Randomized controlled trial to evaluate the digital health application My Dose Coach

Not Applicable

• Conditions: E11; Type 2 diabetes mellitus

• Registration Number: DRKS00024861
• Lead Sponsor: Sanofi-Aventis Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-13
• Study Completion: 2022-07-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 251

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>Furthermore, to record the quality of the diabetes therapy, glucose data from the blood glucose measuring systems are read out and evaluated.