DiabetesNCT04035044
Study of the Analytical Performance of ALLEGRO™ Instrument
An observational study of Diabetes, run by Nova Biomedical at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2017to 1 Jun 2018
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Fifty(50) patients with diabetes will be recruited from Diabetes Clinics, WHSCT or from patients attending primary care diabetes services.
Who may be able to join
- Diabetes patients attending Altnagelvin Area Hospital Clinics or primary care in Western Trust area aged 18-80 years of age
Who cannot join
- Patients who are less than 18 years or over 80 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Analytical Performance of ALLEGRO™ Instrument: Performance Evaluation of In Vitro Diagnostic Device
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 analyser performs to a similar degree of accuracy to the laboratory analyses.
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 analyser 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™ analyser compared to laboratory analyses on finger prick capillary blood samples and urine samples. Fifty (50) 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
- Medical subject headings
- Diabetes Mellitus
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 mmol/mol
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 mmol/L
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 blood results in mmol/L
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 mmol/L
Measured: 10 minutes
Analytical verification of Allegro - Glucose comparison
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Glucose blood results in mmol/L
Measured: 10 minutes
Analytical verification of Allegro - Creatinine comparison
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine 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 posted29 Jul 2019
- Study start1 Jun 2017
- Primary completion31 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- C-TRIC
- Responsible party
- Sponsor
- Investigators
- Bogdan Milojkovic, PhD, Study director, Nova Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035044
- Sponsor's protocol ID
- 225107
- Status last verified
- Jul 2019
- First submitted
- 13 Mar 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Analytical Performance of ALLEGRO™ Instrument: Performance Evaluation of In Vitro Diagnostic Device
- ClinicalTrials.gov ID
- NCT04035044
- Acronym / sponsor ID
- 225107
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nova BiomedicalIndustry (pharma, biotech, devices)
- Collaborators
- C-TRIC
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 29 Jul 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.
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 analyser performs to a similar degree of accuracy to the laboratory analyses.
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 analyser 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™ analyser compared to laboratory analyses on finger prick capillary blood samples and urine samples. Fifty (50) 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
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Fifty(50) patients with diabetes will be recruited from Diabetes Clinics, WHSCT or from patients attending primary care diabetes services.
Key inclusion criteria (1 listed)
- Diabetes patients attending Altnagelvin Area Hospital Clinics or primary care in Western Trust area aged 18-80 years of age
Key exclusion criteria (1 listed)
- Patients who are less than 18 years or over 80 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 mmol/mol
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 mmol/L
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 blood results in mmol/L
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 mmol/L
Analytical verification of Allegro - Glucose comparison
Time frame: 10 minutes
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Glucose blood results in mmol/L
Analytical verification of Allegro - Creatinine comparison
Time frame: 10 minutes
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine 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 29 Jul 2019.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Bogdan Milojkovic, PhD study director
Nova Biomedical
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, run by Nova Biomedical at 1 site in United Kingdom.
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 29 Jul 2019. 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 Kingdom. 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 8 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 29 Jul 2019.