Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 6:44 PM
Study NCT ID:
NCT05097534
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2021-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
Sponsor:
The University of Texas Medical Branch, Galveston
Organization:
Study Overview
Official Title:
A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
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:
To improve diabetes self-management outcomes, patients with type 2 diabetes (n=150 - aged 13-84) recruited from St. Vincent Clinic (SVC) and Teen Health Center Inc., Clinics will be randomized using block randomization to receive standard of care or the integrated model. Patients in the intervention arm will be assessed for social and physical needs before being enrolled in a year-long education program (iDSMES). Enrollees will receive dietary counseling, physical and occupational therapy, in addition to other mental, financial and social benefits counseling. The investigators will compare the intervention outcomes.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: