Liom Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical Demo 2.0.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes, Type2diabetes. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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)
Primary outcome measures
- 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)]
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 2.0.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Germany · 1 center
- Profil for Stoffwechselforschung GmbH — Neuss
Identifiers
NCT: NCT06272136 · SPN-007