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

Not Applicable

Recruiting

• Conditions: Type2diabetes; Type 1 Diabetes
• Interventions: Device: Clinical Demo 2.0

• Registration Number: NCT06272136
• Lead Sponsor: Liom Health AG

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-22
• Study Start: 2024-02-23
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-07-21
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Male or female trial participant with clinically diagnosed type 1 or type 2 diabetes for at least 1 year.
• Age between 18 and 65 years, both inclusive.
• Treated with insulin and/or oral antidiabetic drugs (OADs; type 2 only), multiple dosing insulin therapy (MDI), continuous subcutaneous insulin infusion (CSII) or a hybrid closed loop system.

Exclusion Criteria

• Known or suspected hypersensitivity to any of the components of the Liom Clinical Demo 2.0.
• Trial participant with any injury, infection, atypical skin condition (e.g., hyperkeratosis, hyperpigmentation) of or tattoo on the wrists.
• Presence or history of a cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional arm	Clinical Demo 2.0	Induction of hyperglycaemia and hypoglcemia states and measurements of transcutaneous spectral data with the investigational device and reference blood glucose values measured by Super GL and Freestyle Libre 3.

Primary Outcome Measures

Name	Time	Method
Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia	The data is collected during the study procedure (up to 5 hours)	Spectroscopic research platform and associated computational models will be used to detect and track glucose changes noninvasively and transcutaneously in dynamic states of glycaemia

Trial Locations

Locations (1)

Profil for Stoffwechselforschung GmbH; 🇩🇪 Neuss, Nordrhein-Westfallen, Germany