Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative | NCT07720388

NCT07720388

Overview

NCT ID: NCT07720388
Lead Sponsor: University of Colorado, DenverOTHER
Official Title: Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative
Brief Summary: 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
Conditions: Diabetes Mellitus, Type 1 Diabetes

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Central Contacts: Study CoordinatorContact
Karen.Hernandez@cuanschutz.edu303-724-4315