Use of a Miniaturized Near-Infrared Spectroscopy Device for Type 2 Diabetes Mellitus Screening: Pooled Analysis of the Pilot ANODE01 and ANODE02 Studies
Authors' conclusion
This pooled analysis of two independent studies demonstrates the clinical feasibility and high specificity of rapid NIR spectral assessment of T2DM risk
Study context
- Population
- Individuals with or without T2DM; female-dominant (58.5%), mostly non-smoking (80.0%), diverse cohort100 with/100 without T2D
- Participants
- 200 individuals
- Comparison
- Miniaturized near-infrared (NIR) spectroscopy (Glyconics-DS System) of fingernail keratin vs HbA1c cut-off of 6.5%
- Outcome
- Detection of dichotomized diabetes risk status (HbA1c <6.5%): clinical specificity/sensitivity and true/false positive outcomes
Methodological detailspooled analysis of two independent pilot studies (ANODE01 and ANODE02), HbA1c point-of-care assay served as internal control, Over 12 000 NIR spectral readings collected
- Pooled analysis of two independent pilot studies (ANODE01 and ANODE02)
- HbA1c point-of-care assay served as internal control
- Over 12 000 NIR spectral readings collected
Performance
As reported in the abstract
Detection of T2DM risk status at diagnostic HbA1c cut-off of 6.5% (selected chemometric prediction model)
Specificity
92.9%
95% CI 88.5–97.4
Sensitivity
34.2%
95% CI 23.4–45.1
Concordance
71.5%
Further findings
Consistency and reproducibility of chemometric predictions
- Predictions consistent and reproducible with no relevant impact of anthropometric variables, concomitant conditions/medications, smoking status, number of spectral assessments/nail or hand dominance
Safety
- Adverse events
- 0
- Suspected de novo T2D cases
- 0
Original publication
Use of a Miniaturized Near-Infrared Spectroscopy Device for Type 2 Diabetes Mellitus Screening: Pooled Analysis of the Pilot ANODE01 and ANODE02 Studies. J Diabetes Sci Technol. Published 12 April 2025. doi:10.
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