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Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System

NCT02073058 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2014-05-23

No results posted yet for this study

Summary

The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. During the course of the wear duration, the subject is required to test fingerstick glucose measurement at least eight (8) times a day for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.

Conditions

Interventions

DEVICE

No treatment

Sponsors & Collaborators

  • Abbott Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Timothy Bailey, MD · AMCR Institute

  • Bruce Bode, MD · Atlanta Diabetes Associates

  • Mark Christiansen, MD · Diablo Clinical Research

  • Leslie Klaff, MD · Rainier Clinical Research

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-05-31
Completion
2014-05-31

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 NCT02073058 on ClinicalTrials.gov