Evaluation of the A1CNow+ Test Kit

NCT00798486 | Completed Results

• 1 other identifier: CTD-2008-14
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)

  This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%.

  One hour

Secondary Outcomes (3)

• Average Within Subject Coefficient of Variation CV (PRECISION)

  One hour

• Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing

  One hour

• Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit

  One hour

Study Arms (1)

Subjects with and without Diabetes

OTHER

Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.

Device: A1C Test Kit

Interventions

A1C Test Kit DEVICE

Subjects tested 3 times with A1C test kits. Two tests were performed by the subject and the third test was performed by a healthcare professional (HCP). All results were compared to results from a laboratory glucose analyzer (TOSOH).

Also known as: A1CNow SELFCHECK

Subjects with and without Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age 18 and older) approximately 80% being ≤55 years old
• Persons with:
• known diabetes (type 1 or type 2) and pre-diabetes - approximately 85% of subject population per site
• no known diagnosis of diabetes - approximately 15% of subject population per site
• Individuals who are interested in performing a test using the kit at home
• Individuals willing to complete all study procedures (including venous draw and allowing site staff to perform finger punctures)
• Individuals who are able to speak, read, and understand English
• Individuals able to read out loud the first 5 lines of the A1C Test Kit instructional materials to demonstrate ability to read the print (may use glasses, if needed)

You may not qualify if:

• Individuals taking prescription anticoagulants (such as Warfarin or heparin) or have clotting problems that may prolong bleeding. (Taking Plavix or aspirin daily is not excluded)
• Individuals with known Rheumatoid Arthritis or other condition causing significant impairment of manual dexterity
• Individuals with a known hemoglobin variant such as HbS or HbC
• Individuals with any known disorder of the blood or blood-forming organs (such as recovery from blood loss, hemolytic anemia, or iron deficiency anemia)
• Individuals who have received a blood transfusion within the 4 months prior to the study.
• Persons with known infection with a bloodborne pathogen (e.g. HIV, hepatitis)
• Individuals working for a competitive medical device company
• Individuals who have participated in previous studies on the A1CNow+ product
• Persons missing a digit or partial digits on the hand
• Individuals with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
• Significant visual impairment
• Significant hearing impairment
• Cognitive disorder
• Any other condition as per investigator's discretion

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (2)

John Muir Physician Network Clinical Research Center

Concord, California, 94520, United States

Location

Consumer Product Testing Co., Inc.

Fairfield, New Jersey, 07004, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Senior Clinical Research Scientist
• Organization: Ascensia Diabetes Care

carmine.greene@ascensia.com

574-257-3040

Study Officials

• Anna Chang, MD

  John Muir Physician Network Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Joy Frank, RN

  Consumer Products Testing

  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 26, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 29, 2016
• Results First Posted: March 9, 2010

Record last verified: 2016-01

Locations

US (2)