MiniMed Fit Payload Wear Pediatric Study

June 25, 2026 updated by: Medtronic MiniMed, Inc.

CIP361: MiniMed Fit Payload Wear Pediatric Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Investigational Centers, example, primary care clinic, academic institution, etc.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of device survival
Time Frame: 7 Days
The number of MiniMed Fit Payload that remain securely attached to the skin divided by the total number of MiniMed Fit Payload devices applied at the end of day 7. This is a descriptive endpoint.
7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic MiniMed, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 25, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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