Diabetes MellitusNCT04379427
Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of Sanmina Non-invasive Biosensors During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2
A study testing Sanmina Biosensor 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 Sanmina biosensors in monitoring of glucose, heart rate (HR), and SpO2 in patients with type 1 and type 2 diabetes during a standardized meal experiment. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sanmina Biosensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 25 Mar 2019to 1 Apr 2020
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 1 or Type 2 diabetic subjects or healthy probands
- 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
Pfuetzner Science & Health Institute GmbH
Mainz, Rhineland-Palatinate, 55128
About this study
Measurement algorithm control and optimization with subsequent performance evaluation of Sanmina biosensors in monitoring of glucose, heart rate (HR), and SpO2 in patients with type 1 and type 2 diabetes during a standardized meal experiment.
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 12 patients each. In the third study part 36 patients will be enrolled. Study part 1 and 2 will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. During the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated. The study conduct for all 60 participants of all 3 study parts will be exactly the same. In all groups of participants, the Sanmina finger clip and wearable non-invasive monitoring biosensor will be individually introduced and assigned. During the study visit at the study site, a standardized meal will be given to the participants. At eleven time points before and after the standardized meal, glucose, heart rate, and pO2 will be measured using the Sanmina finger clip and wearable non-invasive monitoring biosensor. The measurement time points are -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. The measurements will be compared to capillary blood glucose measurements by YSI Stat 2300 and StatStrip (glucose), and parallel measurements of the heart rate and the pO2 using a patient monitor. Further the exact skin colour will be evaluated using a skin colour card.
- Conditions
- Diabetes Mellitus
- Being tested
- Sanmina Biosensor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sanmina BiosensorDevice
non-invasive blood glucose measurement using the Sanmina Biosensor referenced with the invasive reference blood glucose device YSI 2400 Plus.
| Study group | Role | What they receive |
|---|---|---|
| Optimization and control 1 | Experimental | The first study part/arm includes 12 patients and will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. Receives: Device: Sanmina Biosensor |
| Optimization and control 2 | Experimental | The second study part/arm includes 12 patients and will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. Receives: Device: Sanmina Biosensor |
| Precision and accuracy | Other | During the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated. Receives: Device: Sanmina Biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance and accuracy of glucose levels
performance and accuracy of the Sanmina biosensors (wearable and finger clip) in monitoring glucose levels (mg/dL) during a standardized meal experiment. Measurements (during the meal experiment) of the Sanmina biosensor will be compared to the capillary blood glucose reference method YSI STAT 2300 (glucose, in mg/dL).
Measured: approx. 240 minutes
Performance and accuracy of pO2
performance and accuracy of the Sanmina biosensors (wearable and finger clip) in monitoring pO2 (%) during a standardized meal experiment. PO2-measurements (during the meal experiment) of the Sanmina biosensor will be compared to the patient monitor (%).
Measured: approx. 240 minutes
Performance and accuracy of heart rate
performance and accuracy of the Sanmina biosensors (wearable and finger clip) in monitoring heart rate (pulse/min) during a standardized meal experiment. Heart rate measurements (during the meal experiment) of the Sanmina biosensor will be compared to the patient monitor heart rate(pulse/min).
Measured: approx. 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start25 Mar 2019
- Primary completion7 Nov 2019
- Study completion1 Apr 2020
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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The first 2 study parts include 12 patients each. In the third study part 36 patients will be enrolled. Study part 1 and 2 will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. During the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciema UG
- Sponsor type
- University, hospital or other
- Collaborators
- Sanmina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379427
- Sponsor's protocol ID
- SNM-NGM-001
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 7 May 2020
- 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 7 May 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 Sanmina Non-invasive Biosensors During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2
- ClinicalTrials.gov ID
- NCT04379427
- Acronym / sponsor ID
- SNM-NGM-001
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sciema UGUniversity, hospital or other
- Collaborators
- Sanmina
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 7 May 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 Sanmina biosensors in monitoring of glucose, heart rate (HR), and SpO2 in patients with type 1 and type 2 diabetes during a standardized meal experiment.
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 12 patients each. In the third study part 36 patients will be enrolled. Study part 1 and 2 will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. During the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated. The study conduct for all 60 participants of all 3 study parts will be exactly the same. In all groups of participants, the Sanmina finger clip and wearable non-invasive monitoring biosensor will be individually introduced and assigned. During the study visit at the study site, a standardized meal will be given to the participants. At eleven time points before and after the standardized meal, glucose, heart rate, and pO2 will be measured using the Sanmina finger clip and wearable non-invasive monitoring biosensor. The measurement time points are -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. The measurements will be compared to capillary blood glucose measurements by YSI Stat 2300 and StatStrip (glucose), and parallel measurements of the heart rate and the pO2 using a patient monitor. Further the exact skin colour will be evaluated using a skin colour card.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The first 2 study parts include 12 patients each. In the third study part 36 patients will be enrolled. Study part 1 and 2 will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. During the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated.
| Arm | Type | Receives |
|---|---|---|
| Optimization and control 1 | Experimental | Device: Sanmina BiosensorThe first study part/arm includes 12 patients and will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. |
| Optimization and control 2 | Experimental | Device: Sanmina BiosensorThe second study part/arm includes 12 patients and will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. |
| Precision and accuracy | Other | Device: Sanmina BiosensorDuring the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or Type 2 diabetic subjects or healthy probands
- 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 |
|---|---|---|
| Sanmina Biosensornon-invasive blood glucose measurement using the Sanmina Biosensor referenced with the invasive reference blood glucose device YSI 2400 Plus. | Device | Optimization and control 1, Optimization and control 2, Precision and accuracy |
Primary outcome
Performance and accuracy of glucose levels
Time frame: approx. 240 minutes
performance and accuracy of the Sanmina biosensors (wearable and finger clip) in monitoring glucose levels (mg/dL) during a standardized meal experiment. Measurements (during the meal experiment) of the Sanmina biosensor will be compared to the capillary blood glucose reference method YSI STAT 2300 (glucose, in mg/dL).
Performance and accuracy of pO2
Time frame: approx. 240 minutes
performance and accuracy of the Sanmina biosensors (wearable and finger clip) in monitoring pO2 (%) during a standardized meal experiment. PO2-measurements (during the meal experiment) of the Sanmina biosensor will be compared to the patient monitor (%).
Performance and accuracy of heart rate
Time frame: approx. 240 minutes
performance and accuracy of the Sanmina biosensors (wearable and finger clip) in monitoring heart rate (pulse/min) during a standardized meal experiment. Heart rate measurements (during the meal experiment) of the Sanmina biosensor will be compared to the patient monitor heart rate(pulse/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 7 May 2020.
- 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.
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?
A study testing Sanmina Biosensor 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 7 May 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 of glucose levels (time frame: approx. 240 minutes). 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 7 May 2020.