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Post Approval Study of the Eversense® Continuous Glucose Monitoring (PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908125
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Senseonics, Inc.

Brief Summary:
A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Device: Eversense® CGM system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Continuous Glucose Monitoring Device Device: Eversense® CGM system
Continuous Glucose monitoring device that lasts up to 90 days




Primary Outcome Measures :
  1. Incidence of procedure-related adverse events [ Time Frame: 12 months ]
    The primary safety endpoint is the Incidence of the composite of infection, secondary procedures to remove the sensor, or procedure-related adverse events of at least moderate severity

  2. Time in Range [ Time Frame: 12 months ]
    The primary effectiveness endpoint is Time in Range, which is defined as glucose values between 70mg/dL and 180 mg/dL, at 12 months post first sensor insertion compared to first month post first sensor insertion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has diabetes
  2. Subject is greater than 18 years of age

Exclusion Criteria:

  1. Subject is critically ill or hospitalized
  2. Subject has a known contraindication to dexamethasone or dexamethasone acetate
  3. Subjects requiring intravenous mannitol or mannitol irrigation solutions
  4. Female subjects who are pregnant, planning on becoming pregnant or nursing
  5. Subjects on hybrid closed loop systems or closed loop systems
  6. Subjects on other CGM systems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908125


Contacts
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Contact: Katherine Tweden, PhD 2406242602 Katherine.tweden@senseonics.com
Contact: Maggie Lewis maggies.lewis@senseonics.com

Locations
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United States, California
Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center Recruiting
Newport Beach, California, United States, 92663
Contact: Valerie Wolf    949-764-8065    valerie.wolf@hoag.org   
Principal Investigator: David Ahn, MD         
United States, Colorado
Denver Endocrinology, Diabetes & Thyroid Center Active, not recruiting
Englewood, Colorado, United States, 80113
United States, Florida
The Center for Diabetes and Endocrine Care Active, not recruiting
Fort Lauderdale, Florida, United States, 33312
United States, Maryland
MODEL Clinical research Recruiting
Baltimore, Maryland, United States, 21204
Contact: Karen Klein    410-828-7417 ext 119      
Principal Investigator: Phil Levin, MD         
United States, Michigan
Metro Detroit Endocrinology Center Active, not recruiting
Dearborn, Michigan, United States, 48126
United States, Missouri
Diabetes and Endocrinology Specialists, Inc. Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Suzette Christopher    314-469-6224 ext 226      
Principal Investigator: Ralph Oiknine, MD         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12206
Contact: Kevin Feisthamel       feisthk@amc.edu   
Principal Investigator: Robert Busch         
United States, North Carolina
Physicians East Recruiting
Greenville, North Carolina, United States, 27834
Contact: Kirsten Taylor    252-413-6299    Ktaylor@physicianseast.com   
Principal Investigator: Mark Warren, MD         
Wilmington Health/PMG Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Brittany Hayes Savoca       bhayes@pmg-research.com   
Principal Investigator: Michael Favorito, MD         
United States, Pennsylvania
Diabetes & Endocrinology Consultants of Pennsylvania, LLC Recruiting
Feasterville, Pennsylvania, United States, 19053
Contact: Nancy Ward    215-953-6804      
Principal Investigator: Alan Schorr, DO         
United States, Tennessee
AM Diabetes & Endocrinology Active, not recruiting
Bartlett, Tennessee, United States, 38133
United States, Texas
Texas Diabetes and Endocrinology Active, not recruiting
Austin, Texas, United States, 78731
Javara, Inc. Recruiting
Houston, Texas, United States, 77095
Contact: Tegan Mead    346-235-0311      
Principal Investigator: Rakesh Patel, MD         
Diabetes and Glandular Disease Clinic Recruiting
San Antonio, Texas, United States, 78229
Contact: Terri Ryan       terri.ryan@dgdclinic.com   
Principal Investigator: Mark Kipnes, MD         
Consano Clinical Research, Diabetes and Metabolism Specialists Recruiting
Shavano Park, Texas, United States, 78231
Contact: Gregory Danet    210-896-7772      
Principal Investigator: Michelle Welch         
Sponsors and Collaborators
Senseonics, Inc.
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Responsible Party: Senseonics, Inc.
ClinicalTrials.gov Identifier: NCT03908125    
Other Study ID Numbers: CTP-0034
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases