MiniMed Fit Payload Wear Pediatric Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-17
SponsorMedtronic MiniMed, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • MiniMed Fit Payload adhesive components

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators