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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06272136

Enrollment

Registered

2024-02-22

Start date

2024-02-23

Completion date

2025-07-31

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes, Type2diabetes

Keywords

Hyperglycemia, Diabetes Mellitus, Transcutaneous, Spectral fingerprint, Non-invasive

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.

Interventions

DEVICEClinical 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Germany

Contacts

Primary ContactBanu Eyueboglu Seitz, PhD

bes@liom.com0041 41 552 00 59

Backup ContactFabien Rebeaud, PhD

fr@liom.com0041 41 552 00 59

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026