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

NCT ID: NCT06676566

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-14
• Study Completion Date: 2034-10-01

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus; Stage 2 Type 1 Diabetes; Stage 1 Type 1 Diabetes; Stage 3 Type 1 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Genetic risk without islet autoantibodies

This group has more than 10% risk of early onset of islet autoimmunity and can come to visits at 2, 6 and 10 years of age. At the visits blood samples are drawn and disease risk information and information about symptoms is given. The child will wear an accelerometer for one week after each visit.

No interventions assigned to this group

Genetic risk with 1 islet autoantibody

This group will be followed annually up to diabetes diagnosis or to 18 years of age. At the visits blood samples are drawn and disease risk information and information about symptoms is given. The child will wear an accelerometer for one week after each visit.

No interventions assigned to this group

Genetic risk with multiple islet autoantibodies

This group will come to visits every three months up to diagnosis or 18 years of age. At the visits blood samples are drawn and disease risk information and information about symptoms is given. An OGTT will be performed at some of the visits. The child will wear an accelerometer and a CGM for one week after each visit.

No interventions assigned to this group

Children with stage 3 type 1 diabetes who have taken part in the study before diagnosis

Annual visits at the study center will continue for the first 5 years after diagnosis.

No interventions assigned to this group

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helena Elding Larsson, MD, PhD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

CRC Jan Waldenströms gata 35

Malmo, , Sweden

Countries

Sweden

Other Identifiers

iT1D/2024

Identifier Type: -

Identifier Source: org_study_id