Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative (APOYO 780G)
17 luglio 2026 aggiornato da: 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
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
15
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Study Coordinator
- Numero di telefono: 303-724-4315
- Email: Karen.Hernandez@cuanschutz.edu
Luoghi di studio
-
-
Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Barbara Davis Center
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Contatto:
- Study Coordinator
- Numero di telefono: 303-724-4315
- Email: Karen.Hernandez@cuanschutz.edu
-
Investigatore principale:
- Andrea Gerard-Gonzalez
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of Participants Continuing Use of the Medtronic MiniMed 780G System at 6 Months
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Baseline in Hemoglobin A1c
Lasso di tempo: 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.
|
Baseline and 8 months
|
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Proportion of Participants Achieving Time in Range (70-180 mg/dL) greater than 60 percent
Lasso di tempo: 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.
|
Baseline and 8 months
|
|
Change from Baseline in Participant Diabetes Treatment Satisfaction
Lasso di tempo: Baseline and 8 months
|
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
Lasso di tempo: Baseline through Month 8
|
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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 agosto 2026
Completamento primario (Stimato)
1 gennaio 2027
Completamento dello studio (Stimato)
1 marzo 2027
Date di iscrizione allo studio
Primo inviato
17 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
17 luglio 2026
Primo Inserito (Effettivo)
22 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 23-0093
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .