MedTrace Logo

Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth

NCT03815552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-10-15

No results posted yet for this study

Summary

The purpose of this clinical investigation is to provide pilot clinical data to direct pivotal study development for the pediatric indication of the Senseonics Continuous Glucose Monitoring System (CGM) measurements when compared with finger stick blood glucose monitoring in an outpatient setting. (The investigation will also evaluate safety of the Senseonics CGM System usage, get feedback regarding subject and caregiver acceptability of the device and the mobile medical application (MMA).

Conditions

  • Self Care

Interventions

DEVICE

Eversense Continuous Glucose Monitoring

The Eversense Continuous Glucose Monitoring System is a glucose monitoring device intended to continually measure interstitial fluid glucose levels in individuals with diabetes for the operating life of the sensor.The System comprises a sensor and a transmitter. The small sensor will be subcutaneously inserted in the arm.The transmitter reads glucose data from the subcutaneous sensor.

Sponsors & Collaborators

  • Senseonics, Inc.

    collaborator INDUSTRY

  • Kinderkrankenhaus auf der Bult

    lead OTHER

Principal Investigators

  • Thomas Danne, MD · Kinder- und Jugendkrankenhaus AUF DER BULT

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2019-09-11
Completion
2019-09-11
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

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 NCT03815552 on ClinicalTrials.gov