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市場調查報告書

持續性血糖監測系統:最新技術

Continuous Glucose Monitoring: The Current State of the Art

出版商 BCC Research 商品編碼 932713
出版日期 內容資訊 英文 76 Pages
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持續性血糖監測系統:最新技術 Continuous Glucose Monitoring: The Current State of the Art
出版日期: 2020年04月13日內容資訊: 英文 76 Pages
簡介

為了使安全且有效的設備能進入市場,隨著技術開發也必須整備法律規章的指南。為了開發糖尿病管理的最好設備並持續商品化,需要有利的法律規章和償付指南。

本報告提供全球持續性血糖監測系統市場相關調查,市場概要與市場成長趨勢,競爭趨勢,主要企業的簡介相關資訊彙整。

第1章 簡介

第2章 摘要整理

第3章 定義

  • 胰臟工作
  • 第一型糖尿病
  • 第二型糖尿病
  • 統計
  • 血紅素A1c(HbA1c)控制
  • 嚴格的血糖控制和時間的重要性
  • 第一型糖尿病患者的每天的糖尿病導願的工作
  • 血糖值管理用CGM的優點
  • 現在歐美上市的CGM
  • FDA和ACE幫浦

第4章 患者的選擇和設備的互相操作性擴大

  • 封閉迴路型胰島素輸送系統的進步
  • 全自動封閉迴路型系統的障礙
  • Tandem的Control-IQ技術
  • Medtronic的下一代最新混合封閉迴路型系統 其他

第5章 新CGM和開發中的零組件

第6章 技術承諾還是炒作

  • MIT和非侵入性血糖監測系統
  • Raman光譜學如何作用
  • 血糖檢測的Raman光譜學的未來 其他

第7章 法律規章與償付趨勢

第8章 臨床實驗趨勢

  • 國際糖尿病封閉迴路型臨床實驗
  • VRIF臨床實驗
  • iDCL臨床實驗
  • Project Nightlight
  • PROMISE實驗
  • 2個不相同的血糖監測系主導療的評估
  • 第二型糖尿病的持續性血糖監測系統與管理

第9章 企業簡介

第10章 附錄:用語和簡稱

目錄
Product Code: HLC255A

Highlights:

This report is designed to investigate and discuss the latest developments in continuous glucose monitoring (CGM) for the management of diabetes.

The study’s goals include:

  • Presenting the current products in the U.S., EU and elsewhere.
  • Looking at the technology—both on the market and in development.
  • Tracing improvements that companies are engineering and where these improvements may lead within the market.
  • Examining how close the industry is to a device-based artificial pancreas (AP).
  • Exploring selected clinical trials, the conclusions drawn from the research, and how the clinical trials affect the further development of CGM.

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

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:

  • 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

Table of Contents

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

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

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