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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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 coordin
• Устройство 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 rout

Первичные конечные точки

• Proportion of Participants Continuing Use of the Medtronic MiniMed 780G System at 6 Months [Срок оценки: 6 months]

Вторичные конечные точки (4)

• Change from Baseline in Hemoglobin A1c [Срок оценки: Baseline and 8 months]
• Proportion of Participants Achieving Time in Range (70-180 mg/dL) greater than 60 percent [Срок оценки: Baseline and 8 months]
• Change from Baseline in Participant Diabetes Treatment Satisfaction [Срок оценки: Baseline and 8 months]
• Change from Baseline in Participant and Caregiver Confidence in Diabetes Technology Use [Срок оценки: Baseline through Month 8]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Barbara Davis Center — Aurora

Публикации

• 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
• 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
• 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.
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07720388 · 23-0093

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗