Clinical Effects of a Digital Health Intervention for Adults With Type 2 Diabetes in the United States: Retrospective Cohort Study.
Source: PubMed, NCBI / U.S. National Library of Medicine
Digital health interventions show promise in supporting adults with type 2 diabetes mellitus (T2DM). Dario is a digital diabetes solution (DDS) that allows individuals with T2DM to automatically log blood glucose (BG) measurements and other variables to facilitate positive behavior changes. This retrospective cohort study compared real-world clinical outcomes of adults with T2DM using the DDS with those of adults with T2DM receiving usual care alone. Health care and claims data collected from the DDS, the Symphony Health Integrated Dataverse, and the Quest Laboratory were integrated into a single dataset using tokenization. DDS users were compared with a matched cohort of nonusers over the period from January 2017 to October 2021. Inclusion criteria were adults ≥18 years of age with T2DM, treated with antidiabetic medications, with ≥7% glycated hemoglobin (HbA) prior to a defined index date, and with valid HbAmeasurements during follow-up. DDS users were matched 1:3 with nonusers using exact-matching criteria and propensity score matching. Difference-in-difference values were determined using a multivariable linear regression model. The primary endpoint was change in HbAfrom baseline to 6 months. The two cohorts included 568 DDS users and 1699 nonusers with matched baseline characteristics. At 6 months, the generalized linear model least squares mean estimate of the difference in change in HbAbetween the two cohorts was -0.23% (95% CI -0.38% to -0.07%, P=.004).
Abstract
Digital health interventions show promise in supporting adults with type 2 diabetes mellitus (T2DM). Dario is a digital diabetes solution (DDS) that allows individuals with T2DM to automatically log blood glucose (BG) measurements and other variables to facilitate positive behavior changes. This retrospective cohort study compared real-world clinical outcomes of adults with T2DM using the DDS with those of adults with T2DM receiving usual care alone. Health care and claims data collected from the DDS, the Symphony Health Integrated Dataverse, and the Quest Laboratory were integrated into a single dataset using tokenization. DDS users were compared with a matched cohort of nonusers over the period from January 2017 to October 2021. Inclusion criteria were adults ≥18 years of age with T2DM, treated with antidiabetic medications, with ≥7% glycated hemoglobin (HbA) prior to a defined index date, and with valid HbAmeasurements during follow-up. DDS users were matched 1:3 with nonusers using exact-matching criteria and propensity score matching. Difference-in-difference values were determined using a multivariable linear regression model. The primary endpoint was change in HbAfrom baseline to 6 months. The two cohorts included 568 DDS users and 1699 nonusers with matched baseline characteristics. At 6 months, the generalized linear model least squares mean estimate of the difference in change in HbAbetween the two cohorts was -0.23% (95% CI -0.38% to -0.07%, P=.004). Similarly, HbAdecreased significantly more in DDS users versus nonusers in sensitivity analyses at 12 months. In four subgroups of individuals with baseline HbA>7.5%, >8.0%, >9.0%, and >11.0%, HbAdecreased significantly more in DDS users than in nonusers at 6 and 12 months. At 6 months, 47.0% of DDS users and 36.8% of nonusers had a ≥1% decrease in HbAfrom baseline (P<.001). Rates of severe hypoglycemia did not increase in either cohort between baseline and 6 months. At 6 months, more DDS users with baseline HbA≥8% had achieved HbA<8% (P=.002). At 6-month follow-up, medication adherence rates were evaluated as an exploratory endpoint and found to be greater for DDS users than for nonusers (P=.03). Engagement with the DDS was also evaluated as an exploratory endpoint and was associated with a significant decrease in HbAfrom baseline to follow-up (r=-0.28, P<.001). Engagement activities associated with reduced HbAwere BG measurement and tagging (timing of BG measurement and meal type). Adults with T2DM and elevated HbAlevels using the DDS had better outcomes at 6 months than matched nonusers across various baseline HbAlevels, with no increase in the rates of severe hypoglycemia. These effects were sustained at 12 months. The results confirm that digital interventions that facilitate behavior change can potentially deliver improvements in health outcomes.