E11
Conditions
Interventions
Group 1: Usual care for three months (baseline visit and follow-up visit)
Group 2: DiaNow eHealth App for three months (baseline visit and follow-up visit)
Sponsors
Universitätsklinik Aachen, AöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes mellitus or anti-diabetic treatment: HbA1c = 7.5 % (= 58 mmol/mol) or < 10.0% (< 86 mmol/mol) • Ability to give consent • Adequate understanding of the German language
Exclusion criteria
Exclusion criteria: Other diabetes mellitus entities (T1DM, LADA, MODY, NODAT, diabetes after steroids or other endocrine diseases, etc.) • HbA1c = 10.0% (=86 mmol/mol) • No technical know-how in the field of smartphone/tablet Uncontrolled or serious illness or any medical or surgical condition (e.g., tumor disease, terminal cardiac failure, severe pulmonary disease, liver cirrhosis, post-organ transplant) that may either interfere with participation in the clinical trial and/or place the subject (in the judgment of the investigator [or delegate]) at significant risk if the subject participates in the clinical trial. • A known underlying disease or surgical, physical, or medical condition (e.g., tumor disease, terminal heart failure, severe lung disease, liver cirrhosis, post-organ transplant) that, in the opinion of the investigator (or delegate), could affect the interpretation of the clinical trial results Participation in a clinical intervention study with comparable endpoints and/or interventions for the treatment of type 2 diabetes (e.g. Vivora Coaching, mySugarApp) Pregnancy Insufficient language skills Inmates or patients under custodial care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change between baseline and 12 weeks of HbA1c levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in quality of life (diabetes-associated problem and distress (PAID)) | — |
Countries
Germany
Contacts
Public ContactJulia Brandts
Koordinierungszentrum für Kardiologische Studien (KKS) der Uniklinik RWTH Aachen
Outcome results
None listed