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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014