check_circleStudy Completed

Diabetes Mellitus, Type 2

Bayer Identifier:

21318

ClinicalTrials.gov Identifier:

NCT04383041

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to learn more about outcomes reported by patients suffering from type 2 diabetes using a digital data collection tool

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - Not applicable

Trial summary

Enrollment Goal
32
Trial Dates
July 2020 - January 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Germany

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Baseline

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Baseline
  • Acceptance of participation
    date_rangeTime Frame:
    Baseline
  • Adherence to documentation
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    Baseline
  • DTSQ Participation rate
    Diabetes Treatment Satisfaction Questionnaire (DTSQ) Number of invited, participating and non-participating patients (reasons for non-acceptance of study participation)
    date_rangeTime Frame:
    Baseline

Trial design

Digital collected Patient Reported Outcomes in a Diabetes Cohort
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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