OpportunityTitle: Continuous Ketone Monitoring for the Safe Use of Sodium-glucose Cotransporter-2 Inhibitors in Type 1 Diabetes (R01 Clinical trial Required)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Description: 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, SGLT2i are not currently approved for individuals with type 1 diabetes (T1D) and there is an 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 evolving technology that could be utilized clinically to prevent DKA by an early warning of elevations in ketone levels.The purpose of this NOFO is to solicit applications for studies that will develop and test risk mitigation strategies that involve 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 NOFO 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 open and closed loop systems or multiple daily injections and developing clinical protocols to control or ameliorate elevated ketone levels in individuals with T1D who are receiving adjunct therapy with SGLT2i.
GrantorContactEmailDescription: See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
GrantorContactText: NIH Grants Information&lt;br/&gt;grantsinfo@nih.gov