Diabetes (Insulin-requiring, Type 1 or Type 2)
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Medtronic MiniMed, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with insulin- requiring diabetes * Subjects 18 years of age or older * Subjects able and willing to sign informed consent
Exclusion criteria
* Subjects who report known skin sensitivity or allergy to pressure-sensitive adhesives, e.g, medical device adhesives, band-aids, other acrylic-containing adhesives * Subjects with any skin condition in the area where device placement (e.g., irritation, rash, infection) could occur, per subject report. * Subjects who are pregnant (per self-report) at initial screening. If a subject becomes pregnant during the study, the site will follow procedures for study withdrawal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The MiniMed Fit Payload success rate at the end of Day 5. | 5 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The MiniMed Fit Payload success rate at the end of Day 7. | 7 Days | 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. |
Countries
United States
Outcome results
None listed