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.
Participants with insulin-requiring diabetes
Participants 7-17 years of age
Participant and parent/guardian/legally authorized representative are able and willing to sign informed consent/assent
Participants who report known skin sensitivity or allergy to polycarbonate or pressure-sensitive adhesives, e.g., medical device adhesives, band-aids, other acrylic-containing adhesives.
Participants with any skin condition in the area where device placement (e.g., irritation, rash, infection) could occur, per participant report.
Participants who are pregnant (per self-report) at initial screening. If a participant becomes pregnant during the study, the site will follow procedures for study withdrawal.
Investigational Centers, example, primary care clinic, academic institution, etc.
Cohort
Prospective
MiniMed Fit Payload adhesive components
DeviceThe 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.
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.
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