Evaluation of the Analytical Performance of ALLEGRO™ Instrument

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.

Study Overview

• Status: Completed
• Conditions: Kidney Diseases; Diabetes Mellitus; Metabolic Disease
• Intervention / Treatment: Diagnostic test: HbA1c, Lipids, UACR

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 Type: Observational
• Enrollment (Actual): 628

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc
    • Medley, Florida, United States, 33166
      • South Florida Research Organization
    • Port Saint Lucie, Florida, United States, 34952
      • Health Awareness, Inc PSL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult diabetic population

Description

Inclusion Criteria:

• patients with ordered HbA1c, lipid profile, and UACr

Exclusion Criteria:

• pediatric

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	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	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	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	10 minutes

Collaborators and Investigators

• Sponsor: Nova Biomedical
• Investigators: Principal Investigator: Allison Blomer, MA, MD, Health Awareness, Inc PSL; Principal Investigator: Jeremy Bleicher, South Florida Research Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2020
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: HbA1c, Lipids, UACR
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Metabolic Diseases
• Other Study ID Numbers: NB19-ALL-NA-FDA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes