NCT04383041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

April 23, 2020

Last Update Submit

June 29, 2021

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (5)

  • Association between SDSCA score and demographic/ disease characteristics

    Baseline

  • Acceptance of participation

    Baseline

  • Adherence to documentation

    Baseline

  • Health related Quality of Life-EuroQol five dimensions Questionnaire (EQ-5D)

    Baseline

  • DTSQ Participation rate

    Baseline

Study Arms (1)

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

Interventions

No interventionOTHER

Completing questionnaires via ePRO app from their own mobile devices

Patients with Type 2 Diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \- Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many locations

Multiple Locations, Germany

Location

Related Publications (2)

  • 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.

    PMID: 35608887DERIVED

  • 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.

    PMID: 33427685DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

May 11, 2020

Study Start

July 2, 2020

Primary Completion

December 9, 2020

Study Completion

January 27, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Locations

DE(1)