NCT00976924

Brief Summary

Blood glucose test strips are tested with the test meters to test the accuracy of the blood pressure monitoring function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jul 2009

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

July 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

Same day

First QC Date

September 8, 2009

Last Update Submit

September 14, 2009

Conditions

Diabetes

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

Lifescan blood glucose test strips with test meter

Device: blood glucose monitor

Interventions

blood glucose monitorDEVICE

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

Also known as: Andon or lifescan blood glucose monitor
AndonLifescan

Eligibility Criteria

Age22 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients with blood glucose within the range of ISO15197

You may not qualify if:

  • The patients with blood glucose out of the range of ISO15197

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University general hospital

Tianjin, Tianjin Municipality, 300070, 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
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 15, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

CN(1)