E10
Conditions
Interventions
Group 1: Intervention (treatment group): patients get online support additionally to usual diabetes care right from the beginning in the form of monthly structured counselling regarding the glucose da
Sponsors
Universittätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck, Klinik für Kinder und Jugendmedizin, Sektion Pädiatrische Endokrinologie und -diabetologie
Eligibility
Sex/Gender
All
Age
1 Years to 17 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multicenter evaluation concept with a waiting control; quantitative and qualitative analysis and health economical analysis (mixed-methods) Sample size: 240 children Primary endpoint: reduction in HbA1c Collection-HbA1c-values 01. Three months before inclusion to trial 02. Inclusion to trial 03. Every three months until the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: glucose variability, quality of life, hospitalization, satisfaction with telemedicine Quality of life Questionnaire KINDL-R WHO-5 Satisfaction Diabetes Questionnaire Diabetes Treatment Satisfaction Questionnaire First data collection at inclusion to trial and then every 6 months until the end of the trial | — |
Countries
Germany
Contacts
Public ContactSimone von Sengbusch
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lu¨beckKlinik fu¨r Kinder- und Jugendmedizin, Sektion Pädiatrische Endokrinologie und –diabetologie
Outcome results
None listed