Diabetes (DM)NCT07675161
MiniMed Fit Payload Wear Pediatric Study
An observational study of Diabetes (DM) and Diabetes (Insulin-requiring, Type 1 or Type 2), run by Medtronic MiniMed, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Diabetes (DM), Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes in Children
- What is being tested?
- MiniMed Fit Payload adhesive components
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Jun 2026to 7 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Investigational Centers, example, primary care clinic, academic institution, etc.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Barry J Reiner MD LLC
Baltimore, Maryland, 21229
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Sutter Institute for Medical Research
Sacramento, California, 95821-2123
Diabetes and Glandular Disease Clinic PA
San Antonio, Texas, 78229
Sansum Diabetes Research Institute
Santa Barbara, California, 93105-4321
About this study
Official title: CIP361: MiniMed Fit Payload Wear Pediatric Study
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
- Diabetes (DM), Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes in Children, Diabetes in Adolescence
- Being tested
- MiniMed Fit Payload adhesive components
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniMed Fit Payload adhesive componentsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MiniMed Fit Payload adhesive components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of device survival
The number of MiniMed Fit Payload that remain securely attached to the skin at the end of day 7. This is a descriptive endpoint.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start25 Jun 2026
- Primary completion7 Aug 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675161
- Sponsor's protocol ID
- CIP361
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIP361: MiniMed Fit Payload Wear Pediatric Study
- ClinicalTrials.gov ID
- NCT07675161
- Acronym / sponsor ID
- CIP361
- Conditions
- Diabetes (DM), Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes in Children, Diabetes in Adolescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MiniMed Fit Payload adhesive components | – | Device: MiniMed Fit Payload adhesive componentsPediatric participants with insulin-requiring diabetes using the MiniMed Fit Payload adhesive components in different wear locations over a 7-day period. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Investigational Centers, example, primary care clinic, academic institution, etc.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiniMed Fit Payload adhesive componentsThe 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. | Device | MiniMed Fit Payload adhesive components |
Primary outcome
Summary of device survival
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes (DM) and Diabetes (Insulin-requiring, Type 1 or Type 2), run by Medtronic MiniMed, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of device survival (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.