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Performance of a New Glucose Meter System in Children and Young Adults

NCT00985257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2016-02-29

Study results available
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Summary

The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.

Conditions

Interventions

DEVICE

DIDGET (Investigational Blood Glucose Monitoring System)

Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Timothy Bailey, MD · AMCR Institute

  • Larry C Deeb, MD PA · Larry C. Deeb, MD PA

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-10-31
Completion
2009-10-31

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 NCT00985257 on ClinicalTrials.gov