Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000125426
Ethics application status
Approved
Date submitted
29/01/2025
Date registered
4/02/2025
Date last updated
13/04/2025
Date data sharing statement initially provided
4/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Sub-Protocol #2 of Umbrella Protocol Study: Limit of Blank Characterization of Vancomycin Biosensor Nutromics Device.
Scientific title
Sub-Protocol #2 of Umbrella Protocol Study: Limit of Blank Characterization of Vancomycin Biosensor Nutromics Device.
Secondary ID [1] 313835 0
NCRC-AU-2024/003
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12625000115437 - Sub Protocol #1 under the same Umbrella Protocol as this Sub Protocol #2

Health condition
Health condition(s) or problem(s) studied:
Therapeutic Drug Monitoring 336483 0
Condition category
Condition code
Infection 332994 332994 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective study with an Umbrella Protocol; where each sub-Protocol investigates a particular condition(s) and challenges to various Vancomycin biosensors and electrode properties. The study will enroll healthy participants in the community. Participants will be recruited for participation in stages depending on the Research and Development needs. This registration described Sub-Protocol #2.

The Sub-Protocol #2 investigates the Impact of physical activity, mobility, and physiological interferences on the Limit of Blank (LoB) of Vancomycin Biosensors used in the Nutromics Sensor Device. The primary aim is to assess the impact of physical activity, mobility and physiological interferences (ie; sweat) on the LoB of the Nutromics Sensor Device. This includes evaluating any potential degradation in accuracy or precision or signal-to-noise ratio of the measurements.

The study will enroll no more than 50 participants. Participants may participate in more than one sub-Protocol of the Study, subject to their continued eligibility.

Potential participants will be recruited by flyers on community, university, and
Nutromics Operations noticeboards. Prospective participants will express interest via email to
[email protected].

Participants who have previously participated or expressed interested in studies at the Nutromics Clinical Research Centre may also be contacted and asked if they are interested in participating. Prospective participants will be sent an Online Health Screening. Nutromics employees can participate in this study.

Participants who meet the inclusion criteria (as per the Online Health Screening Survey) will be contacted for a brief phone screening for inclusion/exclusion criteria, including an explanation of the study details. A copy of the patient information sheet and consent form will be given to the participants who meet the inclusion criteria and still express interest in participating in the study following the phone discussion. Eligible participants who agree to participate in the study will be given time to consider their decision. Eligible participants who agree to participate in the study will be asked to attend an on-site Visit, where written consent will be obtained before any study procedures are conducted.

All on-site visits, and the procedures outlined below will be performed by the Clinical Research Coordinator (research nurse).

Participants will arrive on-site and have two Nutromics Sensor Devices applied to the same upper arm. The Nutromics Sensor Device is wearable device that has four microneedles that enter just below the skin and are the biosensing component of the study Participant shall drink water when required / desired throughout the study. The volume of water consumed will be recorded.

On Site Visit
1. Written informed consent will be obtained
2. Participants without childbearing potential will progress straight to Step #3
3. A test for Pregnancy in all participants with childbearing potential (2mL sample of blood
collected in a serum tube either via venipuncture)
4. Pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected immediately prior to application of Nutromics Sensor Devices.
5. Participants will be weighed wearing minimal clothing, such as a sports bra and shorts, or a gown. No shoes to be worn. Any water to be consumed during the study should also be held during weighing.
6. Selection of site where the Nutromics Sensor Devices will be applied following blood collection (+15 min).
7. Application of two Nutromics Sensor Devices on the same upper arm.
8. Pain Assessment post application (+15 min) of Nutromics Sensor Devices
9. Participant remains seated at rest for 30 minutes (+5 min)
10. Participant walks at steady speed on treadmill for 30 minutes (+5 min) (Rate of Perceived Exertion (RPE) 2-3)
11. Participant jogs on treadmill for 30 minutes (RPE 7-8)
12. Participant remains seated at rest for 30 minutes (+5 min)
13. Participants will be reweighed wearing minimal clothing, same clothing as worn in Step #5
14. Immediately prior to the removal of the Nutromics Sensor Devices, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected (-15 min)
15. Nutromics Sensor Devices are Removed 3.5 hours (+15 min) following their application
16. Images are taken of the application sites for each of the Nutromics Sensor Device following their removal. Care will be taken to avoid identifiable features.
17. The participant is observed for 15 minutes (+15 min) following removal of the Nutromics Sensor Devices, after which they are discharged from the study.
Intervention code [1] 330420 0
Early detection / Screening
Comparator / control treatment
NO control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340535 0
Establish the highest reported concentration Limit of Blank (LoB) likely to be observed for a blank sample using the Nutromics Sensor Device.
Timepoint [1] 340535 0
Across wear period where the Nutromics Sensor Device will collect data on vancomycin concentrations in interstitial fluid every 5 minutes.
Primary outcome [2] 340536 0
The impact of physical activity, mobility and physiological interferences (ie; sweat) on the LoB of the Nutromics Sensor Device will be assessed compositely. This includes evaluating any potential degradation in accuracy or precision or signal-to-noise ratio of the measurements.
Timepoint [2] 340536 0
Across wear period where the Nutromics Sensor Device will collect data on vancomycin concentrations in interstitial fluid every 5 minutes.
Secondary outcome [1] 444368 0
Characterise the impact of hydration on the LoB of Vancomycin biosensors (serum osmolality)
Timepoint [1] 444368 0
Blood will be collected at two occasions to assess safety of the Nutromics Sensor Device; (immediately prior to application of the Devices, and immediately prior to the removal of the Devices to assess the hydration of the participants.
Secondary outcome [2] 444366 0
Evaluate the variability and error associated with Vancomycin biosensors when the target analyte is not present.
Timepoint [2] 444366 0
Across wear period where the Nutromics Sensor Device will collect data on vancomycin concentrations in interstitial fluid every 5 minutes.
Secondary outcome [3] 444367 0
To evaluate the safety of the Nutromics sensor device.
Timepoint [3] 444367 0
Blood will be collected at two occasions to assess safety of the Nutromics Sensor Device; immediately prior to application of the Devices, and immediately prior to the removal of the Devices. Images of the application site will be taken prior to the application and removal of the Device. A pain score is obtained from the participant no more than 15 minutes following application of each Nutromics Sensor Device. Adverse Events will be assessed across the wear time of the Device.

Eligibility
Key inclusion criteria
- Participants self-declaring healthy without any disease, condition or syndrome or on any current prescription medical treatments (other than contraception medication)
- Participants are comfortable (self reported) to walk and jog, each for up to 30 minutes.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participants are pregnant, lactating, planning to become pregnant, breastfeed, or donate ova.
- Participants who declare previous allergic reactions to metals, plastics, and adhesives.
- Participants who have a history of fainting or experiencing vasovagal reactions during blood draws
- Non-English speaking participants

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/02/2025
Actual
11/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318305 0
Commercial sector/Industry
Name [1] 318305 0
Nutromics Operations Pty Ltd
Country [1] 318305 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nutromics Operations Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320689 0
None
Name [1] 320689 0
Address [1] 320689 0
Country [1] 320689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316941 0
Nutromics Diagnostics HREC
Ethics committee address [1] 316941 0
Ethics committee country [1] 316941 0
Australia
Date submitted for ethics approval [1] 316941 0
05/12/2024
Approval date [1] 316941 0
11/02/2025
Ethics approval number [1] 316941 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139502 0
A/Prof Sophie Stocker
Address 139502 0
Rm No S303, Building No A15, The University of Sydney, NSW, 2006
Country 139502 0
Australia
Phone 139502 0
+61 427 490 796
Fax 139502 0
Email 139502 0
[email protected]
Contact person for public queries
Name 139503 0
Emily Birthisel
Address 139503 0
Nutromics; 420 Victoria Street, Brunswick VIC, Australia
Country 139503 0
Australia
Phone 139503 0
+61 450695551
Fax 139503 0
Email 139503 0
[email protected]
Contact person for scientific queries
Name 139504 0
Mark Friedel
Address 139504 0
Nutromics; 420 Victoria Street, Brunswick VIC, Australia
Country 139504 0
Australia
Phone 139504 0
+61432887350
Fax 139504 0
Email 139504 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.