Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2
Brief summary
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.
Interventions
OTHERNo intervention
Completing questionnaires via ePRO app from their own mobile devices
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) Score | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between SDSCA score and demographic/ disease characteristics | Baseline | Association of Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) with demographic and disease characteristics |
| Acceptance of participation | Baseline | — |
| Adherence to documentation | Baseline | — |
| Health related Quality of Life-EuroQol five dimensions Questionnaire (EQ-5D) | Baseline | Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). |
| DTSQ Participation rate | Baseline | Diabetes Treatment Satisfaction Questionnaire (DTSQ) Number of invited, participating and non-participating patients (reasons for non-acceptance of study participation) |
Countries
Germany
Outcome results
None listed