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A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)

NCT03851549 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2019-03-08

No results posted yet for this study

Summary

This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).

Conditions

Interventions

DEVICE

New BGMS (US)

New blood glucose monitoring system / In vitro diagnostic device (IVDD)

Sponsors & Collaborators

  • Institut für Diabetes-Technologie ( IfDT)

    collaborator UNKNOWN

  • LifeScan Scotland Ltd

    lead INDUSTRY

Principal Investigators

  • Kirsty Macleod · LifeScan Scotland

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2019-04-19
Completion
2019-04-19
FDA Device
Yes

Countries

  • Germany
  • United Kingdom

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 NCT03851549 on ClinicalTrials.gov