E11
Conditions
Interventions
Group 1: Intervention group: Data collection 3 months prospectively with the DiGA Una Health added to DMP standard diabetes care
Group 2: Intraindividual Control group: Data collection of the same
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 benefiting from improved self-management ? Enrolled in the Disease Management Program (DMP) for type 2 diabetes diabetes in Germany for at least the last 6 months ? 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 Diabetes 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 Diabetes 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 who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Change in HbA1c during the use of the app Una Health | — |
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, WHO5. ? Patient self-management (SDSCA Questionnaire) ? Depression (PHQ-9 Questionnaire) ? Quality of life (WHO5 Questionnaires) Body fat change measured as: ? Bodyweight change (reported by patients via questionnaire) ? Waist circumference change (reported by patients via questionnaire) Overall satisfaction of subjects and HCPs’ with the Diabetes DiGA: ? the usability and overall satisfaction and of patients with the Diabetes DiGA (Patients Usability questionnaire) and HCP questionnaire. Long-term HbA1c ? Change in HbA1c 3 months after the intervention (at 6 months) | — |
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