Diabetes MellitusNCT01885546
Accuracy Study for Enhanced Meter Feature
A study testing AgaMatrix Blood Glucose Monitor in people with Diabetes Mellitus, run by AgaMatrix, Inc. at 1 site in United States.
Trial summary
This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professionals and can remind patients of the importance of glycemic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- AgaMatrix Blood Glucose Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Type I or type II diabetes inclusive of the following populations:
- Mixed insulin therapies
- Basal insulin therapies
- Continuous subcutaneous insulin infusion therapies
- Multiple daily injection therapies
- Non-insulin diabetic treatments (oral and injectable)
Show all 15Show fewer
- Life style (exercise and diet) diabetes management
- New diagnosis of diabetes
- Non diabetics
- Able to speak and read English proficiently
- Subjects must be willing to:
- once a month, perform a 7 point blood glucose profile over the course of one day
- perform fasting blood glucose tests every day
- complete baseline and follow-up questionnaires
- consent to baseline HbA1c assays
Who cannot join
- Pregnant
- Hct <20 or >60
- Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott)
- Homeless
- Incarcerated
- Mentally ill
- Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.
- Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy Study for the Evaluation of Obtaining an Enhanced Meter Feature Using an AgaMatrix BGMS
This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professionals and can remind patients of the importance of glycemic control.
This study will evaluate a user's ability to obtain the enhanced meter feature.
- Conditions
- Diabetes Mellitus
- Being tested
- AgaMatrix Blood Glucose Monitor
- Keywords
- diabetes, glucose, glucometer
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgaMatrix Blood Glucose MonitorDevice
| Study group | Role | What they receive |
|---|---|---|
| Enhanced meter feature usability | Other | Home diabetes monitoring by patient using provided blood glucose monitoring system. Receives: Device: AgaMatrix Blood Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
User's ability to obtain the enhanced meter feature
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- AgaMatrix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885546
- Sponsor's protocol ID
- AGAFPGM02
- Status last verified
- Jan 2014
- First submitted
- 21 Jun 2013
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sieber J, Flacke F, Dumais B, Peters CC, Mallery EB, Taylor L. Evaluation of a Methodology for Estimating HbA1c Value by a New Glucose Meter. J Diabetes Sci Technol. 2015 May 22;10(1):67-71. doi: 10.1177/1932296815587323.
PubMed 26002835
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Study for the Evaluation of Obtaining an Enhanced Meter Feature Using an AgaMatrix BGMS
- ClinicalTrials.gov ID
- NCT01885546
- Acronym / sponsor ID
- AGAFPGM02
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, glucose, glucometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- AgaMatrix, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professionals and can remind patients of the importance of glycemic control.
This study will evaluate a user's ability to obtain the enhanced meter feature.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced meter feature usability | Other | Device: AgaMatrix Blood Glucose MonitorHome diabetes monitoring by patient using provided blood glucose monitoring system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Type I or type II diabetes inclusive of the following populations:
- Non diabetics
- Able to speak and read English proficiently
- Subjects must be willing to:
Key exclusion criteria (8 listed)
- Pregnant
- Hct <20 or >60
- Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott)
- Homeless
- Incarcerated
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 |
|---|---|---|
| AgaMatrix Blood Glucose Monitor | Device | Enhanced meter feature usability |
Primary outcome
User's ability to obtain the enhanced meter feature
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Derived from this study: PubMed 26002835Sieber J, Flacke F, Dumais B, Peters CC, Mallery EB, Taylor L. Evaluation of a Methodology for Estimating HbA1c Value by a New Glucose Meter. J Diabetes Sci Technol. 2015 May 22;10(1):67-71. doi: 10.1177/1932296815587323.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AgaMatrix Blood Glucose Monitor in people with Diabetes Mellitus, run by AgaMatrix, Inc. at 1 site 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 15 inclusion and 8 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 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
User's ability to obtain the enhanced meter feature (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01885546, which also lists 1 linked publication.
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 8 Jul 2015.