Diabetes MellitusNCT02709707
Lay-user Trial of the iGlucose Blood Glucose Monitoring System
An observational study of Diabetes Mellitus, run by Nina Peled at 1 site in United States.
Trial summary
Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Blood glucose monitor
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jun 2016
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects with a diagnosis of diabetes, either type 1 or type 2, of various duration with blood glucose levels covering the entire measurement range. .
Who may be able to join
- Be 12 years of age and older
- Have pre-existing diagnosis of diabetes
- Be able to read and understand English
- Agree to participate in the study
- Be able and willing to provide informed consent
Who cannot join
- Do not meet Inclusion Criteria
- With Hemophilia or any other bleeding disorder
- With any condition which in the opinion of the Investigator may place the subject or site staff at excessive risk
- With physical condition/limitation preventing the use of SMBG on their own
Trial locations and contacts
1 site in 1 country.
United States1 site
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: A Lay User Study of the iGlucose, a Device for Self-Monitoring of Blood Glucose (SMBG), Marketed by the Smart Meter Corporation
Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users
Read the detailed description
A non-randomized, prospective study of recruited subjects with diabetes. Subjects will include those with type I or type II diabetes of various duration and those who are naive to self-testing of blood glucose. Subjects will use provided instructions-for-use to undergo self-training on the use of the device and will then self-test their blood glucose level. Results will be compared to those obtained by a lab glucose analyzer.
- Conditions
- Diabetes Mellitus
- Being tested
- Blood glucose monitor
- Keywords
- Diabetes, Blood Sugar
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose monitorDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes | Not described Receives: Device: Blood glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of blood glucose measurements as performed by lay users
Measured: 10 minutes to produce self blood result and to perform lab comparative method
Secondary outcomes (1)
Assessment by lay users of the ease of use of the iGlucose Blood Glucose Monitoring System
Measured: 2 -3 hours of going through a self-training session and producing an assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionJun 2016
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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nina Peled
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Nina Peled, Smart Meter Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709707
- Sponsor's protocol ID
- CP00001
- Status last verified
- Jun 2016
- First submitted
- 8 Mar 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lay User Study of the iGlucose, a Device for Self-Monitoring of Blood Glucose (SMBG), Marketed by the Smart Meter Corporation
- ClinicalTrials.gov ID
- NCT02709707
- Acronym / sponsor ID
- CP00001
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Blood Sugar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Nina PeledIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Mar 2016 (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.
Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users
Detailed description
A non-randomized, prospective study of recruited subjects with diabetes. Subjects will include those with type I or type II diabetes of various duration and those who are naive to self-testing of blood glucose. Subjects will use provided instructions-for-use to undergo self-training on the use of the device and will then self-test their blood glucose level. Results will be compared to those obtained by a lab glucose analyzer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes | – | Device: Blood glucose monitor |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with a diagnosis of diabetes, either type 1 or type 2, of various duration with blood glucose levels covering the entire measurement range. .
Key inclusion criteria (5 listed)
- Be 12 years of age and older
- Have pre-existing diagnosis of diabetes
- Be able to read and understand English
- Agree to participate in the study
- Be able and willing to provide informed consent
Key exclusion criteria (4 listed)
- Do not meet Inclusion Criteria
- With Hemophilia or any other bleeding disorder
- With any condition which in the opinion of the Investigator may place the subject or site staff at excessive risk
- With physical condition/limitation preventing the use of SMBG on their own
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 |
|---|---|---|
| Blood glucose monitor | Device | Patients with diabetes |
Primary outcome
Accuracy of blood glucose measurements as performed by lay users
Time frame: 10 minutes to produce self blood result and to perform lab comparative method
1 secondary outcome
Assessment by lay users of the ease of use of the iGlucose Blood Glucose Monitoring System
Time frame: 2 -3 hours of going through a self-training session and producing an assessment
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 21 Jun 2016.
- Individual participant dataSharing planned: No
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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?
An observational study of Diabetes Mellitus, run by Nina Peled 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 5 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 21 Jun 2016. 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?
Accuracy of blood glucose measurements as performed by lay users (time frame: 10 minutes to produce self blood result and to perform lab comparative method). 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 21 Jun 2016.