NCT01268345

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2010

Completed
Last Updated

December 30, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

December 29, 2010

Last Update Submit

December 29, 2010

Conditions

Keywords

blood glucose

Outcome Measures

Primary Outcomes (1)

  • blood glucose value

    5 seconds

Study Arms (2)

Andon

EXPERIMENTAL

Andon blood glucose test strips with test meter

Device: blood glucose monitor

Lifescan

ACTIVE COMPARATOR
Device: blood glucose monitor

Interventions

Blood glucose monitor is used to monitor the blood glucose level of the human-being

Also known as: Andon blood glucose monitor
Andon

Eligibility Criteria

Age21 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Hexi Ruijing metabolism hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 29, 2010

First Posted

December 30, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 30, 2010

Record last verified: 2010-12

Locations