Information, Follow-up and Early Diagnosis of Children at Risk for Type 1 Diabetes

Launched by LUND UNIVERSITY · Nov 4, 2024

Keywords

ClinConnect Summary

This is an observational study called iT1D in Sweden. Researchers want to learn if screening kids for antibodies linked to type 1 diabetes, plus regular follow-up and better family education about how the disease can progress, helps catch type 1 diabetes earlier (before serious symptoms appear) and reduces diabetic emergencies like ketoacidosis. They’ll also study how factors like weight gain, insulin resistance, and physical activity influence the development of autoantibodies and the progression to diabetes. An extra goal is to see if continuous glucose monitoring (CGM) could work as an alternative to the standard glucose tolerance test for early diagnosis, and to understand the psychological impact of screening on families.

Who can join and what to expect: The study mainly includes children from birth up to 18 years who have a higher or moderate genetic risk for type 1 diabetes, or who have one or more islet autoantibodies (indicating early autoimmune activity). Children with established stage 3 type 1 diabetes are not eligible. About 600 participants are expected. Depending on their group, visits happen on different schedules (every 2, 6, or 10 years for some; annually or every few months for others) and involve blood tests, learning about diabetes risk, and wearing devices like an accelerometer (and sometimes CGM or undergoing an OGTT). The study follows people for up to 10 years (and up to 5 years after a diabetes diagnosis for those who reach stage 3). It’s an observational study, not a drug trial, and data may be shared with other researchers. The study is led by Lund University in Sweden, with recruitment starting in 2024 and a planned end around 2034.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children 0 -10 years with high or moderate genetic risk of type 1 diabetes, measured by a combined analysis of HLA and non-HLA SNPs. Moderate genetic risk is defined as 8-10% risk of developing multiple islet autoantibodies before 6 years of age, and high genetic risk as over 10% risk of developing multiple islet autoantibodies before 6 years of age.
• • Children 0-18 years of age screened in other research studies or tested at a clinical site and found to have a single autoantibody (before stage 1 type 1 diabetes) or multiple islet autoantibodies without or with impaired glucose tolerance (stage 1 or 2 type 1 diabetes, respectively).
• • Children will be invited to participate in the current study if they have moderate or high genetic risk and 1) have participated in a prevention trial but have dropped out or the trial has ended 2) are not willing to participate in prevention trial.
• • Children screened and found to be positive for islet autoantibodies in other studies (TEDDY, TrialNet, Innodia etc) or in clinical settings but which have not progressed to stage 3 type 1 diabetes can also be invited to participate in the current study.
• Exclusion Criteria:
• • Stage 3 type 1 diabetes
• • Currently participating in a prevention study