Prevention for Type 1 Diabetes

Recruiting at 21 trial locations

Overseen By TrialNet Central Information Center general info

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must not be taking: Immunosuppressants, Immunomodulators

Disqualifiers: Diabetes, Severe active diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

75000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to understand the development and prevention of type 1 diabetes. It focuses on individuals with family members who have type 1 diabetes or those with blood markers indicating a risk for the disease. Participants will undergo screening for specific antibodies, which are proteins that can attack healthy cells, to assess their risk and will be closely monitored over time. Suitable candidates include those with a family connection to type 1 diabetes or those already aware of having these antibodies. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could lead to new prevention strategies.

Will I have to stop taking my current medications?

If you are currently using medications for diabetes or certain immune system medications, you cannot participate in this study. However, if you are using topical or inhaled immune system medications, those are allowed.

What prior data suggests that this screening and monitoring method is safe for identifying type 1 diabetes risk?

Research has shown that testing for diabetes-related autoantibodies—proteins made by the immune system that mistakenly attack the body's own cells—can identify individuals at high risk for type 1 diabetes. This screening is generally safe and easy, requiring only blood tests.

Studies have found that early screening and regular check-ups are crucial for managing the condition and delaying the onset of type 1 diabetes, thereby reducing the risk of complications later.

In five combined studies, children with certain autoantibodies had an 85% chance of developing type 1 diabetes within 15 years. Knowing these risks allows for careful monitoring and early action, providing reassurance for those at risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TrialNet Pathway to Prevention of T1D because it focuses on early screening and monitoring to identify individuals at risk of developing Type 1 Diabetes (T1D). Unlike traditional treatments that primarily address symptoms after T1D onset, this approach aims to catch the disease before it fully develops, offering a chance to delay or prevent its progression. By identifying at-risk individuals earlier, this method could lead to more personalized and timely interventions, potentially transforming how we manage T1D risk in the future.

What evidence suggests that screening and monitoring for type 1 diabetes risk could be effective?

Studies have shown that specific blood tests for type 1 diabetes (T1D) can identify individuals at high risk for the disease. Once identified, regular check-ups can prevent serious issues like diabetic ketoacidosis (DKA), a condition caused by very high blood sugar. Research indicates that high-risk individuals have a 51% chance of developing T1D within two years, compared to just 4% for those at low risk. Screening and regular monitoring, which participants in this trial will undergo, provide more time for advice and early treatment, potentially reducing long-term problems associated with T1D. ^{2 3 6 7 8}

Who Is on the Research Team?

Kevan Herold, M.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Inclusion Criteria

Individuals 2.5 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)

Individuals 2.5-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)

Individuals 2.5-45 years old without a type 1 diabetes proband, who are known to have 1 or more islet antibody are eligible for screening if needed to determine eligibility for a clinical trial to delay or prevent disease progression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4-6 weeks

1 visit (in-person or local laboratory)

Monitoring

Participants are monitored for the presence of diabetes-related autoantibodies and glucose tolerance

5 years

Annual or semi-annual visits depending on risk level

Follow-up

Participants are monitored for safety and effectiveness after initial monitoring phase

5 years

Annual or semi-annual visits depending on risk level

What Are the Treatments Tested in This Trial?

Interventions

• Screening and Monitoring for Type 1 Diabetes Risk

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

National Center for Research Resources (NCRR)

Collaborator

Trials

540

Recruited

317,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11247126/

Recommendations for Screening and Monitoring the ... T1D can be identified through diabetes-related autoantibody screening and staged accordingly, enabling healthcare providers to identify high-risk individuals.

2. diabetes.org diabetes.org/newsroom/press-releases/american-diabetes-association-showcases-innovations-and-guidance-early-risk

American Diabetes Association Showcases Innovations ... The results of the study showed the probability of developing type 1 diabetes by two years was 4%, 17%, and 51% in the low, medium, and high ...

3. diabetesjournals.org diabetesjournals.org/care/article/48/7/1101/158195/The-Diabetes-Prevention-Program-and-Its-Outcomes

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ... After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...

4. academic.oup.com academic.oup.com/jcem/article/110/8/2371/8103687

Establishing Screening Programs for Presymptomatic Type 1 ... Potential benefits of screening (therapeutic intervention; more time for counseling and monitoring; DKA prevention; reduced long-term risk of complications).

5. esmed.org esmed.org/MRA/mra/article/view/6880

Type 1 Diabetes Prevention: Screening Efforts and ... While relatives of individuals with type 1 diabetes have a 15-fold increase in disease risk, 85-95% of type 1 diabetes diagnoses occur in people ...

6. adces.org adces.org/education/danatech/explore/type-1-diabetes-screening

T1D Screening View our guide and gain insight into the evolving landscape of Type 1 diabetes screening, staging and support.

7. diabetesjournals.org diabetesjournals.org/care/article/47/8/1276/156880/Consensus-Guidance-for-Monitoring-Individuals-With

Consensus Guidance for Monitoring Individuals With Islet ... Combined data from five prospective studies indicate that the 15-year risk for stage 3 type 1 diabetes is 85% for children with two islet ...

8. uptodate.com uptodate.com/contents/type-1-diabetes-mellitus-disease-prediction-and-screening

Type 1 diabetes mellitus: Disease prediction and screening Screening for diabetes-related autoantibodies and metabolic monitoring can detect preclinical type 1 diabetes, identify candidates for disease- ...