NCT06676566

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Lund University · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2024-10-14
• Primary completion: 2034-10-01
• Completion: 2034-10-01
• First posted: 2024-11-06
• Last updated: 2024-11-06

Locations

1 site across 1 country: Sweden