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

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

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes; Type2diabetes
• Intervention / Treatment: Device: Clinical Demo 2.0

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Banu Eyueboglu Seitz, PhD; Phone Number: 0041 41 552 00 59; Email: bes@liom.com
• Study Contact Backup: Name: Fabien Rebeaud, PhD; Phone Number: 0041 41 552 00 59; Email: fr@liom.com

Study Locations

• Germany
  • Nordrhein-Westfallen
    • Neuss, Nordrhein-Westfallen, Germany, 41460
      • Recruiting
      • Profil for Stoffwechselforschung GmbH
      • Contact: Marc Stoffel, MD; Phone Number: 0049213140180

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; 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; During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Liom Health AG
• Collaborators: Profil Institut für Stoffwechselforschung GmbH
• Investigators: Principal Investigator: Marc Stoffel, MD, Profil for Stoffwechselforschung GmbH, Neuss, Germany

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Estimated): July 21, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Hyperglycemia; Non-invasive; Transcutaneous; Spectral fingerprint
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SPN-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No