Clinical trial NCT05198895: Safety and Performance of the Glyconics-SX System
Official title: A Single-centre, Open-label Study Testing the Safety and Performance of the Glyconics-SX System in Individuals With or Without Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Glyconics Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Screening among individuals with or without known diabetes
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 60 seconds
Secondary outcomes:
measure: Assessment of sensitivity and specificity for chemometric model outcomes
timeFrame: 60 seconds
measure: Calculation of negative and positive predictive value for the chemometric model
timeFrame: 60 seconds
measure: Calculation of area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model
timeFrame: 60 seconds
measure: Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device
timeFrame: 4 minutes
measure: 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
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester Diabetes Centre
Study officials:
affiliation: Glyconics Ltd
name: Paivi M Paldanius, MMed PhD
role: STUDY_DIRECTOR
References: