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Background  There is a growing role of digital health technologies (DHTs) in the management of chronic health conditions, specifically type 2 diabetes. It is increasingly important that health technologies meet the evidence standards for health care settings. In 2019, the National Institute for Health and Care Excellence (NICE) published the  NICE Evidence Standards Framework for DHTs . This provides guidance for evaluating the effectiveness and economic value of DHTs in health care settings in the United Kingdom.    Objective  The aim of this study is to assess whether scientific articles on DHTs for the self-management of type 2 diabetes mellitus report the evidence suggested for implementation in clinical practice, as described in the  NICE Evidence Standards Framework for DHTs .    Methods  We performed a scoping review of published articles and searched 5 databases to identify systematic reviews and primary studies of mobile device–delivered DHTs that provide self-management support for adults with type 2 diabetes mellitus. The evidence reported within articles was assessed against standards described in the NICE framework.    Results  The database search yielded 715 systematic reviews, of which, 45 were relevant and together included 59 eligible primary studies. Within these, there were 39 unique technologies. Using the NICE framework, 13 technologies met  best practice  standards, 3 met  minimum  standards only, and 23 technologies did not meet  minimum  standards.    Conclusions  On the assessment of peer-reviewed publications, over half of the identified DHTs did not appear to meet the minimum evidence standards recommended by the NICE framework. The most common reasons for studies of DHTs not meeting these evidence standards included the absence of a comparator group, no previous justification of sample size, no measurable improvement in condition-related outcomes, and a lack of statistical data analysis. This report provides information that will enable researchers and digital health developers to address these limitations when designing, delivering, and reporting digital health technology research in the future.

jmir diabetes

Application of the National Institute for Health and Care Excellence Evidence Standards Framework for Digital Health Technologies in Assessing Mobile-Delivered Technologies for the Self-Management of Type 2 Diabetes Mellitus: Scoping Review