NCT00797563

Brief Summary

The purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2008

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

November 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 22, 2009

Completed
Last Updated

February 29, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

November 24, 2008

Results QC Date

November 17, 2009

Last Update Submit

January 29, 2016

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method

    Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.

    One hour

Secondary Outcomes (2)

  • Percentage of Participants Rated as <=3 (Labeling Comprehension)

    One hour

  • Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter

    One hour

Study Arms (1)

Subjects with diabetes

OTHER

Subjects with diabetes use a new blood glucose monitoring system (BGMS) Apollo Blood Glucose Monitoring System with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.

Device: Apollo Blood Glucose Monitoring System

Interventions

Apollo Blood Glucose Monitoring SystemDEVICE

Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).

Also known as: CONTOUR® USB
Subjects with diabetes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have type 1 or type 2 diabetes
  • Be \> 18, \< 76 year of age at time of consent, with approximately 50% (+10%)being less than 55 years of age
  • Be willing to complete all study procedures
  • Be routinely testing their blood sugar at home (at least once per day)
  • Be able to speak, read, and understand English and understand the Informed Consent document
  • Be able to read the labeling instructions

You may not qualify if:

  • Minors \< 18 years of age and adults \> 75 years of age
  • Pregnancy
  • Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
  • Disorders in the fingertip lancing areas
  • Acute or chronic infections, particularly skin infections
  • Infection with a blood borne pathogen
  • Hemophilia or any other bleeding disorder
  • Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
  • Working for a competitive medical device company

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consumer Product Testing Co., Inc.

Fairfield, New Jersey, 07004, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Carmine Greene, Senior Clinical Research Scientist
Organization
Ascensia Diabetes Care
carmine.greene@ascensia.com
574-257-3040

Study Officials

  • Joy Frank, RN

    Consumer Product Testing Co., Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

February 29, 2016

Results First Posted

December 22, 2009

Record last verified: 2016-01

Locations

US(1)