Kids + Adolescents Research Learning On Tablet Teaching Aachen in children and adolescents with diabetes mellitus type 1 - a multicentre, randomised study

Kids + Adolescents Research Learning On Tablet Teaching Aachen in children and adolescents with diabetes mellitus type 1 - a multicentre, randomised study - DIA-KARLOTTA 2.0

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035301

Enrollment

200

Registered

2025-03-10

Start date

2025-03-18

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10

Interventions

Group 1: Usergroup who plays the tablet game and answers knowledge questions about their disease - Duration of the project for each participant: 6 months - Participation on 3 appointments at interval

Eligibility

Sex/Gender

All

Age

8 Years to 21 Years

Inclusion criteria

Inclusion criteria: 1. female and male children, adolescents and young adults adults aged 8-21 years 2. diagnosis of diabetes mellitus type 1 3. informed consent and signed declaration of consent 4. patients must be able to read and write German (French for parts of the focus group) 5. patients must be able to play independently on the tablet

Exclusion criteria

Exclusion criteria: 1. age 21 years 2. illiteracy 3. mental or psychomotor disability

Design outcomes

Primary

Measure	Time frame
Change in metabolic parameter (HbA1c), measuring on 3 appointments at intervalls of 3 months, capillary or venous blood sample, laboratory diagnostics Improvement of comprehensibility and applicability (for the focus group)	—

Secondary

Measure	Time frame
- Change in the frequency of severe metabolic imbalances (hypoglycaemia or ketoacidosis), asked on all of the 3 appointments, questionnaire - Knowledge change pre- and post-application, measured on 1st and 3rd appointment, questionnaire created by the study team, based on the quiz of the app - Change in knowledge on transition pre- and post-application for the participants > 16 LJ, measured on 1st and 3rd appointment, questionnaire created by the study team - Change in behaviour in relation to dealing with the disease, measured on 1st and 3rd appointment, questionnaire created by the study team - Change in therapy quality of life, measured on 1st and 3rd appointment, KINDL questionnaire - Satisfaction with the app, measured on 3rd appointment, only usergroup, uMARS questionnaire - Application data of the app, selected after each use - Evaluating participants' knowledge levels by analysing the results collected in the questionnaire. (for the focus group) - Investigating possible differences in the way knowledge is imparted at the Cologne and Liège sites (for the focus group)	—

Measure

Time frame

- Change in the frequency of severe metabolic imbalances (hypoglycaemia or ketoacidosis), asked on all of the 3 appointments, questionnaire - Knowledge change pre- and post-application, measured on 1st and 3rd appointment, questionnaire created by the study team, based on the quiz of the app - Change in knowledge on transition pre- and post-application for the participants > 16 LJ, measured on 1st and 3rd appointment, questionnaire created by the study team - Change in behaviour in relation to dealing with the disease, measured on 1st and 3rd appointment, questionnaire created by the study team - Change in therapy quality of life, measured on 1st and 3rd appointment, KINDL questionnaire - Satisfaction with the app, measured on 3rd appointment, only usergroup, uMARS questionnaire - Application data of the app, selected after each use - Evaluating participants' knowledge levels by analysing the results collected in the questionnaire. (for the focus group) - Investigating possible differences in the way knowledge is imparted at the Cologne and Liège sites (for the focus group)

—

Countries

Belgium, Germany

Contacts

Public ContactAngeliki Pappa

Universitätsklinikum der RWTH Aachen Klinik für Kinder- und Jugendmedizin

apappas@ukaachen.de+49 241 80 88359

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026