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Study of an Investigational Glucose Meter System

NCT01466075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2016-02-29

Study results available
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Summary

The purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Conditions

Interventions

DEVICE

Apollo Evolution Investigational BG Monitoring System

Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and Alternative Site Testing (AST) of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback.

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • David Simmons, MD · Ascensia Diabetes Care

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

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 NCT01466075 on ClinicalTrials.gov