Type 1 DiabetesACCESS-T1DNCT06908057
Accessing Care, Clinical Trials and Screening for Underserved Children and Adults With Type 1 Diabetes (ACCESS-T1D)
An observational study of Type 1 Diabetes and Celiac Disease, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Celiac Disease
- What is being tested?
- Blood Draw
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32804
About this study
Official title: Access to Clinical Care, Education 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.
Read the 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
- Being tested
- Blood Draw
- Medical subject headings
- Diabetes Mellitus, Type 1, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1 (1 day, 1-2 hours)- Only visit for the entire study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start11 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Casu, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908057
- Sponsor's protocol ID
- 2130661
- Acronym
- ACCESS-T1D
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Clinical Care, Education and Screening for Underserved Children and Adults With Type 1 Diabetes (ACCESS-T1D)
- ClinicalTrials.gov ID
- NCT06908057
- Acronym / sponsor ID
- ACCESS-T1D / 2130661
- Conditions
- Type 1 Diabetes, Celiac Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 115 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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:
- Resides in the following Counties: Orange, Seminole, Osceola, Lake, Volusia, Brevard, Polk, Hillsborough.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawWe 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. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Related trials for Type 1 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Casu, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Celiac Disease, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sample will be drawn for islet-related autoantibodies (time frame: Visit 1 (1 day, 1-2 hours)- Only visit for the entire study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.