NCT05169034

Feasibility Study of Blood Glucose Monitoring With the Non-invasive Medical Device D-Base

Feasibility of Predicting Blood Glucose Values by Measuring in the Interstitial Fluid of the Skin on the Wrist With the Non-invasive Medical Device D-Base

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Diamontech AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the feasibility of monitoring the blood glucose values by measuring the glucose 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 with type 1 or 2 diabetes mellitus (any therapy form). The clinical investigation will be performed in an outpatient setting on up to two study days with up to 100 subjects. A nearly equal number of subjects with diabetes type 1 and 2 shall participate in the study.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Timeline

• Start date: 2021-12-14
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2021-12-23
• Last updated: 2023-05-16

Locations

1 site across 1 country: Germany