Recruiting NCT07675161
MiniMed Fit Payload Wear Pediatric Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MiniMed Fit Payload adhesive components.
- Who it may be relevant to
- Registry conditions: Diabetes (DM), Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes in Children, Diabetes in Adolescence. Basic parameters: 7 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CIP361: MiniMed Fit Payload Wear Pediatric Study
Overview
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.
Interventions
- Device MiniMed 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.
Primary outcome measures
- Summary of device survival [Time frame: 7 Days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 5 centers
- Sutter Institute for Medical Research — Sacramento
- Sansum Diabetes Research Institute — Santa Barbara
- Rocky Mountain Clinical Research — Idaho Falls
- Barry J Reiner MD LLC — Baltimore
- Diabetes and Glandular Disease Clinic PA — San Antonio
Identifiers
NCT: NCT07675161 · CIP361