Fr1da-/Fr1da-Plus-Study in Bavaria: Early Detection for Early Care of Type 1 Diabetes

Study Overview
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Brief Summary
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The Fr1da study aims to assess whether early staging of type 1 diabetes (1) is feasible at a population-based level, (2) prevents severe metabolic decompensation observed at the clinical manifestation of type 1 diabetes and (3) reduces psychological distress through preventive teaching and care.

Detailed Description
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Type 1 diabetes can be diagnosed at an early presymptomatic stage by the detection of islet autoantibodies. Within the Fr1da-study, 100 000 children aged 1.75-5.99 years are tested for the presence of multiple islet autoantibodies. Screening is performed by primary care paediatricians. Islet autoantibodies are measured in capillary blood, and if positive, confirmed by venous blood in a second follow-up blood sample. Children with confirmed multiple islet autoantibodies are diagnosed with presymptomatic type 1 diabetes. These children and their parents are invited to participate in an education and counselling programme at a local diabetes centre. Depression and anxiety, and burden of early diagnosis are also assessed. The Fr1da-Plus-Study starts in 2019, after the enrollment of 100000 children into Fr1da, and extends screening to ages 9.0-10.99 years, and follows children with single islet autoantibodies for up to 3 years for progression to multiple islet autoantibody positivity. The aims of the Fr1da- and Fr1da-Plus studies are: to prevent life-threatening diabetic ketoacidosis at clinical onset of diabetes to minimize psychological burden and uncertainty by training and intensive support of affected subjects to evaluate feasibility of a comprehensive screening to examine the prevalence of a pre-stage of Type 1 Diabetes to assess geographic differences and association with environmental conditions for development of Type 1 Diabetes The predefined criteria for the feasibility and clinical benefit of the study are >80% participation in the education and staging program, a diabetic ketoacidosis frequency of <5% in children with stage 3 diabetes, and <10% of parents with a Patient Health Questionnaire-9 (PHQ-9) sum score >15.

Official Title
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Fr1da-/Fr1da-Plus-Study in Bavaria: Early Detection for Early Care of Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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children living in Bavaria with written informed consent by one custodial parent

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of multiple islet autoantibodies | multiple islet autoantibodies (IAA, GADA, IA-2A and/or ZnT8A) | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fr1da, Fr1da-Plus, type 1 diabetes, islet autoantibodies