Type 1 DiabetesNCT06272136
Liom Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM)
A study testing Clinical Demo 2.0 in people with Type 1 Diabetes and Type2diabetes, run by Liom Health AG at 1 site in Germany.
Trial summary
This is a single-centre, multiple cohort, open study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Type2diabetes
- What is being tested?
- Clinical Demo 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 23 Feb 2024to 31 Jul 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Profil for Stoffwechselforschung GmbH
Neuss, Nordrhein-Westfallen, 41460
Marc Stoffel, MD, 0049213140180
About this study
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
This is a single-centre, multiple cohort, open study.
Read the 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.
- Conditions
- Type 1 Diabetes, Type2diabetes
- Being tested
- Clinical Demo 2.0
- Keywords
- Hyperglycemia, Diabetes Mellitus, Transcutaneous, Spectral fingerprint, Non-invasive
- Medical subject headings
- Diabetes Mellitus, Type 1, Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Demo 2.0Device
During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid)
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | 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. Receives: Device: Clinical Demo 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia
Spectroscopic research platform and associated computational models will be used to detect and track glucose changes noninvasively and transcutaneously in dynamic states of glycaemia
Measured: The data is collected during the study procedure (up to 5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start23 Feb 2024
- Primary completion21 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liom Health AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Responsible party
- Sponsor
- Investigators
- Marc Stoffel, MD, Principal investigator, Profil for Stoffwechselforschung GmbH, Neuss, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272136
- Sponsor's protocol ID
- SPN-007
- Status last verified
- Sep 2024
- First submitted
- 31 Jan 2024
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06272136
- Acronym / sponsor ID
- SPN-007
- Conditions
- Type 1 Diabetes, Type2diabetes
- Keywords
- Hyperglycemia, Diabetes Mellitus, Transcutaneous, Spectral fingerprint, Non-invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Liom Health AGIndustry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 21 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 22 Feb 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: Clinical Demo 2.0Induction 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Clinical Demo 2.0During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid) | Device | Interventional arm |
Primary outcome
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)
Spectroscopic research platform and associated computational models will be used to detect and track glucose changes noninvasively and transcutaneously in dynamic states of glycaemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- 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.
Marc Stoffel, MD principal investigator
Profil for Stoffwechselforschung GmbH, Neuss, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Demo 2.0 in people with Type 1 Diabetes and Type2diabetes, run by Liom Health AG at 1 site in Germany.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Banu Eyueboglu Seitz, PhD (0041 41 552 00 59, bes@liom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 1 Oct 2024.