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Completed

NCT Number: NCT04096313

Evaluation of the Analytical Performance of ALLEGRO™ Instrument

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Awareness, Inc, Jupiter, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with ordered HbA1c, lipid profile, and UACr

Exclusion criteria

  • pediatric

Treatment and study plan

HbA1c, Lipids, UACR

Diagnostic Test

compare diagnostic tests to reference methods

Primary outcomes

  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 % (percentage)

  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 mg/dL

  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 Cholesterol blood results in mg/dL

  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 mg/dL

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Nova Biomedical

Industry

Registry information

Official study title

Allegro Evaluation Study for FDA Submission

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2019
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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