Healthy volunteers Other
Conditions
Interventions
This study involves 15 healthy volunteers divided into three groups of five. The research is designed to test a new wearable skin sensor (a biosensor) that uses tiny "microneedles" to measure two heal
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or Female, 18-45 years of age 2. Be in good health 3. Able and willing to comply with all study requirements 4. Negative pregnancy test (female participants)
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following apply: 1. Previously diagnosed chronic medical condition 2. Female participant who is pregnant, lactating or planning pregnancy during the course of the study 3. Predisposition to bleeding 4. Predisposition to skin infection or inflammation including a history of atopic dermatitis 5. Participants who have participated in another research study involving an investigational product in the past 12 weeks or plan to participate during the course of the study 6. Under investigation for malignancy 7. Allergy to any component of sensor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measured using absence of serious adverse events and absence of needle breakage at end of follow-up;Tolerability measured using Visual Analogue Scale pain score less than 3 out of 10 at point of sensor removal | — |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy measured using a comparison of sensor-derived glucose and lactate measurements with time-matched venous reference measurements obtained using the Siemens RAPIDPoint 500e Blood Gas System at 1 hour and at each interim measurement until device removal | — |
Countries
England, United Kingdom
Contacts
Public ContactGreta;Benedict Wood;Michael
;
Outcome results
None listed