MedTrace Logo

A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics

NCT02646878 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-11-20

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years.

Conditions

Interventions

DEVICE

Harmony 1 Sensor

Use of Harmony 1 Sensor for 10 days when inserted in the arm and abdomen and used with the Guardian Mobile in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 6 months.

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • Ronald Brazg, MD · Rainer Clinical Research Center

  • Mark Christiansen, MD · Diablo Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-07-31
Completion
2016-07-31
FDA Device
Yes

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 NCT02646878 on ClinicalTrials.gov