Diabetes MellitusNCT04340648
Measurement Algorithm Control, Optimization, and Performance Evaluation of the Vital USA GlucoseDetect
A study testing Vital GlucoseDetect in people with Diabetes Mellitus, run by Sciema UG at 1 site in Germany.
Trial summary
Measurement Algorithm Control and Optimization with Subsequent Performance Evaluation of the Vital USA GlucoseDetect™ During a Standardized Meal Test in Patients with Diabetes mellitus Type 1 and Type 2 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?
- Vital GlucoseDetect
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jun 2019to 30 Nov 2019
- 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 (50 % from each)
- 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 or wrist 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.
Germany1 site
Pfützner Science & Health Institute GmbH
Mainz, Rhineland-Palatinate, 55128
About this study
Official title: Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of the Vital USA GlucoseDetect™ During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2
Measurement Algorithm Control and Optimization with Subsequent Performance Evaluation of the Vital USA GlucoseDetect™ During a Standardized Meal Test in Patients with Diabetes mellitus Type 1 and Type 2
Read the detailed description
This study is a combined, open label, prospective, comparative single-center study.
The study is separated in 3 consecutive study parts. The first 2 study parts include 16 patients each. In the third study part 16 additional patients will be enrolled. Study part 1 and 2 will be used for optimization and validation of the measurement algorithms of the Vital USA biosensor. During the third study part with enrolment of 16 additional patients, the precision and accuracy of the final Vital USA biosensor algorithm will be demonstrated. The visit schedule for all participants of all 3 study parts will be exactly the same. In all groups of participants, the Vital USA non-invasive monitoring biosensor will be individually introduced and assigned. During the experimental study visit, a standardized meal will be given to the participants. Before and after the standardized meal, glucose, heart rate, and pO2 will be measured using the Vital USA monitoring biosensor at time-points -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. The glucose measurements will be compared to capillary blood glucose measurements by YSI Stat 2300. Parallel measurements of the heart rate and the pO2 using a patient monitor will be compared to the device readings.
- Conditions
- Diabetes Mellitus
- Being tested
- Vital GlucoseDetect
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital GlucoseDetectDevice
11 time points for blood glucose measurements over 210 min including the ingestion of a standardized meal 30 min after the first blood glucose measurement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance and accuracy in glucose monitoring and other parameters
Performance and accuracy in monitoring glucose levels (in mg/dL) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to the capillary blood glucose reference method YSI STAT 2300 (glucose in mg/dL).
Measured: 210 min
Performance and accuracy in pO2 monitoring
Performance and accuracy in monitoring pO2 levels (in mmHg) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to a patient monitor (pO2 (in mmHg).
Measured: 210 min
Performance and accuracy in pulse monitoring
Performance and accuracy in monitoring the pulse (in beats/min) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to a patient monitor (pulse (in beats/min).
Measured: 210 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start3 Jun 2019
- Primary completion31 Oct 2019
- Study completion30 Nov 2019
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients are divided in two groups and both groups are enrolled sequential and undergo the same procedures
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciema UG
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Pfützner, Sciema UG
- Investigators
- Andreas Pfützner, Prof. Dr. Dr., Principal investigator, Pfützner Science & Health Institute GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340648
- Sponsor's protocol ID
- VIT-NGM-001
- Status last verified
- Apr 2020
- First submitted
- 23 Mar 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the study will be summarized in a final report
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of the Vital USA GlucoseDetect™ During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2
- ClinicalTrials.gov ID
- NCT04340648
- Acronym / sponsor ID
- VIT-NGM-001
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sciema UGUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 9 Apr 2020 (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.
Measurement Algorithm Control and Optimization with Subsequent Performance Evaluation of the Vital USA GlucoseDetect™ During a Standardized Meal Test in Patients with Diabetes mellitus Type 1 and Type 2
Detailed description
This study is a combined, open label, prospective, comparative single-center study.
The study is separated in 3 consecutive study parts. The first 2 study parts include 16 patients each. In the third study part 16 additional patients will be enrolled. Study part 1 and 2 will be used for optimization and validation of the measurement algorithms of the Vital USA biosensor. During the third study part with enrolment of 16 additional patients, the precision and accuracy of the final Vital USA biosensor algorithm will be demonstrated. The visit schedule for all participants of all 3 study parts will be exactly the same. In all groups of participants, the Vital USA non-invasive monitoring biosensor will be individually introduced and assigned. During the experimental study visit, a standardized meal will be given to the participants. Before and after the standardized meal, glucose, heart rate, and pO2 will be measured using the Vital USA monitoring biosensor at time-points -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. The glucose measurements will be compared to capillary blood glucose measurements by YSI Stat 2300. Parallel measurements of the heart rate and the pO2 using a patient monitor will be compared to the device readings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- patients are divided in two groups and both groups are enrolled sequential and undergo the same procedures
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 (50 % from each)
- 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 or wrist 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 |
|---|---|---|
| Vital GlucoseDetect11 time points for blood glucose measurements over 210 min including the ingestion of a standardized meal 30 min after the first blood glucose measurement. | Device | – |
Primary outcome
Performance and accuracy in glucose monitoring and other parameters
Time frame: 210 min
Performance and accuracy in monitoring glucose levels (in mg/dL) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to the capillary blood glucose reference method YSI STAT 2300 (glucose in mg/dL).
Performance and accuracy in pO2 monitoring
Time frame: 210 min
Performance and accuracy in monitoring pO2 levels (in mmHg) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to a patient monitor (pO2 (in mmHg).
Performance and accuracy in pulse monitoring
Time frame: 210 min
Performance and accuracy in monitoring the pulse (in beats/min) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to a patient monitor (pulse (in beats/min).
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 9 Apr 2020.
- Individual participant dataSharing planned: No. the study will be summarized in a final report
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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 Pfützner, Prof. Dr. Dr. 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 Vital GlucoseDetect 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: finished, as of the sponsor's last update on 9 Apr 2020. 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?
Performance and accuracy in glucose monitoring and other parameters (time frame: 210 min). The study lists 3 primary outcomes in all. 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 9 Apr 2020.