Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001116617
Ethics application status
Approved
Date submitted
18/09/2023
Date registered
26/10/2023
Date last updated
28/07/2024
Date data sharing statement initially provided
26/10/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutromics Biosensor Characterisation (NBC) Study to measure endogenous analytes in the interstitial space with a novel, minimally invasive biosensor in healthy participants.
Scientific title
Nutromics Biosensor Characterisation (NBC) Study to measure endogenous analytes in the interstitial space with a novel, minimally invasive biosensor in healthy participants.
Secondary ID [1] 310631 0
NCRC-AU-2023/001
Universal Trial Number (UTN)
Trial acronym
NBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glucose monitoring 331510 0
Phenylalanine Monitoring
 331752 0
Creatinine Monitoring 331753 0
Condition category
Condition code
Metabolic and Endocrine 328241 328241 0 0
Diabetes
Human Genetics and Inherited Disorders 328356 328356 0 0
Other human genetics and inherited disorders
Renal and Urogenital 328357 328357 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Investigational Device; the Nutromics Sensor Device is worn on the upper arm of a patient and collects raw electrochemical data through DNA sensor on minimally invasive needles piercing the skin.

Specific procedures (Endogenous Analyte Characterisation for Creatinine, Phenylalanine and Glucose), in addition to the below site and follow up activities that are to be completed, conducted by Nurse Coordinators with participants in a 1:1 manner.
Images and videos before application of the Nutromics Sensor Device
- Application of Nutromics Sensor Device to upper arm of participants
- Images and videos post application of the Nutromics Sensor Device
- Physical challenge post application of the Nutromics Sensor Device 2 hours after application (Arm extension for approximately 20 seconds x 2, Arm lifting and turning approximately 10 seconds x 2, Standing and walking approximately 30 seconds x 2 and Lying down for approximately 10 minutes)


- Pain survey after application and before removal of the Nutromics Sensor Device
- Mobility survey before removal of the Nutromics Sensor Device
- Activity log: Participants will be able to go to the toilet and move a round, the time of these activities will be recorded in the activity monitoring log. All meals and beverages will be provided and the time of consumption will be recorded.

The below procedures may also be conduction in conjunction with the above protocol activities. Participants will either be selected as a baseline or challenge participant based on Research and Development needs, and the procedure allocation will also be based upon Research and Development needs. Procedures will be run in parallel and do not have to be completed sequentially. In addition, participants may complete the same procedure on different occasions; and have completed an online Health Screening Survey within the last 30 days.


Endogenous Analyte Characterisation (Creatinine) (Baseline or Challenge participants):
Participants will be either a Baseline or Challenge participant, based on Research and Development requirements.
Baseline Participants:
Baseline participant for the procedure will have venous draws of 4 mL in a Lithium Heparin (LiH) tube, prior to application of the Nutromics Sensor Device, then subsequently at the 1hr, 2hr and 3hr mark post application, that will be tested on the iSTAT for Creatinine concentration.
Challenge Participants:
Participants, will consume 10 g of Creatine Ethyl Ester in 250 mL of a sports drink or soft drink, within 10 minutes, approximately 30 minutes following application of the Nutromics Sensor Device(4). The participant will also have venous draws of 4 mL following application of the Nutromics Sensor Device in an LiH tube, then subsequently at the 1hr, 2hr and 3hr mark post application(in LiH tubes), that will be tested on the iSTAT for Creatinine concentration.

Endogenous Analyte Characterisation (Phenylalanine) (Baseline or Challenge participants):
Participants will be either a Baseline or Challenge participant, based on Research and Development requirements.
Baseline Participants:
Baseline participants will have venous draws of 4 mL in a Lithium Heparin tube (LiH) prior to application of the Nutromics Sensor Device, then subsequently at the 1hr, 2hr and 3hr mark post application, that will be tested for Phenylalanine concentration.
Challenge Participants:
Participants will consume 4 g of Phenylalanine in 250 mL of soft drink within 10 minutes, approximately 30 minutes following application of the Nutromics Sensor Device(s). The participant will have venous draws of 4 mL following application of the Nutromics Sensor Device(s) in a Lithium Heparin tube (LiH), then subsequently at the 1hr, 2hr and 3hr mark post application (in LiH tubes), that will be tested for Phenylalanine concentration.

Endogenous Analyte Characterisation (Glucose) (Baseline or Challenge participants):
Participants will be either a Baseline or Challenge participant, based on Research and Development requirements.
Baseline Participants:
Baseline participants will have venous draws of 4 mL in a Lithium Heparin (LiH) tube prior to application of the Nutromics Sensor Device, then subsequently at the 1hr, 2hr and 3hr mark post application, that will be tested on the iSTAT for Glucose concentration.
Challenge Participants:
Participants, other than the baseline, will consume a 300 mL bottle with 75 g of glucose, within 10 minutes, at least 30 minutes following the application of the Nutromics Sensor Device. The participant will have venous draws of 4 mL in a Lithium Heparin (LiH) tube prior to the Glucose Challenge which will be tested for Glucose.
Should the first Glucose pathology concentration be outside of the below acceptable range (from the Royal College of Pathologists of Australasia), the participant must instead follow the Procedure for a Baseline participant, rather than a Challenge participant (and be re-consented if appropriate):
- Fasting: 3.0-5.4 mmol/L (> 2 hour post-prandial)
- Random: 3.0-7.7 mmol/L
Additional blood draws will be taken at the 1hr, 2hr and 3hr mark post application (in a LiH tube), that will be tested on the iSTAT for Glucose concentration.
Intervention code [1] 327029 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336111 0
This is a characterisation research study investigating the different features of the Nutromics Sensor Device platform, investigating the ability of the device to detect Creatinine.
Timepoint [1] 336111 0
Baseline and 1, 2, 3 hours post application of the Nutromics Sensor Device
Primary outcome [2] 336325 0
This is a characterisation research study investigating the different features of the Nutromics Sensor Device platform, investigating the ability of the device to detect Phenylalanine.
Timepoint [2] 336325 0
Baseline and 1, 2, 3 hours post application of the Nutromics Sensor Device
Primary outcome [3] 336326 0
This is a characterisation research study investigating the different features of the Nutromics Sensor Device platform, investigating the ability of the device to detect Glucose.
Timepoint [3] 336326 0
Baseline and 1, 2, 3 hours post application of the Nutromics Sensor Device
Secondary outcome [1] 426871 0
Mechanical Characterisation: Adhesive performance
Timepoint [1] 426871 0
Upon initial application of the Nutromics Sensor Device and continuous throughout duration of 4 hour Procedure.
Secondary outcome [2] 426872 0
Mechanical Characterisation: Ease of placement on body
Timepoint [2] 426872 0
Upon initial application of the Nutromics Sensor Device and continuous throughout duration of 4 hour Procedure.
Secondary outcome [3] 426873 0
Mechanical Characterisation: Minimally invasive needle insertion adequacy
Timepoint [3] 426873 0
Continuous throughout duration of 4 hour Procedure.
Secondary outcome [4] 426874 0
Mechanical Characterisation: Participant composite pain and mobility assessment to assess comfort/discomfort
Timepoint [4] 426874 0
Pain Survey upon Nutromics Sensor Device application and removal, and Mobility Survey prior to removal.
Secondary outcome [5] 427285 0
Mechanical Characterisation: Participant movement
Timepoint [5] 427285 0
2 hours post Nutromics Sensor Device application, prior to removal of Nutromics Sensor Device and review of Nutromics Sensor Device data.
Secondary outcome [6] 427286 0
Capability of biosensor to detect creatinine
Timepoint [6] 427286 0
At baseline, and 1,2,3 hours post Nutromics Sensor Device application and throughout duration of Procedure.
Secondary outcome [7] 427287 0
Capability of biosensor to detect phenylalanine
Timepoint [7] 427287 0
At baseline, and 1,2,3 hours post Nutromics Sensor Device application and throughout duration of Procedure.
Secondary outcome [8] 427288 0
Capability of biosensor to detect glucose
Timepoint [8] 427288 0
At baseline, and 1,2,3 hours post Nutromics Sensor Device application and throughout duration of Procedure.
Secondary outcome [9] 427289 0
Stability, continuity and reliability of onboard data.
Timepoint [9] 427289 0
Baseline, and 1,2,3 hours post Nutromics Sensor Device application, and comparison to serum, and throughout duration of 4 hour Procedure.

Eligibility
Key inclusion criteria
Participants self-declaring healthy without any disease, condition or syndrome or on any current medical treatment.

Aged 18 and above
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who have declared they are pregnant.

Participants who declare previous allergic reactions to metals, plastics, and adhesives

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
25/08/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
19/04/2024
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
50
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314847 0
Commercial sector/Industry
Name [1] 314847 0
Nutromics Operations
Country [1] 314847 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nutromics Operations
Address
Nutromics: 420 Victoria St, Brunswick VIC 3056
Country
Australia
Secondary sponsor category [1] 316838 0
None
Name [1] 316838 0
Address [1] 316838 0
Country [1] 316838 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313848 0
Nutromics Diagnostics HREC
Ethics committee address [1] 313848 0
Ethics committee country [1] 313848 0
Australia
Date submitted for ethics approval [1] 313848 0
21/08/2023
Approval date [1] 313848 0
23/08/2023
Ethics approval number [1] 313848 0
2023-NDHREC-0002

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

Contacts
Principal investigator
Name 129542 0
Dr Tahir Yahya
Address 129542 0
Nutromics: 420 Victoria St, Brunswick 3056 VICTORIA
Country 129542 0
Australia
Phone 129542 0
+12484952395
Fax 129542 0
Email 129542 0
[email protected]
Contact person for public queries
Name 129543 0
Emily Birthisel
Address 129543 0
Nutromics: 420 Victoria St, Brunswick 3056 VICTORIA
Country 129543 0
Australia
Phone 129543 0
+61450695551
Fax 129543 0
Email 129543 0
[email protected]
Contact person for scientific queries
Name 129544 0
Tahir Yahya
Address 129544 0
Nutromics: 420 Victoria St, Brunswick 3056 VICTORIA
Country 129544 0
Australia
Phone 129544 0
+12484952395
Fax 129544 0
Email 129544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.