NCT00804596

Brief Summary

The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Dec 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 9, 2010

Completed
Last Updated

February 29, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

December 5, 2008

Results QC Date

December 16, 2009

Last Update Submit

January 29, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

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

    Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was: 1. Successful in performing tasks correctly without assistance 2. Successful after being referred to user instructions 3. Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)

    1-2 hours

Secondary Outcomes (1)

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

    1-2 hours

Study Arms (1)

Subjects with diabetes

OTHER

Subjects with diabetes use a new blood glucose monitoring system with subject capillary blood.

Device: Apollo Blood Glucose Monitoring System

Interventions

Apollo Blood Glucose Monitoring SystemDEVICE

Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer.

Also known as: Commercial name is 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 at least 18 years of age but have not reached their 76th birthday, with approximately 50% (+10%) being less than 55 years of age, at time of consent
  • 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
  • Own or operate a computer for personal or professional use beyond that for email correspondence. Subjects will not have to use their personal computer for the study, but computer use will be required.

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)

International Diabetes Center

Minneapolis, Minnesota, 55416, 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
Senior Clinical Research Scientist
Organization
Ascensia Diabetes Care
carmine.greene@ascensia.com
574-257-3040

Study Officials

  • Robert Cuddihy, MD

    International Diabetes Center at Park Nicollet

    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

December 5, 2008

First Posted

December 9, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 29, 2016

Results First Posted

March 9, 2010

Record last verified: 2016-01

Locations

US(1)