Tandem Diabetes Care is advocating for broader insurance coverage of automated insulin delivery (AID) systems for individuals with Type 2 diabetes. These systems, which combine a glucose sensor and an insulin pump to automate dosing, are already covered by Medicare and numerous private insurers in the U.S. for people with Type 1 diabetes. Despite having thousands of Type 2 users benefiting from these devices, hurdles remain due to stringent requirements like C-peptide tests. Tandem aims to change this landscape using pivotal trial data that supported FDA clearance for its Control-IQ+ algorithm. The trial demonstrated significant improvements in hemoglobin A1c levels among Type 2 patients using AID systems compared to traditional methods.

Achieving broader acceptance of AID systems involves addressing specific regulatory barriers. Currently, Medicare demands a C-peptide test to evaluate insulin production, a criterion some private insurers have also adopted. Jordan Pinsker, Tandem's chief medical officer, argues that such requirements do not correlate with treatment outcomes. The recently published trial results in the New England Journal of Medicine underscore the efficacy of AID systems. Over a 13-week period, 319 participants showed marked improvements in their A1c levels when utilizing these systems versus conventional insulin administration techniques.

Beyond clinical effectiveness, the study’s design played a crucial role in convincing regulatory bodies. Unlike competitors such as Insulet, whose trials relied on single-arm studies, Tandem opted for a randomized controlled trial. This approach added credibility and rigor to the findings, enhancing the likelihood of policy changes. Notably, the participant pool was racially and socioeconomically diverse, reflecting real-world conditions. Moreover, it included individuals taking various medications like GLP-1 and SGLT-2 inhibitors, along with those following different insulin regimens.

Pinsker highlights the transformative potential of this research, suggesting it could catalyze policy shifts making AID systems more accessible. Historically, insulin pumps were perceived as complex devices suitable only for certain patient groups. However, the study convincingly demonstrates that Type 2 patients not only desire but can also thrive with this advanced therapy. By showcasing improved health outcomes across diverse populations, Tandem positions itself at the forefront of redefining diabetes management strategies.