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OpenTrials
Completed

NCT Number: NCT07408141

MiniMed Fit Payload Wear Study

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ProSciento, Chula Vista, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 site will follow procedures for study withdrawal.

Treatment and study plan

MiniMed Fit Payload adhesive components

Device

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 outcomes

  1. The MiniMed Fit Payload success rate at the end of Day 5.

    Time frame: 5 Days

    The number of MiniMed Fit Payload that meet the success criteria divided by the total number of MiniMed Fit Payload devices applied at the end of Day 5.

Secondary outcomes

  1. The MiniMed Fit Payload success rate at the end of Day 7.

    Time frame: 7 Days

    The number of MiniMed Fit Payload that meet the success criteria divided by the total number of MiniMed Fit Payload devices applied at the end of Day 7.

Sponsors and collaborators

Lead sponsor

Medtronic MiniMed, Inc.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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