ArticleTrials2022
Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed.
- A Patient- and Function-Centric Model/Approach for Hypoglycemia Management in Older Adults.Geriatrics (Basel, Switzerland) · 2026Review
- Medication adherence in adolescents: physiological, psychosocial, and clinical perspectives.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Improvements in Glycemic Control With a Digital Diabetes Logbook: Secondary Analysis of a Randomized Controlled Trial Enriched by Observational, Real-World Data.Journal of medical Internet research · 2025Observational
- Technology use and health behavior among patients with diabetes: do underlying motives for technology adoption matter?Frontiers in digital health · 2025Article
- Prevalence and Correlators of Diabetes Distress in Adults with Type 2 Diabetes: A Cross-Sectional Study.Patient preference and adherence · 2024Article
- Advancing Diabetes Self-Management: A Novel Smartphone Application Featuring a Scoring Algorithm for Tailored User Engagement.International journal of preventive medicine · 2024Article
- Functions of mHealth Diabetes Apps That Enable the Provision of Pharmaceutical Care: Criteria Development and Evaluation of Popular Apps.International journal of environmental research and public health · 2022Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDiabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support people with diabetes. Since reimbursability would increase the availability of such digital applications to people with diabetes, we designed a study that meets all scientific and methodological requirements set by the German Digital Healthcare Act to allow reimbursement for a specific application (mySugr PRO). Here, we report the protocol of this study that aims at evaluating the efficacy of the digital self-management application with regard to patient-reported outcomes and medical benefits. METHODS/
designThis multicenter, open-label, randomized, parallel-group, controlled trial will evaluate the health care effects and medical benefits of mySugr PRO. A total of 466 people with diabetes will be randomly allocated (2:1 randomization) to the interventional group (n = 311) that will use the digital self-management application during the 12-week study period or the control group (n = 155; no usage of the application). Baseline and follow-up examinations will assess diabetes distress as the primary endpoint as well as empowerment, HbA1c, blood glucose data, self-management, general well-being, and treatment satisfaction as secondary endpoints. Statistical analyses will use an intention-to-treat procedure (using multiple imputation for missing values) as well as a per-protocol approach for sensitivity analysis. DISCUSSION: To the best of our knowledge, this study will be one of the largest diabetes-specific evaluations of a digital health application supporting people with diabetes in their diabetes self-management that follow the requirements of the German Digital Healthcare Act.
trial registrationGerman Clinical Trial Register DRKS00022923 . Registered on 22 October 2020.
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