„Online outpatient diabetes clinic for children and youth

Not Applicable

Conditions: E10
Type 1 diabetes mellitus

Registration Number: DRKS00012645

Lead Sponsor: niversittätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck, Klinik für Kinder und Jugendmedizin, Sektion Pädiatrische Endokrinologie und -diabetologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 240

Inclusion Criteria

Prerequisites: CGM system with or without alarm function, MDI or insulin pump, sufficient Germen, English or Turkish language skills, willingness to participate in a 12-month telemedicine study.
Technical prerequisites are: desktop or laptop, internet access at home, basic knowledge how to send an Email with an attached file
Furthermore, participating children must be insured in one of the participating state health insurances

Exclusion Criteria

Coding
1 = no interest in the study
2 = objection to data security
3 = insufficient or missing technical setting (internet)
4 = worry about use of technology
5 = state health insurance does not participate in the study
6 = too young < 1 year to participate
7 = diabetes onset < 6 months ago
8 = Treatment from a diabetologist not practicing in Schleswig-Holstein state
9 = Language issue (no sufficient German, Turkish or English)
10 = one parent, child or legal guardian rejects study participation
11= patient had already had four telemedicine appointments with consultation or participated in a telemedicine study in the past

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multicenter evaluation concept with a waiting control; quantitative and qualitative analysis and health economical analysis (mixed-methods)<br><br>Sample size: 240 children<br>Primary endpoint: reduction in HbA1c <br><br>Collection-HbA1c-values<br>01. Three months before inclusion to trial <br>02. Inclusion to trial<br>03. Every three months until the end of the trial

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints: glucose variability, quality of life, hospitalization, satisfaction with telemedicine <br><br>Quality of life Questionnaire<br>KINDL-R<br>WHO-5<br><br>Satisfaction Diabetes Questionnaire<br>Diabetes Treatment Satisfaction Questionnaire<br><br>First data collection at inclusion to trial and then every 6 months until the end of the trial <br><br>