Opportunity Information: Apply for RFA DK 21 020
This funding opportunity (RFA DK 21 020) is an NIH cooperative agreement (U01) intended to build a coordinated set of clinical centers, organized as a consortium, focused on adults with Type 1 Diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). The central problem the FOA targets is that IAH is common, clinically dangerous, and poorly understood in terms of why some people regain hypoglycemia awareness while others do not. A major reason for the knowledge gap is practical and historical: people with IAH are often excluded from clinical trials, which limits the field's ability to define the clinical and physiological characteristics that predict recovery of awareness and improvement in counter-regulatory defenses.
The scientific premise is that modern diabetes technologies, especially continuous glucose monitoring (CGM) and automated insulin delivery or closed-loop systems (often referred to as artificial pancreas systems), can reduce exposure to hypoglycemia. Reducing hypoglycemia is believed to be an important step toward restoring symptom awareness and hormonal counter-regulation, but the FOA emphasizes that awareness does not reliably return for everyone even when hypoglycemic events decline. In addition, the physiologic consequences of technology-driven hypoglycemia reduction, particularly whether counter-regulatory responses (such as glucagon and epinephrine responses and endogenous glucose production) improve, remain uncertain. The consortium is therefore meant to study this heterogeneity directly, rather than treating IAH as a uniform condition.
The FOA lays out three main goals for the consortium. First, it aims to determine whether state-of-the-art diabetes technology can optimize glycemic control (including HbA1c targets) while minimizing hypoglycemia in a way that actually restores hypoglycemia awareness and improves counter-regulatory responses in adults with T1D. This goes beyond showing fewer low-glucose events; it asks whether the brain-and-body warning systems that fail in IAH can be rehabilitated under real-world conditions supported by advanced devices. Second, it seeks to identify which CGM-derived exposure metrics are associated with recovery, including the magnitude and duration of time in range (TIR), time spent in hypoglycemia, and potentially other CGM measures (for example, frequency, depth, or duration of lows, or patterns that might matter more than averages). The intent is to define measurable CGM thresholds or profiles that correlate with restored awareness, which could become practical targets for clinical care and future trials. Third, the FOA prioritizes validating commonly used self-report questionnaires or assessments of IAH against objective physiological measurements, because self-reported awareness can be subjective and inconsistent, and the field needs stronger evidence about what these instruments truly capture.
Methodologically, the FOA expects participating centers to use rigorous, state-of-the-art physiological testing to quantify counter-regulatory responses and recovery. It specifically highlights hypoglycemic, hyperinsulinemic clamp techniques, with or without stable isotope tracers, to measure hormonal responses and endogenous glucose production during controlled hypoglycemia. These approaches allow investigators to standardize the hypoglycemic stimulus across participants and quantify how well key defenses respond, providing an objective basis for comparing individuals and for testing whether device-enabled hypoglycemia avoidance changes physiology over time. This emphasis signals that the consortium is intended to generate high-quality mechanistic and translational evidence, not only observational CGM summaries.
Structurally, this is a cooperative agreement, which typically means NIH expects substantial involvement in the program's coordination, milestones, and cross-site harmonization. The award instrument is explicitly "Clinical Trial Required," reflecting that the consortium work is expected to include interventional clinical research rather than purely observational studies. The overall activity area is health (CFDA 93.847), and the opportunity is categorized under discretionary funding.
Eligibility is broad and includes many types of domestic applicants such as state and local governments, public and private institutions of higher education, nonprofits with and without 501(c)(3) status, for-profit organizations (other than small businesses), and small businesses, along with tribal governments and tribal organizations. The FOA also explicitly mentions additional eligible applicant categories that NIH emphasizes for inclusivity and reach, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, faith-based or community-based organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations) and regional organizations. Taken together, that eligibility language underscores an intent to build a consortium that can recruit and study diverse adult T1D populations affected by IAH and to support participation from a wide range of institutional settings.
Key administrative identifiers from the notice include the funding opportunity title "Elucidating the heterogeneity of impaired awareness of hypoglycemia in Type 1 Diabetes (T1D) Clinical Centers (U01 Clinical Trial Required)," the opportunity number RFA DK 21 020, and the original closing date of 2022-03-31. The FOA does not provide an award ceiling or expected number of awards in the text provided, but the overarching deliverable is clear: a multi-center, technology-enabled, physiologically grounded research consortium designed to explain why recovery from IAH varies so widely, to define CGM-based exposure targets linked to recovery, and to strengthen how IAH is assessed by anchoring self-report tools to objective counter-regulatory measurements.Apply for RFA DK 21 020
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Elucidating the heterogeneity of impaired awareness of hypoglycemia in Type 1 Diabetes (T1D) Clinical Centers (U01 Clinical Trial Required)" 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 2022-01-04.
- Applicants must submit their applications by 2022-03-31. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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.
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Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity (RFA DK 21 020) is an NIH cooperative agreement using the U01 activity code. It is designed to build a coordinated set of clinical centers organized as a consortium to study impaired awareness of hypoglycemia (IAH) in adults with Type 1 Diabetes (T1D).
What is the official title of the funding opportunity?
The title provided is: "Elucidating the heterogeneity of impaired awareness of hypoglycemia in Type 1 Diabetes (T1D) Clinical Centers (U01 Clinical Trial Required)."
What is the opportunity number?
The opportunity number is RFA DK 21 020.
What is the NIH award mechanism and why does it matter?
The award mechanism is a cooperative agreement (U01). In a cooperative agreement, NIH typically has substantial involvement in program coordination, milestones, and cross-site harmonization. This structure fits a multi-center consortium where common protocols and coordinated execution are important.
Is a clinical trial required under this FOA?
Yes. The funding opportunity is explicitly designated as "Clinical Trial Required," indicating the consortium is expected to conduct interventional clinical research, not only observational studies.
What population is the consortium focused on?
The focus is on adults with Type 1 Diabetes who have impaired awareness of hypoglycemia (IAH).
What problem is this FOA trying to solve?
The FOA targets the problem that IAH is common, clinically dangerous, and still poorly understood. A key knowledge gap is why some people regain hypoglycemia awareness while others do not, even when low-glucose exposure is reduced.
Why is there a knowledge gap in IAH?
The FOA notes a practical and historical reason: people with IAH are often excluded from clinical trials. This has limited the field's ability to define the clinical and physiological characteristics that predict recovery of awareness and improvement in counter-regulatory defenses.
Why does the FOA emphasize that IAH is heterogeneous?
The consortium is intended to study heterogeneity directly, because awareness does not reliably return for everyone even when hypoglycemic events decline. The FOA aims to understand and measure why outcomes differ across individuals instead of treating IAH as a uniform condition.
What role do diabetes technologies play in this FOA?
The scientific premise is that modern diabetes technologies, especially continuous glucose monitoring (CGM) and automated insulin delivery or closed-loop systems (often called artificial pancreas systems), can reduce exposure to hypoglycemia. Reducing hypoglycemia is believed to be important for restoring symptom awareness and hormonal counter-regulation, but the FOA highlights that this recovery is not consistent across all individuals.
What are the three main goals of the consortium described in the FOA?
The FOA describes three main goals: (1) determine whether state-of-the-art diabetes technology can optimize glycemic control while minimizing hypoglycemia in a way that restores hypoglycemia awareness and improves counter-regulatory responses; (2) identify which CGM-derived exposure metrics are associated with recovery (including time in range and time in hypoglycemia, among other potential measures); and (3) validate commonly used self-report questionnaires or assessments of IAH against objective physiological measurements.
What does the FOA mean by "restoring hypoglycemia awareness" beyond reducing low-glucose events?
The FOA distinguishes between simply having fewer low-glucose events and actually rehabilitating the brain-and-body warning systems that fail in IAH. The goal is to test whether technology-supported, real-world hypoglycemia minimization leads to a true return of symptom awareness and improvements in counter-regulatory physiology.
What counter-regulatory responses are of interest in this FOA?
The FOA specifically mentions counter-regulatory responses such as glucagon and epinephrine responses and endogenous glucose production during hypoglycemia.
What CGM-derived metrics does the FOA highlight?
The FOA highlights metrics such as the magnitude and duration of time in range (TIR), time spent in hypoglycemia, and potentially additional measures like frequency, depth, duration of lows, and patterns that might matter more than averages.
What is the intended output related to CGM metrics?
The intent is to define measurable CGM thresholds or profiles that correlate with restored awareness. These could become practical targets for clinical care and inform future trials.
Why does the FOA prioritize validating self-report IAH questionnaires?
The FOA notes that self-reported awareness can be subjective and inconsistent. The field needs stronger evidence about what these instruments capture, so the FOA prioritizes anchoring commonly used self-report tools to objective physiological measurements.
What physiological testing methods does the FOA expect centers to use?
The FOA emphasizes rigorous, state-of-the-art physiological testing to quantify counter-regulatory responses and recovery. It specifically highlights hypoglycemic, hyperinsulinemic clamp techniques, with or without stable isotope tracers.
What is the purpose of using hypoglycemic, hyperinsulinemic clamps (with or without tracers) in this consortium?
These methods allow investigators to standardize the hypoglycemic stimulus across participants and quantify hormonal responses and endogenous glucose production during controlled hypoglycemia. This creates an objective basis for comparing individuals and for testing whether device-enabled hypoglycemia avoidance changes physiology over time.
Is this consortium intended to generate mechanistic evidence or mainly observational data?
The FOA signals an emphasis on high-quality mechanistic and translational evidence, not only observational CGM summaries, by highlighting standardized clamp testing and objective physiological endpoints.
What is the activity area and assistance listing information provided?
The overall activity area is health, and the CFDA (assistance listing) number provided is 93.847.
What type of funding is this categorized as?
The opportunity is categorized under discretionary funding.
Who is eligible to apply?
Eligibility is broad and includes many types of applicants such as state and local governments, public and private institutions of higher education, nonprofits with and without 501(c)(3) status, for-profit organizations (other than small businesses), small businesses, tribal governments, and tribal organizations.
Does the FOA mention eligibility for institutions that NIH often highlights for inclusivity?
Yes. The FOA explicitly mentions Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, and faith-based or community-based organizations.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly mentioned as eligible applicant categories.
Are non-U.S. (foreign) entities eligible to apply?
Yes. The FOA explicitly mentions non-U.S. entities (foreign organizations) and regional organizations among eligible applicant categories.
What is the closing date provided in the information above?
The original closing date provided is 2022-03-31.
Does the provided text specify an award ceiling or the expected number of awards?
No. The information provided states that the FOA text shown does not include an award ceiling or the expected number of awards.
What is the main deliverable or overall outcome the FOA is aiming for?
The FOA aims to create a multi-center, technology-enabled, physiologically grounded research consortium that explains why recovery from IAH varies widely, defines CGM-based exposure targets linked to recovery, and strengthens IAH assessment by tying self-report tools to objective counter-regulatory measurements.
Why does the FOA emphasize coordinated clinical centers rather than a single site?
The FOA is designed to build a consortium of clinical centers, reflecting the need for coordination, cross-site harmonization, and the ability to recruit and study diverse adult T1D populations affected by IAH while applying rigorous and standardized physiological testing methods.
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