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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 1 Diabetes
• Intervention / Treatment: Other: Culturally and linguistically tailored onboarding and support program; Device: Medtronic MiniMed 780G Insulin Pump System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 303-724-4315; Email: Karen.Hernandez@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center
      • Contact: Study Coordinator; Phone Number: 303-724-4315; Email: Karen.Hernandez@cuanschutz.edu
      • Principal Investigator: Andrea Gerard-Gonzalez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention - Medtronic Pump Onboarding Program

Other: Culturally and linguistically tailored onboarding and support program; 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; Device: Medtronic MiniMed 780G Insulin Pump System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Continuing Use of the Medtronic MiniMed 780G System at 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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Hemoglobin A1c	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.	Baseline and 8 months
Proportion of Participants Achieving Time in Range (70-180 mg/dL) greater than 60 percent	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.	Baseline and 8 months
Change from Baseline in Participant Diabetes Treatment Satisfaction	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.	Baseline and 8 months
Change from Baseline in Participant and Caregiver Confidence in Diabetes Technology Use	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.	Baseline through Month 8

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Barbara Davis Center of Childhood Diabetes, University of Co

Publications and helpful links

General Publications

• Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes. 2007 Oct 10;5:57. doi: 10.1186/1477-7525-5-57.
• Raymond JK, Shea JJ, Berget C, Cain C, Fay-Itzkowitz E, Gilmer L, Hoops S, Owen D, Shepard D, Spiegel G, Klingensmith G. A novel approach to adolescents with type 1 diabetes: the team clinic model. Diabetes Spectr. 2015 Jan;28(1):68-71. doi: 10.2337/diaspect.28.1.68. No abstract available.
• Bradley C, Lewis KS. Measures of psychological well-being and treatment satisfaction developed from the responses of people with tablet-treated diabetes. Diabet Med. 1990 Jun;7(5):445-51. doi: 10.1111/j.1464-5491.1990.tb01421.x.
• Howorka K, Pumprla J, Schlusche C, Wagner-Nosiska D, Schabmann A, Bradley C. Dealing with ceiling baseline treatment satisfaction level in patients with diabetes under flexible, functional insulin treatment: assessment of improvements in treatment satisfaction with a new insulin analogue. Qual Life Res. 2000;9(8):915-30. doi: 10.1023/a:1008921419108.
• Bradley, C., Loewenthal, K., Woodcock, A. and McMillan, C. (2009). Development of the diabetes treatment satisfaction questionnaire (DTSQ) for teenagers and parents: the DTSQ-Teen and the DTSQ-Parent. Diabetologia 52: (Suppl 1) S397, Abstract 1013.
• Bradley, C. (1994). The Diabetes Treatment Satisfaction Questionnaire (DTSQ). In C. Bradley (editor). Handbook of Psychology and Diabetes. Abingdon: Routledge formerly published by Harwood Academic Publishers.
• Wheeler G, Montgomery SB, Beeson L, Bahjri K, Shulz E, Firek A, De Leon M, Cordero-MacIntyre Z. En Balance: the effects of Spanish diabetes education on physical activity changes and diabetes control. Diabetes Educ. 2012 Sep-Oct;38(5):723-32. doi: 10.1177/0145721712457249. Epub 2012 Sep 10.
• Chukwueke I, Firek A, Beeson L, Brute M, Shulz E, De Leon M, Cordero-MacIntyre ZR. The En Balance Spanish diabetes education program improves apolipoproteins, serum glucose and body composition in Hispanic diabetics. Ethn Dis. 2012 Spring;22(2):215-20.
• Mauldon M, Melkus GD, Cagganello M. Tomando Control: a culturally appropriate diabetes education program for Spanish-speaking individuals with type 2 diabetes mellitus--evaluation of a pilot project. Diabetes Educ. 2006 Sep-Oct;32(5):751-60. doi: 10.1177/0145721706291999.
• Metghalchi S, Rivera M, Beeson L, Firek A, De Leon M, Balcazar H, Cordero-MacIntyre ZR. Improved clinical outcomes using a culturally sensitive diabetes education program in a Hispanic population. Diabetes Educ. 2008 Jul-Aug;34(4):698-706. doi: 10.1177/0145721708320913.
• Pascual AB, Pyle L, Nieto J, Klingensmith GJ, Gonzalez AG. Novel, culturally sensitive, shared medical appointment model for Hispanic pediatric type 1 diabetes patients. Pediatr Diabetes. 2019 Jun;20(4):468-473. doi: 10.1111/pedi.12852. Epub 2019 Apr 15.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Investigative Techniques; In Vitro Techniques; Culture Techniques
• Other Study ID Numbers: 23-0093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No