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
Authors: Mueller Christian , Schauerte Isabel , Martin Stephan 
Published: January 2021

Background
Diabetes mellitus (DM) is one of the most common noncommunicable diseases. DM has a substantial negative impact on patients’ quality of life, which is measured using a variety of diabetes-specific measures covering multiple aspects of patients’ psychological state, behavior, and treatment satisfaction. A fully digital data collection system, including patient identification, would represent a substantial advance in how these patient-reported outcome (PRO) data are measured. Within the European Union, one way to identify patients without the involvement of health care professionals is to use the unique 2D matrix codes on the packaging of prescription medication—for example, metformin, the recommended initial treatment for patients with type 2 DM (T2DM).

Objective
In the DePRO study we aim to (1) describe the self-care activities of patients with T2DM using metformin-containing medication; (2) describe the self-reported health status (eg, presence of diabetes complications and quality of life) of these patients; (3) describe associations between self-care activities and demographics and disease characteristics; and (4) assess the usability of the my ePRO app.

Methods
DePRO is an observational, multicenter, cross-sectional, digital, patient-driven study conducted in Germany. Patients with a prescription for a metformin-containing medication will be given a postcard by their pharmacist, which will include a download link for the my ePRO app. In total, 12 diabetes-focused pharmacies, selected to represent urban and rural areas, will be recruited. Participants will use their own mobile device (bring your own device) to download the my ePRO app and access the DePRO study, for which they can register using the 2D matrix code on their medication. An electronic informed consent form will be displayed to the patients and only after giving consent will patients be able to complete the study questionnaires. The PRO instruments used in the study are the Summary of Diabetes Self-Care Activities Scale, the Diabetes Treatment Satisfaction Questionnaire, and the 5 level, 5-dimension EuroQol Questionnaire. Patients will also be asked to complete a questionnaire with items addressing demographics, patient characteristics, disease history, complications, and concomitant medications. Data will be transferred to the study database by the app upon completion of each questionnaire. Statistical analyses of primary and secondary endpoints will be exploratory and descriptive.

Results
Enrollment began in June 2020. The estimated study completion date is December 31, 2020, and the planned sample size is 300 patients.

Conclusions
The DePRO study uses completely digital data collection, including authentication of eligible patients and completion of the study questionnaires. Therefore, the design of the DePRO study represents a substantial advance in the evaluation of the digital capturing of PRO data.

Trial Registration
ClinicalTrials.gov NCT04383041; https://clinicaltrials.gov/ct2/show/NCT04383041

International Registered Report Identifier (IRRID)
PRR1-10.2196/21727