NCT05198895CompletedNot Applicable
A Single-centre, Open-label Study Testing the Safety and Performance of the Glyconics-SX System in Individuals With or Without Type 2 Diabetes
Glyconics Ltd1 site in 1 country100 target enrollmentStarted: August 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Accuracy of the Glyconics-SX System in detection of DM status based on dichotomised outcomes as per the chemometric model (HbA1c measurements as internal control)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Apparently healthy adults (≥18 years of age) with known or unknown T2DM status willing to participate in and provide a written consent for the study
- •willingness to undertake assisted assessment of glycaemia by both the NIR spectra measurement, and HbA1c by finger prick test
- •Individuals with two visually assessed apparently healthy, undamaged, and intact fingernails, one in both right- and left-hand middle fingers
Exclusion Criteria
- •Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as
- •anaemia (iron deficiency sickle cell anaemia or similar)
- •haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular assays,
- •severe renal impairment (CKD stage III-IV) or decompensated hepatic disease
- •severe Vitamin D deficiency
- •known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia
- •eating disorders (as per clinical assessment)
- •Recent (within 28 days) blood donation
- •Any structural, deviating and visually detectable deviations in the appearance of the nails potentially impacting the spectra measurement, including
- •nail dystrophy or deformity
- •severe nail infections (onychomycosis causing visual changes in the appearance of the nail)
- •rare hereditable conditions impacting the structure of keratin
- •mechanical damage or marks on the surface of the nail after removal of nail polish
- •use of acrylic or gel nail decoration and polish, which cannot be removed
- •Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
Outcomes
Primary Outcomes
Accuracy of the Glyconics-SX System in detection of DM status based on dichotomised outcomes as per the chemometric model (HbA1c measurements as internal control)
Time Frame: 60 seconds
Overall probability of correct classification by the chemometric model output (yes / no DM)
Secondary Outcomes
- Assessment of sensitivity and specificity for chemometric model outcomes(60 seconds)
- Calculation of negative and positive predictive value for the chemometric model(60 seconds)
- Calculation of area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model(60 seconds)
- Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device(4 minutes)
- Analysis of safety outcomes (AEs, SAEs), including any safety outcomes listed in the comments, such as potential, suspected de novo diabetes diagnosis cases based on HbA1c readings(15 minutes)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Safety and Performance of the Glyconics-SX System (ANODE02)Diabetes Mellitus, Type 2NCT05476016Glyconics Ltd100
Not yet recruiting
Early Phase 1
iDAP Injection in the Treatment of Parkinson's DiseaseParkinson DiseaseNCT06583291Anhui Provincial Hospital12
Completed
Phase 1
AZD Single Ascending Dose Study In Healthy Japanese SubjectsHealthyNCT01028040AstraZeneca72
Completed
Phase 1
A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the GingivaPeriodontitisNCT00689143Innoventus Project AB10
Terminated
Not Applicable
The Study for Evaluate of Safety and Efficacy of Vein of Marshall RF AblationPersistent Atrial FibrillationNCT05854238Tau-MEDICAL Co., Ltd.4