Diabetes Mellitus, Type 1 Diabetes
Conditions
Brief 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. 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
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.
Interventions
OTHERCulturally 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 coordinator
DEVICEMedtronic 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 routine diabetes management for up to 8 months.
Sponsors
University of Colorado, Denver
Barbara Davis Center of Childhood Diabetes, University of Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Continuing Use of the Medtronic MiniMed 780G System at 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Hemoglobin A1c | 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. |
| Proportion of Participants Achieving Time in Range (70-180 mg/dL) greater than 60 percent | 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. |
| Change from Baseline in Participant Diabetes Treatment Satisfaction | Baseline and 8 months | 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. |
| Change from Baseline in Participant Confidence in Diabetes Technology Use | Baseline through Month 8 | 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. |
| Change from Baseline in Caregiver Diabetes Treatment Satisfaction | Baseline and 8 months | 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. |
| Change from Baseline in Caregiver Confidence in Diabetes Technology Use | 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. |
Countries
United States
Contacts
CONTACTStudy Coordinator
Outcome results
None listed