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.

Recruiting

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Key information

Conditions

Diabetes (DM) Diabetes (Insulin-requiring, Type 1 or Type 2) Diabetes Mellitus Diabetes in Adolescence Diabetes in Children Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sutter Institute for Medical Research, Sacramento, California, United States

Who can participate

Healthy volunteers accepted: No

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

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.

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

Summary of device survival

Time frame: 7 Days

The number of MiniMed Fit Payload that remain securely attached to the skin at the end of day 7. This is a descriptive endpoint.

Study contacts

Contact information is provided by the study sponsor or research team.

McKenna Cherry

CONTACT

[email protected]

763-505-1195

Melissa Vella

CONTACT

[email protected]

416-768-0862

Sponsors and collaborators

Lead sponsor

Medtronic MiniMed, Inc.

Industry

Registry information

Official study title

CIP361: MiniMed Fit Payload Wear Pediatric Study

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jun 30, 2026
Registry last updated: Jul 22, 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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Recruiting