Diabetes MellitusNCT02333864
POGO® Automatic Blood Glucose Monitoring System Clinical Study
An observational study of Diabetes Mellitus, run by Intuity Medical, Inc at 2 sites in United States.
Trial summary
The purpose of this study is to determine if the POGO® system delivers accurate blood glucose readings in the hands of the lay user and assess the POGO® system accuracy when used by trained health care professionals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- POGO® BGMS
- Type of treatment
- Medical device
- How many people
- 287 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Mar 2015
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: People who are 18 years of age or older and have been diagnosed with diabetes
Who may be able to join
- Be diagnosed with diabetes
- Be 18 years of age or older
- Be able to read, write, and understand English fluently
- Be able and willing to give written informed consent and have provided signed, written consent
Who cannot join
- Any condition which in the opinion of the Investigator may place the subject or site personnel at excessive risk
- A physical condition or limitation that prevents the subject from reading the labeling and using a BGMS on their own
- Previous experience with the POGO® BGMS
- Formal experience with clinical (medical) laboratory equipment or formal training in a relevant medical field
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Park Nicollett Institute - International Diabetes Center
Minneapolis, Minnesota, 55416
Diablo Clinical Reasearch
Walnut Creek, California, 94598
About this study
The purpose of this study is to determine if the POGO® system delivers accurate blood glucose readings in the hands of the lay user and assess the POGO® system accuracy when used by trained health care professionals.
Read the detailed description
Subjects will review labeling materials and self-test using the POGO® system. An HCP-assisted test also will be performed; both tests will be compared to a fingerstick capillary sample run on a YSI reference glucose analyzer. Subjects will complete questionnaires on labeling comprehension and POGO® usability.
- Conditions
- Diabetes Mellitus
- Being tested
- POGO® BGMS
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POGO® BGMSDevice
SMBG
| Study group | Role | What they receive |
|---|---|---|
| PWD testing POGO® BGMS | All enrolled persons with diabetes Receives: Device: POGO® BGMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy Validation of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.
Lay-user accuracy
Measured: Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)
Accuracy Verification of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.
HCP accuracy
Measured: Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuity Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333864
- Sponsor's protocol ID
- TP-000321
- Status last verified
- May 2015
- First submitted
- 17 Dec 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POGO® Automatic Blood Glucose Monitoring System Clinical Study
- ClinicalTrials.gov ID
- NCT02333864
- Acronym / sponsor ID
- TP-000321
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Intuity Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Jan 2015 (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.
The purpose of this study is to determine if the POGO® system delivers accurate blood glucose readings in the hands of the lay user and assess the POGO® system accuracy when used by trained health care professionals.
Detailed description
Subjects will review labeling materials and self-test using the POGO® system. An HCP-assisted test also will be performed; both tests will be compared to a fingerstick capillary sample run on a YSI reference glucose analyzer. Subjects will complete questionnaires on labeling comprehension and POGO® usability.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PWD testing POGO® BGMS | – | Device: POGO® BGMSAll enrolled persons with diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who are 18 years of age or older and have been diagnosed with diabetes
Key inclusion criteria (4 listed)
- Be diagnosed with diabetes
- Be 18 years of age or older
- Be able to read, write, and understand English fluently
- Be able and willing to give written informed consent and have provided signed, written consent
Key exclusion criteria (4 listed)
- Any condition which in the opinion of the Investigator may place the subject or site personnel at excessive risk
- A physical condition or limitation that prevents the subject from reading the labeling and using a BGMS on their own
- Previous experience with the POGO® BGMS
- Formal experience with clinical (medical) laboratory equipment or formal training in a relevant medical field
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 |
|---|---|---|
| POGO® BGMSSMBG | Device | PWD testing POGO® BGMS |
Primary outcome
Accuracy Validation of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.
Time frame: Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)
Lay-user accuracy
Accuracy Verification of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.
Time frame: Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)
HCP accuracy
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 28 May 2015.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Intuity Medical, Inc 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 4 inclusion and 4 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 28 May 2015. 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?
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?
Accuracy Validation of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement. (time frame: Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)). The study lists 2 primary outcomes in all. 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 28 May 2015.