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Background  Diabetes mellitus, which causes dysregulation of blood glucose in humans, is a major public health challenge. Patients with diabetes must monitor their glycemic levels to keep them in a healthy range. This task is made easier by using continuous glucose monitoring (CGM) devices and relaying their output to smartphone apps, thus providing users with real-time information on their glycemic fluctuations and possibly predicting future trends.    Objective  This study aims to discuss various challenges of predictive monitoring of glycemia and examines the accuracy and blood glucose control effects of Diabits, a smartphone app that helps patients with diabetes monitor and manage their blood glucose levels in real time.    Methods  Using data from CGM devices and user input, Diabits applies machine learning techniques to create personalized patient models and predict blood glucose fluctuations up to 60 min in advance. These predictions give patients an opportunity to take pre-emptive action to maintain their blood glucose values within the reference range. In this retrospective observational cohort study, the predictive accuracy of Diabits and the correlation between daily use of the app and blood glucose control metrics were examined based on real app users’ data. Moreover, the accuracy of predictions on the 2018 Ohio T1DM (type 1 diabetes mellitus) data set was calculated and compared against other published results.    Results  On the basis of more than 6.8 million data points, 30-min Diabits predictions evaluated using Parkes Error Grid were found to be 86.89% (5,963,930/6,864,130) clinically accurate (zone A) and 99.56% (6,833,625/6,864,130) clinically acceptable (zones A and B), whereas 60-min predictions were 70.56% (4,843,605/6,864,130) clinically accurate and 97.49% (6,692,165/6,864,130) clinically acceptable. By analyzing daily use statistics and CGM data for the 280 most long-standing users of Diabits, it was established that under free-living conditions, many common blood glucose control metrics improved with increased frequency of app use. For instance, the average blood glucose for the days these users did not interact with the app was 154.0 (SD 47.2) mg/dL, with 67.52% of the time spent in the healthy 70 to 180 mg/dL range. For days with 10 or more Diabits sessions, the average blood glucose decreased to 141.6 (SD 42.0) mg/dL ( P <.001), whereas the time in euglycemic range increased to 74.28% ( P <.001). On the Ohio T1DM data set of 6 patients with type 1 diabetes, 30-min predictions of the base Diabits model had an average root mean square error of 18.68 (SD 2.19) mg/dL, which is an improvement over the published state-of-the-art results for this data set.    Conclusions  Diabits accurately predicts future glycemic fluctuations, potentially making it easier for patients with diabetes to maintain their blood glucose in the reference range. Furthermore, an improvement in glucose control was observed on days with more frequent Diabits use.

The Diabits App for Smartphone-Assisted Predictive Monitoring of Glycemia in Patients With Diabetes: Retrospective Observational Study