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BGM and HbA1c POC Device Evaluation

NCT06170515 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 910

Last updated 2023-12-14

No results posted yet for this study

Summary

This study aims to assess analytical performance of four BGMs and four HbA1c POC devices in comparison to suitable comparator or reference methods, with the view to evaluate performance in the hands of trained users, as well as intended users who are unfamiliar with the system (lay users, for BGMs only). System usability will also be assessed for all BGMs (including lancing devices) and HbA1c devices.

Conditions

Interventions

DIAGNOSTIC_TEST

CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor)

BGM Test

DIAGNOSTIC_TEST

Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens)

HbA1c Test

Sponsors & Collaborators

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Priyanka Singh · Foundation for Innovative New Diagnostics (FIND)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Cambodia
  • Colombia
  • Nigeria

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 NCT06170515 on ClinicalTrials.gov