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A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China

NCT03710083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-09-09

Study results available
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Summary

The purpose of this study is to demonstrate the performance and safety of the Guardian™ Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects age 14 - 75 years with the Guardian™ Connect System.

Conditions

Interventions

DEVICE

Guardian™ Sensor (3)

Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • Jian Zhou, MD · Shanghai 6th People's Hospital

  • Xiaofeng Lv, MD · Seventh Medical Center of PLA Army General Hospital

  • Hong Li, MD · Sir Run Run Shaw Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2019-07-25
Completion
2019-07-25
FDA Device
Yes

Countries

  • China

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 NCT03710083 on ClinicalTrials.gov