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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908125
Recruitment Status : Active, not recruiting
First Posted : April 9, 2019
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Senseonics, Inc.

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 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

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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Senseonics, Inc.
More Information
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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: November 14, 2022
Last Verified: November 2022
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