Diabetes (DM), Diabetes in Adolescence, Diabetes in Children, Diabetes (Insulin-requiring, Type 1 or Type 2)
Conditions
Brief summary
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.
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.
Sponsors
Medtronic MiniMed, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of device survival | 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. |
Countries
United States
Outcome results
None listed