MiniMed Fit Payload Wear Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes (Insulin-requiring, Type 1 or Type 2)
• Intervention / Treatment: Device: MiniMed Fit Payload adhesive components

• Study Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911-1350
      • ProSciento
    • Escondido, California, United States, 92025-6428
      • Headlands Research California LLC
  • New York
    • Long Island City, New York, United States, 11106-2329
      • NYC Research Inc
  • Washington
    • Renton, Washington, United States, 98057-5211
      • Rainer Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

MiniMed Fit Payload adhesive components; Adult 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
The MiniMed Fit Payload success rate at the end of Day 5.	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.	5 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The MiniMed Fit Payload success rate at the end of Day 7.	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.	7 Days

Collaborators and Investigators

• Sponsor: Medtronic MiniMed, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: CIP356

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.: No