NCT07408141

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 19, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 6, 2026

Last Update Submit

March 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    7 Days

Study Arms (1)

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

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.

MiniMed Fit Payload adhesive components

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Subjects with insulin- requiring diabetes
  • Subjects 18 years of age or older
  • Subjects able and willing to sign informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

ProSciento

Chula Vista, California, 91911-1350, United States

RECRUITING

Headlands Research California LLC

Escondido, California, 92025-6428, United States

RECRUITING

NYC Research Inc

Long Island City, New York, 11106-2329, United States

RECRUITING

Rainer Clinical Research Center

Renton, Washington, 98057-5211, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 13, 2026

Study Start

February 19, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations