At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 317 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the University of South Florida, is called 'TrialNet Pathway to Prevention of Type 1 Diabetes'. It looks at relatives of people with type 1 diabetes, a condition where the body cannot control blood sugar properly. The study aims to help find people who may be at risk of developing it.
Who can take part
- People aged 2 to 45 who have a close family member with type 1 diabetes (a child, parent, or sibling).
- People aged 2 to 20 who have a wider family member with type 1 diabetes (a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling).
- People aged 2 to 45 who are not family members but are known to have one or more 'islet antibodies' (signs in the blood linked to type 1 diabetes risk).
Who may not be able to
- People who already have diabetes.
- People who have taken or currently take medicines to control high blood sugar or diabetes.
- People currently taking medicines that weaken or change the immune system (creams and inhalers are allowed).
- People with serious active illnesses, or illnesses likely to shorten life or needing long-term immune-system medicines during the study.
What taking part involves
- • Not stated — ask the trial team.
Time commitment: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 2 Years to 45 Years
- Who
- All
- Number of participants
- 75,000
- Started
- 2004-02-01
- Last checked
- 2025-06
Plain English Summary
What is this study?
- • Testing a new treatment for diabetes mellitus, type 1
- • Clinical study - 75,000 participants
- • Rationale: The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM)
Who can take part?
- • Ages 2 Years to 45 Years
- • Diagnosed with diabetes mellitus, type 1
Where?
- • Bristol - University of Bristol
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Rationale: The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM. Purpose: TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes. The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes. The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes.
More detail
Detailed Description: The Pathway to Prevention Study is conducted in two parts: * Screening * Monitoring (annual and semi-annual depending on risk) In Screening , a simple blood test is done to screen for the presence of diabetes-related biochemical autoantibodies (GAD and mIAA). Additional autoantibodies ICA, IA-2A, and ZnT8A will also measured in individuals positive for mIAA. ICA, IA-2A, and ZnT8A will be measured in individuals positive for GAD. Participants can go to a TrialNet Clinical Center, Affiliate, or request a screening kit to have their blood drawn by a local physician or laboratory. Participants will be provided with their screening results within 4-6 weeks. If autoantibodies are present, participants will be invited to have additional testing to determine their average risk of developing diabetes over the next 5 years. Participants that are single autoantibody positive will be re-tested annually for the development of multiple autoantibodies. Multiple autoantibody positive participants will undergo an eligibility visit which will include an Oral Glucose Tolerance Test (OGTT), re-testing for biochemical and islet cell autoantibodies if needed, and measurement of HbA1c. Multiple autoantibody positive individuals with a normal glucose tolerance and an HbA1c \< 6.0% will be asked to come for follow-up on annual basis; multiple autoantibody positive individuals with an abnormal glucose tolerance or an HbA1c ≥ 6.0%will be asked to come for follow-up visits on semi-annual basis. Participants will be monitored for possible progression towards type 1 diabetes and may be offered the opportunity to enter into a prevention study such (e.g., Oral Insulin prevention study) or an early treatment study if they are diagnosed with type 1 diabetes while participating in the Natural History Study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 2 Years - 45 Years
- Who can join: All genders
What the study is looking for
- ✓Individuals 2 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or...
- ✓Individuals 2-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew,...
- ✓Those aged 2 years to 45 years who are not family members and are known to have 1 or more islet antibodies
Who cannot take part
- ✗To be eligible a person must not:
- ✗Have diabetes already
- ✗Have previous or current use of medications for the control of hyperglycemia/diabetes.
- ✗Currently be using immunosuppressive or immunomodulatory agents (topical and inhaled agents are acceptable)
See the full criteria
Where Is This Study? (1 UK site)
University of Bristol
Bristol BS10 5NB UK, United Kingdom
How to Get in Touch
TrialNet Central Information Center general info
Sponsor contactCONTACT