Diabetes Mellitus, Type INCT06860516
HLA Demographics Study in Adults With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type I, run by GentiBio, Inc at 5 sites in United States.
Trial summary
This is a study to evaluate the HLA-DRB1*04:01 genotype in adults that have been diagnosed with type 1 diabetes Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type I
- What is being tested?
- blood draw or cheek swab
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Jun 2025to Mar 2027
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study will enroll up to approximately 200 adults aged ≥ 18 to ≤ 55 years with recently (within 6 months of the study visit) diagnosed T1D who have met the American Diabetes Association T1D diagnosis criteria.
Who may be able to join
- Male and female participants aged ≥ 18 to ≤ 55 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:
- Fasting glucose ≥ 126 mg/dL (7.0 mmol/L), or
- 2-hour oral glucose tolerance test plasma glucose ≥ 200 mg/dL (11.0 mmol/L), or
- Hemoglobin A1c ≥ 6.5%, or
- Random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) (with documented classic hyperglycemia symptoms or hyperglycemic crisis).
- Date of T1D diagnosis within 6 months of the study visit.
- Able and willing to provide written, informed consent as approved by the institutional review board (IRB). Participants must be able to consent directly; no other person or guardian may consent for them in this study.
Who cannot join
- Participant is an employee of, or an immediate family member of an employee, of the Sponsor, study site, or of a contractor/vendor who is involved in direct study conduct for this protocol.
- Participant is unwilling or unable to comply with the study visit assessments.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Michelle Zhang, 888-813-8669, T1DTrials@joslin.harvard.edu
Jason Gaglia, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Alex Kass, 984-974-3004, uncdiabetes@med.unc.edu
Klara Klein, MD
- Recruiting
University of Florida- Gainesville
Gainesville, Florida, 32610
Jennifer Hosford, 352-294-5759, jennifer.hosford@peds.ufl.edu
Michael Haller, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Camilla Levister, NP, 212-241-5355, camilla.levister@mssm.edu
Sarah Rancic, sarah.rancic@mssm.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
Rebecca Wesch, Recruitment Coordinator, 844-813-8273, clinicalresearch@diabetes.ucsf.edu
Stephen Gitelman, MD
About this study
Official title: A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes (T1D)
This is a study to evaluate the HLA-DRB1*04:01 genotype in adults that have been diagnosed with type 1 diabetes
Read the detailed description
This is a non-interventional study to evaluate the distribution of human leukocyte antigen (HLA)-DRB1*04:01 genotype in participants that are recently (within 6 months of the study visit) diagnosed with T1D, with a single blood draw for the analysis of HLA genotype within the study participants. Some participants may elect to collect buccal cells via cheek swabs for genotype analysis. The study duration will be approximately 24 hours and will include a single study visit for the collection of demographic data and a single blood draw or cheek swab, and a follow-up telephone call approximately 24 hours after the study visit.
- Conditions
- Diabetes Mellitus, Type I
- Being tested
- blood draw or cheek swab
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood draw or cheek swabOther
a blood draw or cheek swab for testing of HLA-DRB1*04:01 and other HLA alleles
| Study group | Role | What they receive |
|---|---|---|
| all participants | aged ≥ 18 to ≤ 55 years recently (within 6 months of the study visit) diagnosed with T1D Receives: Other: blood draw or cheek swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
HLA DRB1*04:01 positive
to evaluate the frequency of adults with recently diagnosed type 1 diabetes that are HLA DRB1*04:01 positive at time of enrollment
Measured: Day 1
Secondary outcomes (1)
HLA-DRB1*04:01 genotype by ethnic and racial subgroups
to determine the distribution of HLA-DRB1*04:01 genotype in adults recently diagnosed with type 1 diabetes at the time of enrollment by ethnic and racial subgroups
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start6 Jun 2025
- Primary completion30 Jan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GentiBio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Bach, MD, Study director, GentiBio, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860516
- Sponsor's protocol ID
- GNTI-T1D-HLA-1002
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will share study results through a publication or conference presentation
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes (T1D)
- ClinicalTrials.gov ID
- NCT06860516
- Acronym / sponsor ID
- GNTI-T1D-HLA-1002
- Conditions
- Diabetes Mellitus, Type I
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GentiBio, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Mar 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.
This is a study to evaluate the HLA-DRB1*04:01 genotype in adults that have been diagnosed with type 1 diabetes
Detailed description
This is a non-interventional study to evaluate the distribution of human leukocyte antigen (HLA)-DRB1*04:01 genotype in participants that are recently (within 6 months of the study visit) diagnosed with T1D, with a single blood draw for the analysis of HLA genotype within the study participants. Some participants may elect to collect buccal cells via cheek swabs for genotype analysis. The study duration will be approximately 24 hours and will include a single study visit for the collection of demographic data and a single blood draw or cheek swab, and a follow-up telephone call approximately 24 hours after the study visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all participants | – | Other: blood draw or cheek swabaged ≥ 18 to ≤ 55 years recently (within 6 months of the study visit) diagnosed with T1D |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will enroll up to approximately 200 adults aged ≥ 18 to ≤ 55 years with recently (within 6 months of the study visit) diagnosed T1D who have met the American Diabetes Association T1D diagnosis criteria.
Key inclusion criteria (7 listed)
- Male and female participants aged ≥ 18 to ≤ 55 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:
- Date of T1D diagnosis within 6 months of the study visit.
- Able and willing to provide written, informed consent as approved by the institutional review board (IRB). Participants must be able to consent directly; no other person or guardian may consent for them in this study.
Key exclusion criteria (2 listed)
- Participant is an employee of, or an immediate family member of an employee, of the Sponsor, study site, or of a contractor/vendor who is involved in direct study conduct for this protocol.
- Participant is unwilling or unable to comply with the study visit assessments.
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 draw or cheek swaba blood draw or cheek swab for testing of HLA-DRB1*04:01 and other HLA alleles | Other | all participants |
Primary outcome
HLA DRB1*04:01 positive
Time frame: Day 1
to evaluate the frequency of adults with recently diagnosed type 1 diabetes that are HLA DRB1*04:01 positive at time of enrollment
1 secondary outcome
HLA-DRB1*04:01 genotype by ethnic and racial subgroups
Time frame: Day 1
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 28 Aug 2026.
- Individual participant dataSharing planned: Yes. will share study results through a publication or conference presentation
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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.
Mark Bach, MD study director
GentiBio, Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type I, run by GentiBio, Inc at 5 sites 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 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 5 sites 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?
Contact Kristin M Neff, MS (85-732-75483, kristin.neff@gentibio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HLA DRB1*04:01 positive (time frame: Day 1). 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 28 Aug 2026.