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.
The participant is willing and able to give informed consent to participate in the study.
The participant is at least 18 years of age at the time of enrolment.
The participant has a clinical diagnosis of Type 1 diabetes, with 7% < HbA1C < 10% within the last 6 months, for a minimum of 6 months duration prior to enrolment, as determined by a medical record by an individual qualified to make a medical diagnosis, and is using insulin (either by an insulin pump, subcutaneous injections, and/or inhaled insulin) for at least 6 months prior to enrolment.
If participant is using noninsulin glucose-lowering medications (such as SGLT2I Inhibitor, Metformin, or other), dose has been stable for at least 2 weeks prior to screening.
The participant gave birth within the last 6 months, is pregnant, is trying to conceive or is not willing and able to practice birth control during the study duration.
The participant has serious concomitant disorders or diseases (e.g. history of hypoglycaemia with unawareness requiring third party assistance, coagulation disorders) that would compromise the safety of the participant or their ability to complete the study, at the discretion of the Investigator.
The participant has had a recent cardiovascular event or major surgery in the last 6 months that would compromise the safety of the participant or their ability to complete the study, at the discretion of the Investigator.
The participant has been admitted to the hospital with Diabetic Ketoacidosis in the last 6 months prior to enrolment.
Single group
CGM Devices
DeviceEach participant will wear 3 SAVA CGMs and 1 FSL 3 Plus 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.
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.
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.
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.
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.
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