Behind the scenes: A simple explanation of Sanofi and Dario’s multi-faceted research in digital health

This week Sanofi released new clinical results stemming from its analysis of Dario data at the ADA Scientific Sessions. If you want to know the results…skip to the bottom. But first, a bit of background.

Digital health has an incredible potential to transform healthcare by making care of chronic conditions available when–and where–people need it most, with the devices we already use hundreds of times a day. Health happens between doctors’ visits, and digital health supports people with behavior change when it matters most, and when it can have the greatest impact.

However, digital health is historically challenged when it comes to evidence. Most companies don’t have the infrastructure to conduct the types of studies that customers rightly demand to demonstrate clinical and financial outcomes.

The result has been…. fair evidence quality. Simple pre-/post- studies, often on highly filtered populations, without pre-specified endpoints, conducted by the companies themselves, and often subject to significant bias. This is NOT a bad thing! It’s how everything in medicine generally starts.

But as the industry matures, and as digital health moves beyond pilots to full commercial deployments, the evidence needs to be more rigorous, more arms-length, and needs to cover more types of outcomes that matter. Payers and employers demand that, and the users of these solutions– the people with chronic conditions– deserve it more than anyone. Hence our partnership with Sanofi to do just that.

You might recall Sanofi recently released an exact and propensity matched study at ISPOR showing a 9.3% reduction in all-cause Health Care Resource Utilization among Dario members, including a remarkable 23.5% reduction in hospitalizations.

And now, Sanofi has released the first round of clinical results from its analysis of Dario members. And the results are really impressive. For this study, they matched Dario members to non-members across several domains, including an interesting approach to matching for motivation.

• This was a study of 568 Dario users and 1699 non-users, exact and propensity matched across several key areas
• Primary endpoint was change in actual (lab-measured) HbA1c in members with baseline HbA1c ≥7%.
• Not only did more Dario users achieve HbA1c<8% than non-users receiving usual care (P=0.002), but also, the reductions were even more dramatic when you looked at members with baseline HbA1c>9%, where the improvements were over 2.3%
• Overall, a 1.6% reduction in A1C after Dario use in participants with a baseline HbA1c >8%
• A1c improvement was seen across the full study cohort of T2D participants with baseline HBA1c ≥7%

No study is perfect, and all studies have limitations. But this arms-length study of Dario data, well-matched with a proxy for motivation, looking at actual HbA1c confirms statistically and clinically significant improvement in HbA1c for Dario users compared to usual care.

It’s been an honor to partner with Sanofi and allow them to analyze our data, demonstrating the power of digital health. The results are certainly validating for everyone at Dario, and I hope others find that it advances the field of digital health as a whole. Let’s all continue to raise the bar when it comes to evidence in digital health.