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OpenTrials
Active, Not Recruiting

NCT Number: NCT06908057

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Blood sample will be drawn for islet-related autoantibodies

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

    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.

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Registry information

Official study title

Access to Clinical Care, Education and Screening for Underserved Children and Adults With Type 1 Diabetes (ACCESS-T1D)

Acronym: ACCESS-T1D

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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