Background: Dario Diabetes Solution (DDS) is a digital health application (app) that combines blood glucose (BG) monitoring system with a smartphone app, allowing tracking of BG levels in real time. This study assessed effects of DDS on HbA1c levels in adults with type 2 diabetes mellitus (T2DM) with baseline (BL) HbA1c ≥8% and on severe hypoglycemia (SH).
Methods: This retrospective cohort analysis included adults with T2DM who used DDS (users) and nonusers from 1JAN2017 to 31OCT2021. BL period was 1 year before index date (users, first DDS registration; nonusers, first claim date in the quarter); follow up was 6 months. DDS users and nonusers were sequentially matched 1:3 using exact and propensity score matching. Secondary endpoints included SH (event requiring medical intervention) rates for all patients (pts) and for pts with BL HbA1c ≥8% who achieved predefined target HbA1c <8%. SH incidence in users vs nonusers was examined.
Results: Overall cohort included 568 DDS users and 1699 nonusers: mean age, 57.5±11.3 years; mean BL HbA1c, 9.14±1.83%; oral antidiabetic drugs, 51%; insulin, 6%. BL SH was rare (users, 7/568; nonusers, 12/1699). There were 387 users and 1089 nonusers with BL HbA1c ≥8% (mean BL HbA1c, 10.0±1.7%). In this subgroup, HbA1c <8% was achieved by 9% more DDS users (174/387 [45%]) vs nonusers (393/1089 [36%]) at 6 months; P=0.002. At 6 months, overall SH rate was 38.8 (users) vs 10.6 (nonusers) events/1000 pts per year (incidence rate ratio, 0.9; P=0.9). No observed increase in SH risk was associated with DDS in this population. SH was rare in pts who achieved HbA1c <8% (users, 1/174; nonusers, 3/393).
Conclusions: In this retrospective study, a larger proportion of adults with uncontrolled T2DM (BL HbA1c ≥8%) achieved HbA1c <8% after using DDS vs nonusers, with no increased risk of SH.
N. Thingalaya: None. F. Lee: Employee; Sanofi, Stock/Shareholder; Sanofi. D. Kerr: Consultant; Sanofi-Aventis U. S. P. Potukuchi: None. L. Wilson: Employee; Sanofi. K. C. Lee: Employee; Sanofi. E. K. Han-burgess: Employee; Sanofi. A. Edwards: Employee; Symphony Health, an ICON plc company, Other Relationship; Sanofi. X. Yu: None. A. Kennedy: None.