Real-World Evidence on Mobile App–Supported Diabetes Management in Insulin-Treated Patients - Research Article

Sep 29, 2026

Digital health interventions such as mobile diabetes apps aim to support glycemic control, and real-world data (RWD) offer evidence beyond randomized trial conditions. This study evaluates the effectiveness of the mobile diabetes app ESYSTA for improving glycemic control in insulin-treated patients using real-world evidence. A retrospective analysis of 475 users assessed HbA1c changes after 6 months and longer use (12–15 months), with a linear mixed model adjusting for confounding. ESYSTA users showed a significant HbA1c reduction that persisted up to 15 months.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages8

Reading Time20 min

AccessFree to download

Introduction

Digital health and glycemic control

Evidence from RCTs vs real-world data

Methods

Study design and preregistration

Intervention: ESYSTA app and portal

Data sources and HbA1c availability

Wiley Journal of Diabetes Research Volume 2025, Article ID 6671361, 8 pages [https://doi.org/10.1155/jdr/6671361](https://doi.org/10.1155/jdr/6671361) Research Article Real-World Evidence on Mobile App–Supported Diabetes Management in Insulin-Treated Patients Lena Roth , Julian Stein, and Peter E. H. Schwarz Department for Prevention and Care of Diabetes, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany Correspondence should be addressed to Lena Roth; lena_maria_klara.roth@tu-dresden.de Received 19 March 2025; Revised 20 August 2025; Accepted 27 August 2025 Academic Editor: Syed Anees Ahmed Copyright © 2025 Lena Roth et al. Journal of Diabetes Research published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. Background: Digital health interventions, such as mobile diabetes apps, are aimed at supporting glycemic control. Real-world data (RWD) provide valuable insights into their long-term eﬀectiveness beyond the controlled conditions of randomized trials. Objective: This study evaluates the eﬀectiveness of the mobile diabetes app ESYSTA in improving glycemic control using realworld evidence. Methods: A retrospective analysis of 475 users was conducted to assess HbA1c changes after 6 months of usage and also longterm usage (12 and 15 months) . A linear mixed model was used to adjust for confounding factors. After 6 months, ESYSTA users achieved a signiﬁcant HbA1c reduction of −0.59 (−0.70; −0.48) percentage points compared to baseline, which was maintained for up to 15 months. Users with higher baseline HbA1c showed greater reductions. Seventyﬁve percent of users tracked their blood glucose values consistently during the whole observation period. Conclusion: These real-world evidence ﬁndings demonstrate the eﬀectiveness of a mobile diabetes app in improving glycemic control over an extended period. While statistical adjustments addressed potential biases, missing data remain a challenge. Further research, including controlled studies, is needed to conﬁrm these real-world results and further explore the underlying mechanisms of sustained HbA1c improvement. Keywords: diabetes mellitus; digital health intervention; eHealth; HbA1c; real-world data; real-world evidence; self-management 1. Introduction For insulin-treated people with diabetes, digital diabetes management tools have become a relevant therapy component to improve patients’ self-management and ultimately diabetes-related health outcomes [1] . Glycemic control has been shown to prevent both hypo- and hyperglycemicevents, thereby lowering the risk of diabetes-related microand macrovascular complications, like diabetic retinopathy or neuropathy and cardiovascular diseases [2, 3] . Studies have demonstrated that blood glucose monitoring (BGM) in patients with both type 1 (T1D) and type 2 diabetes (T2D) mellitus is associated with improved glycemic control. Continuous blood glucose monitors (CGMs) have been shown to increase the time in range and decrease HbA1c levels [4] . However, (structured) BGM remains atime- and cost-eﬃcient alternative that can be as eﬀective for managing diabetes as CGMs [7–9]; for example, the self-monitoring of blood glucose (SMBG) has been shown to improve the understanding of blood glucose trends and enhance the precision of medical therapy decisions and adjustments [8] . This retrospective, observational study is aimed at analyzing real-world data (RWD) from a digital device (ESYSTA, Emperra GmbH E-Health Technologies, Germany) that incorporates both CGM and BGM data to enhance the glycemic control and self-management of insulin-treated people with diabetes. Its eﬃcacy has been shown in a previous RCT and a controlled real-world study [10, 11] . While RCTs remain the gold standard to evalua

FAQs

What was the objective of the study?

The study evaluated the effectiveness of the mobile diabetes app ESYSTA in improving glycemic control using real-world evidence.

How was effectiveness measured?

Effectiveness was assessed by changes in HbA1c after 6 months of usage and during longer follow-up (12 and 15 months).

What were the main findings and how long were they maintained?

After 6 months, ESYSTA users achieved a significant HbA1c reduction compared with baseline, and the improvement was maintained for up to 15 months.

Sep 29, 2026

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