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.

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.