Long-Term Real-World Data from glucura: A Digital Therapeutic (DiGA) for Personalized Lifestyle Therapy for Type 2 Diabetes.

Introduction: Lifestyle changes are highly effective in order to manage type 2 diabetes (T2D), but implementing them is accompanied by different challenges. This is where digital therapeutics (DiGA) can help in terms of innovation trying to close the gaps in standard care. This study takes a closer look at the clinical efficacy of glucura, a DiGA which offers personalized lifestyle therapy supported by AI-based algorithms, for T2D patients.

Methods: A total of 118 non-insulin-treated T2D participants underwent the 3-month program of glucura. The intervention includes analysis, rating and prediction of individual postprandial glycemic responses of meals using continuous glucose monitoring (CGM) and AI-based algorithms. It takes different lifestyle changes into account such as adopting a low-glycemic diet, reducing caloric intake, and promoting physical activity. Intraindividual changes in HbA1c, body weight, BMI, and quality of life (SF-36) were assessed using paired t-tests. Patients’ global impression of change was assessed using the PGIC questionnaire. App usage and usability were monitored biweekly. Long-term effectiveness was measured after a second cycle of glucura (6 months; n=67) and are awaited in the future.

Results: After 3 months, HbA1c decreased by -0.67% points ([−0.89,−0.46], n=118, p<0.001), with a greater reduction of−1.08% ([−1.38,−0.78], n=73, p<0.001) in patients with BL-HbA1c≥7%. The proportion of patients within the therapeutic target range (<7.0%) increased from 38% to 60%, and 33% were on the way to remission (<6.5%). Patients who used the DiGA a second time experienced a reduction of−0.76% ([-1.02, -0.50], n=51, p<0.001) in their HbA1c compared to BL. Body weight decreased by−3.5 kg ([−4.27,−2.71], n=116, p<0.001) after 3 months and almost twice as much by−6.84 kg ([−9.45,−4.22], n=51, p<0.001) after a second cycle compared to baseline. Quality of life significantly improved (SF-36), with 73% of participants reporting better general health (PGIC). High engagement and satisfaction levels underlined glucura’s usability.

Discussion: The DiGA glucura makes use of the maximum potential of CGM with AI-driven algorithms in order to deliver personalized lifestyle therapy for T2D patients by addressing day-to-day challenges when modifying their lifestyle. It demonstrates substantial clinical benefits in HbA1c reduction, weight loss, and improvement of quality of life, emphasizing the need for its integration into standard care. Multiple usage indicates that patients can increase their benefit, reinforcing its role as a scalable, long-term, non-pharmacological solution for T2D management.

Publication History

Article published online:
28 May 2025