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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM Devices | Device | Each participant will wear 3 SAVA CGMs and 1 commercially available CGM |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | For the duration of time the participant is wearing the CGM device (Day 0 to Day 14; up to 15 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At device application (Day 0) and removal (up to Day 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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. | 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. | 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. | 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. | Up to 15 days (Day 14) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |