What this study is
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
What's being tested
- Culturally and linguistically tailored onboarding and support program
Intervention · OTHER
The intervention is a structured, eight-month, culturally and linguistically tailored onboarding and support program for the Medtronic MiniMed 780G system. This includes: * Utilization of the Medtronic MiniMed 780G Automated Insulin Delivery system * One-on-one nutrition support with a Registered Dietitian * A pump start class conducted in Spanish or both English and Spanish for bilingual participants by a Certified Diabetes Educator * Virtual check-ins between the participant and study coordinator
- Medtronic MiniMed 780G Insulin Pump System
Intervention · DEVICE
Participants will receive a Medtronic MiniMed 780G Automated Insulin Delivery system, an FDA-approved advanced hybrid closed-loop insulin delivery system that integrates with continuous glucose monitoring technology. A unique feature of the device is its availability with a Spanish-language menu and user interface, which may improve accessibility for Spanish-speaking users and families. Participants will complete standard pump onboarding and training and will use the system as part of their routine diabetes management for up to 8 months.
Study details
- Sponsor
- University of Colorado, Denver
- Conditions
- Diabetes Mellitus, Type 1 Diabetes
- Enrolling
- 15 people
- Starts
- 2026-10-02
- Est. completion
- 2027-10
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 10 Years – 20 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 10 - 20 years old
- Diagnosis of type 1 diabetes
- Self-identify as Latino/Hispanic (determined via self-report and/or electronic health record)
- Currently managing diabetes using any regimen, including multiple daily injections (MDI) or any non-Medtronic automated insulin delivery system
- Willing to transition to and use the Medtronic MiniMed 780G system for the duration of the study
You can't join if
- Current use of any Medtronic technology
- More than 1 episode of diabetic ketoacidosis (DKA) within 12 months of study enrollment
- Current pregnancy (self-reported), due to limited safety data for use of the Medtronic MiniMed 780G system during pregnancy
- Presence of any significant medical condition that, in the opinion of the investigator, would interfere with study participation or data interpretation
- Inability or unwillingness to use the Medtronic MiniMed 780G system for the duration of the study
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBarbara Davis Center
Aurora, Colorado, United States
- Study Coordinator · Contact303-724-4315Karen.Hernandez@cuanschutz.edu
- Andrea Gerard-Gonzalez · Principal investigator
Recruiting
Study team
Sponsor
University of Colorado, Denver
Study ID 26-0093
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.