Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05000840
Status:
RECRUITING
Last Update Posted:
2023-05-03
First Post:
2021-07-21
Brief Title:
Integrating Abbott Point-of-Care Technologies and the Community Scientist Model to Support HbA1c Testing Per ADA
Sponsor:
Sansum Diabetes Research Institute
Organization:
Sansum Diabetes Research Institute
Study Overview
Official Title:
Integrating Abbott Point-of-Care Technologies and the SDRI Community Scientist Model to Support HbA1c Testing Per the American Diabetes Association Guidelines for US Latino Adults With or at Risk of Diabetes
Status:
RECRUITING
Status Verified Date:
2023-05
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:
In the United States the growing HispanicLatino population is at high risk for type 2 diabetes and associated complications yet underserved in healthcare and underrepresented in research The purpose of this Sansum Diabetes Research Institute SDRI study is to create an HbA1c testing and support closed-loop system for US HispanicLatino families This loop will integrate Abbotts point-of-care POC technology with SDRIs Community Scientist Model to contact test intervene and monitor Latinos with or at risk of type 2 diabetes for HbA1c levels This study is built on prior work using specially trained HispanicLatino Community ScientistsEspecialistas to support engagement with and encourage adherence to American Diabetes Association guidelines for HbA1c testing among HispanicLatino adults with type 2 diabetes The study is an unblinded nonrandomized two arm self-controlled single center study It is anticipated to run over 24 months and enroll 750 participants in whom HbA1c will be measured over 6 months This study will provide unique data on the burden of type 2 diabetes for HispanicLatino adults in Santa Barbara County CA In addition the closed-loop approach will provide proof-of-concept evidence for scaling this approach to the larger HispanicLatino community to reduce the risk of poor outcomes due to type 2 diabetes and now COVID-19
Detailed Description:
Hypothesis Adoption of the SDRI Community ScientistEspecialista model will improve adherence to ADA recommended guidelines for HbA1c testing for HispanicLatino adults with T2D
Participants known to have or considered to have diabetes by the Principal Investigator PI will be offered enrollment in the study and their HbA1c will be tested using the Afinion HbA1c point-of-care analyzer The subjects will be stratified into two groups HbA1c 75 and HbA1c 75 All other potential participants unknown diabetes diagnosis will be tested for HbA1c as the site standard practice All participants with HbA1c 75 will be followed up at 6 months those with HbA1c 75 will be followed up at 3 months and again at 6 months post enrollment Participants with HbA1c 75 will be invited to participate in SDRIs existing educational programs
Therapy will be provided as per standard of care by the participants treating physician and is out of the scope of this proposal Those with an HbA1c at or above 75 will be offered diabetes education and support through the tele-health platform andor in person Participants not known to have diabetes but with an HbA1c result 64 will be referred to a local provider for further evaluation and possible diagnosis of diabetes
Participants known to have or considered to have diabetes by the Principal Investigator PI will be offered enrollment in the study and their HbA1c will be tested using the Afinion HbA1c point-of-care analyzer The subjects will be stratified into two groups HbA1c 75 and HbA1c 75 All other potential participants unknown diabetes diagnosis will be tested for HbA1c as the site standard practice All participants with HbA1c 75 will be followed up at 6 months those with HbA1c 75 will be followed up at 3 months and again at 6 months post enrollment Participants with HbA1c 75 will be invited to participate in SDRIs existing educational programs
Therapy will be provided as per standard of care by the participants treating physician and is out of the scope of this proposal Those with an HbA1c at or above 75 will be offered diabetes education and support through the tele-health platform andor in person Participants not known to have diabetes but with an HbA1c result 64 will be referred to a local provider for further evaluation and possible diagnosis of diabetes
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None