Screening for Type 1 Diabetes and Celiac Disease in At-Risk Individuals
Access to Clinical Care, Education and Screening for Underserved Children and Adults With Type 1 Diabetes (ACCESS-T1D)
AdventHealth Translational Research Institute · NCT06908057
This study is testing a new way to screen children and adults with a family history of Type 1 Diabetes to see if they are at risk for both Type 1 Diabetes and Celiac Disease before any symptoms show up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | AdventHealth Translational Research Institute (other) |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT06908057 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify individuals at risk for Type 1 Diabetes (T1D) and Celiac Disease (CD) by screening those with a family history of T1D. Participants include children and adults who may have misdiagnosed T1D or are at elevated risk due to autoimmune diseases. The study will involve blood draws to detect early signs of these conditions before symptoms appear, improving screening methods and patient care. The goal is to enhance early detection and management of T1D and CD.
Who should consider this trial
Good fit: Ideal candidates include children over 2 years and adults with a family history of Type 1 Diabetes or other autoimmune diseases.
Not a fit: Patients without a family history of Type 1 Diabetes or those not at elevated risk for developing the disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of Type 1 Diabetes and Celiac Disease in at-risk populations.
How similar studies have performed: Other studies have shown success in early detection and screening for autoimmune diseases, making this approach promising but still requiring further validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. 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. 2. 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. 3. Resides in the following Counties: Orange, Seminole, Osceola, Lake, Volusia, Brevard, Polk, Hillsborough. Exclusion Criteria 1. People with a diagnosis of type stage 3T1D or T1D clinical definition per ADA Standards of Care 2. History of organ transplant 3. Be deemed unable or unlikely to comply with the protocol. 4. 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.
Where this trial is running
Orlando, Florida
- AdventHealth Translational Research Institute — Orlando, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Anna Casu, MD — Principal Investigator
- Study coordinator: Recruitment Department
- Email: CFD.TRI.Recruitment@AdventHealth.com
- Phone: 407-303-7100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Celiac Disease