DiabetesNCT00798486
Evaluation of the A1CNow+ Test Kit
A study testing A1C Test Kit in people with Diabetes, run by Ascensia Diabetes Care at 2 sites in United States.
Trial summary
The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- A1C Test Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Muir Physician Network Clinical Research Center
Concord, California, 94520
Consumer Product Testing Co., Inc.
Fairfield, New Jersey, 07004
About this study
Official title: In-Clinic Evaluation of the Redwood A1c Test Kit With Lay-Users and Professionals
The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials.
Read the detailed description
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.
- Conditions
- Diabetes
- Being tested
- A1C Test Kit
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A1C Test KitDevice
Also called A1CNow SELFCHECK
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).
| Study group | Role | What they receive |
|---|---|---|
| Subjects with and without Diabetes | Other | Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes. Receives: Device: A1C Test Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: One hour
Secondary outcomes (3)
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.
Measured: One hour
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:
- The subject could not use the product without HCP assistance.
- The subject could not complete the test. User error rendered one or more parts unusable.
- The subject completed the test after one or more mistakes; the result was an error code instead of a numerical value.
Measured: 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).
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Chang, MD, Principal investigator, John Muir Physician Network Clinical Research CenterJoy Frank, RN, Principal investigator, Consumer Products Testing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798486
- Sponsor's protocol ID
- CTD-2008-14
- Status last verified
- Jan 2016
- First submitted
- 24 Nov 2008
- Last updated
- 29 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Clinic Evaluation of the Redwood A1c Test Kit With Lay-Users and Professionals
- ClinicalTrials.gov ID
- NCT00798486
- Acronym / sponsor ID
- CTD-2008-14
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Posted 9 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with and without Diabetes | Other | Device: A1C Test KitSubjects participating in this study included 93 who had diabetes and 17 who did not have diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A1C Test KitAlso: A1CNow SELFCHECKSubjects 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). | Device | Subjects with and without Diabetes |
Primary outcome
Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)
Time frame: One hour
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%.
3 secondary outcomes
Average Within Subject Coefficient of Variation CV (PRECISION)
Time frame: One hour
Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing
Time frame: One hour
Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit
Time frame: One hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Chang, MD principal investigator
John Muir Physician Network Clinical Research Center
Joy Frank, RN principal investigator
Consumer Products Testing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A1C Test Kit in people with Diabetes, run by Ascensia Diabetes Care at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY) (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.