Study to Learn More About Outcomes Reported by Patients Suffering From Type 2 Diabetes Using a Digital Data Collection Tool

Study Overview
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Brief Summary
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In this study researchers want to gain more information on patients who are treated with Metformin for their Type 2 Diabetes. Adult female and male patients with a prescription of a Metformin containing drug will be invited to the study in a public pharmacy after the decision for treatment with Metformin has been made by the treating physician. The pharmacist will provide interested participants access to a special phone App and participants are asked to complete via this phone App a questionnaire on their health situation with special focus on their Type 2 Diabetes. This includes questions on complications and self-care activities in relation to their diabetes, questions on quality of life and health history. There will be no extra visit to the treating doctor or a pharmacy. The study is aiming to have the questionnaire completed by 300 participants.

Official Title
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Digital Collected Patient Reported Outcomes in a Diabetes Cohort

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female or male patient Valid prescription for a Metformin containing drug approved in Germany Decision to initiate treatment with Metformin was made by the treating physician as part of the routine treatment practice Signed informed consent Exclusion Criteria: - Not applicable

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Type 2 Diabetes<br>Patients with Metformin containing prescription drugs will be eligible for participation and consecutively invited to study participation in their pharmacy. | Other: No intervention<br>* Completing questionnaires via ePRO app from their own mobile devices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) Score | The SDSCA measure is a brief self-report questionnaire of diabetes self-management. It assesses the number of days per week in which respondents engage in diabetes health-related behaviors in the areas of general diet, diabetes-specific diet, physical activity, blood-glucose testing, foot care, and smoking. Minimum score 0. Maximum score 77. Higher scores indicate better self care. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between SDSCA score and demographic/ disease characteristics | Association of Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) with demographic and disease characteristics | Baseline | 
| Acceptance of participation |  | Baseline | 
| Adherence to documentation |  | Baseline | 
| Health related Quality of Life-EuroQol five dimensions Questionnaire (EQ-5D) | Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). | Baseline | 
| DTSQ Participation rate | Diabetes Treatment Satisfaction Questionnaire (DTSQ) Number of invited, participating and non-participating patients (reasons for non-acceptance of study participation) | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2