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

NCT07720388 | Not Yet Recruiting FDA Device

• 1 other identifier: 23-0093
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from Baseline in Hemoglobin A1c

  Baseline and 8 months

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

  Baseline and 8 months

• Change from Baseline in Participant Diabetes Treatment Satisfaction

  Baseline and 8 months

• Change from Baseline in Participant and Caregiver Confidence in Diabetes Technology Use

  Baseline through Month 8

Study Arms (1)

Intervention - Medtronic Pump Onboarding Program

EXPERIMENTAL

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

Interventions

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

Intervention - Medtronic Pump Onboarding Program

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.

Intervention - Medtronic Pump Onboarding Program

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You 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 may not qualify 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Barbara Davis Center of Childhood Diabetes, University of Co: collaborator

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Related Publications (11)

• 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.

  PMID: 17927832 BACKGROUND

• 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.

  PMID: 11284211 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 2142043 BACKGROUND

• 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.

  PMID: 22968219 BACKGROUND

• 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.

  PMID: 22764645 BACKGROUND

• 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.

  PMID: 25717281 BACKGROUND

• 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.

  PMID: 16971708 BACKGROUND

• 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.

  PMID: 18669812 BACKGROUND

• 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.

  PMID: 30938029 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Culture Techniques

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques

Central Study Contacts

Study Coordinator

CONTACT

303-724-4315; Karen.Hernandez@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)