Diabetes Mellitus Type 2NCT06088615
Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry
An observational study of Diabetes Mellitus Type 2 and Diabetes Mellitus Type 1, run by Diamontech AG at 1 site in Germany.
Trial summary
This study aims to evaluate the feasibility of non-invasive glucose monitoring by using photothermal deflectometry in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2, Diabetes Mellitus Type 1, Healthy
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 8 Nov 2023to 29 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 36 adults with type 1 or 2 diabetes or without diabetes
Who may be able to join
- Clinical diagnosis of type 1 OR type 2 diabetes OR no diabetes
- For subjects with diabetes: glycated haemoglobin (HbA1c) <10%
- Age ≥ 18 years
- Male or female or diverse
- An understanding of and willingness to follow the protocol
- Signed informed consent
Who cannot join
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- Hypoglycemia unawareness
- Have extensive skin changes/diseases at the proposed measurement site (wrist and upper arm for FreeStyle Libre 3) that could interfere with the accuracy of glucose measurements.
- Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy)
- Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
- Severe diabetes related complications (i.e. macro angiopathy, severe micro angiopathy, severe neuro-, retino- or nephropathy) when unstable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy
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- Known severe tape reactions or allergies
- Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, tremor, language barriers, alcohol or drug misuse
- Not able to understand, write or read German
- Dependency from the sponsor or the clinical investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, 89081
About this study
This study aims to evaluate the feasibility of non-invasive glucose monitoring by using photothermal deflectometry in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.
Read the detailed description
The investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects without diabetes and with type 1 or 2 diabetes mellitus (any therapy form).
The clinical investigation will be performed in an outpatient setting on up to three study days with up to 36 subjects. At least 6 subjects shall be included in each of the three subgroups (type 1 diabetes, type 2 diabetes, no diabetes)
- Conditions
- Diabetes Mellitus Type 2, Diabetes Mellitus Type 1, Healthy
- Keywords
- non-invasive glucose monitoring, photothermal deflectometry
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of non-invasive glucose measurement in comparison to invasive glucose measurement
The accuracy of glucose values determined by D-Base 2.0 Prototype B in comparison with Contour Next (CNXT) values (non-invasive vs invasive glucose measurement) is determined by the following specific analysis:
- Number and percentage of D-Base 2.0 Prototype B results within ±15 mg/dl or ±15% as well as ±20 mg/dl or ±20% and ±30 mg/dl or ±30% of mean CNXT results for mean CNXT results <100 mg/dl or ≥100 mg/dl, respectively
Measured: 3-13 days per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start8 Nov 2023
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diamontech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088615
- Sponsor's protocol ID
- IfDT-2325-DE
- Other IDs
- CIV-23-08-043757
- Status last verified
- Aug 2024
- First submitted
- 19 Sep 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kaluza M, Janik S, Lubinski T, Saita M, Lachmann P, Canini L, Lepro V, Mantele W. Clinical validation of noninvasive blood glucose measurements by midinfrared spectroscopy. Commun Med (Lond). 2025 Nov 15;5(1):509. doi: 10.1038/s43856-025-01241-7.
PubMed 41258444
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry
- ClinicalTrials.gov ID
- NCT06088615
- Acronym / sponsor ID
- IfDT-2325-DE
- Conditions
- Diabetes Mellitus Type 2, Diabetes Mellitus Type 1, Healthy
- Keywords
- non-invasive glucose monitoring, photothermal deflectometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Diamontech AGIndustry (pharma, biotech, devices)
- Collaborators
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 18 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.
This study aims to evaluate the feasibility of non-invasive glucose monitoring by using photothermal deflectometry in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.
Detailed description
The investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects without diabetes and with type 1 or 2 diabetes mellitus (any therapy form).
The clinical investigation will be performed in an outpatient setting on up to three study days with up to 36 subjects. At least 6 subjects shall be included in each of the three subgroups (type 1 diabetes, type 2 diabetes, no diabetes)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 36 adults with type 1 or 2 diabetes or without diabetes
Key inclusion criteria (6 listed)
- Clinical diagnosis of type 1 OR type 2 diabetes OR no diabetes
- For subjects with diabetes: glycated haemoglobin (HbA1c) <10%
- Age ≥ 18 years
- Male or female or diverse
- An understanding of and willingness to follow the protocol
Key exclusion criteria (10 listed)
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- Hypoglycemia unawareness
- Have extensive skin changes/diseases at the proposed measurement site (wrist and upper arm for FreeStyle Libre 3) that could interfere with the accuracy of glucose measurements.
- Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy)
- Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of non-invasive glucose measurement in comparison to invasive glucose measurement
Time frame: 3-13 days per subject
The accuracy of glucose values determined by D-Base 2.0 Prototype B in comparison with Contour Next (CNXT) values (non-invasive vs invasive glucose measurement) is determined by the following specific analysis: * Number and percentage of D-Base 2.0 Prototype B results within ±15 mg/dl or ±15% as well as ±20 mg/dl or ±20% and ±30 mg/dl or ±30% of mean CNXT results for mean CNXT results <100 mg/dl or ≥100 mg/dl, respectively
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 28 Aug 2024.
- Derived from this study: PubMed 41258444Kaluza M, Janik S, Lubinski T, Saita M, Lachmann P, Canini L, Lepro V, Mantele W. Clinical validation of noninvasive blood glucose measurements by midinfrared spectroscopy. Commun Med (Lond). 2025 Nov 15;5(1):509. doi: 10.1038/s43856-025-01241-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2 and Diabetes Mellitus Type 1, run by Diamontech 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 6 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 28 Aug 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?
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?
Accuracy of non-invasive glucose measurement in comparison to invasive glucose measurement (time frame: 3-13 days per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06088615, which also lists 1 linked publication.
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 28 Aug 2024.