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

NCT ID: NCT06908057

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2026-06-30

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, like nieces, nephews, aunts, uncles, grandchildren, or cousins. A relative of someone with T1D is at a higher risk of getting the disease as they are people with other autoimmune diseases. It is possible to detect T1D or CD before it shows any symptoms of high blood sugar. Sometimes, particularly in people who develop T1D in adult life, the disease is misdiagnosed as type 2 diabetes. The treatment and care for the two diseases are different.

Conditions

Type 1 Diabetes; Celiac Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Blood Draw

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AdventHealth Translational Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Casu, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

AdventHealth Translational Research Institute

Orlando, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Recruitment Department

Role: CONTACT

CFD.TRI.Recruitment@AdventHealth.com

407-303-7100

Facility Contacts

Recruitment Department

Role: primary

CFD.TRI.Recruitment@AdventHealth.com

407-303-7100

Other Identifiers

2130661

Identifier Type: -

Identifier Source: org_study_id