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 |
|---|---|
| Jaeb Center for Health Research | OTHER |
Not provided
Not provided
The goal of this surveillance study is to collect real-world data on adults and youth with type 1 diabetes (T1D) using twiist(TM) for insulin delivery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| twiist users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| twiist Automated Insulin Delivery System | Device | twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe hypoglycemia events | Severe hypoglycemia events with cognitive impairment sufficient to require the assistance of a third party for treatment | From enrollment to the end of participation at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severe hypoglycemia events associated with seizure or loss of consciousness | From enrollment to the end of participation at 12 months | |
| Diabetic ketoacidosis | From enrollment to the end of participation at 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants who are diagnosed with Type 1 Diabetes, are at least 6 years old, and have been prescribed and are currently using the twiist system.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaeb Center for Health Research | Recruiting | Tampa | Florida | 33647 | United States |
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
| Hospitalizations related to use of twiist | From enrollment to the end of participation at 12 months |
| Unanticipated adverse device effects | From enrollment to the end of participation at 12 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |