Readout Health Biosense device to be tested in JDRF-funded clinical trial in people with Type 1 Diabetes using SGLT inhibitors at Washington University

$360,000 grant to review safety and accuracy of Biosense® device aimed at DKA risk mitigation in patients using SGLTi drug class.

ST. LOUIS, July 12, 2022 /PRNewswire/ -- Readout Health, a medical digital health startup, announces a sponsored research agreement with Washington University School of Medicine in St. Louis that received a $360,000 research grant from JDRF. The two-year grant is aimed at testing the efficacy of the Biosense® handheld breath ketone monitor in persons with type 1 diabetes (T1D) during usual care with insulin and with the addition of a sodium glucose transporter inhibitor (SGLT2i) drug. Janet McGill, MD, a professor at Washington University School of Medicine and the recipient of the American Diabetes Association's 2022 Outstanding Physician Clinician award, will serve as the principal investigator.

Biosense® was launched in 2020 as the non-invasive option to capillary blood testing or urine testing for in-home biofeedback of fat oxidation levels based on nutrition and exercise. While metabolic disorders like type 2 diabetes (T2D) and obesity have protocols often seeking higher ketone levels, T1D patients can be at a considerable risk with elevated ketones, a problem potentially compounded by medications like SGLT2i if left unchecked. According to Dr. McGill, "Routine monitoring of ketones may alert patients to impeding ketosis and help to prevent episodes of ketoacidosis. Ketone monitoring should be easy, non-invasive, low-cost, and accessible for repeated use to be effective."

Biosense®, a class 1 designated breath ketone analyzer, will be tested for its ability to detect ketosis in persons with T1D during usual care and during usual care plus SGLTi therapy. Ultimately, the goal is to reduce the risk of diabetic ketoacidosis (DKA), which is increased when persons with T1D take an SGLT2i. This increased risk of life-threatening DKA has caused the FDA to withhold approval of SGLT2i in persons with T1D, despite proven benefits of drugs in this class for reduction in the risks of elevated glucose levels, progressive chronic kidney disease and hospitalizations for heart failure in persons with and without type 2 diabetes.

 According to Jonathan Rosen, PhD, JDRF Associate Director of Research, "SGLT inhibitors are improving outcomes in glucose control, heart disease, and kidney disease in non-type 1 diabetes populations, but are rarely used in type 1 diabetes because they increase the risk of DKA. Development of ketone monitoring technologies like Biosense are a critical part of the strategy to enable safe, effective use of SGLT inhibitors in type 1 diabetes."

The JDRF funded research grant is awarded directly to Washington University School of Medicine at St. Louis with first patients targeted late summer.

Readout Health is developing digital breath biomarker technologies for chronic disease prevention, management, and reversal. Readout's patented breath sampling technology isolates high concentration samples of breath compounds within handheld medical devices an supportive mobile apps. Targeting behavior modification through precision biofeedback, Biosense®, a Class 1 medical device, was launched as an FDA Class 1 medical device after a successful 2019 clinical trial, enabling pharma and academic researchers and clinicians to monitor patient dosing of therapeutic ketosis (area-under-the-curve) in several therapeutic areas, including metabolic, neurocognitive, and oncology. For more information, visit https://mybiosense.com.

JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit https://www.jdrf.org.

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SOURCE Readout Health