Status:
RECRUITING
Accessing Care, Clinical Trials and Screening for Underserved Children and Adults With Type 1 Diabetes (ACCESS-T1D)
Lead Sponsor:
AdventHealth Translational Research Institute
Conditions:
Type 1 Diabetes
Celiac Disease
Eligibility:
All Genders
2+ years
Brief Summary
The purpose of this study is to identify people with T1D or celiac disease (CD) early in the course of their disease and to improve the methods of screening for these diseases.
Detailed Description
The study will screen people who may be at risk for T1D because they have at least one person in the family with probable T1D. It can be a parent or a sibling. It can also be a second-degree relative,...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Able to provide informed consent (adults 18 and above) and assent if seven or above. Legally authorized representative (LAR) is able to provide consent in case of minors or in case of adults unable to consent.
- Children \> 2 years and adults at elevated risk of developing (or having misdiagnosed) clinically evident Stage 3 T1D because they have at least one of the following:
- i. have one or more first- or second-degree family members (siblings, parents, cousins, aunts/uncles, grandparents) diagnosed with type 1 diabetes or ii. have other autoimmune diseases such as but not limited to celiac disease, Multiple sclerosis, rheumatoid arthritis or, thyroid disease or iii. Those diagnosed with other forms of diabetes which are suspected of being T1D because of a BMI ≤28 or progression to insulin dependence within 3 years from diagnosis.
- Resides in the following Counties: Orange, Seminole, Osceola, Lake, Volusia, Brevard, Polk, Hillsborough.
- Exclusion Criteria
- People with a diagnosis of type stage 3T1D or T1D clinical definition per ADA Standards of Care
- History of organ transplant
- Be deemed unable or unlikely to comply with the protocol.
- Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study visit/s.
Exclusion
Key Trial Info
Start Date :
March 11 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06908057
Start Date
March 11 2024
End Date
June 1 2026
Last Update
April 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32804