Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487962
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-13
Brief Title:
Pilot RCT FQHC Intervention for Uptake of CGM in Hispanic Adults with T1D
Sponsor:
University of Connecticut
Organization:
University of Connecticut
Study Overview
Official Title:
Pilot RCT FQHC Intervention for Uptake of CGM in Hispanic Adults with T1D
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hispanics adults with type 1 diabetes T1D despite their disproportionate burden of acute complications hypoglycemia and diabetes ketoacidosis and related emergency department visits hospitalizations and death remain largely disenfranchised from continuous glucose monitoring CGM an efficacious technology to mitigate these inequities To increase CGM uptake in low-income Hispanic adults with T1D receiving diabetes management in federally qualified health centers FQHCs this pilot randomized control trial RCT will assess the feasibility of our study protocol including our multi-level intervention informed by the Socio-Ecological Model
Detailed Description:
Low-income Hispanic adults with T1D experience a disproportionate burden of life-threatening acute complications with high rates of related emergency department visits hospitalizations and death Use of CGM may mitigate these inequities Yet Hispanics with T1D have exceptionally low levels of CGM use This reflects social determinants of health SODH as framed by the multiple levels of the Socio-Ecological Model SEM The SEMs healthcare provider level is a main driver in Hispanic disenfranchisement from CGM With a severe shortage of endocrinologists primary care providers are increasingly managing T1D although many report inadequate confidence in titrating insulin and using CGM With limited access to endocrinology low-income Hispanic adults with T1D thus often receive diabetes management in FQHCs with scant or no access to CGM Hence to foster equitable uptake of CGM in the most vulnerable Hispanic adults with T1D a 4-year mixed-methods feasibility study with a pilot randomized controlled trial RCT is underway to primarily assess the feasibility of the SEM-guided 6-month intervention targeting the individual familysocial networks and healthcare provider levels The SEM-guided intervention was refined by our Community Advisory Board Refinements were informed by qualitative research exploring SDOH barriers to CGM uptake in Hispanic adults with T1D from the perspectives of four stakeholder groups
The individual level of the intervention guided by the Information-Motivation-Behavioral-Skills Model fosters essential acquisition of information motivation and behavioral skills for CGM uptake through two principal approaches 1 4-week personalized CGM sessions with a RN certified diabetes care and education specialist CDCES and 2 subsequent virtual peer educator-led support groups integrating CGM education through study month six The familysocial networks level leverages the core Hispanic values of familismo and collectivismo to promote critical support in CGM uptake with a family member co-attending the 4-week sessions and participant engagement in peer-led support group sessions respectively The provider level of the intervention is designed to promote enhanced cultural competency in intervention delivery and provide clinical support for CGM informed by rigorous training in T1D management and CGM via Project ECHO Extension for Community Healthcare Outcomes
A total of 4 FQHC sites were randomized to deliver the intervention n2 or control n2 conditions with a total enrollment goal of 30 Hispanics with T1D sites having roughly equivalent enrollment rates The feasibility of the study protocol eg recruitment and retention yields data collection procedures intervention implementation and intervention acceptability among others will be routinely assessed Significant intervention signals in terms of physiological eg A1C and time within above and below range glucose range psychosocial eg quality of life and family support and behavioral CGM adherence outcomes from baseline to 3- and 6-months post-baseline will be assessed The long-term goal of this study is to inform a large multi-site RCT and with successful results provide a model for CGM uptake in Hispanic adults with T1D for FQHCs nationally
The individual level of the intervention guided by the Information-Motivation-Behavioral-Skills Model fosters essential acquisition of information motivation and behavioral skills for CGM uptake through two principal approaches 1 4-week personalized CGM sessions with a RN certified diabetes care and education specialist CDCES and 2 subsequent virtual peer educator-led support groups integrating CGM education through study month six The familysocial networks level leverages the core Hispanic values of familismo and collectivismo to promote critical support in CGM uptake with a family member co-attending the 4-week sessions and participant engagement in peer-led support group sessions respectively The provider level of the intervention is designed to promote enhanced cultural competency in intervention delivery and provide clinical support for CGM informed by rigorous training in T1D management and CGM via Project ECHO Extension for Community Healthcare Outcomes
A total of 4 FQHC sites were randomized to deliver the intervention n2 or control n2 conditions with a total enrollment goal of 30 Hispanics with T1D sites having roughly equivalent enrollment rates The feasibility of the study protocol eg recruitment and retention yields data collection procedures intervention implementation and intervention acceptability among others will be routinely assessed Significant intervention signals in terms of physiological eg A1C and time within above and below range glucose range psychosocial eg quality of life and family support and behavioral CGM adherence outcomes from baseline to 3- and 6-months post-baseline will be assessed The long-term goal of this study is to inform a large multi-site RCT and with successful results provide a model for CGM uptake in Hispanic adults with T1D for FQHCs nationally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None