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AST Clinical Investigation

This study has been completed.
Sponsor:
Information provided by:
Andon Medical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01268345
First received: December 29, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.


Condition Intervention
Diabetes
 Device: blood glucose monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Andon Medical Co.,Ltd:

Primary Outcome Measures:
  • blood glucose value [ Time Frame: 5 seconds ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Lifescan blood glucose monitor

  Eligibility

Ages Eligible for Study:   21 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268345

Locations
China, Tianjin
Tianjin Hexi Ruijing metabolism hospital
Tianjin, Tianjin, China
Sponsors and Collaborators
Andon Medical Co.,Ltd
  More Information

No publications provided

Responsible Party: Yi Liu, Andon Medical Co.,Ltd
ClinicalTrials.gov Identifier: NCT01268345     History of Changes
Other Study ID Numbers: AndonMedical2
Study First Received: December 29, 2010
Last Updated: December 29, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Andon Medical Co.,Ltd:
blood glucose

ClinicalTrials.gov processed this record on June 17, 2013