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.
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
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).
DOI: 10.1056/NEJMoa2024001
Impact Factor: 176.1
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
DOI: 10.1089/dia.2024.0156
Impact Factor: 4.8
Objective
To evaluate the safety, usability, and psychological impact of DiagnoX technology in pediatric populations with Type 1 diabetes, focusing on device-related anxiety and treatment compliance.
Key Results
DOI: 10.1111/pedi.13512
Impact Factor: 3.2
Regulatory Approvals
DiagnoX has received approvals and certifications from leading regulatory bodies worldwide.
FDA Clearance
510(k) clearance for glucose monitoring device
Approved: March 2024CE Marking
European conformity for medical devices
Approved: February 2024Health Canada
Medical device license approved
Approved: April 2024TGA Australia
Therapeutic Goods Administration approval
Approved: May 2024Peer-Reviewed Publications
Our research has been published in leading medical journals with rigorous peer-review processes.
Ongoing & Future Studies
We continue to advance our research with additional studies and real-world evidence collection.
Research Collaboration
Interested in collaborating on diabetes research? We welcome partnerships with academic institutions, healthcare organizations, and research groups.
Contact Research Team