First-in-human Testing of a Multi-Analyte Sensor Platform for Glucose/Lactate/Oxygen/Choline in People with Diabetes
- Conditions
- DiabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12623000537651
- Lead Sponsor
- St Vincent's Hospital Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
Participants will be considered for inclusion in the study if they meet all of the following criteria:
1. Participant is 18-65 years of age at time of screening.
2. A clinical diagnosis of Type-1 diabetes, or Type-2 diabetes as determined by the Investigator.
3. Participant is willing to comply with all requirements associated with the protocol.
Participants will be excluded from the study for any of the following reasons:
1.Participant has experienced an episode of major hypoglycaemia or diabetic ketoacidosis within the last month
2.Participant has a major illness precluding safe implementation of the protocol
3. Participant is or plans to become pregnant during the course of the study.
4. Participant is unable to tolerate tape adhesive in the area of sensor placement.
5. Participant has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the investigational sensor accuracy for glucose and lactate (including Day 1 vs. Day 4 performance and performance in the high vs. low glucose range) compared with point-of-care meter data, commercial continuous glucose sensor data and YSI glucose and lactate values as reference values.[Day 1 and Day 4 of wearing the investigational sensing platform]
- Secondary Outcome Measures
Name Time Method Descriptive comparison of differences in sensor lactate values for the two investigational lactate sensors between devices.[Day 1 and Day 4 of wearing the investigational sensing platform];Comparison of investigational sensor currents and retrospective accuracy of investigational sensor oxygen data [Day 1 and Day 4 of wearing the investigational sensing platform];Descriptive analysis of the investigational sensor currents for the choline sensor including stability over the study and response dynamics during challenge periods.[Day 1 and Day 4 of wearing the investigational sensing platform]