Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative (APOYO780G)
2026年8月6日 更新者：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
研究概览
地位
尚未招聘
条件
详细说明
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.
研究类型
介入性
注册 (估计的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Study Coordinator
- 电话号码：303-724-4315
- 邮箱：Karen.Hernandez@cuanschutz.edu
学习地点
-
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Colorado
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Aurora、Colorado、美国、80045
- Barbara Davis Center
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接触：
- Study Coordinator
- 电话号码：303-724-4315
- 邮箱：Karen.Hernandez@cuanschutz.edu
-
首席研究员：
- Andrea Gerard-Gonzalez
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of Participants Continuing Use of the Medtronic MiniMed 780G System at 6 Months
大体时间：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.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Hemoglobin A1c
大体时间：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.
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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
大体时间：Baseline and 8 months
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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
大体时间：Baseline and 8 months
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Participant diabetes treatment satisfaction will be assessed using the Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc).
The DTSQc is a validated questionnaire administered to participants aged 13 years and older.
The Treatment Satisfaction (Change) score is calculated by summing items 1, 4, 5, 6, 7, and 8. Scores range from negative 18 to 18, with higher scores indicating greater improvement in treatment satisfaction, lower scores indicating greater deterioration in treatment satisfaction, and 0 indicating no change.
Participants younger than 13 years of age will not complete this questionnaire; analyses will be limited to participants aged 13 years and older.
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Baseline and 8 months
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Change from Baseline in Participant Confidence in Diabetes Technology Use
大体时间：Baseline through Month 8
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Participant confidence in diabetes technology use will be assessed qualitatively through discussions conducted during virtual check-ins.
Responses will be analyzed using thematic analysis to identify recurring themes related to confidence in technology use, onboarding experiences, troubleshooting, perceived support needs, language-related challenges, and barriers and facilitators to successful insulin pump adoption.
Themes will be summarized descriptively to inform development of a culturally and linguistically tailored insulin pump onboarding program.
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Baseline through Month 8
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Change from Baseline in Caregiver Diabetes Treatment Satisfaction
大体时间：Baseline and 8 months
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Caregiver diabetes treatment satisfaction will be assessed using the Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) completed by caregivers of enrolled minor participants.
The Treatment Satisfaction (Change) score is calculated by summing items 1, 4, 5, 6, 7, and 8. Scores range from -18 to +18, with higher scores indicating greater improvement in treatment satisfaction, lower scores indicating greater deterioration in treatment satisfaction, and 0 indicating no change.
|
Baseline and 8 months
|
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Change from Baseline in Caregiver Confidence in Diabetes Technology Use
大体时间：Baseline through Month 8
|
Caregiver confidence in supporting diabetes technology use will be assessed qualitatively through discussions conducted during virtual check-ins with caregivers of enrolled minor participants.
Responses will be analyzed using thematic analysis to identify recurring themes related to confidence in supporting insulin pump use, onboarding experiences, troubleshooting, perceived support needs, language-related challenges, and barriers and facilitators to successful insulin pump adoption.
Themes will be summarized descriptively to inform development of a culturally and linguistically tailored insulin pump onboarding program.
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Baseline through Month 8
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2027年1月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年7月17日
首先提交符合 QC 标准的
2026年7月17日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年8月11日
上次提交的符合 QC 标准的更新
2026年8月6日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.