Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643936
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
E3 Diabetes - Closing the Gap in Diabetes Control
Sponsor:
None
Organization:
None
Study Overview
Official Title:
E3 Diabetes - Closing the Gap in Diabetes Control
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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:
E3 Diabetes
Brief Summary:
This study aims to decrease the racial gap in type 2 diabetes control in African American and Latinx patients in Rush University Medical Center clinics
Detailed Description:
Cardiovascular disease CVD is the leading cause of death in the US as well as in Chicago Risk factors for CVD include hypertension diabetes and lifestyle factors such as smoking diet and obesity Among the critical social and structural determinants of cardiovascular health are food access neighborhood safety education poverty and chronic stress Chicago and its surrounding region suffer from longstanding racial disparities in both social conditions and chronic disease burden contributing to stark racial gaps in cardiometabolic disease mortality Life expectancy is as high as 84 years on Chicagos North Side but only 68 years on the West Side - a gap of 16 years Cardiometabolic disease accounts for 40 to 50 of this lifespan gap The diabetes-related death rate is 70 higher among Chicagos African Americans than among non-African Americans In Rush primary care clinics under conditions of usual clinical care African American and Latinx patients with diabetes have worse glycemic control than white patients raising the question whether modifying the model of diabetes care from intermittent clinic-based care to more frequent home-based care remote monitoring might reduce these stubborn disparities We are proposing a feasibility trial of a remote diabetes monitoring social care medication adherence and dietary intervention to improve diabetes control among African American and Latinx patients attending primary care clinics at Rush University Medical Group locations with the eventual aim of closing the racialethnic disparity in diabetes control The proposed feasibility trial will use a randomized-control four-pronged approach to improve glycemic control The intervention group will receive the following 1 remote glucose monitoring 2 a multidisciplinary team to address social needs 3 medication titration and adherence support and 4 culturally tailored diabetes self-management and dietary education The control group will receive standard of care diabetes primary care in addition to dietary education around diabetes through written materials We hypothesize that E3 Diabetes program participants will achieve a change in A1c of 05 in at least 30 of the participants in 6 months and will be a greater percentage than seen with the propensity matched control of African American and Latinx patients receiving usual care for Diabetes
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