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A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics

NCT02456922 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-09-29

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 2 - 75 years

Conditions

Interventions

DEVICE

Harmony 1 Sensor

Use of Harmony 1 Sensor over 10 days in arm and abdomen and used with the Guardian Mobile App in subjects aged 2-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • Ronald Brazg, MD · Rainier Clinical Research Center

  • Mark Christiansen, MD · Diablo Clinical Research

  • Timothy Bailey, MD · AMCR Institute

  • Satish Garg, MD · Barbara Davis Center

  • Robert Slover, MD · Barbara Davis Center

  • Kevin Kaiserman, MD · SoCal Diabetes

  • Bruce Bode, MD · Atlanta Diabetes Associates

  • Luis Casaubon, MD · Texas Diabetes & Endocrinology

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Device
Yes

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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 NCT02456922 on ClinicalTrials.gov