MiniMed Fit Payload Wear Pediatric Study
CIP361: MiniMed Fit Payload Wear Pediatric Study
1 other identifier
observational
59
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2026
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2026
CompletedStudy Start
First participant enrolled
June 25, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2026
CompletedAugust 25, 2026
August 1, 2026
1 month
June 18, 2026
August 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Summary of device survival
The number of MiniMed Fit Payload that remain securely attached to the skin at the end of day 7. This is a descriptive endpoint.
7 Days
Study Arms (1)
MiniMed Fit Payload adhesive components
Pediatric participants with insulin-requiring diabetes using the MiniMed Fit Payload adhesive components in different wear locations over a 7-day period.
Interventions
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.
Eligibility Criteria
Investigational Centers, example, primary care clinic, academic institution, etc.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Sutter Institute for Medical Research
Sacramento, California, 95821-2123, United States
Sansum Diabetes Research Institute
Santa Barbara, California, 93105-4321, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Barry J Reiner MD LLC
Baltimore, Maryland, 21229, United States
Diabetes and Glandular Disease Clinic PA
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2026
First Posted
June 30, 2026
Study Start
June 25, 2026
Primary Completion
August 7, 2026
Study Completion
August 7, 2026
Last Updated
August 25, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share