NCT06272136

Liom Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM)

An Exploratory Study to Assess the Accuracy in the Normo- to Hyperglycemic Range of the Spiden Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM), in Trial Participants with Type 1 or Type 2 Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Liom Health AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-centre, multiple cohort, open study.

Detailed description

The study will include 5 cohorts. After each cohort, optimisation of the Spiden Clinical Demo 2.0 system and machine learning models may be pursued before the next cohort is started. Trial participants with type 1 or type 2 diabetes mellitus.

Conditions

• Type 1 Diabetes
• Type2diabetes

Interventions

Type	Name	Description
DEVICE	Clinical Demo 2.0	During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid)

Timeline

• Start date: 2024-02-23
• Primary completion: 2025-07-21
• Completion: 2025-07-31
• First posted: 2024-02-22
• Last updated: 2024-10-01

Locations

1 site across 1 country: Germany