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The Digital Diabetes Patient Reminder Tool for Adults With Type 2 Diabetes: Protocol for a Proof-of-Concept
Barbara Annancy1, Steve Van den Bulck1,2, Steffen Fieuws3
1Academic Center for General Practice, Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 7 blok g - bus 7001, Leuven, Flanders, 3000, Belgium, 32 16330078.
Background:
About 828 million adults were estimated to be living with diabetes, and this is projected to affect 1 in 9 adults by 2045. In Belgium, 7.6% of adults have been diagnosed with the disease; however, approximately 1 in 3 people remain unaware of their condition. Advances in information and communication technology (ICT) have improved care quality and health management, and facilitated communication between health care providers and patients. The Digital Diabetes Patient Reminder (DIPAR) tool was developed as an extension of the existing patient portal to support diabetes management through automated reminders for overdue monitoring, and a consultation dashboard that facilitates communication between patients and health care providers. This pilot study was conducted within the European Joint Action on Cardiovascular Diseases and Diabetes framework.
Objective:
This trial aims to evaluate whether the implementation of the DIPAR tool improves adherence to recommended diabetes follow-up. The primary objective is to determine whether the intervention increases the proportion of adults with type 2 diabetes mellitus (T2DM) who receive at least one documented annual albuminuria measurement in the electronic medical records (EMR). The key secondary objective is to assess whether the intervention increases the proportion of patients with at least 2 documented hemoglobin A1c (HbA1c) measurements within 12 months. Exploratory objectives include evaluating changes in diabetes-related clinical parameters (HbA1c, albuminuria, low-density lipoprotein (LDL)-cholesterol, and systolic blood pressure), as well as the usability and acceptability of the intervention among patients and health care professionals.
Methods:
This multicenter, pragmatic, parallel-group, proof-of-concept randomized controlled trial (RCT) will recruit approximately 200 adults with T2DM receiving outpatient diabetes care at 2 hospitals in Flanders, Belgium. Participants will be randomized (1:1), stratified only by study center, to receive either the DIPAR tool extension in addition to usual care or usual care alone using the standard patient portal. The intervention consists of automated reminders for timely follow-up and a consultation dashboard to be used by patients and physicians. The intervention will last 12 months. Clinical outcomes will be extracted from the EMR, while usability and acceptability will be evaluated using the Dutch and English versions of the Mobile Health App Usability Questionnaire (MAUQ), semistructured interviews, and focus group discussions. The primary analysis will follow the intention-to-treat principle using regression-based methods appropriate for each outcome.
Results:
Recruitment started in October 2025 and was completed in December 2025. A total of 201 patients were recruited, with 100 participants allocated to the intervention group. Data extraction did not commence until March 2026, after the completion of the statistical analysis plan and the protocol submission. Data analysis has not started.
Conclusions:
This study will provide insights into the potential added value of a digital reminder tool for T2DM management in a real-world setting as well as the usability and acceptability of this tool.