E10 E11
Conditions
Interventions
Group 1: The intervention group uses the ESYSTA® digital health application (consisting of app, portal and compatible measuring devices) as part of diabetes treatment
Group 2: The control group receiv
Sponsors
Emperra GmbH E-Health Technologies
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diabetes mellitus type 1 or type 2 - Treated with insulin - HbA1c at baseline = 7.5% and = 11.0%. - No use of ESYSTA® in the past 12 months. - Willingness to use a smart glucometer and/or smart insulin pen - Internet access, smartphone/computer compatible with ESYSTA®. - Digital literacy for sufficient understanding of the user interface (ESYSTA®).
Exclusion criteria
Exclusion criteria: - Use of other apps connected to a blood glucose meter or use of an insulin pump or continuous glucose monitoring - Use of ESYSTA® in the past 12 months - Impairments (including mental impairments) - Current participation in a weight loss program - Current participation in another study - Steroid therapy within the last three months (not an exclusion criterion if used topically or inhaled less than five times per week) - Blood pressure = 200 mmHg at screening - Body mass index (BMI) = 40 kg/m² - Anemia (as defined by WHO) - Glomerular filtration rate (GFR) = 40 ml/min - Current or planned pregnancy, breastfeeding women - Alcohol or drug abuse (within the last three months) - Patients with home care (assistance with BG measurement) - Employees of Emperra GmbH E-Health Technologies (or other institutions involved in the study in any way)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c value during the use of ESYSTA® (data collection by measuring the HbA1c value) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change from baseline of the PAID after 6 months of treatment (diabetes related distress) • Veränderung gegenüber dem Ausgangswert der WHO-5 nach 6-monatiger Behandlung (Wohlbefinden) | — |
Countries
Germany
Contacts
Public ContactPeter E. H. Schwarz
Universitätsklinikum Carl Gustav Carus
Outcome results
None listed