Evaluation of the Impact of mebix in Patients with Type II Diabetes mellitus in daily practice

Not Applicable

• Conditions: E11; Type 2 diabetes mellitus

• Registration Number: DRKS00032547
• Lead Sponsor: niversitätsklinikum Carl Gustav Carus der Technischen Universität Dresden Medizinische Klinik III Abteilung Prävention und Versorgung des Diabetes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-01-31
• Study Start: 2023-08-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Patients = 18 years old
• Type 2 diabetes patients benefitting from improved self-management
• Patients using/willing to use a Diabetes DiGA as part of their diabetes management
• HbA1c at baseline = 7,5 % and = 11.0 %
• Patients with internet access and a computer and/or smartphone compatible with the Vitadio DiGA
• Digital literacy to use a smartphone adequately and willing to use it for their diabetes self-management
• Sufficient understanding of user interface (UI) of the Vitadio DiGA
• Participants willing and able to comply with all scheduled visits, laboratory tests, lifestyle considerations and other study procedures
• Participants capable of giving personal informed consent

Exclusion Criteria

• Patients using other Apps for their diabetes management
• Patients who have been using a Diabetes DiGA in the past twelve months
•Patients with impairments – including mental or psychic impairments – or conditions which, in the opinion of the investigator, would seriously compromise the integrity of the study
• Patients under 18 years of age
• Patients participating in a weight loss program in the last 6 months
• Patients treated with an insulin pump or continuous glucose management (CGM)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c during the use of mebix (digital health application)<br>

Secondary Outcome Measures

Name	Time	Method
changes in quality of life, problem areas in diabetes and patient self-management with the using the Diabetes DiGA measured by the daily conducted blood glucose values and questionnaire SDSCA, PHQ-9, SF-12. <br>• Patient self-management (SDSCA Questionnaire)<br>• problem areas in diabetes (PAID 5 Questionnaire)<br>• Quality of life (WHO-5 Questionnaires)<br><br>Body fat change measured as:<br>• Bodyweight change (reported by patients via questionnaire)