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

Diabetes Mellitus, Type 2 Clinical Trial

— DePRO  

Official title:

Digital Collected Patient Reported Outcomes in a Diabetes Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383041
• Other study ID #: 21318
• Status: Completed
• Start date: July 2, 2020
• Est. completion date: January 27, 2021

Study information

• Verified date: June 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 27, 2021
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• No intervention
Completing questionnaires via ePRO app from their own mobile devices

Locations

Country	Name	City	State
Germany	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Acceptance of participation		Baseline
Secondary	Adherence to documentation		Baseline
Secondary	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
Secondary	DTSQ Participation rate	Diabetes Treatment Satisfaction Questionnaire (DTSQ) Number of invited, participating and non-participating patients (reasons for non-acceptance of study participation)	Baseline

External Links

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