E11 E12 E13 E14
Conditions
Interventions
Group 1: Intervention group:
Usual care + mebix app over a time period of 6 months
Group 2: Control group:
Usual care over a time period of 6 months
Sponsors
Vision2B GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • DMT2 patients (ICD-10 E11, E12, E13, E14). • Participation in the DMP Diabetes mellitus type 2 • Age = 18 years • HbA1c value > 7.5% • Stable therapy setting in the last quarter before study inclusion as assessed by the study physician • Present, signed declaration of participation/consent form. • Patients of the participating practices/study centres • Statutory health insurance • Suitable smartphone available (Android from version 8.0 or IOS from version 12) • Patients who are able to use the app according to the doctor's assessment
Exclusion criteria
Exclusion criteria: • Newly adjusted to insulin within the last four weeks before study inclusion • Patients with malignancy • Patients with infectious diseases • Patients with uncontrolled psychosis • Patients with significant immobility as assessed by the study doctor • Patients with cognitive impairment as assessed by the study doctor • Lack of German language skills according to the assessment of the study doctor • No suitable smartphone available (Android version 8.0 or higher or IOS version 12 or higher) • Private health insurance • Patients with guardian • Simultaneous participation in another intervention study during the study period • Simultaneous use of another digital health application (DiGA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c value [t0, t1 & t2] Time of survey: t0 = at inclusion in the study t1 = 3 months after inclusion t2 = 6 months after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| • Diabetes-related distress measured by the Problem areas in diabetes questionnaire (PAID) [t0, t1 & t2] • Psychological well-being measured by the WHO-5 questionnaire [t0, t1 & t2] • Body weight [t0, t1 & t2] • Fasting triglycerides [t0, t1 & t2] • Medication adherence as measured by the Medication Adherence Report Scale (MARS-D) [t0, t1 & t2] • Self-treatment behavior as measured by the Diabetes Self-Management Questionnaire (DSMQ) and the Summary of Diabetes Self-Care Activities Measure (SDSCA) [t0, t1 & t2] • Health-Related Quality of Life as measured by the Short Form 12 (SF-12) [t0, t1 & t2] • Number of depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) [t0, t1 & t2] Time of survey: t0 = at inclusion in the study t1 = 3 months after inclusion t2 = 6 months after inclusion | — |
Countries
Germany
Contacts
Public ContactWinfried Keuthage
Diabetologische Schwerpunktpraxis
Outcome results
None listed