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A Performance Evaluation of the Lumiradx Point of Care HbA1c Device

NCT05403853 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2024-01-12

No results posted yet for this study

Summary

In patients who have diabetes, symptoms of diabetes or attending a diabetic clinic the study will evaluate agreement between the HbA1c measurements from the LumiraDx POC HbA1c assay and the Tosoh G8, as an aid in the monitoring of diabetes Mellitus

Conditions

Interventions

DIAGNOSTIC_TEST

Venepuncture

Venous blood draw

DIAGNOSTIC_TEST

Fingerstick

Capillary Blood Draw

Sponsors & Collaborators

  • LumiraDx UK Limited

    lead INDUSTRY

Principal Investigators

  • Rory McCrimmon · NHS Tayside

  • Isabel Howat · NHS Lanarkshire

  • Catherine Patterson · NHS Fife

  • Louise Brown · Intelligent Clinical

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2022-10-07
Completion
2022-10-07

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05403853 on ClinicalTrials.gov