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.
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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.”