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

June 29, 2021 updated by: Bayer

Digital Collected Patient Reported Outcomes in a Diabetes Cohort

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Multiple Locations, Germany
        • Many locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No intervention
Completing questionnaires via ePRO app from their own mobile devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) Score
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between SDSCA score and demographic/ disease characteristics
Time Frame: Baseline
Association of Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) with demographic and disease characteristics
Baseline
Acceptance of participation
Time Frame: Baseline
Baseline
Adherence to documentation
Time Frame: Baseline
Baseline
Health related Quality of Life-EuroQol five dimensions Questionnaire (EQ-5D)
Time Frame: Baseline
Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
Baseline
DTSQ Participation rate
Time Frame: Baseline
Diabetes Treatment Satisfaction Questionnaire (DTSQ) Number of invited, participating and non-participating patients (reasons for non-acceptance of study participation)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2020

Primary Completion (Actual)

December 9, 2020

Study Completion (Actual)

January 27, 2021

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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