CLINICAL TRIAL article
Front. Digit. Health
Sec. Health Technology Implementation
Volume 7 - 2025 | doi: 10.3389/fdgth.2025.1544668
This article is part of the Research TopicExploring the Benefits of Digital Health Technologies in Diabetes ManagementView all 9 articles
Impact of a Digital Application on HbA1c Levels in People with diabetes: A Randomized Controlled Study
Provisionally accepted
- Department of General Medicine, Faculty of Medicine Carl Gustav Carus, School of Medicine, Technical University Dresden, Dresden, Lower Saxony, Germany
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Digital applications have the potential to enhance diabetes management, particularly in patients that are treated with insulin. This study aims to evaluate the impact of a digital application on self-management (ESYSTA ® , Germany), expressed in a change in HbA1c levels, in people with diabetes treated with insulin.A randomized controlled trial including 204 people with diabetes (60% type 2 diabetes) that are treated with insulin to assess the efficacy of ESYSTA ® . Participants were randomly assigned to either the intervention group (IG) using ESYSTA ® in addition to the German standard of Care (SoC) according to the German disease management programs (DMP) for six months or a control group (CG) receiving SoC only. The primary endpoint was the change in HbA1c levels. Secondary endpoints included wellbeing and diabetes-related distress.A clinically relevant reduction in HbA1c levels of on average -0.48% points [-0.66; -0.29] was observed in the IG after 6 months. Compared to the CG this reduction was Field Code Changed Deleted: involving Deleted: Patients Formatted: English (UK) Formatted: English (UK) Deleted: 0.4% also more pronounced, especially in the per-protocol sample (mean difference: -0.28% points, 95% CI: [-0.54; -0.02]). Improvements in the IG in further secondary endpoints, like well-being or diabetes-related distress, indicate enhanced overall glycemic control and patient satisfaction in the IG.The use of ESYSTA ® improved HbA1c levels and other secondary outcomes in people with diabetes that are treated with insulin in comparison to German SoC in the context of DMP. These findings support the integration of digital tools in routine diabetes care to optimize patient outcomes.
Keywords: glycemic control, digital application (DiGA), insulin-treated diabetes mellitus, Diabetes care technology, diabetes self-management, blood glucose tracking
Received: 13 Dec 2024; Accepted: 12 May 2025.
Copyright: © 2025 Roth, Steckhan and Schwarz. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Lena Roth, Department of General Medicine, Faculty of Medicine Carl Gustav Carus, School of Medicine, Technical University Dresden, Dresden, 01307, Lower Saxony, Germany
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