Notice of Intent to Publish a Request for Applications for Feasibility Studies for Clinical Trials in Type 1 Diabetes (R03)


Notice Number: NOT-DK-11-003

Key Dates

Release Date:  January 6, 2011  

Issued by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to promote clinical research related to type 1 diabetes through a series of initiatives.  The first will be a Funding Opportunity Announcement (FOA) to solicit applications for feasibility studies for clinical trials to improve the care and clinical outcomes of individuals with type 1 diabetes.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The FOA is expected to be published in the early spring of 2011 for funding in September 2011.

This FOA will utilize the R03 activity code.  Details of the planned Funding Opportunity Announcement (FOA) are provided below.

Research Initiative Details

Type 1 diabetes is a serious chronic disease.  New types of insulin, along with improved management and monitoring technologies, have the potential to improve outcomes.  However, diabetes management requires complex balancing of medication dosing, diet and exercise in order to achieve good glucose control while avoiding hypoglycemia. The constant burden of the disease affects the quality of life of individuals with type 1 diabetes and their families, and may be associated with poor adherence to medical regimens.

The results of the Diabetes Control and Complications Trial and its long-term follow-up through the Epidemiology of Diabetes Interventions and Complications study clearly demonstrate the efficacy of good glucose control in preventing the long-term vascular complications of diabetes. Nevertheless, despite efforts of patients to keep their glucose levels as normal as possible, it is still nearly impossible for individuals with type 1 diabetes to achieve the precise level of glucose control attained by a healthy pancreas. Therefore, individuals with type 1 diabetes inevitably experience hyperglycemia, resulting in organ damage that produces morbidity for the individual and contributes to the high cost of health care for society.  In addition, individuals with diabetes have a life span that is reduced by up to 15 years.

Therefore, the NIDDK wishes to expand its portfolio of clinical trials that will inform clinical management of type 1 diabetes across the lifespan. This FOA will utilize the NIH Small Grant program (R03) to solicit applications to establish feasibility and plan the design of clinical trials in individuals with type 1 diabetes. These trials should be designed to improve glycemic control and/or treat or reduce diabetes complications. The results of such trials should be of practical importance to clinical management and applicable immediately.  The development or validation of new technologies, and studies of immune-modulation or islet transplantation will not be solicited in this planned FOA, as such efforts are currently underway and may be expanded through other mechanisms.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Teresa Jones, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 435-2996
FAX: (301) 480-3503
E-mail: jonester@mail.nih.gov


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