Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany

Completed

• Conditions: Type 1 Diabetes; Familial Hypercholesterolemia

• Registration Number: NCT02750527
• Lead Sponsor: Kinderkrankenhaus auf der Bult

Brief Summary

This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6 years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9) routine check-ups and any voluntary visits to the pediatricians office.

Detailed Description

The Fr1dolin-Study will be presented to the parents of ca. 320,000 children living in Lower Saxony, Germany. The recruitment of subjects, collection of written consent, the capillary blood sample and the screening questionnaire will be done by the registered pediatricians in their local medical practices.

After study enrolment 200 µl of capillary blood are be taken from the subject and are sent pseudo-anonymized to the lab. LDL-C and the diabetes-associated antibodies are identified. Based on the results a second blood sample will be required. In case of pre-type-1 diabetes or signs for a familial hypercholesterolemia the pediatrician will be informed. He will contact the parents and discuss the further procedure in cooperation with the study center.

In case of a positive result by measuring diabetes-related antibodies and LDL-C the goal of this trial is to advise and educate the families appropriate and to treat them if necessary. In addition families should have the possibility to participate in prevention trials.

All data will be registered in a study database.

Follow-up pre-type 1 diabetes:

During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years or up to 6 months after the clinical onset of type 1 diabetes.

Follow-up familial hypercholesterolemia:

During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years.

Study Timeline

• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-25
• Study Start: 2016-09
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13049

Inclusion Criteria

• Children living in Lower Saxony (primary residence)
• Age between 2 and 6 years (both included)
• Written consent by at least one parent / legal representative
• Willingness to deliver 200 µl of capillary blood
• Willingness to complete a questionnaire
• Willingness to participate to the follow-up visits

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of familial hypercholesterolemia or pre-type-1-diabetes	18 month	identification of patients/ families with familial hypercholesterolemia or pre-type-1 diabetes