Opportunity Information: Apply for RFA DK 08 013

  • The National Institutes of Health in the food and nutrition health income security and social services sector is offering a public funding opportunity titled "Closed Loop Technologies Pilot and Exploratory Clinical and Behavioral Approaches to Improve Type 1 Diabetes Outcomes (R21)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research 93.865 Child Health and Human Development Extramural Research.
  • This funding opportunity was created on Dec 8, 2008 and posted on Dec 8, 2008.
  • Applicants must submit their applications by Mar 19, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $200,000.00 in funding.
  • Eligible applicants include: Public and State controlled institutions of higher education Private institutions of higher education 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 Native American tribal governments (Federally recognized) Small businesses For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) State governments Native American tribal organizations (other than Federally recognized tribal governments).
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:

This funding opportunity, RFA-DK-08-013, is a National Institutes of Health (NIH) grant announcement from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It supports pilot and exploratory human research focused on closed loop technologies for type 1 diabetes, specifically systems that connect continuous glucose monitoring (CGM) with insulin delivery so that insulin dosing can be adjusted automatically or semi-automatically based on real-time glucose data. The overall intent is to move the field closer to a closed loop, highly reliable, easy-to-operate “artificial pancreas” style approach that patients can actually use in day-to-day life.

A central theme of the announcement is that technical performance alone is not enough. The NIH is explicitly calling for research that tackles barriers slowing progress toward real-world closed loop systems. Two emphasis areas are highlighted: first, behavioral factors that limit adoption, sustained use, and effective operation of these systems by people with type 1 diabetes (and, where relevant, their caregivers); and second, using these evolving technologies as research tools to deepen understanding of glucose regulation physiology and pathophysiology in type 1 diabetes. In other words, the technology is both the intervention and a platform for learning more about how glucose dynamics behave under different conditions, which can feed back into better control algorithms and better clinical strategies.

The practical outcomes NIH is aiming for include better metabolic control and fewer extreme glucose swings, along with reduced glycemic excursions across daily life. The announcement also stresses patient-centered benefits such as more lifestyle flexibility and improved quality of life, reflecting the reality that people often struggle with the burdens of frequent monitoring, dosing decisions, fear of hypoglycemia, and the daily workload of diabetes management. Projects responsive to the announcement must be human studies; non-human or purely preclinical work would not meet the stated responsiveness criterion.

The mechanism for this opportunity is the NIH R21, which is designed for early-stage, pilot, or exploratory studies that can generate proof-of-concept data, test feasibility, or establish preliminary evidence to justify larger trials. The FOA is described as running in parallel with a companion solicitation, RFA-DK-08-012, that uses the R01 mechanism for more mature, full-scale research projects. For this R21 opportunity, the award ceiling is listed as $200,000, and the estimated total funding across awards is $2,000,000. No cost sharing or matching is required.

Eligibility is broad and includes public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), state governments, tribal governments and tribal organizations, small businesses, and for-profit organizations (including those other than small businesses). The announcement also explicitly includes a wide range of other eligible applicants such as historically Black colleges and universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-domestic (foreign) entities. This wide eligibility reflects the multidisciplinary nature of closed loop work, which can involve clinical investigators, biomedical engineers, behavioral scientists, informatics teams, device developers, and health services researchers.

Administratively, the opportunity was posted on December 8, 2008, with an original and current closing date of March 19, 2009, and an archive date of April 19, 2009. It is categorized as a discretionary grant opportunity, and it aligns with CFDA numbers 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research) and 93.865 (Child Health and Human Development Extramural Research). The funding announcement is associated with NIH and provides a link to the full RFA text hosted on the NIH grants site, along with contacts for technical issues accessing the posting through NIH’s Office of Extramural Research (OER) web support.

Frequently Asked Questions (FAQs)

What is the grant opportunity RFA-DK-08-013?

RFA-DK-08-013 is a National Institutes of Health (NIH) funding announcement for pilot and exploratory human research on closed loop technologies for type 1 diabetes. It is issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

What type of research does this opportunity support?

This opportunity supports pilot and exploratory human studies focused on closed loop systems that connect continuous glucose monitoring (CGM) with insulin delivery, enabling insulin dosing to be adjusted automatically or semi-automatically using real-time glucose data.

What is the overall goal of the research funded under this RFA?

The intent is to move the field closer to a closed loop, highly reliable, easy-to-operate “artificial pancreas” style approach that people with type 1 diabetes can realistically use in everyday life.

Are projects required to be human studies?

Yes. Projects responsive to this announcement must be human studies. Non-human or purely preclinical work would not meet the stated responsiveness criterion.

Does the RFA focus only on technical performance of devices?

No. A central theme is that technical performance alone is not sufficient. NIH is explicitly calling for research that addresses barriers slowing progress toward real-world closed loop systems.

What emphasis areas are highlighted in the announcement?

Two emphasis areas are highlighted: (1) behavioral factors that limit adoption, sustained use, and effective operation of closed loop systems by people with type 1 diabetes (and, where relevant, their caregivers); and (2) use of evolving closed loop technologies as research tools to improve understanding of glucose regulation physiology and pathophysiology in type 1 diabetes.

How does NIH describe the role of the technology in this program?

The technology is positioned both as an intervention (to improve glucose control in real-world use) and as a platform for learning more about glucose dynamics, with insights that can inform better control algorithms and clinical strategies.

What practical outcomes is NIH aiming for?

NIH is aiming for better metabolic control, fewer extreme glucose swings, and reduced glycemic excursions across daily life.

What patient-centered benefits are emphasized?

The announcement highlights potential benefits such as more lifestyle flexibility and improved quality of life, acknowledging burdens like frequent monitoring, dosing decisions, fear of hypoglycemia, and the daily workload of diabetes management.

What grant mechanism is used for this opportunity?

This opportunity uses the NIH R21 mechanism, which is designed for early-stage, pilot, or exploratory studies that can generate proof-of-concept data, test feasibility, or establish preliminary evidence to justify larger trials.

Is there a related companion funding opportunity?

Yes. The FOA is described as running in parallel with a companion solicitation, RFA-DK-08-012, which uses the R01 mechanism for more mature, full-scale research projects.

What is the award ceiling for this R21?

The award ceiling listed for this R21 opportunity is $200,000.

How much total funding is estimated across awards?

The estimated total funding across awards is $2,000,000.

Is cost sharing or matching required?

No. The announcement states that no cost sharing or matching is required.

Who is eligible to apply?

Eligibility is broad and includes public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), state governments, tribal governments and tribal organizations, small businesses, and for-profit organizations (including those other than small businesses).

Are foreign (non-U.S.) entities eligible to apply?

Yes. The announcement explicitly includes non-domestic (foreign) entities among eligible applicants.

Does the RFA specifically call out certain institution types as eligible?

Yes. It explicitly includes historically Black colleges and universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and other eligible applicants described in the announcement.

Which NIH institutes are involved?

NIDDK and NICHD are the named NIH institutes for this funding opportunity.

When was this opportunity posted?

The opportunity was posted on December 8, 2008.

What were the closing dates for applications?

The original and current closing date listed is March 19, 2009.

When was the opportunity archived?

The archive date listed is April 19, 2009.

How is this funding opportunity categorized?

It is categorized as a discretionary grant opportunity.

What CFDA numbers are associated with this RFA?

The announcement aligns with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research) and 93.865 (Child Health and Human Development Extramural Research).

Where can applicants find the full RFA text and help with accessing the posting?

The announcement references the full RFA text hosted on the NIH grants site and notes contacts for technical issues accessing the posting through NIH’s Office of Extramural Research (OER) web support.

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