• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Celmatix Sues Research Partner 23andMe for $100M

    FDA Cleared New Cochlear Osia 2 System

    FDA Approves First Nasal Rescue Treatment for Frequent Seizure Activity

    Lens-Free Microendoscope Generates High Quality Images

    Roche's Blood Glucose Reading Smartphone App Gains CE Mark
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    From Genome Sequencing to the World’s First Portable MRI

    An Update on Digital Health

    ‘If You’re Reading This, You Need to Be at This Meeting’

    Five Steps for Succeeding Globally in Medtech

    Unlocking Market Doors with Real-World Evidence
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    FUTEK Advanced Sensor Technology Inc.

    Fusion Biotec Inc.

    Zeus

    Accumold

    MicroLumen Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Localizing Medical Devices

    Sounding Board: Looking Back at 2019 and Gazing at 2020

    Understanding Key Processes for Mixing APIs with Silicone

    How to Minimize Color Variations in Your Medical Device

    Don’t Touch: Gesture Tech Is Reshaping How We Interact with Devices
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Nelson Laboratories LLC

    Halkey-Roberts Corporation

    Accumold

    Carclo Technical Plastics

    GS Plastic Optics
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    Data on Long-Term Eversense CGM System Show Sustained Accuracy in Pediatric Continuous Sensor Study

    Eversense System also demonstrates best result in CGM comparative accuracy study.

    Data on Long-Term Eversense CGM System Show Sustained Accuracy in Pediatric Continuous Sensor Study
    The Eversense CGM System helps people actively manage their diabetes simply and confidently. Image courtesy of Senseonics Holdings Inc.
    Related CONTENT
    • Tandem Diabetes Care Completes First Pilot Study Using Hybrid Closed Loop System
    • AngioDynamics Receives FDA Expedited Access Pathway Designation for the NanoKnife System
    • FDA Expands Heart Valve Approval to Include Size for Newborn Patients
    • Tandem Diabetes Care, Rubin Medical Forge Agreement to Distribute Insulin Pump Products
    • Monteris Medical NeuroBlate System Recalled Over Unexpected Laser Delivery Probe Heating
    Business Wire08.03.18
    Senseonics Holdings Inc., a developer and commercializer of transformative glucose monitoring products, has presented new data from a clinical study evaluating the performance of the Eversense XL Continuous Glucose Monitoring (CGM) system for up to 180 days in pediatrics and adults with diabetes.
     
     “This is the first study to examine any CGM system in a pediatric population for a period of continuous wear for more than 14 days,” said Dr. Ronnie Aronson, M.D., FRCPC, FACE, primary investigator, endocrinologist and chief medical officer of LMC Diabetes & Endocrinology in Toronto, Canada. “The Eversense System was observed to be a safe and durable alternative to currently available CGM systems and demonstrated excellent accuracy. The sensor insertion and removal procedures for the device were also well-tolerated in subjects studied. Further, patients in the study expressed a high degree of likeability for the Eversense system as relates to its features, which could make it a valuable tool for improved diabetes management.”
     
    In this prospective, unblinded, single-arm, single-center study, pediatrics (n=30) and adults (n=6) with diabetes were evaluated on the accuracy and safety of the Eversense XL CGM System through the 180-day study duration. When referenced against a lab analyzer, the findings demonstrated the accuracy of Eversense XL (MARD of 9.4 percent, 15/15 percent metric of 83 percent, and 99.6 percent of consensus error grid data in zones A and B). Study participants also expressed an overall favorable rating of the system (long sensor life, implantable wear and vibratory alerts). No serious adverse events related to the insertion/removal of the sensor or device were reported.
     
    In another third party study conducted by the MGH Bionic Pancreas Monitoring Study group, each of Eversense, Dexcom G5 and Libre Pro were worn simultaneously by 23 subjects and evaluated using blood glucose meter as the reference method. In the three-way comparison study, Eversense achieved the lowest nominal MARD (14.8 percent) followed by Dexcom G5 (16.3 percent) and Libre Pro (18  percent).
     
    “We found that the point accuracy of the Eversense was significantly better than two other CGM systems,” the study’s authors said. “The Eversense CGM system may be useful to provide glucose values to artificial pancreas devices.”
     
    On June 21, the U.S. Food and Drug Administration (FDA) approved Senseonics’ Pre-market Approval (PMA) application to market the Eversense CGM System in the United States to people age 18 and older with diabetes for up to 90 days.
     
    “On the heels of the U.S. FDA approval of the Eversense CGM System, we are pleased to see these new data evaluating the long-term safety and accuracy of the device,” said Tim Goodnow, president and CEO of Senseonics. “We look forward to further advancing the science of CGM research, which includes demonstrating clinical support for new product indications for wider populations with an even longer sensor life. In particular, we believe the results of the pediatric study will potentially help inform the design of our future pediatric clinical trials.”
     
    The Eversense System is the first and only CGM system approved by the FDA to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months.
     
    The Eversense Continuous Glucose Monitoring System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days. It is intended to complement, not replace, fingerstick blood glucose monitoring. The sensor insertion and removal is performed by a physician.
    Related Searches
    • medical
    • diabetes
    • diabetes management
    • senseonics
    Suggested For You
    FDA Approves First Ever CGM System with Implanted Sensor and Mobile App FDA Approves First Ever CGM System with Implanted Sensor and Mobile App
    Tandem Diabetes Care Tandem Diabetes Care's t:slim X2 Insulin Pump with Basal-IQ Technology Wins FDA Nod
    FDA Approves Medtronic FDA Approves Medtronic's 200 & 250mm IN.PACT Admiral Drug Coated Balloons
    Dexcom G6 CGM System Wins CE Mark Dexcom G6 CGM System Wins CE Mark
    Senseonics and Beta Bionics Partner to Develop the Bionic Pancreas System Senseonics and Beta Bionics Partner to Develop the Bionic Pancreas System
    Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry
    Home Field Advantage: Examining Home Diagnostics for Chronic Disease Home Field Advantage: Examining Home Diagnostics for Chronic Disease
    FDA Initiates Device Development Challenge to Help Combat Opioid Crisis FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
    Tandem Diabetes Care Forges Agreements for Distribution of Insulin Pump Products Tandem Diabetes Care Forges Agreements for Distribution of Insulin Pump Products
    3 Critical Considerations for U.S. Medical Device Commercialization 3 Critical Considerations for U.S. Medical Device Commercialization
    FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics
    Tandem Diabetes Care, Movi SpA Announce Agreement for Distribution of Insulin Pump Products Tandem Diabetes Care, Movi SpA Announce Agreement for Distribution of Insulin Pump Products
    Tandem Diabetes Care Tandem Diabetes Care's t:slim X2 Insulin Pump Wins CE Mark
    Software Validation: How It Should Be Done Software Validation: How It Should Be Done
    FDA FDA's Expansion of 510(k) Program Seeks to End Predicate Testing for Some Devices

    Related Breaking News

    • Celmatix Sues Research Partner 23andMe for $100M

      Celmatix Sues Research Partner 23andMe for $100M

      Celmatix claims breaches of the parties' agreement and tortious interference with efforts to raise capital.
      PR Newswire 12.11.19

    • FDA Cleared New Cochlear Osia 2 System

      FDA Cleared New Cochlear Osia 2 System

      The world’s first active osseointegrated steady-state implant.
      Cochlear 12.11.19

    • Neurological
      FDA Approves First Nasal Rescue Treatment for Frequent Seizure Activity

      FDA Approves First Nasal Rescue Treatment for Frequent Seizure Activity

      Aptar’s Unidose Liquid System can deliver a formulation in an emergency situation quickly and easily and be administered by a non-healthcare professional.
      Business Wire 12.10.19


    • Diagnostics
      Lens-Free Microendoscope Generates High Quality Images

      Lens-Free Microendoscope Generates High Quality Images

      It also doesn't require movement to focus on objects at different depths.
      Johns Hopkins University 12.10.19

    • Patient Monitoring | Software & IT
      Roche

      Roche's Blood Glucose Reading Smartphone App Gains CE Mark

      The app determines blood glucose ranges by taking photos with the smartphone camera without the need for a blood glucose meter.
      GlobeNewswire 12.10.19

    • FDA BDP Designation for the iLet Bionic Pancreas System

      FDA BDP Designation for the iLet Bionic Pancreas System

      The world’s first fully automated bionic pancreas.
      Beta Bionics 12.10.19


    • Diagnostics
      NeuMoDx Molecular and Sentinel Diagnostics Partner

      NeuMoDx Molecular and Sentinel Diagnostics Partner

      Work together to develop multiple new assays for the NeuMoDx Molecular Systems.
      NeuMoDx Molecular 12.10.19

    • Neural Analytics Enrolls First Patient With Its Next-Generation Lucid Robotic System

      Neural Analytics Enrolls First Patient With Its Next-Generation Lucid Robotic System

      The new IDE version of the technology is intended to improve performance and ease of use for the company’s robotic platform.
      Business Wire 12.10.19

    • Cardiovascular | Neurological
      Imperative Care Closes a Series C Financing of $85 Million for Stroke Treatments

      Imperative Care Closes a Series C Financing of $85 Million for Stroke Treatments

      The funds will support the commercial launch of the company’s portfolio.
      Imperative Care Inc. 12.10.19


    • Contract Manufacturing
      Medical Murray Holds Open House

      Medical Murray Holds Open House

      Event centered around new 35,000 square foot facility.
      Medical Murray 12.10.19

    • Cardiovascular
      FDA Grants Supplemental-PMA Approval to Impulse Dynamics

      FDA Grants Supplemental-PMA Approval to Impulse Dynamics' Next-Generation Optimizer Smart System

      Product offers a new therapy for heart failure patients with reduced ejection fraction.
      Businesswire 12.10.19

    • OmniGuide Holdings Expands Executive Team

      OmniGuide Holdings Expands Executive Team

      Company hires global marketing VP and managing director of Surgical Strategic Business Unit.
      Businesswire 12.10.19

    • Survey: Device Tax

      Survey: Device Tax's Return Will Harm Innovation

      Medical Alley Association survey shows 83 percent of respondents will be decreasing R&D spending if tax is reinstated.
      Business Wire 12.10.19

    • Surgical
      CMR Surgical Taps New CEO

      CMR Surgical Taps New CEO

      Per Vegard Nerseth joins the company from ABB.
      CMR Surgical 12.09.19

    • Diagnostics
      Companies Partner to Develop Instrument-Free Molecular Diagnostic Tests

      Companies Partner to Develop Instrument-Free Molecular Diagnostic Tests

      Collaboration facilitated by the Bill & Melinda Gates Foundation through an expansion of an existing grant.
      Business Wire 12.09.19


    Breaking News
    • Celmatix Sues Research Partner 23andMe for $100M
    • FDA Cleared New Cochlear Osia 2 System
    • FDA Approves First Nasal Rescue Treatment for Frequent Seizure Activity
    • Lens-Free Microendoscope Generates High Quality Images
    • Roche's Blood Glucose Reading Smartphone App Gains CE Mark
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • Adding Fabrication Capabilities: Additive Manufacturing for Production Parts
    • Delivering the Goods: The Evolving World of Combination Products
    • Anxious Undertones: The 2019 Year in Review
    • View More >
    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Deerland Obtains Certification from Australia’s Therapeutic Goods Administration
    OptiMSM Shown to Improve Hair & Nail Appearance and Condition
    DCC Acquires Contract Manufacturer Ion Laboratories
    Coatings World

    Latest Breaking News From Coatings World

    Beckers Group Announces Global Price Increase on Coil, Industrial Coatings
    Evonik, Wynca Celebrate Groundbreaking of New Fumed Silica Plant in Zhenjiang
    Personnel Changes in Corporate Communications, Government Relations at BASF
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Celmatix Sues Research Partner 23andMe for $100M
    FDA Cleared New Cochlear Osia 2 System
    FDA Approves First Nasal Rescue Treatment for Frequent Seizure Activity
    Contract Pharma

    Latest Breaking News From Contract Pharma

    CatSci Expands Capabilities with Lab Expansion
    Smart Tags on Pills Set to Improve Supply Chain Security and Patient Adherence
    PCI Pharma Services Invests in Tredegar, UK Site
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Time Features 5 Best Beauty Inventions
    CES 2020 Preview - Innovation Award Honorees in Health & Wellness
    Star of E!'s Botched Gets Line Leaping Bunny Certified
    Happi

    Latest Breaking News From Happi

    Birchbox Partners with Buzzfeed
    Coty Strengthens Its Leadership
    Jennifer Garner Joins Virtue Labs
    Ink World

    Latest Breaking News From Ink World

    Smurfit Kappa, Wings for Aid Create Disaster Relief Packaging Solution
    ePac Flexible Packaging Expands into Asia Pacific Market
    United Carton Industries Company Invests in EFI Nozomi Corrugated Printer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Materials Exchange launches to solve excess inventory issue
    Mark Andy joins forces with UPM Raflatac
    Omet India opens in New Delhi
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Simavita Set to License Sensor Technology in EU
    NDC Appoints President
    AATC Adds Two Scholarships
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FDA OKs Shoulder Innovations' Augmented Glenoids for Total Shoulder System
    OrthoGrid Systems Receives FDA 510(k) Clearance for New PhantomMSK Trauma Application
    Tyber Medical Opens $8M Office and Manufacturing Facility
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    SEMI Releases Global Semiconductor Equipment Sales Forecast
    eMagin Corporation Announces Approximately $4.3 Million Order for Military Program
    CPI Supports Smart Food-labeling Project Set to Reduce Food Waste in 2020

    Copyright © 2019 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.