The Clinical Research Department is offering this grant to establish a consortium investigating the inconsistent restoration of impaired awareness of hypoglycemia (IAH) and counter-regulatory responses in adults with Type 1 Diabetes (T1D). This grant is for the purpose of resolving why IAH awareness often fails to return, even with advanced glucose monitoring technologies. The consortium will assess if state-of-the-art diabetes technology can restore IAH and improve responses, identify specific CGM metrics linked to restoration, and validate self-report assessments with physiological measurements. This research aims to enhance T1D understanding and treatment.
Opportunity ID: 337221
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DK-21-020 |
| Funding Opportunity Title: | Elucidating the heterogeneity of impaired awareness of hypoglycemia in Type 1 Diabetes (T1D) Clinical Centers (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| 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 05, 2022 |
| Last Updated Date: | Jan 05, 2022 |
| Original Closing Date for Applications: | Mar 31, 2022 |
| Current Closing Date for Applications: | Mar 31, 2022 |
| Archive Date: | May 06, 2022 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Native American tribal organizations (other than Federally recognized tribal governments) City or township governments For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts Small businesses State governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities |
| 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: | The purpose of this FOA is to establish a clinical consortium to determine the factors that contribute to the heterogeneity in the restoration of impaired awareness of hypoglycemia (IAH) and improved counter-regulatory responses in adult individuals with Type 1 Diabetes (T1D). Individuals with IAH are often excluded from clinical trials and this omission contributes greatly to a lack of knowledge regarding the clinical characteristics which determine or predict an individuals ability to restore hypoglycemic awareness. New technologies such as continuous glucose monitors (CGM) and closed loop systems (i.e. artificial pancreas) have been shown to reduce hypoglycemic events. However, despite a reduction in hypoglycemic events, restoration of hypoglycemia awareness does not occur in all individuals and the effects on improving the counter-regulatory responses are not known. The goals of the clinical consortium will be to 1) determine if state-of-the-art diabetes technology to optimize HbA1c while minimizing hypoglycemia can restore awareness of hypoglycemia and improve counter-regulatory responses in individuals with T1D; 2) identify the magnitude and duration of time in range (TIR), time spent in hypoglycemia or other CGM metrics that are associated with restoration of awareness of hypoglycemia; and 3) validate current self-report assessments of impaired awareness of hypoglycemia with physiological measurements. It is expected that state of the art techniques such as hypoglycemic, hyperinsulinemic clamps (with or without stable isotopes) for the measurement of counter-regulatory responses and endogenous glucose production will be utilized to determine restoration of awareness and validate self-report assessments. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-21-020.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 337221 Full Announcement-RFA-DK-21-020 -> RFA-DK-21-020-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or after January 25, 2022 | PKG00271225 | Mar 01, 2022 | Mar 31, 2022 | View |
Package 1
Mandatory forms
337221 RR_SF424_5_0-5.0.pdf
337221 PHS398_CoverPageSupplement_5_0-5.0.pdf
337221 RR_OtherProjectInfo_1_4-1.4.pdf
337221 PerformanceSite_4_0-4.0.pdf
337221 RR_KeyPersonExpanded_4_0-4.0.pdf
337221 PHS398_ResearchPlan_4_0-4.0.pdf
337221 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
337221 RR_Budget_3_0-3.0.pdf
337221 RR_SubawardBudget30_3_0-3.0.pdf
337221 PHS398_ModularBudget_1_2-1.2.pdf
337221 PHS_AssignmentRequestForm_3_0-3.0.pdf
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