Source – DarioHealth
A joint effort between DarioHealth and Sanofi has yielded promising results in a real-world study presented at the annual meeting of the American Diabetes Association (ADA) 28 June. The study highlights the effectiveness of a digital tool developed by the companies in improving blood glucose control for patients with uncontrolled type II diabetes.
The Dario system, which combines a smartphone-connected glucometer with a companion app, demonstrated superior outcomes compared to non-users. Among the participants with uncontrolled diabetes, those using the Dario system were more likely to achieve the target reduction in a surrogate marker for blood glucose levels. The study involved 568 Dario users and a matched cohort of 1,699 non-users over a six-month period.
Previous research had already shown that the digital therapeutic led to a significant decrease in healthcare resource utilization (9.3%) and hospitalizations (23%) when added to standard care. In this latest analysis, a subgroup of 387 Dario users and 1,089 non-users with hemoglobin A1c (HbA1c) levels of 8% or higher were examined. The results demonstrated that 45% of the Dario users successfully reduced their HbA1c levels below 8%, compared to 36% of non-users, without an increased risk of severe hypoglycemia episodes.
Notably, the digital intervention showed even greater benefits in individuals with more severe diabetes. Among those with HbA1c levels above 9%, Dario app usage resulted in a 2.3% reduction in HbA1c, compared to 1.8% for non-users.
This study represents the first in a series aimed at showcasing the impact of Dario on clinical, resource utilization, and financial outcomes in diabetes. The collaboration between Sanofi and DarioHealth, formed through a $30 million alliance, has allowed for the integration of Sanofi’s digital health tools, expertise in clinical and real-world studies, and sales and marketing capabilities.
“This data broadly demonstrates a proof-of-concept for a digital health evidence generation platform that has combined the best attributes of real-world evidence studies and traditional randomized controlled trials. There is tremendous potential for digital health interventions to complement usual care for people living with chronic conditions such as diabetes and we are proud to be collaborating with Dario to showcase the value of whole-person care.”
– Felix Lee, medical head of digital healthcare at Sanofi
“The new study is evidence that the collaboration with Sanofi is paying off, allowing it to “leapfrog” other companies developing digital diabetes interventions “in terms of quality of evidence, as well as clinical effect sizes. With payers rightly demanding rigour in evidence for digital health solutions, this new evidence ensures that Dario is uniquely positioned to exceed these requirements.”
– Omar Manejwala, DarioHealth’s chief medical officer
