Type 1 Diabetes MellitusNCT06097689
A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults with Type-1 Diabetes Mellitus
A study testing Lab Demo 1.0 in people with Type 1 Diabetes Mellitus and Type 1 Diabetes Mellitus with Hypoglycemia, run by Liom Health AG at 1 site in Switzerland.
Trial summary
The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus with Hypoglycemia, Type 1 Diabetes Mellitus with Hyperglycemia
- What is being tested?
- Lab Demo 1.0
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Nov 2023to 16 May 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.1nformed Consent signed by the subject
- 1.2 Male and female subjects 18 - 60 years of age (inclusive)
- 1.3 Skin colour Type I, II, or III according to Fitzpatrick Scale (see Appendix 1)
- 1.4 Type 1 diabetes diagnosed > 12 months ago
- 1.5 Intensified insulin therapy scheme using multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) for more than 6 months
- 1.6 BMI between 18.5 and 28.0 kg/m2
- 1.7 Using a CGM/FGM system (Freestyle Libre2, Freestyle Libre3, Dexcom G6 or Dexcom G7)
- 1.8 Willingness to follow the study procedure
Who cannot join
- 2.1 In female subjects: pregnancy or breastfeeding period (self-reported)
- 2.2 HbA1c of > 9.0% (based on last measurement by treating physician but not older than 120 days) Note: To be repeated at the study site if measurement is older than 120 days or not available
- 2.3 History of cardiovascular diseases
- 2.4 Irregular 12-lead ECG upon investigator's judgement
- 2.5 Medical history of epilepsy or other neurological disease associated with seizure events
- 2.6 Atypical skin condition (e.g., Hyperkeratosis, Hyperpigmentation) or presence of tattoos or scars in the measurement area (wrist) that could impair validity of measurement upon investigator's judgement
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- 2.7 Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
- 2.8 Not able to understand, write or read German
- 2.9 Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
- 2.10 Enrolment of the PI, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Feasibility of a Novel Non-Invasive Technology to Measure Glucose Dynamics in Adults Living with Type 1 Diabetes Mellitus: a Single-Arm Pilot Study
The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.
- Conditions
- Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus with Hypoglycemia, Type 1 Diabetes Mellitus with Hyperglycemia
- Being tested
- Lab Demo 1.0
- Keywords
- Hypoglycemia, Hyperglycemia, Diabetes, Transcutaneous, Spectral fingerprint, Noninvasive
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab Demo 1.0Device
Lowering of the participants blood glucose with the application of insulin to induce hypoglycaemia, followed by the application of glucose to induce hyperglycaemia and finally insulin to restore euglycemia.
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 |
|---|---|---|
| Investigational arm | Experimental | Induction of different glycaemia states via intravenous regular insulin and intravenous glucose administration and measurements of transcutaneous spectral data with the investigational device and reference blood 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.
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels
The primary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of venous blood glucose levels in ranges of hypoglycaemic and hyperglycaemic states.
Measured: The data is collected during the study procedure (6 to 8 hours)
Secondary outcomes (5)
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels
The secondary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of interstitial fluid glucose levels in ranges of hypoglycaemic and hyperglycaemic states.
Measured: The data is collected during the study procedure (6 to 8 hours)
Spectral fingerprints measured by the Lab Demo 1.0
This secondary objective consists of describing the spectral fingerprints at different blood glucose levels (defined by both venous blood glucose and interstitial fluid glucose)
Measured: The data is collected during the study procedure (6 to 8 hours)
Blood glucose levels
Blood glucose levels at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Measured: During the study procedure (6 to 8 hours)
Heart rate
Heart rate at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Measured: During the study procedure (6 to 8 hours)
Oxygen saturation
Oxygen saturation at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Measured: During the study procedure (6 to 8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start24 Nov 2023
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liom Health AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DCB Research AG
- Responsible party
- Sponsor
- Investigators
- Fabien Rebeaud, PhD, Study director, Liom Health AGMarkus Laimer, Prof Dr med, Principal investigator, University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097689
- Sponsor's protocol ID
- SPN-005
- Status last verified
- Sep 2024
- First submitted
- 10 Oct 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- A Pilot Study to Assess the Feasibility of a Novel Non-Invasive Technology to Measure Glucose Dynamics in Adults Living with Type 1 Diabetes Mellitus: a Single-Arm Pilot Study
- ClinicalTrials.gov ID
- NCT06097689
- Acronym / sponsor ID
- SPN-005
- Conditions
- Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus with Hypoglycemia, Type 1 Diabetes Mellitus with Hyperglycemia
- Keywords
- Hypoglycemia, Hyperglycemia, Diabetes, Transcutaneous, Spectral fingerprint, Noninvasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Liom Health AGIndustry (pharma, biotech, devices)
- Collaborators
- DCB Research AG
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 24 Oct 2023 (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.
The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.
Study design
- Primary purpose
- Device feasibility
- 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 different glycaemia states via intravenous regular insulin and intravenous glucose administration and measurements of transcutaneous spectral data with the investigational device and reference blood glucose values. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 1.1nformed Consent signed by the subject
- 1.2 Male and female subjects 18 - 60 years of age (inclusive)
- 1.3 Skin colour Type I, II, or III according to Fitzpatrick Scale (see Appendix 1)
- 1.4 Type 1 diabetes diagnosed > 12 months ago
- 1.5 Intensified insulin therapy scheme using multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) for more than 6 months
Key exclusion criteria (10 listed)
- 2.1 In female subjects: pregnancy or breastfeeding period (self-reported)
- 2.2 HbA1c of > 9.0% (based on last measurement by treating physician but not older than 120 days) Note: To be repeated at the study site if measurement is older than 120 days or not available
- 2.3 History of cardiovascular diseases
- 2.4 Irregular 12-lead ECG upon investigator's judgement
- 2.5 Medical history of epilepsy or other neurological disease associated with seizure events
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 1.0Lowering of the participants blood glucose with the application of insulin to induce hypoglycaemia, followed by the application of glucose to induce hyperglycaemia and finally insulin to restore euglycemia. During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid). | Device | Investigational arm |
Primary outcome
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels
Time frame: The data is collected during the study procedure (6 to 8 hours)
The primary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of venous blood glucose levels in ranges of hypoglycaemic and hyperglycaemic states.
5 secondary outcomes
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels
Time frame: The data is collected during the study procedure (6 to 8 hours)
Spectral fingerprints measured by the Lab Demo 1.0
Time frame: The data is collected during the study procedure (6 to 8 hours)
Blood glucose levels
Time frame: During the study procedure (6 to 8 hours)
Heart rate
Time frame: During the study procedure (6 to 8 hours)
Oxygen saturation
Time frame: During the study procedure (6 to 8 hours)
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 1 Oct 2024.
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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
Markus Laimer, Prof Dr med principal investigator
University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital
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 Type 1 Diabetes Mellitus and Type 1 Diabetes Mellitus with Hypoglycemia, 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 8 inclusion and 10 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 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 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?
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels (time frame: The data is collected during the study procedure (6 to 8 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.