Real-world data (RWD) in clinical research on specific categories of medical devices can generate sufficient quality evidence which will be used in decision making. This paper discusses the limitations of traditional randomized controlled trials in clinical research of medical devices, summarizes and analyses the applicable conditions of real-world evidence (RWE) for medical devices, interprets the new FDA guidance document on the characteristics of RWD for medical devices, in order to provide evidence for the use of RWE in medical devices in our country.
ObjectiveTo systematically review the efficacy of interactive message management on patients with type 2 diabetes mellitus (T2DM).MethodsCNKI, VIP, WanFang Data, Web of Science, PubMed and The Cochrane Library databases were electronically searched to collect randomized controlled trials (RCTs) of T2DM with interactive message intervention from inception to May 2021. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed by using Revman5.3 software.ResultsA total of 17 RCTs involving 1 827 patients were included. Results of meta-analyses showed that compared with routine management, interactive message combined with routine management was associated with improvement of glycosylated hemoglobin, fasting blood glucose, body mass index, systolic blood pressure, and total cholesterol in T2DM patients. However, diastolic blood pressure, triglyceride, low-density lipoprotein, or high-density lipoprotein were not improved. ConclusionsThe current evidence shows that interactive message combined with routine management can significantly reduce blood glucose level, body mass index, systolic blood pressure and total cholesterol in T2DM patients. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusions.