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Home Use Sensor Study

NCT02932514 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-05-22

No results posted yet for this study

Summary

The purpose of this clinical investigation is to evaluate the accuracy of the Eversense Continuous Glucose Monitoring System (Eversense System) measurements when compared with a Self-monitoring blood glucose (SMBG) meter. The investigation will assess device performance in two insertion locations (abdomen and upper arm), evaluate safety of the Eversense System usage, and assess the usability of the Eversense system in the hands of user at home setting. Changes in HbA1c from baseline will also be evaluated.

Conditions

Interventions

DEVICE

Eversense (Senseonics) Continuous Glucose Monitoring System

* Evaluate accuracy of Eversense CGM System to SMBG Meter. * Compare performance between abdomen and arm insertion sites. * Determine the usability of the Eversense System in a home-use setting for 180 days.

Sponsors & Collaborators

  • Senseonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Mona Landin-Olsson, M.D., Ph.D · Skane University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-07-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02932514 on ClinicalTrials.gov