CIP361: MiniMed Fit Payload Wear Pediatric Study
Medtronic MiniMed, Inc.
Summary
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
- Age range
- 7–17 years
- Sex
- All
- Healthy volunteers
- No
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 a…
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 (3)
- Rocky Mountain Clinical ResearchIdaho Falls, Idaho
- Barry J Reiner MD LLCBaltimore, Maryland
- Diabetes and Glandular Disease Clinic PASan Antonio, Texas