MiniMed Fit adhesive patch: 7-day wear at different body sites
Minimed Fit Payload Wear Study
This will test how well the MiniMed Fit adhesive components stick and stay on during 7 days of wear in adults with insulin-requiring diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic MiniMed, Inc. Industry-sponsored |
| Locations | 4 sites (Chula Vista, California and 3 other locations) |
| Trial ID | NCT07408141 on ClinicalTrials.gov |
What this trial studies
This observational study asks adults with insulin-requiring diabetes to wear the MiniMed Fit Payload adhesive components at specified body locations for a 7-day period to record adhesion success or failure and skin tolerance. Study staff will document detachment events, skin irritation, and any other device-related issues during and at the end of the wear period. The collected data will be used to guide the adhesive design for a future commercialized patch pump. Participants with known adhesive allergies, active skin conditions at the placement site, or pregnancy are excluded.
Who should consider this trial
Good fit: Adults (18+) with insulin-requiring Type 1 or Type 2 diabetes who can consent and are willing to wear the adhesive for 7 days without known adhesive sensitivity are ideal candidates.
Not a fit: People with known sensitivity to pressure-sensitive or acrylic-containing adhesives, current skin irritation or infection at placement sites, or those who are pregnant will not be eligible and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could lead to a more reliable adhesive for a future MiniMed patch pump, reducing device failures and skin problems.
How similar studies have performed: Adhesive wear testing for insulin pump components is a common development step with mixed but improving results across devices, while this specific MiniMed Fit payload configuration is a product-specific test.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chula Vista, California and 3 other locations
- ProSciento — Chula Vista, California, United States (Recruiting)
- Headlands Research California LLC — Escondido, California, United States (Recruiting)
- NYC Research Inc — Long Island City, New York, United States (Recruiting)
- Rainer Clinical Research Center — Renton, Washington, United States (Recruiting)
Study contacts
- Study coordinator: McKenna Cherry
- Email: mckenna.cherry@medtronic.com
- Phone: 763-505-1195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.