Evaluation of the Analytical Performance of ALLEGRO™ Instrument

NCT04096313 | Completed FDA Device

• 1 other identifier: NB19-ALL-NA-FDA
• Study Type: observational
• Target: 628
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Diabetes Mellitus; Kidney Diseases; Metabolic Disease

Keywords

HbA1c, Lipids, UACR

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

HbA1c, Lipids, UACR DIAGNOSTIC_TEST

compare diagnostic tests to reference methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult diabetic population

You may qualify if:

• patients with ordered HbA1c, lipid profile, and UACr

You may not qualify if:

• pediatric

Sponsors & Collaborators

• Nova Biomedical: lead

Study Sites (3)

Health Awareness, Inc

Jupiter, Florida, 33458, United States

Location

South Florida Research Organization

Medley, Florida, 33166, United States

Location

Health Awareness, Inc PSL

Port Saint Lucie, Florida, 34952, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Kidney Diseases; Metabolic Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ronald Surowitz

  Health Awareness, Inc

  PRINCIPAL INVESTIGATOR

• Allison Blomer, MA, MD

  Health Awareness, Inc PSL

  PRINCIPAL INVESTIGATOR

• Jeremy Bleicher

  South Florida Research Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 19, 2019
• Study Start: March 25, 2020
• Primary Completion: November 11, 2021
• Study Completion: December 15, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)