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NCT Number: NCT07720388

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

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location contact

Andrea Gerard-Gonzalez

PRINCIPAL_INVESTIGATOR

Study Coordinator

CONTACT

[email protected]

303-724-4315

About this study

This interventional, single-group study will assess the effectiveness of a structured, culturally tailored onboarding and support program designed to promote initiation and sustained use of the Medtronic MiniMed 780G system among Latino/Hispanic youth with type 1 diabetes. Participants will transition to the Medtronic MiniMed 780G system and receive ongoing education and support over an 8-month period. The primary outcome is the proportion of participants continuing use of the system at 6 months. Secondary outcomes include clinical measures derived from routine care (HbA1c, time in range, hypoglycemia) and participant-reported satisfaction and confidence with diabetes technology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culturally and linguistically tailored onboarding and support program

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

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.

Primary outcomes

  1. Proportion of Participants Continuing Use of the Medtronic MiniMed 780G System at 6 Months

    Time frame: 6 months

    Adoption will be defined as continued use of the Medtronic MiniMed 780G insulin pump system at 6 months following initiation. The outcome will be calculated as the proportion of enrolled participants who remain actively using the system at the 6-month time point.

Secondary outcomes

  1. Change from Baseline in Hemoglobin A1c

    Time frame: Baseline and 8 months

    Hemoglobin A1c (HbA1c) values will be obtained from routine clinical care (standard-of-care laboratory assessments) and not collected as part of study-specific procedures. The outcome will assess the proportion of participants achieving a reduction of greater than or equal to 0.5 percent from baseline.

  2. Proportion of Participants Achieving Time in Range (70-180 mg/dL) greater than 60 percent

    Time frame: Baseline and 8 months

    Continuous glucose monitoring (CGM) data will be obtained from devices used as part of routine clinical care. Time in Range (TIR) is defined as the percentage of time glucose values are between 70-180 mg/dL. Outcome is the proportion of participants achieving greater than 60 percent TIR.

  3. Change from Baseline in Participant Diabetes Treatment Satisfaction

    Time frame: Baseline and 8 months

    Participant diabetes treatment satisfaction will be assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The DTSQ is a validated questionnaire for individuals aged greater than or equal to 13 years. The questionnaire will be administered to participants who meet the age criteria. The questionnaire will also be administered to caregivers. For participants under 13 years of age, satisfaction will not be assessed using this instrument. Scores will be compared from baseline to follow-up, with higher scores indicating greater satisfaction. Analyses will be limited to participants aged greater than or equal to 13 years old.

  4. Change from Baseline in Participant and Caregiver Confidence in Diabetes Technology Use

    Time frame: Baseline through Month 8

    Qualitative data collected during virtual check-ins will be used to assess participant experiences with insulin pump initiation and ongoing use. Discussions will focus on device utilization, troubleshooting experiences, onboarding experiences, perceived support needs, and barriers and facilitators to successful pump adoption. Responses will be documented and analyzed using thematic analysis to identify recurring themes related to technology use, confidence, training needs, language-related challenges, and recommendations for improving onboarding and support services. Themes will be summarized descriptively to inform the development of a culturally and linguistically tailored insulin pump onboarding program.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

303-724-4315

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Barbara Davis Center of Childhood Diabetes, University of Co

Registry information

Acronym: APOYO 780G

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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