Access to Clinical Care, Education and Screening for Underserved Children and Adults With Type 1 Diabetes (ACCESS-T1D)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Blood sample will be drawn for islet-related autoantibodies
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported