Not provided
Not provided
Not provided
Not provided
Not provided
Change of sponsor and trial design
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a randomized trial to determine if an extended wear infusion set can be worn for up to 7 days with a hybrid closed-loop system in adult with Type 1 Diabetes
This study will compare use of a standard infusion set with an extended wear infusion set. Subjects will be asked to wear both types of sets twice for up to 7 days, alternating wear of set type over 4 weeks. The order of infusion set wear will be randomized with the first set wear. The investigators aim to see whether there is a benefit to using an extended wear infusion set.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard then Extended Infusion Set | Experimental | Participants will start with wearing the standard infusion set for up to 7 days, then switch to the Extended Wear infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks |
|
| Extended then Standard Infusion Set | Experimental | Participants will start with wearing the Extended Wear infusion set for up to 7 days, then switch to the standard infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Wear Infusion Set | Device | For two of the 4 weeks, the Extended Wear insulin infusion set will be used |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of infusion set failures due to "unexplained hyperglycemia" | Defined as:
| 14 days for each type of infusion set, with each type of infusion set worn twice |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of infusion set wear | The maximum number of days that 75% of the infusion sets are still working, excluding those that kinked on insertion or were accidentally pulled out. | 14 days for each type of infusion set, with each type of infusion set worn twice |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bruce Buckingham, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | 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
Not provided
Not provided
| Standard Infusion Set | Device | For two of the 4 weeks, the standard insulin infusion set will be used |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |