E11
Conditions
Interventions
Group 1: Intervention group: access to the Una Health for Diabetes app + standard diabetes treatment according to Disease Management Program (DMP) for six months followed by 12 months of follow-up
Gro
Sponsors
Una Health GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes (ICD-10-GM: E11.-) Patients using/willing to use the Una Health for Diabetes app as part of their diabetes management HbA1c at baseline = 7.0 % and = 11.0 % Participation in the DMP (Disease Management Program) Diabetes for a minimum of 6 months Patients with internet access and a computer and/or smartphone compatible with the Una Health for Diabetes app Participants willing and able to comply with all scheduled visits, laboratory tests, lifestyle considerations and other study procedures Participants capable of giving personal signed informed consent
Exclusion criteria
Exclusion criteria: Patients using other certified DiGAs for their diabetes management Patients who have used the Una Health for Diabetes app in the past Patients with impairments – including mental or psychological impairment – or conditions which, in the opinion of the investigator, would seriously compromise the integrity of the study Patients already using 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 used more than five times a week) Uncontrolled blood pressure = 180 mmHg systolic at screening Body mass index (BMI) > 40 kg/m² Underwent bariatric surgery in the last 3 months Current pregnancy or pregnancy planned during the study, or breastfeeding women Alcohol or illicit drug abuse Patients with home health aides who assist with their blood glucose testing and/or insulin adjustment Current participation in another trial Employees of Una Health GmbH, or any other institution carrying out the study or being involved in conducting/ organizing/ coordinating/ financing the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c after six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in HbA1c after 18 months Changes in body weight Changes in patient self-management (SDSCA Questionnaire) Changes in presence and severity of depressed mood (PHQ-9 Questionnaire) Changes in quality of life (SF-12 Questionnaire) | — |
Countries
Germany
Contacts
Public ContactChristina Holzapfel
Institut für Ernährungsmedizin, Technische Universität München
Outcome results
None listed