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Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

NCT02390167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2019-07-17

Study results available
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Summary

The purpose of this study was to determine if untrained subjects with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Conditions

Interventions

DEVICE

ONYX NEXT BGMS

Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested venous blood from subjects WITH Diabetes and BG results were compared to reference method results obtained from the subjects' venous plasma.

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Timothy Bailey, MD, FACP · AMCR Institute

  • Mark Christiansen, MD · Diablo Clinical Research

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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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 NCT02390167 on ClinicalTrials.gov