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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 7 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
MiniMed Fit Payload adhesive components Pediatric 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.

Recruiting Locations

Rocky Mountain Clinical Research
Idaho Falls, Idaho 83404
Contact:
Nikki Sharp
(208) 528-9643
nikki.sharp@rmclinicalresearch.com

Barry J Reiner MD LLC
Baltimore, Maryland 21229
Contact:
Barry Reiner
sugardoc18@gmail.com

Diabetes and Glandular Disease Clinic PA
San Antonio, Texas 78229
Contact:
Joann Hernandez
210-614-8612
joann.hernandez@dgdclinic.com

More Details

Status
Recruiting
Sponsor
Medtronic MiniMed, Inc.

Study Contact

McKenna Cherry
763-505-1195
mckenna.cherry@medtronic.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.