None listed
Conditions
Brief summary
This is a characterisation research study investigating the different features of the Nutromics Sensor Device platform.Characterisation studies to help guide development of the Nutromics Sensor Device platform will provide invaluable information to Research and Development (R&D) teams. Since this is a minimally invasive patch based platform, with minimally invasive needle, characterisation of adhesive, ergonomics and human factors will be crucial.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants self-declaring healthy without any disease, condition or syndrome or on any current medical treatment. Aged 18 and above
Exclusion criteria
Participants who have declared they are pregnant. Participants who declare previous allergic reactions to metals, plastics, and adhesives