Clinical evidence for high-risk medical devices used to manage diabetes: protocol for a systematic review and meta-analysis

Introduction Medical devices, including high-risk medical devices, have greatly contributed to recent improvements in the management of diabetes. However, the clinical evidence that is submitted for regulatory approval is not transparent, and thus a comprehensive summary of the evidence for high-risk devices approved for managing diabetes in Europe is lacking. In the framework of the Coordinating Research and Evidence for Medical Devices group, we will, therefore, perform a systematic review and meta-analysis, which will evaluate the efficacy, safety and usability of high-risk medical devices for the management of diabetes.Method and analysis This study has been reported according to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. We will search Embase (Elsevier), Medline All (Ovid), Cochrane Library (Wiley), Science Citation Index Expanded and Emerging Sources Citation Index (Web of Science) to identify interventional and observational studies that evaluate the efficacy and/or safety and/or usability of high-risk medical devices for the management of diabetes. No language or publication dates’ limits will be applied. Animal studies will be excluded. In accordance with the Medical Device Regulation in European Union, high-risk medical devices are those in classes IIb and III. The following medical devices for diabetes management are considered as having a high risk: implantable continuous glucose monitoring systems, implantable pumps and automated insulin delivery devices. Selection of studies, data extraction and quality of evidence assessment will be performed independently by two researchers. Sensitivity analysis will be performed to identify and explain potential heterogeneity.Ethics and dissemination No ethical approval is needed for this systematic review, as it is based in already published data. Our findings will be published in a peer-reviewed journal.PROSPERO registration number CRD42022366871

Protective and risk factors for mental distress and its impact on health-protective behaviors during the SARS-CoV-2 pandemic between march 2020 and march 2021 in Germany

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is posing a global public health burden. These consequences have been shown to increase the risk of mental distress, but the underlying protective and risk factors for mental distress and trends over different waves of the pandemic are largely unknown. Furthermore, it is largely unknown how mental distress is associated with individual protective behavior. Three quota samples, weighted to represent the population forming the German COVID-19 Snapshot Monitoring study (24 March and 26 May 2020, and 9 March 2021 with >900 subjects each), were used to describe the course of mental distress and resilience, to identify risk and protective factors during the pandemic, and to investigate their associations with individual protective behaviors. Mental distress increased slightly during the pandemic. Usage of cognitive reappraisal strategies, maintenance of a daily structure, and usage of alternative social interactions decreased. Self-reported resilience, cognitive reappraisal strategies, and maintaining a daily structure were the most important protective factors in all three samples. Adherence to individual protective behaviors (e.g., physical distancing) was negatively associated with mental distress and positively associated with frequency of information intake, maintenance of a daily structure, and cognitive reappraisal. Maintaining a daily structure, training of cognitive reappraisal strategies, and information provision may be targets to prevent mental distress while assuring a high degree of individual protective behaviors during the COVID-19 pandemic. Effects of the respective interventions have to be confirmed in further studies