Liom Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM)
NCT ID: NCT06272136
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-02-23
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Profil Institut für Stoffwechselforschung GmbH
INDUSTRY
Liom Health AG
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Stoffel, MD
Role: PRINCIPAL_INVESTIGATOR
Profil for Stoffwechselforschung GmbH, Neuss, Germany
Locations
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Profil for Stoffwechselforschung GmbH
Neuss, Nordrhein-Westfallen, Germany
Countries
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Central Contacts
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Facility Contacts
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Marc Stoffel, MD
Role: primary
Other Identifiers
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SPN-007
Identifier Type: -
Identifier Source: org_study_id
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