Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546930
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Device Use Reimagined Through Education And Mentorship
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Diabetes Technology Use for Latinx Youth Through DREAM Device Use Reimagined Through Education And Mentorship Virtual Peer Groups Study-wide - DREAM Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DREAM
Brief Summary:
Diabetes technology such as insulin pumps and continuous glucose monitoring devices can help improve glucose control for people with type 1 diabetes T1D which keeps them at lower risk for diabetes complications but many Latinx adolescents who make up the largest marginalized ethnic group of youth with T1D in California use these devices less often and have less optimal glucose control compared to White youth In phase 1 of this project we worked directly with Latinx youth their families and diabetes care team members in California to develop DREAM Device use Reimagined through Education And Mentorship a virtual peer group VPG intervention that will encourage and support the use of diabetes devices in Latinx adolescents with T1D The goals for phase 2 intervention of this project are to evaluate the feasibility and acceptability of the stakeholder-informed VPG intervention and evaluate clinical and person-centered outcomes
Detailed Description:
This multi-site project has two phases phase 1 involved stakeholders focus groups to assess barriers and facilitators to diabetes technology and the creation of advisory councils Feedback was obtained and used to develop phase 2 the single arm trial A virtual peer group curriculum is being refined and will be implemented The aims of this project are 1 Partner with stakeholders to design a virtual peer group VPG intervention to promote the initiation and continued use of diabetes technology among Latinx adolescents with T1D 2 Evaluate the feasibility and acceptability of DREAM VPGs in a pragmatic single arm trial 3 Assess the effects of DREAM VPGs on clinical and person-centered outcomes
Our DREAM intervention will
Build trustrapport and relational connections between participants
Empower participants to be advocates in theirtheir adolescents diabetes care
Provide toolsknowledge to navigate healthcare and diabetes technology systems
Increase knowledge confidence and interest in using diabetes technology
Create a culturally sensitiveinclusive VPG toolkit that will be scalable feasible and sustainable in broader clinical contexts if found to be beneficial
The DREAM projects findings will inform future efforts to improve diabetes technology use and T1D health outcomes among Latinx adolescents If found to be effective the VPG curriculum can be adapted for other clinic settings in order to improve education and peer support for Latinx patients and families Future studies may extend or adapt DREAM to other cohorts including other age groups geographic settings or marginalized and historically excluded populations with T1D
Our DREAM intervention will
Build trustrapport and relational connections between participants
Empower participants to be advocates in theirtheir adolescents diabetes care
Provide toolsknowledge to navigate healthcare and diabetes technology systems
Increase knowledge confidence and interest in using diabetes technology
Create a culturally sensitiveinclusive VPG toolkit that will be scalable feasible and sustainable in broader clinical contexts if found to be beneficial
The DREAM projects findings will inform future efforts to improve diabetes technology use and T1D health outcomes among Latinx adolescents If found to be effective the VPG curriculum can be adapted for other clinic settings in order to improve education and peer support for Latinx patients and families Future studies may extend or adapt DREAM to other cohorts including other age groups geographic settings or marginalized and historically excluded populations with T1D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None