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The purpose of this study is to assess MiniMed Fit Payload adhesive components in different wear locations over a 7-day period to support development of the future commercialized patch pump in participants 7-17 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiniMed Fit Payload adhesive components | Pediatric 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 |
|---|---|---|
| Summary of device survival | The number of MiniMed Fit Payload that remain securely attached to the skin divided by the total number of MiniMed Fit Payload devices applied at the end of day 7. This is a descriptive endpoint. | 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
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Investigational Centers, example, primary care clinic, academic institution, etc.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| McKenna Cherry | Contact | 763-505-1195 | mckenna.cherry@medtronic.com | |
| Melissa Vella | Contact | 416-768-0862 | melissa.vella@medtronic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Clinical Research | Recruiting | Idaho Falls | Idaho | 83404 | United States |
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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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| Barry J Reiner MD LLC | Recruiting | Baltimore | Maryland | 21229 | United States |
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| Diabetes and Glandular Disease Clinic PA | Recruiting | San Antonio | Texas | 78229 | United States |
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