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.

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.

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.