Clinical trial NCT04383041: Study to Learn More About Outcomes Reported by Patients Suffering From Type 2 Diabetes Using a Digital Data Collection Tool
Official title: Digital Collected Patient Reported Outcomes in a Diabetes Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-05-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female and male patients with a valid prescription of a Metformin containing drug will be consecutively invited to the study in a public pharmacy after the decision for treatment with Metformin has been made by the treating physician.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) Score
timeFrame: Baseline
Secondary outcomes:
measure: Association between SDSCA score and demographic/ disease characteristics
timeFrame: Baseline
measure: Acceptance of participation
timeFrame: Baseline
measure: Adherence to documentation
timeFrame: Baseline
measure: Health related Quality of Life-EuroQol five dimensions Questionnaire (EQ-5D)
timeFrame: Baseline
measure: DTSQ Participation rate
timeFrame: Baseline
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Mueller C, Schauerte I, Martin S, Irrgang V. Evaluation of Self-care Activities and Quality of Life in Patients With Type 2 Diabetes Treated With Metformin Using the 2D Matrix Code of Outer Drug Packages as Patient Identifier: the DePRO Proof-of-Concept Observational Study. JMIR Diabetes. 2022 May 24;7(2):e31832. doi: 10.2196/31832.
citation: Mueller C, Schauerte I, Martin S. Evaluation of Self-Care Activities and Quality of Life in Patients With Type 2 Diabetes Mellitus Treated With Metformin Using the 2D Matrix Code of Outer Drug Packages as Patient Identifier: Protocol for the DePRO Proof-of-Concept Observational Study. JMIR Res Protoc. 2021 Jan 11;10(1):e21727. doi: 10.2196/21727.