HealthyNCT06406075
Non-invasive Measurement of Glucose with Advanced Spectroscopy Techniques and Machine Learning Models
A study testing Lab demo 1.0 in people with Healthy, run by Liom Health AG at 1 site in Switzerland.
Trial summary
Primary aim of this pilot study is to provide evidence for a non-invasive, continuous, and transcutaneous measurement method to determine blood glucose levels robustly and accurately. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lab demo 1.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Jan 2024to 25 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide signed and dated written informed consent by study participant prior to any mandatory study-specific procedures, sample collection, or analysis
- Apparently healthy Male or Female adult aged between 18 and 75
- Willingness to follow the study procedures
Who cannot join
- In Female subjects: pregnancy or breastfeeding period
- A diagnosis of diabetes mellitus (any type) with ongoing insulin therapy (basal or basal plus bolus) or sulfonylurea therapy
- Prior severe hypoglycemia event (stage 3 or above; e.g., seizure, loss of consciousness, emergency hospitalisation)
- Prior event of severe hyperglycemia resulting in diabetic ketoacidosis or hyperosmolar hyperglycemic state, or emergency hospitalisation
- Documented medical history of bleeding disorder
- Being under anticoagulant medication
- Insufficient knowledge of project languages (English/German)
- Known sensitivity to medical-grade adhesives or other skin-related complications, which might influence the outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Ability of Advanced Spectroscopy Techniques and Machine Learning Models to Non-invasively Measure Glucose Robustly and Accurately
Primary aim of this pilot study is to provide evidence for a non-invasive, continuous, and transcutaneous measurement method to determine blood glucose levels robustly and accurately.
Read the detailed description
The study is divided into 3 sub-studies focusing on
- Interchangeability of Lab demo 1.0
- Evaluation of advanced spectroscopy methods and their miniaturisation potential
- Robustness of machine learning model to changes over time
- Conditions
- Healthy
- Being tested
- Lab demo 1.0
- Keywords
- Continuous glucose monitoring, Noninvasive, Transcutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab demo 1.0Device
During the intervention, transcutaneous spectral data are collected continuously with the Lab demo. Up to 20 whole blood glucose reference values are also collected, as well as interstitial fluid glucose values using a continuous glucose monitoring device. Some participants will attend multiple measurement sessions.
| Study group | Role | What they receive |
|---|---|---|
| Investigational arm | Experimental | Induction of glycose dynamics and collection of transcutaneous spectral data and reference glucose values Receives: Device: Lab demo 1.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of glucose changes measured over a time series of transcutaneous measurements with reference measurements
The transcutaneous glucose measurements and the corresponding spectral fingerprints are compared with the values of interstitial fluid (ISF) and capillary blood glucose.
Measured: The data is collected during the study procedure (up to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start29 Jan 2024
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liom Health AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabien Rebeaud, PhD, Study director, Liom Health AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406075
- Sponsor's protocol ID
- SPN-006
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Ability of Advanced Spectroscopy Techniques and Machine Learning Models to Non-invasively Measure Glucose Robustly and Accurately
- ClinicalTrials.gov ID
- NCT06406075
- Acronym / sponsor ID
- SPN-006
- Conditions
- Healthy
- Keywords
- Continuous glucose monitoring, Noninvasive, Transcutaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Liom Health AGIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary aim of this pilot study is to provide evidence for a non-invasive, continuous, and transcutaneous measurement method to determine blood glucose levels robustly and accurately.
Detailed description
The study is divided into 3 sub-studies focusing on
- Interchangeability of Lab demo 1.0
- Evaluation of advanced spectroscopy methods and their miniaturisation potential
- Robustness of machine learning model to changes over time
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational arm | Experimental | Device: Lab demo 1.0Induction of glycose dynamics and collection of transcutaneous spectral data and reference glucose values |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provide signed and dated written informed consent by study participant prior to any mandatory study-specific procedures, sample collection, or analysis
- Apparently healthy Male or Female adult aged between 18 and 75
- Willingness to follow the study procedures
Key exclusion criteria (8 listed)
- In Female subjects: pregnancy or breastfeeding period
- A diagnosis of diabetes mellitus (any type) with ongoing insulin therapy (basal or basal plus bolus) or sulfonylurea therapy
- Prior severe hypoglycemia event (stage 3 or above; e.g., seizure, loss of consciousness, emergency hospitalisation)
- Prior event of severe hyperglycemia resulting in diabetic ketoacidosis or hyperosmolar hyperglycemic state, or emergency hospitalisation
- Documented medical history of bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lab demo 1.0During the intervention, transcutaneous spectral data are collected continuously with the Lab demo. Up to 20 whole blood glucose reference values are also collected, as well as interstitial fluid glucose values using a continuous glucose monitoring device. Some participants will attend multiple measurement sessions. | Device | Investigational arm |
Primary outcome
Comparison of glucose changes measured over a time series of transcutaneous measurements with reference measurements
Time frame: The data is collected during the study procedure (up to 3 hours)
The transcutaneous glucose measurements and the corresponding spectral fingerprints are compared with the values of interstitial fluid (ISF) and capillary blood glucose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien Rebeaud, PhD study director
Liom Health AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lab demo 1.0 in people with Healthy, run by Liom Health AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of glucose changes measured over a time series of transcutaneous measurements with reference measurements (time frame: The data is collected during the study procedure (up to 3 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.