The goal of this clinical trial is to evaluate the safety and performance of the SAVA Continuous Glucose Monitor across glucose ranges over a period of 15-day wear in adults over 18 years of age with Type 1 Diabetes. This is a pilot study, so the main purposes are to collect preliminary data for future studies, assess comfort and safety, and explore the accuracy of the CGM against references and benchmarks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Each participant will wear 3 SAVA CGMs and 1 commercially available CGM
Paired Sensor-Venous Blood Glucose Readings
The primary outcome is at least 98% of all paired sensor-venous blood glucose reference readings fall within the clinically acceptable Zones A and B of the Clarke Error Grid.
Time frame: For the duration of time the participant is wearing the CGM device (Day 0 to Day 14; up to 15 days)
Assessment of comfort associated with devices at insertion and removal
Assess participant-reported comfort and pain associated with sensor application and removal using the Numeric Pain Rating Scale which measures participants' pain level on a scale of 0 to 10 where higher scores mean worse pain.
Time frame: At device application (Day 0) and removal (up to Day 14)
Assessment of duration of pain associated with devices at insertion and removal
Assess participant-reported comfort and pain associated with sensor application and removal using the Pain Duration Scale which measures participants' pain level at different time points (within 5 seconds, 5-30 seconds, more than 30 seconds) after sensor application or removal, on a scale of 0 to 10 where higher scores mean worse pain.
Time frame: At device application (Day 0) and removal (up to Day 14)
Evaluation of skin response at device wear sites
Characterise the skin and evaluate skin response at sensor wear sites before and after device removal using the Draize Scale where higher scores mean worse skin response.
Time frame: At device application (Day 0) and removal (up to Day 14)
Characterisation of the safety profile of the SAVA CGMs
Characterise the safety profile of the SAVA CGM in terms of adverse events and device deficiencies. The number, type, and severity of adverse events and device deficiencies will be evaluated.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 15 days (Day 14)
Description of SAVA CGM clinical safety profile
Describe the clinical safety profile of the SAVA CGM based on the percentage distribution of paired sensor-reference glucose readings across zones of the Consensus (Parkes) Error Grid.
Time frame: Up to 15 days (Day 14)