NCT06088615

Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Diamontech AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the feasibility of non-invasive glucose monitoring by using photothermal deflectometry in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.

Detailed description

The investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects without diabetes and with type 1 or 2 diabetes mellitus (any therapy form). The clinical investigation will be performed in an outpatient setting on up to three study days with up to 36 subjects. At least 6 subjects shall be included in each of the three subgroups (type 1 diabetes, type 2 diabetes, no diabetes)

Conditions

• Diabetes Mellitus Type 2
• Diabetes Mellitus Type 1
• Healthy

Timeline

• Start date: 2023-11-08
• Primary completion: 2024-04-29
• Completion: 2024-04-29
• First posted: 2023-10-18
• Last updated: 2024-08-28

Locations

1 site across 1 country: Germany