Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood

NCT00797563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2016-02-29

Study results available
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Summary

The purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects.

Conditions

Interventions

DEVICE

Apollo Blood Glucose Monitoring System

Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Joy Frank, RN · Consumer Product Testing Co., Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

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Entities

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 NCT00797563 on ClinicalTrials.gov