Diabetes MellitusNCT04096313
Evaluation of the Analytical Performance of ALLEGRO™ Instrument
An observational study of Diabetes Mellitus and Kidney Diseases, run by Nova Biomedical at 3 sites in United States.
Trial summary
To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care methods and central laboratory reference methods. 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, Kidney Diseases, Metabolic Disease
- What is being tested?
- HbA1c, Lipids, UACR
- How many people
- 628 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Mar 2020to 15 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: Adult diabetic population
Who may be able to join
- patients with ordered HbA1c, lipid profile, and UACr
Who cannot join
- pediatric
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Health Awareness, Inc
Jupiter, Florida, 33458
South Florida Research Organization
Medley, Florida, 33166
Health Awareness, Inc PSL
Port Saint Lucie, Florida, 34952
About this study
Official title: Allegro Evaluation Study for FDA Submission
To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care methods and central laboratory reference methods.
To assess the Ease of Use of the Allegro in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package insert sheets, a Quick Reference Guide poster and Instructions for Use. No training, coaching, or prompting will be provided other than clarifying the protocol.
Read the detailed description
Blood and urine tests are used in the assessment of diabetes and to guide clinical management. In the traditional model of care, blood samples are taken from patients at the clinic and are sent to the laboratory for analysis and the results may not be available for a number of hours/days after the clinic visit.
A new analyser has been developed (Allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes. This means that patients can get immediate feedback and that the doctors/nurses can adjust treatment before the patient leaves the clinic. It is obviously important that this analyzer performs to a similar degree of accuracy to the laboratory analyses.
The aim of this research study is to assess the accuracy of the Allegro™ analyzer compared to laboratory analyses on capillary and venous whole blood samples and urine samples. Three hundred sixty (360) patients with diabetes will be invited to give a venous blood sample, finger prick capillary blood sample and urine sample. The venous blood sample, finger prick capillary blood sample and urine sample will be analysed by both the Allegro™ analyser and laboratory analyses and the results compared. The Allegro™ results will not be used in the management of the patients' diabetes.
- Conditions
- Diabetes Mellitus, Kidney Diseases, Metabolic Disease
- Being tested
- HbA1c, Lipids, UACR
- Keywords
- HbA1c, Lipids, UACR
- Medical subject headings
- Diabetes Mellitus, Kidney Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HbA1c, Lipids, UACRDiagnostic test
compare diagnostic tests to reference methods
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytical verification of Allegro - HbA1c comparison
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HbA1c blood results in % (percentage)
Measured: 10 minutes
Analytical verification of Allegro - Cholesterol comparison
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Cholesterol blood results in mg/dL
Measured: 10 minutes
Analytical verification of Allegro - HDL comparison
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HDL Cholesterol blood results in mg/dL
Measured: 10 minutes
Analytical verification of Allegro - Triglycerides comparison
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Triglycerides blood results in mg/dL
Measured: 10 minutes
Analytical verification of Allegro - Urine creatinine comparison
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine urine results in mg/dL
Measured: 10 minutes
Analytical verification of Allegro - Urine Albumin comparison
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Albumin urine results in g/L
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start25 Mar 2020
- Primary completion11 Nov 2021
- Study completion15 Dec 2021
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
- Cohort
- Time perspective
- Other
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Surowitz, Principal investigator, Health Awareness, IncAllison Blomer, MA, MD, Principal investigator, Health Awareness, Inc PSLJeremy Bleicher, Principal investigator, South Florida Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096313
- Sponsor's protocol ID
- NB19-ALL-NA-FDA
- Status last verified
- Dec 2021
- First submitted
- 16 Sep 2019
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allegro Evaluation Study for FDA Submission
- ClinicalTrials.gov ID
- NCT04096313
- Acronym / sponsor ID
- NB19-ALL-NA-FDA
- Conditions
- Diabetes Mellitus, Kidney Diseases, Metabolic Disease
- Keywords
- HbA1c, Lipids, UACR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Nova BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 19 Sep 2019 (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.
To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care methods and central laboratory reference methods.
To assess the Ease of Use of the Allegro in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package insert sheets, a Quick Reference Guide poster and Instructions for Use. No training, coaching, or prompting will be provided other than clarifying the protocol.
Detailed description
Blood and urine tests are used in the assessment of diabetes and to guide clinical management. In the traditional model of care, blood samples are taken from patients at the clinic and are sent to the laboratory for analysis and the results may not be available for a number of hours/days after the clinic visit.
A new analyser has been developed (Allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes. This means that patients can get immediate feedback and that the doctors/nurses can adjust treatment before the patient leaves the clinic. It is obviously important that this analyzer performs to a similar degree of accuracy to the laboratory analyses.
The aim of this research study is to assess the accuracy of the Allegro™ analyzer compared to laboratory analyses on capillary and venous whole blood samples and urine samples. Three hundred sixty (360) patients with diabetes will be invited to give a venous blood sample, finger prick capillary blood sample and urine sample. The venous blood sample, finger prick capillary blood sample and urine sample will be analysed by both the Allegro™ analyser and laboratory analyses and the results compared. The Allegro™ results will not be used in the management of the patients' diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult diabetic population
Key inclusion criteria (1 listed)
- patients with ordered HbA1c, lipid profile, and UACr
Key exclusion criteria (1 listed)
- pediatric
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 |
|---|---|---|
| HbA1c, Lipids, UACRcompare diagnostic tests to reference methods | Diagnostic test | – |
Primary outcome
Analytical verification of Allegro - HbA1c comparison
Time frame: 10 minutes
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HbA1c blood results in % (percentage)
Analytical verification of Allegro - Cholesterol comparison
Time frame: 10 minutes
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Cholesterol blood results in mg/dL
Analytical verification of Allegro - HDL comparison
Time frame: 10 minutes
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HDL Cholesterol blood results in mg/dL
Analytical verification of Allegro - Triglycerides comparison
Time frame: 10 minutes
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Triglycerides blood results in mg/dL
Analytical verification of Allegro - Urine creatinine comparison
Time frame: 10 minutes
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine urine results in mg/dL
Analytical verification of Allegro - Urine Albumin comparison
Time frame: 10 minutes
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Albumin urine results in g/L
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 16 Dec 2021.
- 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.
Ronald Surowitz principal investigator
Health Awareness, Inc
Allison Blomer, MA, MD principal investigator
Health Awareness, Inc PSL
Jeremy Bleicher principal investigator
South Florida Research Organization
3 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 and Kidney Diseases, run by Nova Biomedical at 3 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 1 inclusion and 1 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Analytical verification of Allegro - HbA1c comparison (time frame: 10 minutes). The study lists 6 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 16 Dec 2021.