Evaluation of the Analytical Performance of ALLEGRO™ Instrument

Diabetes Mellitus Clinical Trial

Official title:

Allegro Evaluation Study for FDA Submission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096313
• Other study ID #: NB19-ALL-NA-FDA
• Status: Completed
• Start date: March 25, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: December 2021
• Source: Nova Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: December 15, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with ordered HbA1c, lipid profile, and UACr

Exclusion Criteria:

• pediatric

Related Conditions & MeSH terms

• Diabetes Mellitus
• Kidney Diseases
• Metabolic Disease
• Metabolic Diseases

Intervention

Diagnostic Test:
• HbA1c, Lipids, UACR
compare diagnostic tests to reference methods

Locations

Country	Name	City	State
United States	Health Awareness, Inc	Jupiter	Florida
United States	South Florida Research Organization	Medley	Florida
United States	Health Awareness, Inc PSL	Port Saint Lucie	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nova Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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