U-M TrialNet patient, Ashlynn B., pictured alongside her science fair project on TrialNet and T1D.
According to Breakthrough T1D (previously known as JDRF), approximately 1.5 million children and adolescents under the age of 20 worldwide are living with type 1 diabetes. This number significantly increases to 7.5 million when considering adults over 20 years old. TrialNet, an international collaborative network, brings together physicians, scientists, and healthcare professionals dedicated to preventing type 1 diabetes and slowing its progression. Through this worldwide alliance, individuals identified as having elevated risk factors can access screening services, participate in clinical trials, and contribute to vital research initiatives.
TrialNet’s mission is to provide knowledge. With knowledge, families are able to plan and potentially change their course to have a healthier life. Even though I do not like to have to tell someone that their child will develop type 1 diabetes, I know that families will use that information to keep their child healthier, either by continuing through our monitoring program which reduces the chance of a child presenting in diabetic ketoacidosis (DKA), enrolling their child in a prevention study or asking for a diabetes-delaying treatment such as Teplizumab. - Dr. Inas Thomas, Principal Investigator, U-M TrialNet Research Study
Michigan Medicine is proud to serve as a TrialNet clinical research site. Our site actively participates in various new-onset and preventive clinical trials through TrialNet, with a current focus on recruiting participants for the Pathway to Prevention Study.
The Pathway to Prevention study is a global initiative aimed at identifying individuals at risk for Type 1 diabetes (T1D) and developing strategies to prevent or delay its onset. The primary goal of the study is to improve early detection and provide participants with access to preventive trials.
Michigan Medicine has successfully screened 1,614 family members of T1D patients since 2007. The global impact of TrialNet screening has reached an impressive milestone, with over 250,000 family members of T1D individuals gaining awareness about their risk factors! This remarkable achievement was recently shared in honor of National Diabetes Month, recognized annually each November.
The following section provides important updates regarding TrialNet:
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Improved Screening Initiatives
- The screening process is streamlined to allow quicker identification of individuals with T1D autoantibodies. There have been recent protocol improvements that have reduced the timeline from initial contact to enrollment. The screening, monitoring and follow-up are all free to participants.
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Preventive Interventions
- TrialNet is evaluating new interventions aimed at delaying the onset of T1D. Recent findings from ongoing trials indicate promising results in slowing disease progression for participants with early-stage autoimmunity. The team at TrialNet participated in the two oral insulin studies as well as the hydroxychloroquine study which unfortunately were not effective. New studies are currently open across the country.
- Expanded Recruitment Initiatives
- Outreach efforts have expanded by targeting high-risk communities. Family members of individuals with T1D are also encouraged to participate which provides important data for risk assessment.
Looking forward, the Michigan Medicine pediatric endocrinology research team, led by division director Dr. Inas Thomas, in collaboration with the TrialNet team, will continue to prioritize recruitment, the development of new interventions, and participant support. Through ongoing analysis, TrialNet is committed to making significant progress in the prevention of Type 1 diabetes.
LEARN MORE ABOUT TYPE 1 DIABETES AND ITS PROGRESSION
Three Stages of Progression:
- Genetic risk
- Individuals who develop T1D have a genetic predisposition, which means that they have certain genes that put them at higher risk. Everyone who develops T1D has these genes, even if there is no family history of T1D. The risk for people in the general population (with no known family members with a T1D) is about 1 in 300. For those who have a family member with T1D, the risk is 1 in 20, or 15x greater.
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Stage 1
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This is considered the start of type 1 diabetes. These individuals have tested positive for two or more diabetes-related autoantibodies. The immune system has started attacking beta cells which makes insulin. Blood glucose levels are normal, and no symptoms are present. About 20% of people in Stage 1 will progress to Stage 3 (clinical diagnosis) within four years.
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Stage 2
- Blood glucose levels have become abnormal although individuals are still asymptomatic. This is attributed to an increased loss of beta cells,. Almost 50% of people in stage 2 will progress to Stage 3 within four years. Age plays a key role in disease progression. Younger children typically progress faster through the stages of diabetes than adults.
- For those who have been diagnosed with stage 2 T1D, Michigan Medicine is offering TZIELD (teplizumab) infusions. This drug was studied through TrialNet and found to delay the onset of stage 3 T1D by a median of 2 years in children and adults at high risk. This medication is now FDA-approved to be prescribed to delay the onset of stage 3 T1D in patients who are 8 years of age and older. For more information about TZIELD, please visit this website: TZIELD.com | For US Consumers.
- The pediatric endocrinology department is enrolling patients who receive TZIELD into an observational registry study which will follow participants during and after treatment for 10 years. This will hopefully give us more information into the long-term outcomes of this treatment.
- Blood glucose levels have become abnormal although individuals are still asymptomatic. This is attributed to an increased loss of beta cells,. Almost 50% of people in stage 2 will progress to Stage 3 within four years. Age plays a key role in disease progression. Younger children typically progress faster through the stages of diabetes than adults.
- Stage 3
- Stage 3 used to be known at the start of T1D, but it is now the clinical diagnosis of T1D when individuals present with clinical disease. In stage 3, T1D symptoms are present due to significant beta cell loss and symptoms of diabetes (increased urination and thirst, increased hunger with weight loss) are now present. Some individuals are diagnosed with T1D when they are hospitalized for diabetic ketoacidosis (DKA), a serious and potentially life-threatening condition. TrialNet is focused on early diagnosis which is meant to reduce the risk of the life-threatening presenting symptoms.
If you or someone you know would like to learn more about TrialNet or sign-up to participate, please feel free to contact the U-M pediatric endocrinology team via phone: 734-232-4213 or email: UMHS-Trialnet@med.umich.edu. You can also visit the TrialNet homepage for more information or other locations for screening across the world.
For more information on Type 1 Diabetes and other studies the department is involved in, please visit:
U-M Pediatric Diabetes Clinic (umpedsdiabetes.com).
For additional information on T1D studies and clinical trials, please visit: Home | ClinicalTrials.gov.