OBJECTIVES: The objective of this study was to evaluate the effectiveness of diabetes digital health tools in improving diabetic patient outcomes when deployed in the 'real world'. METHODS: A literature review was conducted in PubMed using key terms such as ‘diabetes’, ‘digital’, ‘health’, ‘e-health’, ‘m-health’, ‘mobile’, and ‘randomized’. Only English language publications published from 2011 through 2016 were targeted for abstraction. Abstracts were included if they were interventional studies, utilized a parallel group randomized design, enrolled diabetes only patients and evaluated diabetic study end-points. Studies were excluded if they were screening or prevention studies; product feasibility evaluations, meta-analyses; systematic reviews, and small pilot studies (<20 patients). Full articles from study eligible abstracts were retrieved for review. RESULTS: A total of 186 abstracts were initially identified and 28 articles (15%) were deemed to be eligible for study inclusion. More than half (57%) of these studies were US studies. 83% of these studies were published between 2014-2016. Three quarters of these studies focused on tools that promoted self-management or improved overall diabetes management. The remainder focused on tools that improved lifestyle education (7%), telemedicine/telehealth (14%), and treatment adherence (4%). A thorough review revealed that across these studies, the populations were small (range: 30-567 patients); were of short duration (range: 30 days-1 year); and had a modest or no impact on glycemic outcomes such as hemoglobin A1-C. (average hemoglobin A1-C difference, active vs. control arms: 0.3%). CONCLUSIONS: The effective clinical management of diabetes may be enhanced using digital health technologies. However, a review of the studies conducted recently to evaluate the clinical effectiveness of diabetes-focused digital health tools revealed modest or no impact on important diabetes outcomes..