Diabetes Mellitus, Type 1 DiabetesAPOYO780GNCT07720388
Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative
A study testing Culturally and linguistically tailored onboarding and support program and Medtronic MiniMed 780G Insulin Pump System in people with Diabetes Mellitus, Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Diabetes Mellitus, Type 1 Diabetes
- What is being tested?
- Culturally and linguistically tailored onboarding and support program and Medtronic MiniMed 780G Insulin Pump System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2026to Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barbara Davis Center
Aurora, Colorado, 80045
Study Coordinator, 303-724-4315, Karen.Hernandez@cuanschutz.edu
Andrea Gerard-Gonzalez
About this study
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
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes
- Being tested
- Culturally and linguistically tailored onboarding and support program, Medtronic MiniMed 780G Insulin Pump System
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally and linguistically tailored onboarding and support programOther
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
Medtronic MiniMed 780G Insulin Pump SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Medtronic Pump Onboarding Program | Experimental | Not described Receives: Other: Culturally and linguistically tailored onboarding and support program; Device: Medtronic MiniMed 780G Insulin Pump System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Change from Baseline in Hemoglobin A1c
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.
Measured: Baseline and 8 months
Proportion of Participants Achieving Time in Range (70-180 mg/dL) greater than 60 percent
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.
Measured: Baseline and 8 months
Change from Baseline in Participant Diabetes Treatment Satisfaction
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.
Measured: Baseline and 8 months
Change from Baseline in Participant Confidence in Diabetes Technology Use
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.
Measured: Baseline through Month 8
Change from Baseline in Caregiver Diabetes Treatment Satisfaction
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.
Measured: Baseline and 8 months
Change from Baseline in Caregiver Confidence in Diabetes Technology Use
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.
Measured: Baseline through Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start2 Oct 2026
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Barbara Davis Center of Childhood Diabetes, University of Co
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720388
- Sponsor's protocol ID
- 23-0093
- Acronym
- APOYO780G
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 17927832Howorka 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.
PubMed 11284211Bradley, 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.
PubMed 2142043Wheeler 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.
PubMed 22968219Chukwueke 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.
PubMed 22764645Raymond 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.
PubMed 25717281Mauldon 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.
PubMed 16971708Metghalchi 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.
PubMed 18669812Pascual 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.
PubMed 30938029