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Study of the Analytical Performance of ALLEGRO™ Instrument

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ClinicalTrials.gov Identifier: NCT04035044
Recruitment Status : Completed
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
C-TRIC
Information provided by (Responsible Party):
Nova Biomedical

Brief 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. It is obviously important that this analyser performs to a similar degree of accuracy to the laboratory analyses.

Condition or disease
Diabetes

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.


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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of the Analytical Performance of ALLEGRO™ Instrument: Performance Evaluation of In Vitro Diagnostic Device
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Fifty(50) patients with diabetes will be recruited from Diabetes Clinics, WHSCT or from patients attending primary care diabetes services.
Criteria

Inclusion Criteria:

  • Diabetes patients attending Altnagelvin Area Hospital Clinics or primary care in Western Trust area aged 18-80 years of age

Exclusion Criteria:

  • Patients who are less than 18 years or over 80 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035044


Locations
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United Kingdom
C-TRIC
Derry, United Kingdom, BT476SB
Sponsors and Collaborators
Nova Biomedical
C-TRIC
Investigators
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Study Director: Bogdan Milojkovic, PhD Nova Biomedical
  Study Documents (Full-Text)

Documents provided by Nova Biomedical:
Study Protocol  [PDF] July 18, 2016


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Responsible Party: Nova Biomedical
ClinicalTrials.gov Identifier: NCT04035044     History of Changes
Other Study ID Numbers: 225107
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frovatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs