MiniMed Fit Payload Wear Pediatric Study

CIP361: MiniMed Fit Payload Wear Pediatric Study

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.