The Role of Sleep Deficiency in Persons with Type 1 Diabetes: Sleep, Glycemic Control, and Cardiovascular Risk (R34 Clinical Trial Optional) | RFA HL 24 009

Opportunity Information: Apply for RFA HL 24 009

The National Institutes of Health (NIH) funding opportunity titled "The Role of Sleep Deficiency in Persons with Type 1 Diabetes: Sleep, Glycemic Control, and Cardiovascular Risk (R34 Clinical Trial Optional)" (Funding Opportunity Number RFA-HL-24-009) supports early-stage, preparatory research meant to lay the groundwork for a future, fully powered randomized controlled trial. The central idea is to fund pilot and feasibility studies that generate the practical and scientific information needed to design a definitive trial testing whether improving sleep and circadian health can meaningfully improve clinical course, treatment outcomes, and cardiometabolic risk in people living with Type 1 Diabetes (T1D). Rather than aiming for a final, practice-changing efficacy trial right away, this program focuses on the kind of preliminary evidence that reduces uncertainty and makes a later large trial more realistic, efficient, and informative.

Projects funded under this NOFO are expected to concentrate on the nuts-and-bolts questions that determine whether a larger trial can succeed and what it should look like. That includes feasibility metrics such as how best to recruit participants with T1D (including strategies that reach underrepresented groups), how to retain them over time, and how to implement randomization procedures smoothly. Applicants are encouraged to work through intervention logistics that commonly derail larger studies, such as clarifying which intervention components will serve as the independent variable(s), how to deliver the intervention, what dose or intensity is realistic, what duration is needed to produce measurable change, and how to monitor and support adherence. The NOFO also emphasizes strong study design and statistical planning, including generating estimates of effect size, informing sample size targets, refining inclusion and exclusion criteria, identifying key confounders and control variables, and selecting the most appropriate primary and secondary endpoints for a later trial.

A major theme is linking sleep and circadian processes to clinically meaningful outcomes in T1D, especially glycemic control and cardiovascular risk. Pilot studies can include measurement of intermediate markers that help explain mechanisms or early signals of benefit, such as glycemic metrics (for example, continuous glucose monitoring-derived outcomes, hypoglycemia burden, or glycemic variability), vascular dysfunction indicators, inflammation-related biomarkers, and neuroendocrine or metabolic function measures. The program also explicitly values patient-centered implementation outcomes, including participants' acceptance of the intervention, satisfaction, real-world practicality, and adherence patterns. The overall expectation is that these pilot results will directly inform a well-justified, evidence-based protocol for a subsequent definitive clinical trial and, longer term, contribute to stronger clinical guidance for sleep and circadian care in people with T1D.

The NOFO encourages transdisciplinary teams, reflecting that this topic sits at the intersection of sleep and circadian science, diabetes clinical care, and cardiovascular risk research. Competitive applications are therefore expected to bring together expertise in sleep/circadian biology and measurement, T1D management and outcomes, cardiovascular risk assessment, and the technical skills needed for clinical trials, including trial design and biostatistics. Studies should involve active participation of individuals with T1D across the lifespan, explicitly including children, adolescents, and/or adults, which aligns with the reality that sleep patterns, circadian timing, diabetes management demands, and cardiometabolic risk profiles can differ substantially by developmental stage.

There are clear boundaries on what this funding is and is not intended to support. It is not meant to develop or validate new sleep or circadian devices or new treatments; instead, it is aimed at testing and refining intervention approaches and trial methods that can be deployed practically and sustainably. Animal studies are considered non-responsive, meaning the program is focused on human research that directly informs clinical trial design and implementation in people with T1D.

In terms of eligibility, the opportunity is broadly open across many organization types, including state, county, and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; independent school districts; special district governments; and Native American tribal governments and organizations (including federally recognized tribal governments and other tribal organizations). The NOFO also highlights interest in applications from a range of institutions and community-linked entities, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Non-U.S. (non-domestic) entities and foreign institutions are not eligible to apply as applicant organizations, but non-domestic components of U.S. organizations may be included, and foreign components (as defined by NIH policy) are allowed, which can enable specialized collaborations without shifting the applicant organization outside the United States.

Operationally, this is a discretionary NIH grant mechanism under an R34 framework with clinical trial optionality, meaning applicants may propose a pilot clinical trial if appropriate, but the mechanism can also support preparatory work that does not rise to a full clinical trial. The original closing date listed is October 11, 2023, and the award ceiling is $225,000. The funding activity category is health, and associated CFDA numbers include 93.233, 93.837, and 93.838. The practical takeaway is that NIH is signaling a targeted interest in building a solid evidence base and a workable trial blueprint around sleep and circadian interventions as a pathway to better glycemic management and reduced cardiovascular risk in Type 1 Diabetes, with an emphasis on feasibility, implementation realism, and high-quality trial design.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "The Role of Sleep Deficiency in Persons with Type 1 Diabetes: Sleep, Glycemic Control, and Cardiovascular Risk (R34 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838.
• This funding opportunity was created on 2023-07-20.
• Applicants must submit their applications by 2023-10-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $225,000.00 in funding.
• Eligible applicants include: 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 governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA HL 24 009

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