Minimed Fit Payload Wear Study
Medtronic MiniMed, Inc.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DeviceMiniMed Fit Payload adhesive components
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.
Locations (4)
- ProScientoChula Vista, California
- Headlands Research California LLCEscondido, California
- NYC Research IncLong Island City, New York
- Rainer Clinical Research CenterRenton, Washington