Randomized controlled trial to evaluate the digital health application mySugr PRO

Not Applicable

• Conditions: E10; E11; O24.4; Type 1 diabetes mellitus; Type 2 diabetes mellitus; Diabetes mellitus arising in pregnancy

• Registration Number: DRKS00022923
• Lead Sponsor: Roche Diabetes Care GmbH - DCSDB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-22
• Study Completion: 2022-10-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

? Diagnosed type 1 diabetes (E10) or type 2 diabetes (E11) or gestational diabetes (O24.4)
? Carrying out regular, daily blood sugar measurements and using the blod glucose values to carry out or adjust diabetes therapy
? Age = 16 years
? Last measured HbA1c value <12% or 107.6 mmol / mol
? Use of a smartphone compatible with the mySugr PRO (Android 5.0 or higher; iOS 11.4 or higher)
? Willingness to consent to the terms and conditions of the mySugr PRO
? Knowledge of spoken and written German
? Given written declaration of consent to participate in the study.
For adolescents: a written declaration of consent for participation in the study must be available both from the adolescent himself and from a legal guardian

Exclusion Criteria

? Use of continuous glucose measurement systems (rtCGM, isCGM)
? Use of a digital diabetes diary or a (diabetes) app for digital therapy documentation in the last 3 months
? Existence of an acute psychiatric illness which, in the opinion of the investigator, impairs the patient's ability to properly carry out the diabetes therapy or the study
? In adults (= 18 years): Lack of consent due to restricted legal capacity or legal support
? Dependency on the sponsor or the clinical investigator (e.g. employees of the sponsor or a test center and their family members)
? Simultaneous participation in another clinical study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome variable is the lowering of disease burden through a reduction in diabetes distress in the intervention group using the mySugr PRO compared to the control group without using the mySugr PRO in a 3-month follow-up.<br>Diabetes distress is assessed at the beginning and at the end of the study with a validated questionnaire to evaluate diabetes-specific distress (German translation of the Problem Areas in Diabetes Questionnaire).

Secondary Outcome Measures

Name	Time	Method
Secondary outcome variables are: diabetes self-management (therapy adherence), psychological well-being (quality of life), empowerment, expectation of self-efficacy and therapy satisfaction (patient sovereignty). These variables are assessed using various validated questionnaires.<br>Furthermore, in order to record the quality of the diabetes therapy, glucose data from the blood glucose measurement systems are read out and evaluated, and the HbA1c value is recorded or determined (medical benefit).<br>All variables are recorded at the beginning and at the end of the study.