The nonprofit will act as a liaison between the adrenal insufficiency community and regulators as device makers develop continuous cortisol monitors.
The Global Adrenal Testing Consortium, a nonprofit focused on adrenal and pituitary disorders, has been accepted into the US Food and Drug Administration’s (FDA) Patient and Caregiver Connection program, part of the agency’s Center for Devices and Radiological Health.
Established in 2018, the program brings patient and caregiver perspectives into the evaluation and development of medical devices, which helps inform regulatory decision-making and device innovation. According to the consortium, it is the first organization for adrenal insufficiency in the program, with stakeholders in 25 countries.
A Gap in Cortisol Measurement
Adrenal insufficiency occurs when the body does not produce enough cortisol, a hormone that helps regulate blood pressure, blood glucose, and other vital functions, including the body’s stress response to illness and injury. Conditions that can lead to the disorder include Addison’s disease, Cushing’s disease, congenital adrenal hyperplasia, and other endocrine disorders.
According to the consortium, no device currently exists that allows patients and healthcare providers to measure cortisol levels in real time. As a result, treatment decisions are often based on symptoms alone, increasing the risk of both steroid overreplacement and underreplacement. In severe cases, insufficient cortisol production and steroid replacement can trigger a life-threatening adrenal crisis.
“The [Global Adrenal Testing Consortium] is filling a significant void in the Adrenal Insufficiency community. For as long as patients have been diagnosed, nothing has changed. While other conditions saw a revolution in wearable tech, our community was left behind and paid for that delay with patients’ lives,” says Kirsten Norgaard, founder and executive director of the Global Adrenal Testing Consortium, in a release.
Working With Regulators on Device Development
With medical device makers developing continuous cortisol monitors, the consortium is working directly with regulators to help ensure the devices perform for patients in real-world settings. By serving as the liaison between the adrenal insufficiency community and key FDA stakeholders, the group says it will work to facilitate solutions for more precise and effective disease management, with a particular focus on accurate, real-time cortisol monitoring.
“While much work remains to be done, we are finally moving from survival mode into an era of genuine hope,” says Norgaard, in a release.
The consortium also recently announced a collaboration with Trialport to help connect patients with clinical trial opportunities around the world. People living with adrenal insufficiency and related conditions are encouraged to join the consortium’s patient engagement directory and explore clinical trial participation.
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