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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: No intervention

• Registration Number: NCT04383041
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-11
• Study Start: 2020-07-02
• Primary Completion: 2020-12-09
• Study Completion: 2021-01-27
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Type 2 Diabetes	No intervention	Patients with Metformin containing prescription drugs will be eligible for participation and consecutively invited to study participation in their pharmacy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
DTSQ Participation rate	Baseline	Diabetes Treatment Satisfaction Questionnaire (DTSQ) Number of invited, participating and non-participating patients (reasons for non-acceptance of study participation)
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).

Trial Locations

Locations (1)

Many locations; 🇩🇪 Multiple Locations, Germany