E11
Conditions
Interventions
Group 1: Study participants who are randomized to the intervention group use the My Dose Coach app to adjust their basal insulin dose during the 12-week study period.
Group 2: Participants in the cont
Sponsors
Sanofi-Aventis Deutschland GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diagnosed type 2 diabetes (E11) - Indication for therapy with basal insulin in combination with oral antidiabetic agents - Age = 18 years - HbA1c value> 7.5% or 58.5 mmol / mol and <10.0% or 85.6 mmol / mol (last measured HbA1c value from the patient file) - Use of a smartphone compatible with the My Dose Coach app (iPhone models 5 and higher with iOS 10 or higher; Android version 4.4 or higher) - Willingness to consent to the terms and conditions of the My Dose Coach app - Knowledge of German, spoken and written - Existence of a written declaration of consent for participation in the study
Exclusion criteria
Exclusion criteria: - Treatment with prandial insulin (mealtime insulin) - Body Mass Index (BMI) <25 kg / m2 - Renal insufficiency (GFR <30 ml / min) - The presence of an acute psychiatric illness which, in the opinion of the investigator, affects the patient's ability to properly carry out the diabetes therapy or the study - Use of another titration app - Lack of consent due to limited legal capacity or legal support - Dependency on the sponsor or the clinical investigator (e.g. employees of the sponsor or a trial center and their family members) - Simultaneous participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable is the reduction in the HbA1c value in the intervention group using the My Dose Coach app compared to the control group without using the My Dose Coach app over a 12-week follow-up period. The HbA1c (from the patient file or current determination in the central laboratory) is collected at the beginning and at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome variables are: diabetes distress (coping with difficulties and reducing stress), diabetes self-management (therapy adherence), empowerment, expectation of self-efficacy and therapy satisfaction (patient sovereignty), psychological well-being (quality of life). These variables are recorded using various validated questionnaires. Furthermore, to record the quality of the diabetes therapy, glucose data from the blood glucose measuring systems are read out and evaluated. | — |
Countries
Germany
Contacts
Public ContactBernhard Kulzer
Forschungsinstitut Diabetes Akademie Bad Mergentheim (FIDAM GmbH)
Outcome results
None listed