Diabetes MellitusNCT06063759
Comparative Measurement of Microcirculation and Other Parameters With the Vital USA VitalDetect™ in Patients With Diabetes Mellitus Type 1 and Type 2 Versus Healthy Participants
A study testing VitalDetect in people with Diabetes Mellitus, run by Sciema UG at 1 site in Germany.
Trial summary
The purpose of this clinical study is to optimize the measurement algorithm of the Vital USA VitalDetectTM in measuring the microcirculating blood flow. Further optimization and finally the demonstration of the performance of the VitalDetectTM non-invasive monitoring biosensor in monitoring glucose, and heart rate in… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- VitalDetect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 25 Sep 2023to 30 Nov 2023
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 1 or Type 2 diabetic or healthy subject (25 Type 1, 25 Type 2, 50 healthy subjects)
- Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
- 18 years old and above;
- Anatomically suitable finger in discretion of the investigator
Who cannot join
- Does not meet inclusion criteria;
- Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars, tattoos;
- Pregnancy;
- Nursing mothers;
- Any skin scratch(es), damage, over dry, long nails on the measured finger;
- Unsuitable finger with the device might be excluded if recognized during the trial;
- Medication containing nitrates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Measurement of Microcirculation and Other Parameters With the Vital USA VitalDetect™ in Patients With Diabetes Mellitus Type 1 and Type 2 Versus Healthy Paricipants
The purpose of this clinical study is to optimize the measurement algorithm of the Vital USA VitalDetectTM in measuring the microcirculating blood flow. Further optimization and finally the demonstration of the performance of the VitalDetectTM non-invasive monitoring biosensor in monitoring glucose, and heart rate in patients with type 1 and type 2 diabetes and healthy participants, when operated according to the instructions for use.
Read the detailed description
The study procedures will be the same for all three groups during the single visit. In all groups of participants, the Vital USA VitalDetect™ will be individually introduced and assigned. During the experimental study visit, microcirculating blood flow (MBF), heart rate, and SpO2 will be measured using the Vital USA VitalDetect™ at 2 time points in between approx. 15 min. MBF will be measured in parallel by use of the LEA Medizintechnik O2C also using a finger on the same hand. The YSI glucose measurements will be employed to generate a robust algorithm for glucose measurements using the VitalDetect™. Parallel measurements of the heart rate and the SpO2 using a patient monitor (Edan iM8b) will be compared to the Vital USA VitalDetect™ device readings. Venous blood will be drawn from every subject to determine proinsulin, insulin and HbA1c values.
- Conditions
- Diabetes Mellitus
- Being tested
- VitalDetect
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalDetectDevice
measurement of microcirculating blood flow, SpO2 (mmHg or %), heart rate (beats/min)
| Study group | Role | What they receive |
|---|---|---|
| VitalDetectTM | Other | Determination of microcirculating blood flow, glucose, SpO2, and heart rate. Receives: Device: VitalDetect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the Vital USA VitalDetectTM for assessment of microcirculation (in AU)
Accuracy and performance of Vital USA VitalDetectTM for assessment of microcirculation (in AU) by measuring microcirculation using the VitalDetectTM in comparison to the LEA Medizintechnik O2C device.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start25 Sep 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Why it stopped: Study was postponed due to manufacturing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3 groups with the same study procedures in sequential timely series.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sciema UG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Pfuetzner, MD, Principal investigator, Pfützner Science & Health Institute GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063759
- Sponsor's protocol ID
- VIT-NGM-002
- Status last verified
- Sep 2023
- First submitted
- 31 Mar 2020
- Last updated
- 3 Oct 2023
- 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 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Measurement of Microcirculation and Other Parameters With the Vital USA VitalDetect™ in Patients With Diabetes Mellitus Type 1 and Type 2 Versus Healthy Paricipants
- ClinicalTrials.gov ID
- NCT06063759
- Acronym / sponsor ID
- VIT-NGM-002
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study was postponed due to manufacturing issues
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sciema UGUniversity, hospital or other
- Study start
- 25 Sep 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 3 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 purpose of this clinical study is to optimize the measurement algorithm of the Vital USA VitalDetectTM in measuring the microcirculating blood flow. Further optimization and finally the demonstration of the performance of the VitalDetectTM non-invasive monitoring biosensor in monitoring glucose, and heart rate in patients with type 1 and type 2 diabetes and healthy participants, when operated according to the instructions for use.
Detailed description
The study procedures will be the same for all three groups during the single visit. In all groups of participants, the Vital USA VitalDetect™ will be individually introduced and assigned. During the experimental study visit, microcirculating blood flow (MBF), heart rate, and SpO2 will be measured using the Vital USA VitalDetect™ at 2 time points in between approx. 15 min. MBF will be measured in parallel by use of the LEA Medizintechnik O2C also using a finger on the same hand. The YSI glucose measurements will be employed to generate a robust algorithm for glucose measurements using the VitalDetect™. Parallel measurements of the heart rate and the SpO2 using a patient monitor (Edan iM8b) will be compared to the Vital USA VitalDetect™ device readings. Venous blood will be drawn from every subject to determine proinsulin, insulin and HbA1c values.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 groups with the same study procedures in sequential timely series.
| Arm | Type | Receives |
|---|---|---|
| VitalDetectTM | Other | Device: VitalDetectDetermination of microcirculating blood flow, glucose, SpO2, and heart rate. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or Type 2 diabetic or healthy subject (25 Type 1, 25 Type 2, 50 healthy subjects)
- Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
- 18 years old and above;
- Anatomically suitable finger in discretion of the investigator
Key exclusion criteria (7 listed)
- Does not meet inclusion criteria;
- Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars, tattoos;
- Pregnancy;
- Nursing mothers;
- Any skin scratch(es), damage, over dry, long nails on the measured finger;
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 |
|---|---|---|
| VitalDetectmeasurement of microcirculating blood flow, SpO2 (mmHg or %), heart rate (beats/min) | Device | VitalDetectTM |
Primary outcome
Accuracy of the Vital USA VitalDetectTM for assessment of microcirculation (in AU)
Time frame: 30 minutes
Accuracy and performance of Vital USA VitalDetectTM for assessment of microcirculation (in AU) by measuring microcirculation using the VitalDetectTM in comparison to the LEA Medizintechnik O2C device.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- 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.
Andreas Pfuetzner, MD principal investigator
Pfützner Science & Health Institute GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitalDetect in people with Diabetes Mellitus, run by Sciema UG 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 4 inclusion and 7 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: paused, as of the sponsor's last update on 3 Oct 2023. 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?
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 the Vital USA VitalDetectTM for assessment of microcirculation (in AU) (time frame: 30 minutes). 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 3 Oct 2023.