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The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials.
The purpose of this study was to assure that consumers could successfully use the new version of A1CNow+ Test Kit along with revised instructional materials. The primary objective was to establish accuracy and secondary objectives were to establish precision, comprehension of instructional materials, and user feedback about the overall testing experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with and without Diabetes | Other | Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Within Subject Coefficient of Variation CV (PRECISION) | The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of A1c self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root. | One hour |
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Inclusion Criteria:
Adults (age 18 and older) approximately 80% being ≤55 years old
Persons with:
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)
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Chang, MD | John Muir Physician Network Clinical Research Center | Principal Investigator |
| Joy Frank, RN | Consumer Products Testing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | United States | ||
| Consumer Product Testing Co., Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With and Without Diabetes | Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With and Without Diabetes | Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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%. | Posted | Nov 2009 | Number | number of A1c results | One hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With and Without Diabetes | Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Research Scientist | Ascensia Diabetes Care | 574-257-3040 | carmine.greene@ascensia.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing |
For the comprehension analysis, subjects were divided into 2 groups. One group (n=56 subjects) was given both written (Quick Reference Guide) and DVD instruction material. The other group (n=54 subjects) was given only written instruction material. First time failure (FTF) was defined as:
|
| One hour |
| Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit | Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor). | One hour |
| Fairfield |
| New Jersey |
| 07004 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Average Within Subject Coefficient of Variation CV (PRECISION) | The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of A1c self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root. | Precision Coefficient of Variation (CV)was analyzed using meter results from subject data that had numeric values for duplicate A1c self-tests. Subject data was not used in this outcome measure analysis when there had been a protocol deviation or when one (or both) A1c self-tests resulted in an error code. | Posted | Nov 2009 | Number | average percentage CV | One hour |
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|
| Secondary | Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing | For the comprehension analysis, subjects were divided into 2 groups. One group (n=56 subjects) was given both written (Quick Reference Guide) and DVD instruction material. The other group (n=54 subjects) was given only written instruction material. First time failure (FTF) was defined as:
| Posted | Nov 2009 | Number | percentage of subjects | One hour |
|
|
|
| Secondary | Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit | Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor). | Posted | Nov 2009 | Number | number of participants | One hour |
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|
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| 0 |
| 110 |
| 0 |
| 110 |
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| 1 - Poor |
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