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

Liom Health AG1 site in 1 country80 target enrollmentFebruary 23, 2024

ConditionsType 1 Diabetes Type2diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Liom Health AG
Enrollment: 80
Locations: 1
Primary Endpoint: Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 23, 2024

End Date

July 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Liom Health AG

Responsible Party

Sponsor

Eligibility Criteria

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.
•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.

Outcomes

Primary Outcomes

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

Time Frame: 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