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

Background The use of digital technology to assess patients remotely can reduce clinical study costs. In the European Union, the 2D matrix code on prescription drug packaging serves as a unique identifier of a given package of medication, and thus, also of the patient receiving that medication. Scanning of the 2D matrix code may therefore allow remote patient authentication in clinical studies. Objective The aim of the DePRO study was to assess the feasibility of a fully digital data-capture workflow, the authentication of participants via drug packaging 2D matrix codes, in patients with type 2 diabetes mellitus (T2DM) who use metformin. The primary objective was to describe the self-care activities of these patients. Secondary objectives were to evaluate (1) the self-reported health status of these patients, (2) the association of self-care activities with demographics and disease characteristics, and (3) the usability of the my ePRO app. Methods DePRO was an observational, multicenter, cross-sectional, digital, and patient-driven study conducted in Germany from June to December 2020. Adult patients prescribed metformin were invited to participate via their pharmacist or a medication tracker app. Participants downloaded the my ePRO app onto their own mobile device, scanned the 2D matrix code on their metformin package for registration and authentication, and provided informed consent via an electronic form. They were then able to complete a study-specific questionnaire on demographics and clinical characteristics, the German version of the Summary of Diabetes Self-Care Activities measure (SDSCA-G), the Diabetes Treatment Satisfaction Questionnaire (DTSQ), and the EQ-5D-5L. The patients conducted the study without support from a health care professional. Statistical analyses were exploratory and descriptive. Results In total, 3219 patients were invited to participate. The proportion of patients giving consent was greater among those invited by pharmacists (19/217, 8.8%) than among those invited via the medication tracker app (13/3002, 0.4%). Of the 29 patients eligible for analysis, 28 (97%) completed all study questionnaires. Most of the patients (23/29, 79%) were aged <60 years, and 59% (17/29) were male. The patients spent a mean total of 3.5 (SD 1.3) days out of 7 days on self-care activities (SDSCA-G). Most patients (24/29, 83%) were satisfied to extremely satisfied with their current treatment (DTSQ). Events of perceived hyperglycemia or hypoglycemia were reported by 20 of 29 (69%) patients. The best possible health status (EQ-5D-5L) was reported by 18 of 28 (64%) patients. Age was positively correlated with time spent on general and specific diet (Spearman coefficient 0.390 and 0.434, respectively). Conclusions The DePRO study demonstrates the feasibility of fully digital authentication (via 2D matrix codes on drug packaging) and data capture in patients with T2DM. Personal invitations yielded higher recruitment rates than remote invitations via the medication tracker app. A high questionnaire completion rate was realized, based on completion by 28 out of 29 patients. Trial Registration ClinicalTrials.gov NCT04383041; https://clinicaltrials.gov/ct2/show/NCT04383041 International Registered Report Identifier (IRRID) RR2-10.2196/21727

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BACKGROUND Type 2 Diabetes Mellitus affects patients’ quality of life which easily can be assessed directly with patients using standardized and validated instruments. The my ePRO app was constructed as an innovative mobile application to collect patient-reported outcomes in an investigator free study (Digital collected Patient Reported Outcomes in a Diabetes population - DePRO study). OBJECTIVE We aimed to describe the qualitative and quantitative feedback received during user experience testing in a diabetes mellitus type 2 focus group. METHODS The DePRO user experience study was conducted in a qualitative and quantitative research design with focus group methodology to test the my ePRO app. Metformin containing drug taking patients aged 18 years or older completed a 37-item qualitative questionnaire as the quantitative 6 scales and 26 items containing User Experience Questionnaire (UEQ) in a single focus group interview. The qualitative interview required next to the completion of the entire study workflow feedback on user experience to 1) the download of the app, 2) scanning the 2D matrix code, 3) accepting the informed consent form, 4) completing the demographic questionnaire and the 3 PRO instruments EQ-5D-5L, SDSCA and DTSQ, 5). Furthermore, feedback on finding the informed consent form, the withdrawl button and data protection information within the app was requested. RESULTS Nine T2DM patients, 3 female and 6 male, aged 55-88 years were interviewed for 45 to 65 minutes. Patients missed lay language within the app, criticized the length of the patient information informed consent form, the completeness of health information which was requested, missed pictures of the drugs they scanned and judged the questions to income and education as too indiscreet. As positive feedback patient reported that everything was fine, the answering of the questions was self-explaining and could be read without glasses. The UEC scales (mean; variances) Perspicuity (0.722; 1.73), Efficiency (0.5; 0.89) and Novelty (0.25; 1.13) were rated neutral, Attractiveness (0.854: 0.63), Dependability (1.031; 0.1) and Stimulation (1.094; 0.39) represent a positive evaluation. CONCLUSIONS The qualitative feedback of T2DM patients increased the awareness to test study applications like the my ePRO app in an indication and age specific user group. User experiences were captured, analyzed and implemented in the final app version which was used to run the DePRO study. The quantitative feedback was compared to a benchmark data set, to which the my ePRO app means were below average in all scales. The user experience testing provided insight into usage, challenges and areas of improvement of my ePRO app in a type 2 Diabetes Mellitus focus group. Understanding the different views, experiences and expectations can lead to a better design of health apps and a successful study conduct. CLINICALTRIAL ClinicalTrials.gov: NCT04383041