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

Type 1 Diabetes Mellitus Clinical Trial

— Fr1da-Plus  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04039945
• Other study ID #: 808040014
• Status: Recruiting
• Start date: February 2015
• Est. completion date: December 2028

Study information

• Verified date: September 2023
• Source: Helmholtz Zentrum München
• Contact: Anette-Gabriele Ziegler, Prof.Dr.med.
• Phone: +49 800-4648835
• Email: diabetes.frueherkennung[@]helmholtz-muenchen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180000
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years
• Eligibility: children living in Bavaria with written informed consent by one custodial parent

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
Germany	Institut für Diabetesforschung, Helmholtz Zentrum München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Helmholtz Zentrum München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of multiple islet autoantibodies	multiple islet autoantibodies (IAA, GADA, IA-2A and/or ZnT8A)	up to 3 years