NCT06676566Enrolling by invitation
Information, Follow-up and Early Diagnosis of Children at Risk for Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 28 Oct 2024
- Start date
- 14 Oct 2024
- Primary completion date
- 1 Oct 2034
- Lead sponsor
- Lund University
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06676566
What you commit to
- Study type: Observational
- Planned participants: 600
- From 14 Oct 2024 to the primary completion date, 1 Oct 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Stage 3 type 1 diabetes
Other
- Currently participating in a prevention study
Who the study is looking for
- 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.
Age in the registry: 0 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CRC Jan Waldenströms gata 35 Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.