Continuous Ketone Monitoring for the Safe Use of Sodium-Glucose Cotransporter-2 Inhibitors Type 1 Diabetes (R01 Clinical Trial Required)
January 2023 Council
Point(s) of Contact
Teresa Jones; Afshin Parsa; Guillermo Arreaza-Rubin
Sodium-glucose co-transporter-2 inhibitors (SGLT2i) that were developed for the treatment of type 2 diabetes (T2D) have significant protective effects for cardiac and renal diseases for people with and without diabetes. However, the benefits of SGLT2i are not available to individuals with type 1 diabetes (T1D) because of the increased risk of diabetic ketoacidosis (DKA) for this population. Despite this concern, these drugs are increasingly being prescribed off-label for people with T1D. Continuous ketone monitoring (CKM) is a rapidly advancing technology that could be leveraged to prevent DKA by an early warning of ketone elevations. The purpose of this proposal is to systematically study the clinical integration of CKM for the safe use of SGLT2i for people living with T1D so that they may benefit from the cardiac and renal protection and glucose-lowering effects of this drug class. The funding opportunity will support short-term, clinical trials to gain and disseminate knowledge on safety and glucose control with CKM and SGLT2i use. Possible topics include testing optimal insulin delivery in closed loop systems or multiple daily injections and developing clinical protocols to control or ameliorate elevated ketone levels. Research studies would be conducted through individual R01 grants to accelerate the execution and increase the flexibility of trial design with coordination of efforts among the investigators and NIDDK program staff through regular meetings.