Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Sep 30, 2024
Date Accepted: Mar 24, 2026
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Clinical Effects of a Digital Health Intervention for Adults with Type 2 Diabetes in the United States: A Retrospective Cohort Study
ABSTRACT
Background:
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.
Objective:
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.
Methods:
Healthcare and claims data collected from the DDS, the Symphony Health Integrated Dataverse, and Quest Laboratory data were integrated into a single dataset using tokenization. DDS users were compared with a matched cohort of non-users over the period from January 2017 to October 2021. Inclusion criteria were adults ≥18 years of age with T2DM, treated with antidiabetic medications, with HbA1c ≥7.0% prior to a defined index date, and valid HbA1c measurements during follow-up. DDS users were matched 1:3 with non-users 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 HbA1c from baseline to 6 months.
Results:
The two cohorts included 568 DDS users and 1699 non-users with matched baseline characteristics. At 6 months, the generalized linear model least squares mean estimate of the difference in change in HbA1c between the two cohorts was −0.23% (95% CI: −0.38%, −0.07%, P=.004). Similarly, HbA1c decreased significantly more in DDS users versus non-users in sensitivity analyses at 12 months. In four subgroups of individuals with baseline HbA1c >7.5%, >8.0%, >9.0%, and >11.0%, HbA1c decreased significantly more in DDS users than in non-users at 6 months and at 12 months. At 6 months, 47.0% of DDS users and 36.8% of non-users had a ≥1% decrease in HbA1c from baseline (P<.0001). Rates of severe hypoglycemia did not increase in either cohort between baseline over 6 months. At 6 months, more DDS users with baseline HbA1c ≥8.0% had achieved HbA1c <8.0% (P=.0021). During 6 months’ follow-up, medication adherence rates were evaluated as an exploratory endpoint, and found to be greater for DDS users than non-users (P=.03). Engagement with DDS was also evaluated as an exploratory endpoint and was associated with a significant decrease in HbA1c from baseline to follow-up (r=−0.28, P<.0001). Engagement activities associated with reduced HbA1c were BG measurement and tagging (timing of BG measurement and meal type).
Conclusions:
Adults with T2DM and elevated HbA1c levels using the DDS had better outcomes at 6 months than matched non-users across various baseline HbA1c levels, with no increase in 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.
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