXECUTIVE SUMMARY
Overview of the Pancreas
T1D and T2D
Tight Glycemic Control and the Importance of Time in Range
CGMs on the U.S. Market
The iCGM Trend
Timeline of Recent Device and Software Approvals
Increasing Patient Choice and Device Interoperability
Advances in the Closed-Loop Insulin Delivery System
Tandem's Control-IQ Technology
WaveForm Technologies' Cascade CGM
Novel Device Developments
Smartwatches and Wristbands
Implantable CGM Sensors
Regulatory and Reimbursement Events
FDA Approves New Interoperable Insulin Dosing 'Controller'
FDA's 'Breakthrough Device Designation' for Diabetes Management Devices
CGM for T2Ds
CGM Usage for T2Ds in the European Union
Selected Clinical Trials
CHAPTER 3 DEFINITIONS
What Does the Pancreas Do?
T1D
T2D
A Few Statistics
Improving Hemoglobin A1c (HbA1c) Control
Tight Glycemic Control and the Importance of Time in Range
Daily Diabetes-Oriented Tasks of a Person with T1D
Advantages of CGM for Managing Glucose Levels
How a Diabetic Uses a CGM
CGMs Currently on the Market in the EU and U.S.
The FDA and ACE Pumps
CHAPTER 4 INCREASING PATIENT CHOICE AND DEVICE INTEROPERABILITY
Advances in the Closed-Loop Insulin Delivery System
Barriers to a Fully Automated Closed-Loop System
Tandem's Control-IQ Technology
Tidepool Loop and Interoperable Insulin Pumps
Medtronic's Next-Gen Advanced Hybrid Closed Loop System
Medtronic's European Envision Pro CGM
Biolinq's New CGM Sensor
Insulet's Omnipod
Dexcom CGM
Senseonics and Its Eversense Implantable CGM
Lilly: Connected Pens, Dexcom and Hybrid Closed-Loop System
WaveForm Cascade CGM
Timeline of Recent Device and Software Approvals
CHAPTER 5 NOVEL CGMS AND COMPONENTS IN DEVELOPMENT
Smartwatches and Wristbands
Apple
Alertgy
Know Labs
PKvitality
Prediktor Medical
Traditional Wearable Sensors
I-SENS Inc.
Pacific Diabetes Technologies
Medtrum Technologies Inc.
SanVita Medical, LLC
Infinovo
GlucoRx
Implantable CGM Sensors
Integrated Medical Sensors Inc.
Profusa
GlySens
PercuSense
Patch/Microneedle Sensors
Nemaura Medical
Sano
University of California, San Diego
Other Potential Noninvasive CGMs
CHAPTER 6 TECHNOLOGICAL PROMISES OR HYPE?
MIT and Noninvasive Blood Glucose Monitoring
How Raman Spectroscopy Works
The Future of Raman Spectroscopy for Measuring Blood Glucose
Optogenetics: Ready to Revolutionize Diabetes Treatment?
NASA, Mars and Diabetes
Cam Med's Bandage-Like, Flexible 'Patch' Insulin Pump
CHAPTER 7 SELECTED REGULATORY AND REIMBURSEMENT AFFAIRS
The iCGM Trend
iCGM Development 'Helped' Along by Hackers
iCGM: The Most Important Trend in CGMs
FDA Approves New Interoperable Insulin Dosing 'Controller'
FDA's 'Breakthrough Device Designation' for Diabetes Management Devices
Medicare Supports CGM Smartphone App Use for Diabetes
CGM for T2Ds
CGMs Have Come Far Since 1999
Data Show Improved Glycemic Control in T2Ds
CGMs Advanced to the Point of Cost Savings, Even for T2Ds
CGM Usage for T2Ds in the European Union
Dexcom Granted CE mark for CGM Use by Pregnant Women
February 2019: FDA Approves Tandem's and Insulet's ACE Pumps
CHAPTER 8 SELECTED CLINICAL TRIALS
The International Diabetes Closed Loop Trial: Clinical Acceptance of the Artificial Pancreas
Description
Method
Conclusions
The VRIF Trial: Hypoglycemia Reduction with Automated-Insulin Delivery System
Description
Method
Conclusions
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas in Pediatrics: A Study of t:Slim X2 With Control-IQ Technology
Description
Method
Conclusions
Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24 hr Closed Loop Control
Description
Method
Conclusions
PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days
Description
Method
Conclusions
Evaluation of Two Different Glucose Monitoring Treatments and Their Impact on Time in Target, Sleep and Quality of Life in Children with Type 1 Diabetes and Primary Caregivers: The QUEST Study
Description
Method
Conclusions
Continuous Glucose Monitoring and Management In Type 2 Diabetes (T2D) (COMMITTED)
Description
Method
Conclusions
CHAPTER 9 COMPANY PROFILES
ABBOTT LABORATORIES
ALERTGY
BETA BIONICS
BETA-O2 TECHNOLOGIES
BIGFOOT BIOMEDICAL
BIOLINQ
CAM MED INC.
DEXCOM
DIABELOOP SA
ELI LILLY & CO.
EOFLOW INC.
INSULET CORP.
LIFESCAN
MEDTRONIC DIABETES
NEMAURA MEDICAL INC.
PACIFIC DIABETES TECHNOLOGIES
PREDIKTOR MEDICAL
ROCHE DIABETES CARE
SENSEONICS
TANDEM DIABETES CARE INC.
TIDEPOOL
WAVEFORM TECHNOLOGIES
CHAPTER 10 APPENDIX: TERMS AND ABBREVIATIONS
LIST OF TABLES
Table 1: Timeline of Selected Device Approvals in the U.S. and EU
Table 2: Normal and Elevated HbA1c Levels
Table 3: Timeline of Selected Device Approvals in the U.S. and EU
Table 4: Selected Start-up Developers of CGM and Sensors
Table 5: Closed Loop Trial: Arms and Intervention/Treatment
Table 6: The VRIF Trial: Arms and Intervention/Treatment
Table 7: The International Diabetes Closed Loop (iDCL) Trial: Arms and Intervention/Treatment
Table 8: Project Nightlight: Arms and Intervention/Treatment
Table 9: PROMISE Study: Arms and Intervention/Treatment
Table 10: The QUEST Study: Arms and Intervention/Treatment
Table 11: COMMITTED: Arms and Intervention/Treatment
Table 12: Terms and Abbreviations
Table 1: Timeline of Selected Device Approvals in the U.S. and EU
Table 2: Normal and Elevated HbA1c Levels
Table 3: Timeline of Selected Device Approvals in the U.S. and EU
Table 4: Selected Start-up Developers of CGM and Sensors
Table 5: Closed Loop Trial: Arms and Intervention/Treatment
Table 6: The VRIF Trial: Arms and Intervention/Treatment
Table 7: The International Diabetes Closed Loop (iDCL) Trial: Arms and Intervention/Treatment
Table 8: Project Nightlight: Arms and Intervention/Treatment
Table 9: PROMISE Study: Arms and Intervention/Treatment
Table 10: The QUEST Study: Arms and Intervention/Treatment
Table 11: COMMITTED: Arms and Intervention/Treatment
Table 12: Terms and Abbreviations
LIST OF FIGURES
Figure 1: Global CGM Market Share, by Type of Users, 2018
Figure 2: Anatomy of the Pancreas
Figure 3: Selected Global, U.S., EU and Rest of World Diabetes Statistics
Figure 4: Global CGM Market Share, by Type of User, 2018
Figure 1: Global CGM Market Share, by Type of Users, 2018
Figure 2: Anatomy of the Pancreas
Figure 3: Selected Global, U.S., EU and Rest of World Diabetes Statistics
Figure 4: Global CGM Market Share, by Type of User, 2018
