RecruitingNot ApplicableNCT06272136

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


Sponsor

Liom Health AG

Enrollment

80 participants

Start Date

Feb 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

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)


Locations(1)

Profil for Stoffwechselforschung GmbH

Neuss, Nordrhein-Westfallen, Germany

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NCT06272136


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