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 
http://www.health.gov/healthypeople. 

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 
http://www.niddk.nih.gov/fund/other/centers.htm. 

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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  
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: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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 301-435-0714, email: 
GrantsInfo@nih.gov.

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 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html. 

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:  garfields@extra.niddk.nih.gov

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:  linderb@extra.niddk.nih.gov

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: pad@nei.nih.gov

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:	nell_armstrong@nih.gov

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:  chickc@extra.niddk.nih.gov

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: mbaritz@nei.nih.gov

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: tarwater@nih.gov

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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