E11
Conditions
Interventions
Group 1: Intervention group: Data collection 3 months prospectively with the DiGA Vitadio added to DMP standard diabetes care
Group 2: Intraindividual control group: Data collection of the same patien
Sponsors
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden Medizinische Klinik III Abteilung Prävention und Versorgung des Diabetes
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 = 6.5 % 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c during the use of Vitadio (digital health application) | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in quality of life, depression 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. • Patient self-management (SDSCA Questionnaire) • Depression (PHQ-9 Questionnaire) • Quality of life (SF-12 Questionnaires) Body fat change measured as: • Bodyweight change (reported by patients via questionnaire) • Waist circumference change (reported by patients via questionnaire) | — |
Countries
Germany
Contacts
Public ContactPeter Schwarz
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden Medizinische Klinik III Abteilung Prävention und Versorgung des Diabetes
Outcome results
None listed