Technological Advances Fail to Improve Diabetes and Health Outcomes in the US, FDA Commissioner Argues

ORLANDO — FDA Commissioner Robert Califf, MD, delivered a keynote address at the Scientific Sessions, highlighting the failure of technological advancements to fulfill their promise in improving diabetes and overall health outcomes in the United States. Califf emphasized the need to harness digital technology and artificial intelligence (AI) to benefit the population.

Citing alarming statistics, Califf pointed out that the US, along with other high-income countries, had similar life expectancies and healthcare expenditures. However, as per-capita health expenditure increased over time, the US fell behind other countries in terms of longer life expectancy and reasonable healthcare costs. The COVID-19 pandemic further exacerbated this decline, placing the US in last place among high-income nations.

Califf identified high fasting glucose, poor diet, and high BMI as contributing factors to the loss of disability-adjusted life years and mortality in the US. Diabetes, in particular, has surpassed cancer as the leading economic burden on healthcare, affecting approximately 34 million adults in 2020.

While technology has brought significant advancements in diabetes management, such as continuous glucose monitoring and pumps, Califf highlighted the disparity in access. These innovations tend to benefit individuals with advanced degrees residing in urban areas, leaving many others underserved. High costs, limited insurance coverage, drug shortages, and clinical inertia prevent many individuals with type 2 diabetes from accessing highly effective treatments like GLP-1 receptor agonists and continuous glucose monitors.

To address these challenges, Califf emphasized the importance of digital health tools, which can help bridge the gap in healthcare access. However, he noted that current analyses do not demonstrate meaningful clinical benefits from widely used digital tools for blood glucose management in type 2 diabetes. Califf drew a parallel with the aviation industry, where a standardized approach was adopted to ensure pilots could effectively interpret information without being overwhelmed.

Califf called for pragmatic research embedded in the healthcare system, involving rural areas and community health centers. He highlighted the National Institutes of Health’s initiative to establish a national primary care research network, expressing optimism about its potential impact. Additionally, efforts are underway to create a comprehensive home health docking station and dashboard to streamline the integration of various devices.