Study of the Analytical Performance of ALLEGRO™ Instrument

NCT04035044 | Completed

• 1 other identifier: 225107
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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 analyser performs to a similar degree of accuracy to the laboratory analyses.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (8)

• 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 mmol/mol

  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 mmol/L

  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 blood results in mmol/L

  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 mmol/L

  10 minutes

• Analytical verification of Allegro - Glucose comparison

  Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Glucose blood results in mmol/L

  10 minutes

• Analytical verification of Allegro - Creatinine comparison

  Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifty(50) patients with diabetes will be recruited from Diabetes Clinics, WHSCT or from patients attending primary care diabetes services.

You may qualify if:

• Diabetes patients attending Altnagelvin Area Hospital Clinics or primary care in Western Trust area aged 18-80 years of age

You may not qualify if:

• Patients who are less than 18 years or over 80 years of age

Sponsors & Collaborators

• Nova Biomedical: lead
• C-TRIC: collaborator

Study Sites (1)

C-TRIC

Londonderry, BT476SB, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bogdan Milojkovic, PhD

  Nova Biomedical

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: July 29, 2019
• Study Start: June 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: June 1, 2018
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)