The National Institutes of Health is offering this grant to support clinical trials focused on the safe integration of Sodium-glucose Cotransporter-2 inhibitors (SGLT2i) for individuals with Type 1 Diabetes (T1D). While SGLT2i offer significant cardiac and renal benefits, their use in T1D carries an increased risk of diabetic ketoacidosis (DKA). This grant is for the purpose of developing and testing risk mitigation strategies, specifically utilizing Continuous Ketone Monitoring (CKM) technology, to prevent DKA. The aim is to enable safe SGLT2i prescription for T1D patients, allowing them to access the drugs’ protective effects and glucose-lowering benefits. Proposed studies include optimizing insulin delivery methods and establishing clinical protocols to manage elevated ketone levels in T1D patients on SGLT2i.
Opportunity ID: 352101
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DK-23-011 |
| Funding Opportunity Title: | Continuous Ketone Monitoring for the Safe Use of Sodium-glucose Cotransporter-2 Inhibitors in Type 1 Diabetes (R01 Clinical trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 30, 2024 |
| Last Updated Date: | Jan 30, 2024 |
| Original Closing Date for Applications: | Jun 27, 2024 |
| Current Closing Date for Applications: | Jun 27, 2024 |
| Archive Date: | Aug 02, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Special district governments Native American tribal governments (Federally recognized) Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Private institutions of higher education County governments Public and State controlled institutions of higher education Independent school districts City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | 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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-23-011.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for Due Dates on or after January 25, 2023 | PKG00286783 | May 30, 2024 | Jun 27, 2024 | View |
Package 1
Mandatory forms
352101 RR_SF424_5_0-5.0.pdf
352101 PHS398_CoverPageSupplement_5_0-5.0.pdf
352101 RR_OtherProjectInfo_1_4-1.4.pdf
352101 PerformanceSite_4_0-4.0.pdf
352101 RR_KeyPersonExpanded_4_0-4.0.pdf
352101 PHS398_ResearchPlan_5_0-5.0.pdf
352101 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
352101 RR_Budget_3_0-3.0.pdf
352101 RR_SubawardBudget30_3_0-3.0.pdf
352101 PHS398_ModularBudget_1_2-1.2.pdf
352101 PHS_AssignmentRequestForm_3_0-3.0.pdf
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