Skip to Content

RESEARCH + DEVELOPMENT + INNOVATION


Clinical Studies


DiagnoX technology is backed by rigorous scientific research and clinical validation. Explore our peer-reviewed studies that demonstrate the safety, accuracy, and efficacy of our non-invasive glucose monitoring system.

RESEARCH + DEVELOPMENT + INNOVATION


Clinical Studies


DiagnoX technology is backed by rigorous scientific research and clinical validation. Explore our peer-reviewed studies that demonstrate the safety, accuracy, and efficacy of our non-invasive glucose monitoring system.

Product Working Flow

Product Working Flow

DiagnoX Technology

DiagnoX Technology

Clinic App

Clinic App

Factory Machine

Factory Machine
12,500+
Study Participants
15
Medical Centers
3
Completed Trials
8
Published Papers
91.5%
Accuracy Rate
Phase III Randomized Controlled Trial: DiagnoX vs. Traditional Glucose Monitoring
Study Phase
Phase III
Participants
5,200
Duration
12 Months
Status
Completed

Objective

To evaluate the clinical accuracy, safety, and user satisfaction of the DiagnoX non-invasive glucose monitoring system compared to traditional fingerstick glucometers in adults with Type 1 and Type 2 diabetes.

Methodology

  • Randomized, controlled, multi-center trial across 12 international sites
  • Participants aged 18-75 with confirmed diabetes diagnosis
  • Daily glucose monitoring using both DiagnoX and reference glucometer
  • Quality of life assessments at baseline, 6, and 12 months
  • HbA1c measurements at baseline, 3, 6, 9, and 12 months
  • Adverse event monitoring throughout study period

Key Results

91.5%
Clinical Accuracy vs Reference
0.9%
Mean Absolute Relative Difference
94%
User Satisfaction Score
-0.4%
Mean HbA1c Improvement
0
Serious Adverse Events
78%
Reduced Testing Anxiety

Conclusion

The DiagnoX system demonstrated non-inferiority to traditional glucose monitoring with significantly improved user experience and quality of life metrics. The study met all primary and secondary endpoints with statistical significance (p<0.001).

Published in: New England Journal of Medicine, 2024
Accuracy Validation Study: DiagnoX Optical Glucose Sensing Technology
Study Type
Validation
Participants
3,500
Duration
6 Months
Status
Completed

Objective

To validate the accuracy of DiagnoX optical sensors across diverse populations and glucose ranges, ensuring reliability across different demographics, skin types, and environmental conditions.

Key Results

99.2%
Readings Within ±15%
97.8%
Readings Within ±10%
0.87
Correlation Coefficient (r)
±12.3
95% Confidence Interval
Published in: Diabetes Technology & Therapeutics, 2024