Post Approval Study of the Eversense® Continuous Glucose Monitoring

Part of paid clinical trials in Newport Beach, California.

Sponsor
Senseonics, Inc.
Study ID
NCT03908125
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Eversense® CGM System — DEVICE
    Continuous Glucose monitoring device

Study Details

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

Key Dates

Start date
Mar 19, 2019
Status verified
Mar 2025
Primary completion
Feb 1, 2024
Completion
Feb 1, 2024

Study Design

Enrollment
273 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Continuous Glucose Monitoring Device
    Commercial Continuous Glucose Monitoring Device

Primary Outcome Measure

The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. [ Time Frame: up to 27 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes CenterNewport BeachCalifornia92663-
Denver Endocrinology, Diabetes & Thyroid CenterEnglewoodColorado80113-
The Center for Diabetes and Endocrine CareFort LauderdaleFlorida33312-
Atlanta Diabetes AssociatesAtlantaGeorgia30318-
MODEL Clinical researchBaltimoreMaryland21204-
Metro Detroit Endocrinology CenterDearbornMichigan48126-
Diabetes and Endocrinology Specialists, Inc.ChesterfieldMissouri63017-
Albany Medical CollegeAlbanyNew York12206-
Physicians EastGreenvilleNorth Carolina27834-
PMG Research of Wilmington, LLCWilmingtonNorth Carolina28401-
Diabetes & Endocrinology Consultants of Pennsylvania, LLCFeastervillePennsylvania19053-
AM Diabetes & EndocrinologyBartlettTennessee38133-
Texas Diabetes and EndocrinologyAustinTexas78731-
Clinical Research Solution, LLCCypressTexas77433-
Javara, IncHoustonTexas77095-
Diabetes and Glandular Disease ClinicSan AntonioTexas78229-
Consano Clinical Research, LLCShavano ParkTexas78231-

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