None listed
Conditions
Brief summary
This study aims to evaluate the safety and functionality of the ProtonPetal Alpha One device, focusing on generating early feasibility data regarding its performance. The device will measure participants' interstitial potassium levels, and these measurements will be retrospectively compared to standard clinical blood potassium measurements, both during baseline conditions and after introducing a potassium challenge.
Interventions
This investigational study will assess the ProtonPetal Alpha One device's ability to monitor interstitial potassium and other analytes in healthy adults. The ProtonPetal Alpha One is a wearable investigational device that uses a sensor inserted under the skin, designed for the continuous measurement of potassium levels in the subcutaneous Interstitial Fluid (ISF).
The study will be performed by an investigator that is a qualified general practitioner (GP) and an experienced clinical research n
This investigational study will assess the ProtonPetal Alpha One device's ability to monitor interstitial potassium and other analytes in healthy adults. The ProtonPetal Alpha One is a wearable investigational device that uses a sensor inserted under the skin, designed for the continuous measurement of potassium levels in the subcutaneous Interstitial Fluid (ISF). The study will be performed by an investigator that is a qualified general practitioner (GP) and an experienced clinical research nurse with over 5 years of experience. The study will be performed at a GP clinic. Participants will be assessed for study inclusion that will include a blood test and electrocardiogram. They will then undergo and the insertion of one peripheral intra-venous (IV) catheter, and three ProtonPetal Alpha One devices to the upper arm. All three ProtonPetal Alpha One devices will be applied to a single arm, and the catheter will be applied to the arm which does not contain any wearable devices. The study will be performed only once per participant, over the course of a single 6 hour session, after which the investigational devices and catheters will be removed. Throughout this 6 hour period, blood samples will be taken from the IV catheter every 15 minutes to measure serum potassium and glucose levels which will be analyzed in a certified pathology laboratory. During the study, participants will also ingest a known potassium concentration in the form of a single Chlorvescent tablet at the 3 hour mark following wearable device and catheter application, This Chlorvescent tablet contains; 14 mmol K+, 8 mmol Cl-, 1.1 mmol CO32-, and 3.8 mmol HCO-3. The tablet will be prepared by the nurse by dissolving a single tablet in 250 mL of water. During the study, the clinical nurse will perform the preparation and administration of the Chlorvescent tablet to ensure compliance with the intervention protocol.
Sponsors
Proton Intelligence Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1) At least 18 years of age. 2) Participant is willing to participate in study and comply with protocol requirements. 3) Participants can read and comprehend English. 4) Participants have completed the study Informed Consent Form.
Exclusion criteria
1) Known allergy to polyurethane, polyvinyl chloride, acesulfame potassium, aspartame, citric acid, leucine, macrogol 6000, sorbitol, blackcurrant flavour 502009 AP0551. 2) Baseline haematology panel readings outside of the pathology laboratories published reference range, and deemed by the investigator as clinically significant, 3) Baseline UEC panel readings outside of the pathology laboratories published reference range, and deemed by the investigator as clinically significant, 4) Abnormal ECG readings detecting heart arrhythmia, elevated heart rate or other phenotypes deemed a potential risk by a qualified medical practitioner. 5) Underlying heart/kidney impairment. 6) Has skin lesions, scarring, redness, infection, edema at the application sites or anything that could interfere with device placement or the accuracy of interstitial potassium measurements. 7) Pregnant, planning pregnancy or breastfeeding during the study period or producing a positive urine pregnancy test result at the time of enrolment. 8) Any condition that in the Investigator’s opinion would make the participant unable to complete the study or would make it not in the participants best interest to participate in the study.
Outcome results
None listed