Insulin Pump Support Program for Type 1 Diabetes

(APOYO780G Trial)

SC
Overseen ByStudy Coordinator
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study plans to learn more about whether a support program delivered in Spanish or both English and Spanish for bilingual families helps Latino youth with Type 1 Diabetes (T1D) successfully use the Medtronic MiniMed 780G system.

The main question it aims to answer is:

Does a linguistically and culturally tailored onboarding model for an automated insulin delivery system close the gap in technology adoption and improve health outcomes?

Participants will:

* Use the Medtronic MiniMed 780G Automated Insulin Delivery system for eight months

* Attend one in-person nutrition support and insulin pump start class

* Participate in regular virtual check-ins with native Spanish-speaking study team members

Are You a Good Fit for This Trial?

This trial is for Latino/Hispanic youth ages 10-20 with type 1 diabetes who are willing to use the Medtronic MiniMed 780G insulin pump for eight months. People can't join if they're pregnant, already using Medtronic tech, had more than one serious diabetes complication recently, or have other major health issues.

Inclusion Criteria

Self-identify as Latino/Hispanic (determined via self-report and/or electronic health record)
I am between 10 and 20 years old.
I am willing to use the Medtronic MiniMed 780G system during the study.
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Exclusion Criteria

Current pregnancy (self-reported), due to limited safety data for use of the Medtronic MiniMed 780G system during pregnancy
Current use of any Medtronic technology
I am unable or unwilling to use the Medtronic MiniMed 780G system during the study.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Onboarding

Participants attend a nutrition support and insulin pump start class and begin using the Medtronic MiniMed 780G system

1 week
1 visit (in-person)

Treatment

Participants use the Medtronic MiniMed 780G Automated Insulin Delivery system with regular virtual check-ins

8 months
Regular virtual check-ins

Follow-up

Participants are monitored for continued use and effectiveness of the insulin pump system

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests whether a Spanish or bilingual support program helps Latino youth better adopt and use the Medtronic MiniMed 780G insulin pump system. Participants get in-person training and regular virtual check-ins over eight months.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Intervention - Medtronic Pump Onboarding ProgramExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Barbara Davis Center of Childhood Diabetes, University of Co

Collaborator

Trials
1
Recruited
200+