AST Clinical Investigation

December 29, 2010 updated by: Andon Medical Co.,Ltd
Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Hexi Ruijing metabolism hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • people ( disbetes people)with at least 8 hours of limosis

Exclusion Criteria:

  • After meal(when doing the test)
  • take Hypoglycemic Drugs(when doing the test)
  • with insulin(when doing the test)
  • after strenuous exercise(when doing the test)
  • Pregnant women
  • neonates
  • patients in a hyperglycemic-hyperosmolur state, with or without ketosis.
  • patients who are dehydrated, hypertensive, hypotensive or in shock.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Andon
Andon blood glucose test strips with test meter
Device: blood glucose monitor
Blood glucose monitor is used to monitor the blood glucose level of the human-being.
Other Names:
  • Lifescan blood glucose monitor
Device: blood glucose monitor
Blood glucose monitor is used to monitor the blood glucose level of the human-being
Other Names:
  • Andon blood glucose monitor
Active Comparator: Lifescan
Device: blood glucose monitor
Blood glucose monitor is used to monitor the blood glucose level of the human-being.
Other Names:
  • Lifescan blood glucose monitor
Device: blood glucose monitor
Blood glucose monitor is used to monitor the blood glucose level of the human-being
Other Names:
  • Andon blood glucose monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood glucose value
Time Frame: 5 seconds
5 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andon Medical Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 29, 2010

First Submitted That Met QC Criteria

December 29, 2010

First Posted (Estimate)

December 30, 2010

Study Record Updates

Last Update Posted (Estimate)

December 30, 2010

Last Update Submitted That Met QC Criteria

December 29, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AndonMedical2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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