RecruitingOBSERVATIONAL

TrialNet Pathway to Prevention of T1D

This study, called "Pathway to Prevention," aims to better understand how type 1 diabetes develops. It involves screening close and extended family members of people who already have type 1 diabetes for early warning signs in their blood. Specifically, we look for certain markers called autoantibodies. Finding these antibodies can show that the body's immune system might be starting to affect the cells that make insulin. If these signs are found, you'll be offered more tests to see how likely you are to develop diabetes in the future. This monitoring helps us learn more and potentially offer you a chance to take part in studies that test ways to prevent or treat type 1 diabetes early on.

At a glance

Status

Recruiting

Sponsor

University of South Florida

Enrolment target

75,000

Start

01 Feb 2004

Estimated completion

31 Jul 2030

Diabetes Mellitus, Type 1

What is this study about?

Type 1 diabetes happens when the body's immune system mistakenly attacks and destroys the cells in the pancreas that make insulin. We know that certain genes and immune system factors play a big part in this, but we're still learning exactly how it all starts and progresses before someone is diagnosed. This study, led by TrialNet, aims to fill in those gaps.

The main goal is to understand the early stages of type 1 diabetes. By carefully studying people who might be at risk, we can learn more about the warning signs and how the condition develops over time. This knowledge is really important because it helps scientists develop new ways to prevent type 1 diabetes or to treat it much earlier. TrialNet is a worldwide group of researchers dedicated to stopping type 1 diabetes.

To achieve this, the study asks family members of people with type 1 diabetes to get screened. This is because having a family member with type 1 diabetes means you have a slightly higher chance of developing it. If early signs are found in your blood, you'll be invited for more detailed checks and close monitoring. This helps researchers track the condition's progression and offers you the chance to be considered for new prevention or early treatment studies.

Key takeaways

A study looking for early signs of type 1 diabetes in family members.
A simple blood test checks for early markers called autoantibodies.
If markers are found, you'll get more tests and regular monitoring.
Helps researchers understand how type 1 diabetes develops.
Might offer a chance to join studies for prevention or early treatment.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for volunteers, particularly those with a family history of type 1 diabetes. You can take part if you are between 2 and 45 years old and have a close family member (like a parent, child, or sibling) with type 1 diabetes.

If you are between 2 and 20 years old, you can also join if you have a more distant family member (such as an aunt, uncle, cousin, grandparent, or half-sibling) with type 1 diabetes. Additionally, people aged 2 to 45 who are not family members but are known to have certain early markers in their blood can also participate.

However, you cannot join this study if you already have diabetes, are currently taking medication to control high blood sugar, or are using medicines that affect your immune system (unless they are topical, like a cream, or inhaled). You also can't join if you have other serious health conditions that might shorten your life or require strong immune-affecting medicines during the study.

Quick self-check

Are you between 2 and 45 years old?
Do you have a parent, child, or sibling with type 1 diabetes?
If you are 2-20 years old, do you have a grandparent, aunt, uncle, or cousin with type 1 diabetes?
Do you already have diabetes or take medicine for high blood sugar?
Are you currently taking strong medicines that affect your immune system (unless it's a cream or inhaler)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study involves two main steps: screening and then, for some, ongoing monitoring. Firstly, you'll have a simple blood test. This can be done at a TrialNet centre, an associated clinic, or you can even request a kit to have your blood drawn by your local doctor or lab. This blood test looks for certain markers in your blood that can be early signs of type 1 diabetes. You'll get your results within 4-6 weeks.

If these early markers are found, you'll be invited for more tests to understand your risk of developing diabetes over the next five years. This might include another blood test and a special drink called an Oral Glucose Tolerance Test (OGTT), which checks how your body handles sugar. Depending on your results, you'll then be asked to come for follow-up visits either once or twice a year. During these visits, we'll continue to monitor your blood. If you are diagnosed with type 1 diabetes while in the study, you may be offered the chance to take part in studies looking at early treatments. The total duration of your participation will depend on your individual results and risk.

Potential risks and benefits

Potential benefits include gaining a better understanding of your personal risk for type 1 diabetes and receiving close monitoring, which could lead to an earlier diagnosis if you do develop the condition. You might also have the opportunity to participate in future studies testing ways to prevent or treat type 1 diabetes. Risks are generally small and include the minor discomfort and bruising from blood draws. There's also the emotional impact of learning about an increased risk. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

Childrens Hospital of Orange County
Orange, United States· Recruiting
University of California San Francisco
San Francisco, United States· Recruiting
Stanford University Medical Center
Stanford, United States· Recruiting
Barbara Davis Center for Childhood Diabetes
Denver, United States· Recruiting
Yale University School of Medicine
New Haven, United States· Recruiting
University of Florida
Gainesville, United States· Recruiting
Emory Children's Center
Atlanta, United States· Recruiting
Riley Hospital for Children, Indiana University
Indianapolis, United States· Recruiting
Joslin Diabetes Center
Boston, United States· Recruiting
University of Minnesota
Minneapolis, United States· Recruiting
The Children's Mercy Hospital
Kansas City, United States· Recruiting
Columbia University
New York, United States· Recruiting

+10 more sites — see the official record for the full list.

Common questions

What are "autoantibodies"?

Autoantibodies are special proteins in your blood that your immune system makes by mistake. In type 1 diabetes, they attack the cells that make insulin, which is an early sign.

Why do you only test relatives of people with type 1 diabetes?

Because having a close or extended family member with type 1 diabetes slightly increases your own risk, making these individuals important for understanding the early stages of the condition.

What happens if I test positive for autoantibodies?

If autoantibodies are found, you'll be offered more tests to determine your risk of developing diabetes and may be invited for regular monitoring.

Will I get diabetes if I participate in this study?

No, participating in the study doesn't mean you will get diabetes. It helps us understand your risk and monitor you should early signs appear.

Is there a cost to participate?

No, there are no costs for you to participate in this research study.

How to find out more

TrialNet Central Information Center general info

1-800-425-8361 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.