DRKS00024861
Completed
未知
Randomized controlled trial to evaluate the digital health application My Dose Coach
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- E11
- Sponsor
- Sanofi-Aventis Deutschland GmbH
- Enrollment
- 251
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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