This NIH grant supports preliminary studies to inform the design of a full randomized control trial (RCT) exploring whether sleep and circadian-targeted interventions improve clinical course and cardiometabolic health in Type 1 Diabetes (T1D). The grant funds pilot research to develop practical, sustainable strategies by addressing feasibility (e.g., recruitment, retention), intervention logistics, and robust study design. Studies should assess intermediate markers like glycemic control and vascular function. Results will guide a well-powered clinical trial aimed at enhancing T1D patient care and informing clinical guidelines. Transdisciplinary teams with expertise in sleep, T1D, and clinical trial design are encouraged. Research must include children, adolescents, or adults with T1D, and should not develop new treatments or involve animal studies.
Opportunity ID: 349483
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-24-009 |
| Funding Opportunity Title: | The Role of Sleep Deficiency in Persons with Type 1 Diabetes: Sleep, Glycemic Control, and Cardiovascular Risk (R34 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jul 20, 2023 |
| Last Updated Date: | Jul 20, 2023 |
| Original Closing Date for Applications: | Oct 11, 2023 |
| Current Closing Date for Applications: | Oct 11, 2023 |
| Archive Date: | Nov 16, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $225,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) For profit organizations other than small businesses Independent school districts State governments Public and State controlled institutions of higher education Small businesses Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) |
| 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This NOFO will support preliminary studies aimed to obtain information necessary to guide the design of a full randomized control trial to test whether sleep and circadian targeted interventions improve the clinical course and treatment outcomes in individuals with Type 1 Diabetes (T1D). Applications should focus on pilot studies to inform practical and potentially sustainable strategies to improve processes of care and cardiometabolic health outcomes in individuals with T1D. The scope of research for this NOFO includes a range of feasibility metrics (e.g., optimizing recruitment, retention, randomization); intervention logistics (e.g., determine independent variable(s), dose-response, duration); study design/statistical considerations (e.g., determination of effect size, sample size, and statistical power; inclusion/exclusion criteria, control variables); adherence outcomes (measures of patient acceptance of, satisfaction with, and adherence to treatment); assessment of intermediate markers of the intervention (e.g. glycemic control, vascular dysfunction, inflammation, and/or neuroendocrine and metabolic function); and selection of primary and/or secondary outcome(s) measures. Ultimately, results from these pilot studies will be used to develop a well-powered, evidence-based definitive clinical trial that could improve clinical care and cardiometabolic outcomes in individuals with T1D and to inform guidelines for this patient population. Transdisciplinary investigative teams including relevant expertise in sleep/circadian, T1D and cardiovascular research, as well as needed expertise in clinical trial design, biostatistics and other appropriate areas are encouraged. Studies should include active participation of children, adolescents, and/or adults with T1D. This program is not intended to develop or validate new treatments of devices for sleep and/or circadian deficiency. Animal studies will not be considered responsive to this initiative. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-24-009.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
Folder 349483 Full Announcement-RFA-HL-24-009 -> RFA-HL-24-009-Full-Announcement.pdf
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 | PKG00282631 | Sep 11, 2023 | Oct 11, 2023 | View |
Package 1
Mandatory forms
349483 RR_SF424_5_0-5.0.pdf
349483 PHS398_CoverPageSupplement_5_0-5.0.pdf
349483 RR_OtherProjectInfo_1_4-1.4.pdf
349483 PerformanceSite_4_0-4.0.pdf
349483 RR_KeyPersonExpanded_4_0-4.0.pdf
349483 PHS398_ResearchPlan_5_0-5.0.pdf
349483 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
349483 RR_Budget_3_0-3.0.pdf
349483 RR_SubawardBudget30_3_0-3.0.pdf
349483 PHS398_ModularBudget_1_2-1.2.pdf
349483 PHS_AssignmentRequestForm_3_0-3.0.pdf
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