Continuous Ketone Monitoring for the Safe Use of Sodium-glucose Cotransporter-2 Inhibitors in Type 1 Diabetes (R01 Clinical trial Required)

The goal of this grant, titled "Continuous Ketone Monitoring for the Safe Use of Sodium-glucose Cotransporter-2 Inhibitors in Type 1 Diabetes," (required R01 Clinical Trial), is to fund research that improves the safety and effectiveness of a specific type of medication, Sodium-glucose co-transporter-2 inhibitors (SGLT2i), for individuals with Type 1 Diabetes (T1D). SGLT2i, initially developed for Type 2 Diabetes (T2D), have proven to be beneficial in protecting against cardiac and renal diseases, applicable to both diabetic and non-diabetic individuals. However, they are not currently approved for T1D patients due to the elevated risk of diabetic ketoacidosis (DKA).

Despite this risk, growing numbers of T1D patients are being prescribed SGLT2i off-label. To ensure their safety, the integration of Continuous Ketone Monitoring (CKM) into clinical practice is encouraged. CKM is a newly emerging technology, promising to alert of heightened ketone levels, which can effectively prevent DKA.

The grant aims to fund studies designed to create and test risk reduction strategies. These strategies should incorporate CKM into the clinical application of SGLT2i for T1D patients, enabling them to safely benefit from the drug's cardiac and renal protective abilities, as well as its glucose-lowering effects. Successful applications will likely focus on short-term clinical trials aimed at further understanding and sharing knowledge on the safe application of CKM in combination with SGLT2i.

Applicants could focus on several potential topics, such as testing the most suitable insulin delivery methods (whether through open and closed loop systems or multiple daily injections), or formulating clinical protocols to manage or reduce high ketone levels in T1D patients who use SGLT2i as an additional treatment.