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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

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children who have a higher chance of type 1 diabetes, or who already have islet autoantibodies (early signs of the disease) but not yet full diabetes.

Age
0 to 18 years. Children with a genetic risk only: 0 to 10 years.
Sex
Girls and boys can both join.
Disease stage
Children at moderate or high genetic risk of type 1 diabetes, or with a single autoantibody, or with multiple autoantibodies (stage 1 or 2 type 1 diabetes). Stage 3 type 1 diabetes is not allowed.
Earlier treatment
Children at genetic risk who left a prevention trial, whose prevention trial has ended, or who are not willing to join a prevention trial can be invited.
Biomarker or test result
Moderate or high genetic risk measured by HLA and non-HLA SNPs (8-10% moderate, over 10% high risk of multiple islet autoantibodies before 6 years of age), or islet autoantibodies found in other studies or clinics.

Main reasons for not taking part

  • Stage 3 type 1 diabetes
  • Currently taking part in a prevention study

Read by machine on 12 November 2026.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

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.

ClinicalTrials.gov NCT06676566