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User Performance of the Thunder Plus BGMS

NCT04008836 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2024-06-17

Study results available
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Summary

T-PLUS (Thunder PLUS) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and CONTOUR PLUS test strips. The meter can wirelessly transmit BG results using Bluetooth® Low Energy technology to the meter mobile application that will be available on specified versions of the iOS and Android mobile platforms.

This clinical trial will assess the performance (accuracy) of the T-PLUS meters by lay users enrolled as subjects in the study, and by health care professionals (also called study staff).

Conditions

Interventions

DEVICE

T-PLUS Meter

Blood Glucose Monitoring System (BGMS)

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Mark Christiansen, MD · Diablo Clinical Research

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2019-07-31
Completion
2019-07-31
FDA Device
Yes

Countries

  • United States

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 NCT04008836 on ClinicalTrials.gov