Diabete MellitusNCT05144971
StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
An observational study of Diabete Mellitus and CKD, run by Nova Biomedical at 1 site in United States.
Trial summary
The primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabete Mellitus, CKD, ESRD
- What is being tested?
- Glucose, Creatinine
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2021to 3 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A minimum of 150 to a maximum of 200 individual subjects (lay users) will be enrolled. Subjects included in the study may be healthy, diabetic or having kidney diseases. The study will be conducted at one study site. Adult subjects (≥ 18 years old) of both genders will be included in this study. Potential subjects may be screened prior to testing to assess their baseline glucose/creatinine levels. The screening may be done by inspecting medical records.
Who may be able to join
- Adult subjects (≥ 18 years old) with diabetes.
- Adult subjects (≥ 18 years old) with kidney diseases (CKD, ESRD) and/or in dialysis.
- Adult subjects (≥ 18 years old) that are healthy.
- Subjects willing to complete all study procedures.
- Subjects whose pre-screen glucose or creatinine medical history is deemed of value by the study site
- Subjects able to read, write, speak in English.
Who cannot join
- Subjects unable to consent to participating in the study.
- Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
- Subjects taking prescription anticoagulants (such as Warfarin or Heparin) or has clotting problems that may prolong bleeding.
- Subjects having hemophilia or any other bleeding disorder.
- Subjects having an infection with a blood borne pathogen (e.g. HIV, hepatitis).
- Subjects working for a medical device or diagnostic company.
Trial locations and contacts
1 site in 1 country.
United States1 site
Excellence Medical Research
Miami Gardens, Florida, 33169
About this study
The primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician.
Read the detailed description
To assess the performance of the StatStrip A Glucose/Creatinine assay in the hands of lay users on capillary whole blood obtained by finger stick and compare with the performance characteristics to a central laboratory traceable reference method.
To assess the Ease of Use of the StatStrip Glucose / Creatinine Meter System in the hands of the intended lay users. Lay users will be provided with all package insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the lay users other than clarifying the protocol.
- Conditions
- Diabete Mellitus, CKD, ESRD
- Being tested
- Glucose, Creatinine
- Keywords
- Diabetes, CKD, ESRD, POCT
- Medical subject headings
- Diabetes Mellitus, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose, CreatinineDiagnostic test
Compare diagnostic tests to reference methods
What is being measured
The primary outcome is the main question the study is designed to answer.
Nova StatStrip A Glucose/Creatinine Meter System
The primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician.
The two parameters for the outcome measure in this study are glucose and creatinine. The unit of measure for glucose and creatinine is mg/dL and mmol/L, respectively.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start28 Oct 2021
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Excellence Medical and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144971
- Sponsor's protocol ID
- NB21-SSA-NA-LAY-FDA
- Status last verified
- Sep 2022
- First submitted
- 22 Nov 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
- ClinicalTrials.gov ID
- NCT05144971
- Acronym / sponsor ID
- NB21-SSA-NA-LAY-FDA
- Conditions
- Diabete Mellitus, CKD, ESRD
- Keywords
- Diabetes, CKD, ESRD, POCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Nova BiomedicalIndustry (pharma, biotech, devices)
- Collaborators
- Excellence Medical and Research
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 6 Dec 2021 (actual)
- 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 primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician.
Detailed description
To assess the performance of the StatStrip A Glucose/Creatinine assay in the hands of lay users on capillary whole blood obtained by finger stick and compare with the performance characteristics to a central laboratory traceable reference method.
To assess the Ease of Use of the StatStrip Glucose / Creatinine Meter System in the hands of the intended lay users. Lay users will be provided with all package insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the lay users other than clarifying the protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 150 to a maximum of 200 individual subjects (lay users) will be enrolled. Subjects included in the study may be healthy, diabetic or having kidney diseases. The study will be conducted at one study site. Adult subjects (≥ 18 years old) of both genders will be included in this study. Potential subjects may be screened prior to testing to assess their baseline glucose/creatinine levels. The screening may be done by inspecting medical records.
Key inclusion criteria (6 listed)
- Adult subjects (≥ 18 years old) with diabetes.
- Adult subjects (≥ 18 years old) with kidney diseases (CKD, ESRD) and/or in dialysis.
- Adult subjects (≥ 18 years old) that are healthy.
- Subjects willing to complete all study procedures.
- Subjects whose pre-screen glucose or creatinine medical history is deemed of value by the study site
Key exclusion criteria (6 listed)
- Subjects unable to consent to participating in the study.
- Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
- Subjects taking prescription anticoagulants (such as Warfarin or Heparin) or has clotting problems that may prolong bleeding.
- Subjects having hemophilia or any other bleeding disorder.
- Subjects having an infection with a blood borne pathogen (e.g. HIV, hepatitis).
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 |
|---|---|---|
| Glucose, CreatinineCompare diagnostic tests to reference methods | Diagnostic test | – |
Primary outcome
Nova StatStrip A Glucose/Creatinine Meter System
Time frame: 20 days
The primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician. The two parameters for the outcome measure in this study are glucose and creatinine. The unit of measure for glucose and creatinine is mg/dL and mmol/L, respectively.
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 Sep 2022.
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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 Diabete Mellitus and CKD, run by Nova Biomedical 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 6 inclusion and 6 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 Sep 2022. 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?
Nova StatStrip A Glucose/Creatinine Meter System (time frame: 20 days). 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 Sep 2022.