The effectiveness of a personalized lifestyle therapy for type 2 diabetes treatment: Real World Data from the Digital Health Application (DiGA) glucura

 

Introduction: Lifestyle interventions are fundamental in managing type 2 diabetes (T2D), yet their successful implementation remains challenging. Digital health applications (DiGA) offer new opportunities for improving therapy adherence and addressing gaps in routine care. This study evaluates the clinical effectiveness of glucura, a DiGA providing dynamic and personalized lifestyle therapy supported by an AI-based algorithm for non-insulin-treated T2D patients.

Methods: Over 12 weeks, 118 non-insulin-treated T2D patients participated in the study. glucura encompasses personalized analyses of individuals' postprandial glycemic responses based on continuous glucose monitoring (CGM), guideline-based digital support for dietary changes, guidance for increased physical activity, and educational content. Intraindividual differences (baseline (BL) vs. after 12 weeks) in HbA1c, body weight, BMI, and quality of life (SF-36) were analyzed using the t-test. General condition changes were assessed with the validated PGIC questionnaire after 12 weeks. App usage and usability were evaluated every 4 weeks.

Results: After 12 weeks of using glucura, there was a reduction in HbA1c of -0.65% points ([-0.79; -0.50], n=118, p<0.001) compared to standard of care (Disease Management Program, DMP). The target population with a BL-HbA1c ≥ 7% achieved a reduction of -0.91% points ([-1.10; -0.71], n=73, p<0.001). Body weight decreased by -3.57 kg ([-4.58; -2.56], n=117, p<0.001) and BMI by 1.23 kg/m2. Health-related quality of life increased by 1.92 ([0.67; 3.18], n=100-115, p=0.003) on the physical summation scale and by 3.28 ([1.11; 5.45], n=100-115, p=0.003) on the psychological summation scale. 73% reported a subjective improvement in their general condition (PGIC). The patients used glucura on average 4.7 to 6.5 days a week, rating the comprehensibility of recommendations at an average of 4.3 to 4.5 out of 5 points. Patients found that glucura´s content enabled them to manage their disease effectively, with an average score of 3.8 to 4.0 out of 5 points.

Discussion: The study demonstrates therapeutic improvements in HbA1c, body weight, and quality of life after 12 weeks of using glucura compared to standard care (DMP). The target group with a baseline HbA1c above 7% particularly benefited. Patients reported a positive user experience, indicating high satisfaction with the use and usability of the diabetes DiGA. In conclusion, glucura proves to be a therapeutically effective digital intervention with good use and usability for T2D patients, suitable for standard care as basic therapy and for therapy escalation.

Publication History

Article published online:
18 April 2024

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