Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| DYN Diagnostic LTD | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Evaluation of Long-Term Implanted Sensor in Patients on Quality of life
Assess satisfaction and acceptance of long-term implanted single sensor use (eversense XL) for up to 6 months in type 1 insulin-using patients
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eversense | Device | eversense CGM |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in quality of life evaluated questionnaires (DTSQ) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HBA1C | 3 / 6 months | |
| CGM Time In Range (70-180 mg/dl) | 3 / 6 months | |
| CGM Time in hypoglycaemia below 70 mg/dl |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 / 6 months |
| CGM Time in hypoglycaemia below 54 mg/dl | 3 / 6 months |
| CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit] | 3 / 6 months |
| Change in HFS-ii (hypoglycaemia fear survey II) | 6 months |
| Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT) | 6 months |
| Any adverse event related to study device | 6 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |