Accessing Care, Clinical Trials and Screening for Underserved Children and Adults With Type 1 Diabetes (ACCESS-T1D)

NCT06908057 | Active Not Recruiting

• 1 other identifier: 2130661
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Celiac Disease

Outcome Measures

Primary Outcomes (1)

• Blood sample will be drawn for islet-related autoantibodies

  A blood sample will be drawn for islet-related autoantibodies. The initial autoantibody measurement will be done with the ECL research method which detects multiple autoantibodies at once. Positive results will be confirmed with a RBA validated for clinical use.

  Visit 1 (1 day, 1-2 hours)- Only visit for the entire study.

Interventions

Blood Draw OTHER

We will draw blood to measure islet-related autoantibodies and celiac disease markers with a combined research method, blood sugar, C-peptide (an indicator of insulin production that controls sugar levels) and hemoglobin A1c. Additional blood will be collected for the study of biomarkers of T1D and for long-term storage for potential future use.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The targeted study population is categorized as vulnerable. Cognitively Impaired Adults: Cognitively impaired adults will be evaluated case to case. For example, a high functioning person with Trisomy 21 (Down's syndrome) could be a possible participant, since they are at high risk of diabetes. Children: above the age of two with a sibling, parent, or other first or second-degree relatives with T1D or children with another other autoimmune diseases will be able to participate. Participation involves minimal risk (not greater than that encountered for clinical purposes) with the prospect of individual benefit. Pregnant Women: Participation involves minimal risk (not greater than that encountered for clinical purposes) with the prospect of individual benefit.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Celiac Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anna Casu, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 3, 2025
• Study Start: March 11, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)