TRANSLATIONAL RESEARCH FOR THE PREVENTION AND CONTROL OF DIABETES Release Date: March 15, 2001 PA NUMBER: PA-01-069 National Institute of Diabetes and Digestive and Kidney Diseases National Eye Institute National Institute of Nursing Research American Diabetes Association PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Eye Institute (NEI), the National Institute of Nursing Research (NINR), and the American Diabetes Association (ADA) solicit research to translate recent advances in the prevention and treatment of type 1 or type 2 diabetes into clinical practice for individuals and communities at risk. This program announcement establishes a diabetes prevention and control program, and seeks applications for clinical or behavioral studies to develop and test 1) improved methods of health care delivery to patients with or at risk of diabetes, 2) improved methods of diabetes self management, and 3) cost effective community-based strategies to promote healthy lifestyles that will reduce the risk of diabetes and obesity. Studies should focus on testing strategies for 1) achieving objectives that have already been proven beneficial, such as control of glycemia and other risk factors for diabetic complications, or 2) enhancing behaviors that are expected to improve health outcomes for individuals with type 1 or type 2 diabetes. Of particular interest are interventions that focus on translating new advances into practice in underserved and minority populations. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA, (Translational Research for the Prevention and Control of Diabetes), is related to the priority area of diabetes. Potential applicants may obtain a copy of "Healthy People 2010" at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research demonstration and dissemination project (R18) award mechanism. This mechanism is designed to support the testing and evaluation of interventions and activities that lead to application of existing knowledge to disease control and prevention. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 5 years. DURATION OF PROGRAM ANNOUNCEMENT This PA will remain active for three years, until October 2004, at which time applications may no longer be submitted in response to this announcement. RESEARCH OBJECTIVES Background The Diabetes Control and Complications Trial (DCCT), for type 1 diabetes, and the United Kingdom Prospective Diabetes Study (UKDPS), for type 2 diabetes, established the importance of intensive diabetes control in dramatically reducing the devastating complications that result from poorly controlled diabetes. Both the DCCT and the UKPDS demonstrated the efficacy of intensive glucose control in reducing the risk for the microvascular complications of diabetes, such as retinopathy, neuropathy, and nephropathy. In addition, results from the UKPDS suggested that strokes may be reduced in patients with type 2 diabetes through a combined regimen of intensive blood pressure and glycemic control. Unfortunately, the advances of these studies have not been successfully incorporated into general health care practice. Prevention and treatment of long-term micro- and macrovascular complications remain a critical problem in the management of type 1 and type 2 diabetes mellitus. In the United States, diabetes is the leading cause of new blindness in working-age adults, of new cases of end stage renal disease and of non-traumatic lower leg amputations. In addition, cardiovascular complications are now the leading cause of diabetes- related morbidity and mortality, particularly among women and the elderly. In adult patients with diabetes, the risk of cardiovascular disease (CVD) is three to five fold greater than in nondiabetics. For cardiovascular disease, comorbid conditions (hypertension, hyperlipidemia and hyperinsulinemia) combine with hyperglycemia to contribute to accelerated athersclerosis. These additional risk factors may also contribute the microvascular disease. Thus, control of hyperglycemia, although critical, may not be sufficient to substantially reduce morbidity and mortality. Available data suggest that patients with diabetes would benefit from more aggressive and comprehensive risk factor management. Underutilization of current knowledge was highlighted in a recent study of diabetic individuals that demonstrated a low frequency of self- monitoring of blood glucose, good glycemic control, regular foot care, and ophthalmic examinations, all of which markedly reduce the incidence and progression of diabetic complications. Alarmingly, less than 2% of adults with diabetes receive the level of care that has been recommended by the American Diabetes Association (ADA), with self- monitoring of blood glucose following the ADA guidelines performed by only one in five adults with diabetes. Thus, it is clear that effective mechanisms for diabetes treatment, shown by the DCCT and the UKPDS to reduce the burden of diabetes, are not being implemented. The results of ongoing clinical trials that address the prevention and/or treatment of type 1 or type 2 diabetes (e.g., DPT-1, DPP and ACCORD) are likely to become available in the near future. In the event of positive outcomes in either or both of these studies, it will be even more crucial that effective translation strategies be developed and adopted to improve adherence to accepted standards of diabetes care, and to overcome barriers to the translation of scientific advances into clinical practice. Objectives and Scope The NIDDK, the NEI, the NINR and the ADA seek to enhance diabetes prevention and control research. The overall objective of this program announcement is to support research to develop intervention strategies that will enhance health promotion, diabetes self control and reduction in risk at the health care system level, the provider level and the patient level. Trials proposed under this program should test 1) improved methods of health care delivery to patients with or at risk of diabetes, 2) improved methods of diabetes self management, and 3) cost effective community-based strategies to promote healthy lifestyles that will reduce the risk of diabetes and obesity. Generally, these studies will take interventions that have been demonstrated to be beneficial by controlled laboratory or clinical investigations (e.g., intensive glycemic control), and extend or adapt these interventions to larger populations or other settings. Alternatively, trials may focus on enhancing behaviors (e.g., increased physical activity in individuals at risk for diabetes) generally accepted as likely to improve health outcomes for patients with or at risk of diabetes. The translation of new science to patient care would occur more rapidly if it were not for the existence of certain barriers, which impede the adoption and implementation of current knowledge. Such barriers include but are not limited to: o health care provider knowledge, o communication between patient and health care provider, o attitudes and beliefs of the patient, community/culture, health care provider and health care system, o racial and ethnic disparities, o variations in settings, o clinical traditions, o socioeconomic status, o cost. Proposed research studies should be designed to overcome these barriers. Topics of interest include, but are not limited to: o strategies to enhance glycemic control or reduce risk factors for the development of the complications of type 1 or type 2 diabetes, o strategies to promote the adoption of healthy lifestyles which will reduce obesity and diabetes, o studies that test interventions within the changing health care delivery system and changing patient demographics, o studies to determine the role of patient/provider communication on diabetes outcomes, and strategies to facilitate such communication, o strategies to enhance patient or provider education, o the testing of community-based programs to provide education and behavior modification at lower cost, o strategies to alter health care system features that reduce the efficiency or effectiveness of patient/provider interaction and health outcomes. Of particular interest are studies to improve self management and enhance health care delivery to underserved and minority populations. Such studies may seek to improve outcomes in populations (with either type 1 or type 2 diabetes) that historically have had poor glycemic control, or promote effective prevention strategies in minority populations known to be at high risk for the development of type 2 diabetes. These prevention and control projects should be effectiveness trials and will generally have the same research design as a single-center randomized clinical trial. There should be convincing preliminary data that show that the intervention has the potential to alter behavior and that the intervention can feasibly be carried out. The intervention should be clearly described. Applicants should provide a detailed description of the design of the study, including what eligibility, baseline and follow-up tests are to be done, what surrogate markers and endpoints will be examined, the duration of follow-up, and the statistical analysis to be employed. The process for biologic sample collection, storage and handling needs should be included. A description of the laboratory tests that are needed with appropriate methods for performing them should be provided. Applicants should describe their physical facilities, data management and computer resources, and facilities for data retrieval and storage. Examples of data forms, questionnaires and software/computer programs should be included and described. Methods for data collection, management and quality control procedures must be detailed. Applicants must include a plan for randomization of patients into protocols. Methods for assuring privacy and maintaining confidentiality should be included. There must be a data and safety management plan. Applicants should provide a detailed description of the target population to be studied, with justification, including a definition of the cohort by age, gender, sex and race/ethnicity. The ability to recruit this target population and the methods to be used should be described, with an estimation of the potential number of patients who fit the eligibility criteria and expected accrual rates. Sample size needs and the assumptions and calculations used to estimate sample size should be detailed. Applicants must state their plans for reporting accrual by gender, race and ethnicity and for the reporting of results that examine differences in treatment effects across these subgroups (see below, Inclusion of Women and Minorities in Research Involving Human Subjects ). Studies may utilize methodology from the fields of biomedical, social or behavioral sciences, epidemiology (including clinical trials), and health services research. The outcome will generally be some form of behavior change, health care status, or health care use. An intervention aimed at producing a behavioral change should be grounded in behavior change theory, which should be incorporated into the intervention. The application will be strengthened by the inclusion of a process evaluation i.e., an evaluation of whether the intervention is actually delivered as intended. Investigators should provide detailed evidence that the research team has the experience and expertise to conduct the research study. Most translation research will require a multidisciplinary research team. Thus, a variety of researchers may be required for these studies, including, but not limited to, endocrinologists, public health physicians, primary care physicians, epidemiologists, statisticians, psychologists, health educators, sociologists, nurses, nutritionists and other health related professionals. The interdisciplinary nature of the research team should be fully described and justified. Investigators located at existing Diabetes Research and Training Centers (DRTC) should include a complete description of how the research being proposed in response to this PA will utilize the core facilities funded through the Prevention and Control (P&C) Division of their DRTC. A central purpose of the P&C Divisions is to support translation research into the barriers that restrict the adoption of advances in diabetes treatment into practice. It should therefore be made clear how the research being proposed integrates into the DRTC, its cores and overall biomedical research focus. Investigators who are not affiliated with a DRTC may, but are not required to, form collaborations with such centers in order to utilize the resources of a P&C Division, which may provide support for such aspects of the proposed research as statistical analysis and instrument development. A list of DRTCs is available at SPECIAL REQUIREMENTS Letter of Authorization Following notification by CSR of the Institute assignment, applicants should submit a brief letter to the appropriate program official (see below, Inquiries ) indicating whether or not they wish their application to be considered for funding by the ADA. While applicants may request that their applications be considered only by the NIH and not by the ADA, it is necessary that the record indicate the applicant"s consideration of this opportunity. For those applicants who wish to have the ADA consider their application, all materials relating to the application will be promptly forwarded to that organization and the summary statements for such applications will be shared with the ADA when available. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (, a complete copy of the updated Guidelines are available at The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES All applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research, or may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email: Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the appropriate Institute’s program staff (see below, Inquiries ) before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at FOR ALL APPLICATIONS The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit the signed, original, single-sided application, including the Checklist, along with five signed photocopies and five collated sets of appendix materials in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040-MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be assigned to the relevant Institute on the basis of established Public Health Service referral guidelines. Applications will be reviewed for completeness by the Center for Scientific Research (CSR) and responsiveness by the Institutes (ICs). As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. o Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? o Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? o Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? o Translation: Does the intervention strategy proposed have the ability to be translated into primary care, community, family or other patient care/support settings? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o Adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration to the proposed research. o The adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the relevant Institute. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review, o Availability of funds, o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sanford Garfield, Ph.D (for NIDDK-supported behavioral research) Division of Diabetes, Endocrinology and Metabolic Diseases NIDDK 6707 Democracy Boulevard, Rm. 685 Bethesda, MD 20892-5460 Telephone: (301) 594-8803 FAX: (301) 480-3503 E-mail: Barbara Linder, M.D., Ph.D. (for NIDDK-supported medical research) Division of Diabetes, Endocrinology and Metabolic Diseases NIDDK 6707 Democracy Boulevard, Rm. 699 Bethesda, MD 20892-5460 Telephone: (301) 594-0021 FAX: (301) 480-3503 E-mail: Peter Dudley, Ph.D. Vision Research Program NEI Executive Plaza South, Rm. 350 Bethesda, MD 20892 Telephone: (301) 496-0484 FAX: (301) 402-0528 E-mail: Nell Armstrong, Ph.D., R.N. NINR Building 45, Room 3AN12 Bethesda, MD 20892 6300 Telephone, (301) 594-5973 FAX: (301) 480-8260 E-mail: Direct inquiries regarding fiscal matters to: Cheryl Chick Division of Extramural Activities NIDDK 6707 Democracy Boulevard, Rm. 606 Bethesda, MD 20892-5456 Telephone: (301) 594-8825 FAX: (301) 480-3504 E-mail: Margie Baritz Division of Extramural Activities NEI Executive Plaza South, Rm. 350 Bethesda, MD 20892-6600 Telephone: (301) 496-5884 FAX: (301) 496-9997 E-mail: Robert L. Tarwater Office of Grants and Contracts Management NINR Building 45, Room 3AN12 Bethesda, MD 20892-6300 Telephone: (301) 594-2807 FAX: (310) 480-8260 E-mail: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847, 93.867, and 93.361. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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