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The purpose of this study is to assess success/failure of the MiniMed Fit Payload adhesive components in different wear locations over a 7-day period to support development of the future commercialized patch pump.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiniMed Fit Payload adhesive components | Adult participants with insulin-requiring diabetes using the MiniMed Fit Payload adhesive components in different wear locations over a 7-day period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMed Fit Payload adhesive components | Device | The MiniMed Fit Payload device used in this study will be made of polycarbonate materials, will not contain any electronic or mechanical components, and is intended to mimic the shape and weight of a future product. Each device will consist of the payload assembly and an adhesive patch, which will be adhered to the payload on one side and the subject's skin on the other. |
| Measure | Description | Time Frame |
|---|---|---|
| The MiniMed Fit Payload success rate at the end of Day 5. | The number of MiniMed Fit Payload that meet the success criteria divided by the total number of MiniMed Fit Payload devices applied at the end of Day 5. | 5 Days |
| Measure | Description | Time Frame |
|---|---|---|
| The MiniMed Fit Payload success rate at the end of Day 7. | The number of MiniMed Fit Payload that meet the success criteria divided by the total number of MiniMed Fit Payload devices applied at the end of Day 7. | 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
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Investigational Centers, example, primary care clinic, academic institution, etc.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProSciento | Chula Vista | California | 91911-1350 | United States | ||
| Headlands Research California LLC |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Escondido |
| California |
| 92025-6428 |
| United States |
| NYC Research Inc | Long Island City | New York | 11106-2329 | United States |
| Rainer Clinical Research Center | Renton | Washington | 98057-5211 | United States |