Clinical trial NCT04096313: Evaluation of the Analytical Performance of ALLEGRO™ Instrument
Official title: Allegro Evaluation Study for FDA Submission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Kidney Diseases
Metabolic Disease
Keywords: HbA1c, Lipids, UACR
Lead sponsor: Nova Biomedical
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 628
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult diabetic population

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.

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.

Eligibility criteria: Inclusion Criteria:

* patients with ordered HbA1c, lipid profile, and UACr

Exclusion Criteria:

* pediatric

Primary outcomes:
measure: Analytical verification of Allegro - HbA1c comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - Cholesterol comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - HDL comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - Triglycerides comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - Urine creatinine comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - Urine Albumin comparison
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jupiter
country: United States
facility: Health Awareness, Inc
state: Florida
city: Medley
country: United States
facility: South Florida Research Organization
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness, Inc PSL
state: Florida
Study officials:
affiliation: Health Awareness, Inc
name: Ronald Surowitz
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Awareness, Inc PSL
name: Allison Blomer, MA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Florida Research Organization
name: Jeremy Bleicher
role: PRINCIPAL_INVESTIGATOR
References: