Elucidating the Effect of Glycemic Excursions on Patient Well-being and Cognitive Status in People with Type 1 Diabetes (T1D) (R01 Clinical Trial Optional) | RFA DK 18 003

Opportunity Information: Apply for RFA DK 18 003

This grant opportunity, titled "Elucidating the Effect of Glycemic Excursions on Patient Well-being and Cognitive Status in People with Type 1 Diabetes (T1D) (R01 Clinical Trial Optional)" (Funding Opportunity Number RFA-DK-18-003), is a National Institutes of Health (NIH) research grant sponsored by the U.S. Department of Health and Human Services. It uses the R01 mechanism, meaning it is intended to support substantial, hypothesis-driven research projects, and it allows (but does not require) a clinical trial component. The overall aim is to deepen understanding of how real-world blood glucose fluctuations, not just average glucose control, relate to how people with type 1 diabetes feel and function in daily life, especially in terms of perceived well-being and cognitive status.

A central theme of the announcement is the use of current and emerging glucose monitoring technologies to capture glycemic excursions with enough detail to connect biology to lived experience. In practice, this points heavily toward approaches such as continuous glucose monitoring (CGM) and other advanced sensing or analytics methods that can measure the frequency, duration, and severity of hypoglycemia and hyperglycemia, as well as glucose variability and time spent in different glycemic ranges. The FOA is interested in research that goes beyond traditional metrics like A1C by leveraging richer, higher-resolution data streams that better reflect day-to-day glucose dynamics. The expectation is that these technology-enabled measures can be mapped to outcomes that matter directly to patients, such as mood, fatigue, stress, sleep quality, ability to concentrate, and overall quality of life.

The opportunity specifically emphasizes studying the relationship between glycemic excursions and two connected outcome areas: patient well-being (often captured through patient-reported outcomes, or PROs) and cognitive status. Well-being can include subjective experiences like anxiety about lows, fear of hypoglycemia, diabetes distress, perceived energy levels, social functioning, and broader quality-of-life measures. Cognitive status can involve domains such as attention, processing speed, memory, executive function, and mental flexibility, all of which may be affected acutely by out-of-range glucose levels and potentially by repeated exposure over time. By focusing on both perception and cognition, the FOA signals an interest in pairing objective glucose data with validated psychological, behavioral, and neurocognitive assessments to clarify which glycemic patterns are most disruptive and under what circumstances.

A major practical goal of the research supported under this FOA is to generate evidence that can improve future intervention design. If researchers can identify which aspects of glycemic variability are most tightly linked to diminished well-being or cognitive performance, that knowledge can guide the development of more effective treatment strategies, technology features, behavioral supports, and clinical recommendations aimed at outcomes patients actually notice. In addition, the FOA highlights the need to validate glycemic measures that could serve as meaningful outcomes in clinical trials focused on improving glucose management in T1D. This reflects an ongoing shift in diabetes research toward endpoints like time in range, time below range, glucose variability, and related metrics, provided they can be convincingly tied to clinical benefit and patient experience.

From an administrative standpoint, this is a discretionary grant in the Health and related category (CFDA 93.847). The listed award ceiling is $500,000, and the announcement anticipated making about two awards, indicating a relatively competitive and targeted funding round. The original posting date was February 15, 2018, with an original closing date of July 10, 2018, which situates it as a time-limited solicitation rather than an always-open mechanism.

Eligibility is broad and includes many organization types that commonly apply to NIH funding. Eligible applicants include public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations other than small businesses, small businesses, and multiple government entities (state, county, city/township, special district). It also explicitly includes Native American tribal governments (federally recognized) and other tribal organizations, as well as public housing authorities and independent school districts. In other words, the FOA is open to a wide range of research-capable institutions, with the expectation that applicants will have the necessary expertise in diabetes, glucose monitoring technologies, clinical research methods, and measurement of patient-centered and cognitive outcomes.

In summary, this funding opportunity is aimed at advancing T1D research that connects detailed glucose monitoring data to the real-life impacts of glucose swings on how people feel and think. It seeks studies that use modern monitoring tools to quantify glycemic excursions, link those patterns to validated measures of well-being and cognition, and produce evidence that can shape better interventions and establish stronger trial endpoints for improving glucose management in type 1 diabetes.

• The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Elucidating the Effect of Glycemic Excursions on Patient Well-being and Cognitive Status in People with Type 1 Diabetes (T1D) (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on Feb 15, 2018.
• Applicants must submit their applications by Jul 10, 2018. (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 $500,000.00 in funding.
• The number of recipients for this funding is limited to 2 candidate(s).
• 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 (see text field entitled Additional Information on Eligibility for clarification).

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