Diabetes MellitusNCT01889355
User 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 in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of… 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
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2014
- 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
- IC 1. Age of subject is 18 years or older
- IC 2. Type I or type II diabetes inclusive of the following populations:
- Mixed insulin therapies
- Basal insulin therapies
- Bolus insulin therapies
- CSII therapies
Show all 12Show fewer
- MDI therapies
- Non-insulin diabetic treatments (oral and injectable)
- Life style (exercise and diet) diabetes management IC 3. Able to speak and read English proficiently
- Exclusion criteria EC 1. Pregnant EC 2. Hct <20 or >60 EC 3. Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott) EC 4. Homeless EC 5. Incarcerated EC 6. Institutionalized EC 7. Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.
- EC 8. Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
- EC 9. Previous experience using the MyStar Extra BGMS
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS
This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control.
This study will evaluate a user's ability to use 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.
Enhanced Meter Feature Usability
The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionMar 2014
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 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
- 121 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
- NCT01889355
- Sponsor's protocol ID
- AGAFPGM01
- Status last verified
- Mar 2014
- First submitted
- 21 Jun 2013
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS
- ClinicalTrials.gov ID
- NCT01889355
- Acronym / sponsor ID
- AGAFPGM01
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, glucose, glucometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- AgaMatrix, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Posted 6 Aug 2018
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 in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control.
This study will evaluate a user's ability to use 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 (12 listed)
- IC 1. Age of subject is 18 years or older
- Mixed insulin therapies
- Basal insulin therapies
- Bolus insulin therapies
- CSII therapies
Key exclusion criteria (0 listed)
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
Enhanced Meter Feature Usability
Time frame: 4 weeks
The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- 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.
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 12 inclusion and 0 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 6 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2018). 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?
Enhanced Meter Feature Usability (time frame: 4 weeks). 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 6 Aug 2018.