The Raymond A. Wood Foundation (RAWF) entered an agreement with Giner Labs, a world-renowned center of excellence in electrochemical research and development, to collaborate in the development of a home use blood sodium meter for management of diabetes insipidus (DI). DI causes excess production of dilute urine and, as a result, high blood sodium levels and intense thirst, and is a common complication of hypothalamic-pituitary brain tumors. Phase one development of the sodium meter is funded by a small business innovation research (SBIR) grant from NIH and RAWF intends to raise funds to support the project between federal funding phases to keep the development work moving forward.
Development of a home use sodium meter was initiated through a collaboration between Dr. Shana McCormack, Scientific Director of Children’s Hospital of Philadelphia (CHOP) Neuroendocrine Clinic, who routinely treats patients with sodium regulation challenges from DI, Amy Wood, executive director of RAWF and caregiver of a child with difficult-to-manage diabetes insipidus and Dr. Khushbu Patel, the Director of CHOP’s Clinical Chemistry Laboratory.
According to Dr. McCormack, “For a long time, we have recognized the need to give patients and families better tools to manage their DI. We envision that this new device, once in use, will help us partner with affected individuals to identify and address small problems early, before they turn into bigger problems that lead to emergency room visits and hospitalizations.”
About Central Diabetes Insipidus (DI)
Central DI is a condition where the brain does not produce the anti-diuretic hormone that regulates the body’s fluid balance, which can result in dehydration and high blood sodium levels. Treatment for DI with synthetic forms of vasopressin can lead to excess hydration and dangerously low sodium levels. In addition, patients with hypothalamic injury from a brain tumor or treatment of the tumor, may also have absent thirst (adipsic diabetes insipidus), making fluid management even more difficult. This condition is particularly challenging to manage in pediatric patients and both extremes of sodium in the blood can lead to seizures or coma and can even be fatal.
These patients are often seen in the emergency department or hospitalized when sodium becomes too high or low. Currently, there is no mechanism for testing sodium at home, making it very hard for caregivers and patients to proactively manage this condition and avoid hospitalizations.
About Raymond A. Wood Foundation
In 2017, Raymond A. Wood Foundation (RAWF) was founded by Shawn and Amy Wood, when their son, Alex, was treated for a craniopharyngioma brain tumor which caused him to develop adipsic DI. He suffered multiple sodium related seizures that resulted in hospital admissions. The family identified and obtained a hospital-grade device that would allow them to test his blood sodium at home.
RAWF’s mission is to empower hypothalamic-pituitary brain tumor survivors for improved quality of life by providing access to education, technology, and evolving treatments. As part of this mission, the organization provides these hospital-grade blood analyzers to caregivers of pediatric brain tumor patients so they can take immediate measures to adjust fluids and medications when results are out of range which has mitigated hospitalizations and ED visits. The caveat is that this an off-label use of these devices and they are costly to purchase and maintain.
“As the foundation has grown, we have received more and more requests for these devices and it has become clear that we need a more sustainable and affordable long-term solution,” said Amy Wood, executive director of RAWF.
About Giner Labs
Giner, Inc. (Newton, MA) is a small business founded in 1973 with the objective of performing applied research and development in electrochemistry and related areas. Our work is directed to applications with the goal of developing processes, components, subsystems and complete systems through the development of innovative electrochemical and engineering concepts. During its 49 years of operation, Giner has successfully conducted R&D programs and developed innovations. Successful commercialization of its electrochemical, biomedical, and sensor technologies is Giner’s primary focus and priority, resulting in many recent examples including its transdermal alcohol sensor technology, implantable oxygenation system, and high-pressure electrolyzers.
“Giner aims to develop an economical and practical blood sodium monitor for in-home use,” said Anni Argun, Ph.D, Vice President for Advanced Materials. “We envision it to be used for DI patients, researchers, clinical users, and elite athletes. A rapid and simple fingerstick blood sodium test, similar to self-monitoring of blood sugar to guide insulin treatment, would meet a critical need within DI care as well as other sodium abnormalities.”
Current Project Timeline
Phase one development launched in late 2021 and will continue through early 2023. RAWF seeks to raise $200,000 to continue development through the end of 2023 to keep the project moving forward during funding gaps. The timeline to commercialization is estimated to be 2027.
Market Analysis
In spring of this year, RAWF commissioned the Penn Biotech Group to conduct a marketing analysis for DI along with other conditions that would benefit from sodium testing outside of a lab. DI is rare, with an estimated prevalence of 1:25,000. Among that group, a smaller population suffers from adipsia. Research was conducted to identify a larger market that could support commercialization of a home use sodium meter.
Inpatient costs associated with treating DI are projected to be at least $42.7 million per year by 2025. Additionally, most hospital ED visits for DI result in admissions, with a mean length of stay of seven days.
Blood sodium testing could be beneficial in managing hyponatremia (sodium <135 mmol/L) from causes other than DI as well, including congestive heart failure, cirrhosis and chronic kidney disease. Sodium testing in endurance athletes, particularly long-distance swimming and running, and for the military in combat, could help avoid and manage exertional hyponatremia.
A Three-Pronged Approach
RAWF has identified a short-term solution through access to these handheld blood analyzers that are currently provided to the most critical pediatric brain tumor patients that suffer from DI, but access to these devices is limited well below the current need. RAWF is also working to develop a web-based app to help with monitoring fluids and medications for those without access to a means to test sodium at home to troubleshoot between lab visits. The ideal long-term solution comes in the
form of this meter that could be FDA approved, covered by insurance and easy to use with rapid results on just a few drops of blood.
“We are confident that we can solve many of the challenges that come with the DI diagnosis and sodium management with a home use sodium meter,” said Wood. “This device would not only keep children out of hospitals but have an impact in treatment of other conditions and address a costly healthcare issue.”
How Can You Help?
RAWF is one quarter of the way to its goal to raise $200,000 to contribute to the work of our research and development partners on the home use sodium meter prototype to take to market. Having an easy-to-use, at-home sodium meter will help make DI more manageable by giving survivors and their caregivers a way to detect sodium swings in real time which could prevent seizures or worse outcomes and minimize hospitalizations.
Those interested in seeing this project advance in development can make a contribution to RAWF’s Roar for Rare campaign or host a fundraiser in support of this project. Find out more.
