Following children at high genetic risk for type 1 diabetes
Screens and follows children at risk of type 1 diabetes to detect it earlier.
Plain-language title generated from the registry record
Registry title: Information, Follow-up and Early Diagnosis of Children at Risk for Type 1 Diabetes
Key facts
- Where
- Malmö, SwedenSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 18 years old?
Source: NCT06676566, who can take part
Where in Sweden
- CRC Jan Waldenströms gata 35Malmö, SwedenNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lund University
- Trial code
- NCT06676566
- Record updated
- 3 September 2026
- Original description
The aim is to investigate whether screening for islet autoantibodies, regular follow-up, and increased knowledge in families about the progression of the disease in children at high genetic risk or with single or multiple islet autoantibodies (stage 1 or 2 type 1 diabetes) ensures an earlier diagnosis of stage 3 type 1 diabetes compared to no screening or follow-up.Read full original descriptionShow less
Information, Follow-up and Early Diagnosis of Children at Risk for Type 1 Diabetes
The aim is to investigate whether screening for islet autoantibodies, regular follow-up, and increased knowledge in families about the progression of the disease in children at high genetic risk or with single or multiple islet autoantibodies (stage 1 or 2 type 1 diabetes) ensures an earlier diagnosis of stage 3 type 1 diabetes compared to no screening or follow-up.
Risk factors studied in relation to disease progression are the impact of higher-than-average weight gain, insulin resistance, and physical activity, both individually and in combination, on the risk of developing autoantibodies and disease progression.
An alternative diagnostic method, continuous glucose monitoring (CGM), will be evaluated for its for usefullness in early diagnosis of stage 2 and 3 type 1 diabetes as alternatives to oral glucose tolerance tests.
Another aim is to investigate the psychological impact of being aware that the children are at a higher risk of type 1 diabetes.
When a child in the study develops stage 3 type 1 diabetes, the psychological impact and metabolic control during the first five years after diagnosis will be compared to children not followed before the diagnosis.
Inclusion: 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: Stage 3 type 1 diabetes; Currently participating in a prevention study.