Study shows digital Dario tool effective in severe diabetes

A digital tool being developed by DarioHealth and Sanofi has been shown to improve blood glucose control in a real-world study reported at the American Diabetes Association (ADA) annual meeting.

Patients with uncontrolled type 2 diabetes who used the Dario system, which combines a glucometer that plugs into a smartphone with a companion app, were more likely to meet the goal of reducing a surrogate marker for blood glucose levels to a predefined target than non-users.

The study compared 568 Dario users to a matched cohort of 1,699 non-users over a six-month period and previously showed that use of the digital therapeutic was associated with a 9.3% reduction in their use of healthcare resources and a 23% reduction in hospitalisations when added to standard care.

The latest analysis at the ADA zeroed in on a subgroup of 387 Dario users and 1,089 non-users who had haemoglobin A1c (HbA1c) levels – a marker for blood glucose control – of 8% or more at enrolment, meaning they had uncontrolled diabetes.

45% of the Darion user group were able to reduce their HbA1c levels below 8% by the end of the study, compared to 36% of non-users, which was a statistically significant difference, without any increased risk of severe hypoglycaemia (low blood sugar) episodes.

Moreover, in a group with HbA1c levels above 9%, the app was associated with a 2.3% reduction in HbA1c compared to 1.8% for non-users, suggesting for the first time that the benefits of the digital intervention may be more pronounced in people whose diabetes is more severe.

Dario said the study is the first of several that will aim to show the impact of Dario on clinical, resource utilisation, and financial outcomes in diabetes.

“[This] data broadly demonstrate[s] a proof-of-concept for a digital health evidence generation platform that has combined the best attributes of real-world evidence studies and traditional randomised controlled trials,” said Felix Lee, medical head of digital healthcare at Sanofi.

The French pharma group formed a $30 million alliance with DarioHealth last year, adding its own digital health tools to the repertoire and contributing clinical and real-world study expertise, as well as sales and marketing muscle.

“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,” added Lee.

DarioHealth’s chief medical officer, Omar Manejwala, commented that 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,” he added.

Among other companies working in this category are Livongo, Glooko, Lyra Health, and Omada Health.