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

NCT06272136 | Recruiting

• 1 other identifier: SPN-007
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes; Type2diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia

  Spectroscopic research platform and associated computational models will be used to detect and track glucose changes noninvasively and transcutaneously in dynamic states of glycaemia

  The data is collected during the study procedure (up to 5 hours)

Study Arms (1)

Interventional arm

EXPERIMENTAL

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.

Device: Clinical Demo 2.0

Interventions

Clinical Demo 2.0 DEVICE

During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid)

Interventional arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liom Health AG: lead
• Profil Institut für Stoffwechselforschung GmbH: collaborator

Study Sites (1)

Profil for Stoffwechselforschung GmbH

Neuss, Nordrhein-Westfallen, 41460, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marc Stoffel, MD

  Profil for Stoffwechselforschung GmbH, Neuss, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Banu Eyueboglu Seitz, PhD

CONTACT

0041 41 552 00 59; bes@liom.com

Fabien Rebeaud, PhD

CONTACT

0041 41 552 00 59; fr@liom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 22, 2024
• Study Start: February 23, 2024
• Primary Completion: July 21, 2025
• Study Completion: July 31, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)