E11
Conditions
Interventions
Group 1: Standard care + mebix app over a period of six months
Group 2: Standard care + placebo app over a period of six months
Sponsors
Vision2B GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients = 18 years old - Patients with type 2 diabetes (ICD-10-GM: E11.-) who benefit from improved self-management - Patients who have not used mebix in the past - Patients who use mebix as part of their diabetes management or are willing to use mebix - HbA1c at the start of the study = 7.5% and = 11.0% - Participation in the DMP Diabetes for at least 6 months before the start of the study - Patients with internet access and a smartphone compatible with mebix - Digital literacy to be able to use a smartphone appropriately and willingness to use it for their diabetes self-management - Sufficient understanding of the mebix user interface (UI) - Patients who are currently adjusting their diabetes management and lifestyle as part of their self-management - Participants who are willing and able to comply with all scheduled visits, lab tests, lifestyle considerations and other study procedures - Participants who are able to provide a personal, signed informed consent form
Exclusion criteria
Exclusion criteria: - Patients who use other apps for their diabetes management - Patients who have used mebix - Patients with impairments - including mental or psychological impairments - or conditions that, in the opinion of the investigator, would seriously jeopardize the integrity of the study - Patients already using a continuous subcutaneous insulin infusion (CSII, “insulin pump”) - Patients currently participating in a weight loss program - Steroid therapy within the last three months (only topical or inhaled use is not an exclusion criterion as long as it is not more than five times per week) - Uncontrolled blood pressure = 200 mmHg at screening - Current or planned pregnancy during the study or breastfeeding women - Abuse of alcohol or illegal drugs in the last three months - Patients with home care staff helping them with blood glucose monitoring and/or insulin adjustment - Current participation in another study or investigation - Employees of vision2be or another institution conducting the study or involved in the conduct/organization/coordination/funding of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c during the use of mebix | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the change in bodyweight, changes in patient self-management (SCSDA-G), changes in Depression (PHQ-9) and changes in Quality of life (SF12). For the SCSDA-G and the PHQ-9 the overall global scales will be used; for Quality of Life the psychological scale. | — |
Countries
Germany
Contacts
Public ContactPeter Schwarz
TU Dresden
Outcome results
None listed