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

Ceiling: $500,000
Applications Due: Closed
Federal
HHS-NIH11 (National Institutes of Health)

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.

Eligibility

States
All
Regions
All
Eligible Entities
State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal organizations, Public housing authorities, Nonprofits

Funding

Program Funding
Award Ceiling
$500,000
Award Floor
Award Count

Timing

Posted Date
January 31, 2024
App Status
No Longer Accepting Applications
Pre-app Deadline
Application Deadline
June 27, 2024

Funder

Funding Source
Source Type
Federal
Contact Name
NIH Grants Information
Contact Email
Contact Phone
--

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