Non-invasive continuous glucose monitoring for diabetes management
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 study is testing a new non-invasive glucose monitoring system to see if it can help people with type 1 or type 2 diabetes manage their condition better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Liom Health AG Industry-sponsored |
| Locations | 1 site (Neuss, Nordrhein-Westfallen) |
| Trial ID | NCT06272136 on ClinicalTrials.gov |
What this trial studies
This clinical demo involves a single-center, multiple cohort approach to evaluate the Liom Clinical Demo 2.0 system for continuous glucose monitoring in patients with type 1 or type 2 diabetes. The study will consist of five cohorts, with optimizations to the monitoring system and machine learning models made after each cohort. Participants will be monitored for their glucose levels using a non-invasive method, aiming to improve diabetes management and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with clinically diagnosed type 1 or type 2 diabetes for at least one year, currently treated with insulin or oral antidiabetic drugs.
Not a fit: Patients with known hypersensitivity to the components of the monitoring system or those with significant skin conditions or cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a more convenient and less invasive method for glucose monitoring in diabetes patients.
How similar studies have performed: Other studies have explored non-invasive glucose monitoring, but the specific approach of this study may offer novel advancements in the field.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Neuss, Nordrhein-Westfallen
- Profil for Stoffwechselforschung GmbH — Neuss, Nordrhein-Westfallen, Germany (Recruiting)
Study contacts
- Principal investigator: Marc Stoffel, MD — Profil for Stoffwechselforschung GmbH, Neuss, Germany
- Study coordinator: Banu Eyueboglu Seitz, PhD
- Email: bes@liom.com
- Phone: 0041 41 552 00 59
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.