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

NCT ID: NCT04383041

Last Updated: 2021-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-02

Study Completion Date

2021-01-27

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with Type 2 Diabetes

Patients with Metformin containing prescription drugs will be eligible for participation and consecutively invited to study participation in their pharmacy.

No intervention

Intervention Type OTHER

Completing questionnaires via ePRO app from their own mobile devices

Interventions

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No intervention

Completing questionnaires via ePRO app from their own mobile devices

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many locations

Multiple Locations, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 35608887 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33427685 (View on PubMed)

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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21318

Identifier Type: -

Identifier Source: org_study_id

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