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Safety and Performance of the Glyconics-SX System

NCT05198895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-10-23

No results posted yet for this study

Summary

The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status of the participants and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with validated, comparator device.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Near-infrared (NIR)

NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c)

Sponsors & Collaborators

  • Glyconics Ltd

    lead INDUSTRY

Principal Investigators

  • Paivi M Paldanius, MMed PhD · Glyconics Ltd

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2022-10-19
Completion
2022-10-28

Countries

  • United Kingdom

Study Locations

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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 NCT05198895 on ClinicalTrials.gov