Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative (APOYO 780G)
17 de julio de 2026 actualizado por: University of Colorado, Denver
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
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
15
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Study Coordinator
- Número de teléfono: 303-724-4315
- Correo electrónico: Karen.Hernandez@cuanschutz.edu
Ubicaciones de estudio
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-
Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Barbara Davis Center
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Contacto:
- Study Coordinator
- Número de teléfono: 303-724-4315
- Correo electrónico: Karen.Hernandez@cuanschutz.edu
-
Investigador principal:
- Andrea Gerard-Gonzalez
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention - Medtronic Pump Onboarding Program
|
The intervention is a structured, eight-month, culturally and linguistically tailored onboarding and support program for the Medtronic MiniMed 780G system. This includes:
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of Participants Continuing Use of the Medtronic MiniMed 780G System at 6 Months
Periodo de tiempo: 6 months
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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.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Hemoglobin A1c
Periodo de tiempo: Baseline and 8 months
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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.
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Baseline and 8 months
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Proportion of Participants Achieving Time in Range (70-180 mg/dL) greater than 60 percent
Periodo de tiempo: 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.
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Baseline and 8 months
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Change from Baseline in Participant Diabetes Treatment Satisfaction
Periodo de tiempo: Baseline and 8 months
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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.
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Baseline and 8 months
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Change from Baseline in Participant and Caregiver Confidence in Diabetes Technology Use
Periodo de tiempo: Baseline through Month 8
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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.
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Baseline through Month 8
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de enero de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
17 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2026
Publicado por primera vez (Actual)
22 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades metabólicas
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Enfermedades Nutricionales y Metabólicas
- Diabetes Mellitus, Tipo 1
- Técnicas de investigación
- Técnicas in vitro
- Técnicas de cultivo
Otros números de identificación del estudio
- 23-0093
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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