Release Date:  January 27, 2000

PA NUMBER:  PA-00-049

National Institute of Nursing Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute on Aging
National Institute of Dental and Craniofacial Research



This Program Announcement (PA) solicits applications for investigator-
initiated research related to sociocultural, environmental, and behavioral 
mechanisms and biological/technological factors that contribute to successful 
and ongoing self-management in diabetes.  Self-management is defined as client 
strategies and behaviors that contribute to blood glucose normalization, 
improved health, and prevention or reduction of complications. It is broader 
than adherence to specific regimen components and incorporates deliberate 
problem solving and decision making processes. Applications are encouraged for 
both type 1 and type 2 diabetes; representative and minority populations; and 
all age groups.


The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2000," a PHS led national 
activity for setting priority areas.  This Program Announcement (PA), Title of 
PA, is related to one or more of the priority areas.   Potential applicants 
may obtain a copy of "Healthy People 2000" at 


Applications may be submitted by domestic and foreign, for-profit and non-
profit 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 


This PA will use the National Institutes of Health (NIH) research project 
grant (R01) award mechanism.  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.

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 Institute 
or Center (IC) program staff (see INQUIRIES, below) before submitting the 
application, i.e., as plans for the study are being developed.  Furthermore, 
the applicant must obtain agreement from IC staff that the IC 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 or 
Center 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 subsequent amendment.  Refer to the NIH Guide for Grants 
and Contracts, March 20, 1998 

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at 



Although more effective medications, delivery devices and methods for diabetes 
self monitoring have improved the ability to control glycemia, normal 
metabolic control remains difficult to achieve.  Results from the Diabetes 
Control and Complications Trial (DCCT) have shown that improving blood glucose 
control in type 1 diabetes, in which the body produces no insulin to regulate 
blood glucose levels, markedly reduces related complications of the eyes, 
kidneys, and nerves.  Results from the United Kingdom Prospective Diabetes 
Study (UKPDS) has similarly demonstrated that improved control of blood 
glucose in type 2 diabetes also reduces diabetes related complications.

Both type 1 and type 2 diabetes require careful self-management and both can 
lead to acute and chronic complications compromising health and quality of 
life. Often multiple self-care regimens are required to manage the diabetes 
and help prevent, detect, or reduce complications. All age, socioeconomic, and 
ethnic groups are affected. Type 1 diabetes results from an autoimmune 
destruction of insulin-producing beta cells in the pancreas, thereby leading 
to a lack of insulin. Current methods of insulin replacement cannot replicate 
the normal pancreatic beta cell ability to precisely control blood glucose 
metabolism. In type 2 diabetes, the metabolic problem is related to certain 
tissues’ resistance to insulin action and to inability of the pancreas to 
appropriately regulate the pattern and quantity of insulin for glucose 
metabolism. These metabolic abnormalities lead to the many complications of 
both types of diabetes. 

Type 2 diabetes has always been more prevalent than type 1 and has occurred 
predominantly in adults aged 40 and over. A trend has developed in the last 
ten years, however, indicating that children and adolescents are increasingly 
susceptible to type 2 diabetes. This trend is particularly evident in minority 
ethnic groups, especially in African Americans and American Indians. The 
increase in U.S. citizens, including children and adolescents, who are 
overweight may be contributing to this trend. With both types of diabetes 
becoming more prevalent in the population, and with the associated risk for 
serious complications, issues related to proactive self-management become a 
greater concern.

Chronic diabetes complications are many and varied. Microvascular 
complications include  retinopathy, nephropathy, and peripheral or autonomic 
neuropathy. These complications can lead to vision impairment or blindness, 
the need for kidney dialysis or transplant, and limb amputations. 
Macrovascular complications include cardiac, cardiovascular, and peripheral 
vascular diseases. Other problematic comorbidities can occur, including, for 
example, periodontal disease (that may lead to early tooth loss) or 
respiratory infections. These diseases and their impact on metabolic control, 
personal lifestyle, work productivity, the society as a whole, and health care 
costs underscore the need to develop more efficacious and effective diabetes 
self management interventions.
The most common acute complication of diabetes is hypoglycemia which can range 
from mild to severe. Hypoglycemia can occur more often with tighter (more 
normal) blood glucose control. This can lead to conflict for the individual 
between the recognized need for normal blood glucose levels versus the fear or 
concern about having a hypoglycemic reaction at work or school, while driving, 
or in any social situation. The resulting loss of control of mental function 
with hypoglycemia due to confusion or decreasing awareness can lead to 
avoidance of hypoglycemia by overeating or underexercising. Self-management 
decisions related to the needs for both blood glucose control and as normal a 
lifestyle as possible can be problematic for the individual, the family, and 
health care providers. 

Coping with a complex chronic illness such as diabetes affects the individual 
as well as family members throughout the entire life-course. The daily 
responsibilities and knowledge of the risk for serious complications such as 
blindness, amputations, and heart disease, place a heavy burden of self-care 
on individuals with diabetes. Persons with diabetes are faced with decision 
making that involves establishing priorities in allocating time, effort, and 
resources to attain multiple types of health care (e.g., nursing, medical, 
ophthalmic, dental, nutrition, and podiatry). In general, much of the 
responsibility for managing diabetes falls on the individuals themselves, 
whose responsibilities, in addition to usual health maintenance, include 
regimens of meal planning and timing, physical activity, blood glucose 
monitoring, management of acute complications, and adjustments in therapies 
and lifestyle behaviors. Family members and family life, however, are also 
affected by the disease. Family members have greater responsibility for 
participating in diabetes care when the person with diabetes is a child, 
adolescent, or dependent older adult.

The report of a national conference on diabetes convened by NIH in 1997 
suggests that insight into the behavioral barriers that prevent application of 
effective therapies and the development of the means to lower those barriers 
will help to implement current and future therapies.  A Congressionally-
established Diabetes Research Working Group developed a comprehensive plan for 
diabetes research priorities in 1999.  The recommendations include studies 
related to the optimization of glucose control and the need for behavioral 
research.  The report notes that in many cases, successful metabolic control 
and prevention of complications depends on changing the behaviors of patients, 
providers, and persons at risk for development of diabetes.

The DCCT, UKDPS, and a recent meeting3 at NIH on behavioral science research 
in diabetes all stress the need to extend research on self-management, 
adherence, and other biopsychosocial aspects of diabetes management to assist 
persons with diabetes to achieve normal blood glucose levels, to reduce 
complications, and to improve their quality of life. The investigation of 
factors associated with effective and long-term diabetes self-management is 
critical to improving diabetes health outcomes. This announcement is aimed at 
meeting the diabetes self-management research needs.


Translational and patient-oriented research on self-management and adherence 
in diabetes that affects both psychosocial and biophysiological outcomes is 
solicited through this program announcement. This announcement solicits 
proposals on both type 1 and type 2 diabetes populations and all age groups 
and ethnic backgrounds. Research is needed to develop effective methodologies 
for promoting sustained adherence to appropriate diabetes self-management 
behaviors. Intervention proposals are particularly solicited, especially those 
to test approaches that are feasible and cost effective to translate into 


Research areas specific to diabetes self-management that need to be explored 
include, but are not limited to:

o  identification of critical intervention components in promoting sustained, 
effective diabetes self-management to improve glycemic control and reduce a 
wide array of complications;

o  factors related to degree of success with sustained intensive self-
management (examples: coping styles, social support strategies/systems, 
personality dispositions, burden of care, stress, impact on quality of life, 
economic considerations, health outcomes);

o  intervention strategies with a defined focus on cultural, ethnic, 
lifestyle, and age-related factors (examples: how do intervention strategies 
need to be tailored to be optimally effective for (1) persons with life-long 
diabetes versus those with late-life onset, (2) persons who have long, intense 
work hours, persons with health beliefs at variance with mainstream beliefs?);

o  strategies that promote quality of life or that ease the psychosocial 
burden of diabetes on individuals and their families; 

o  intervention strategies that promote effective self-monitoring, problem 
solving, and decision making in addition to routine diabetes management 
actions (examples: processes underlying decisions related to working with 
health care providers, for both primary and collateral health care; self-
management decisions and problem solving);

o  interdisciplinary team or health care provider roles and relationships with 
the person with diabetes to support shared decision making and successful 

o  supporting strategies of the health care delivery system in promoting 
diabetes self-management (specifically in conjunction with other 

o  strategies that promote behavior change in sub-populations that have 
significant difficulties (examples: adolescents, children, obese individuals, 
frail elders, low-income, hard-to-reach inner-city, rural, ethnic groups);

o  integrating technologies into self-management strategies (examples: glucose 
monitoring, computer based communications/strategies, insulin pump).

1. National Institutes of Health  (September, 1997).  Diabetes Mellitus: 
Challenges and Opportunities.  Final Report and Recommendations.  Bethesda, 

2.  Congressionally-Established Diabetes Research Working Group.  (1999).  
Conquering Diabetes: A Strategic Plan for the 21st Century.  Bethesda, MD: NIH 
Publication No. 99-4398.

3.  National Institutes of Health (November, 1999) Behavioral Science Research 
in Diabetes meeting. Presented by National Institute of Diabetes and Digestive 
and Kidney Diseases and the Office of Behavioral and Social Sciences Branch, 


It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, 
No. 11, March 18, 1994 available on the web at the following URL address:  

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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.


Some applications received in response to this program announcement are 
expected to focus on scientific issues related to aging and to aging-related 
aspects of disease. In describing the plan to recruit human subjects 
investigators may cite a focus on aging or on aging-related aspects of disease 
as the justification for why children will be excluded. In this regard 
applicants may use Justification 1, the research topic to be studied is 
irrelevant to children, from the policy announcement.


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 
Institute or Center (IC) program staff before submitting the application, 
i.e., as plans for the study are being developed.  Furthermore, the 
application must obtain agreement from the IC staff that the IC 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 or Center 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 

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only when 
there is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and Institute 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for  these grants, with the modifications noted below.


Modular Grant applications will request direct costs in $25,000 modules, up to 
a total direct cost request of $250,000 per year.  (Applications that request 
more than $250,000 direct costs in any year must follow the traditional PHS398 
application instructions.)  The total direct costs must be requested  in 
accordance with the  program guidelines and  the modifications made to the 
standard  PHS 398 application  instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total 
Direct plus Facilities and Administrative  (F&A) costs] for the initial budget 
period Items 8a and 8b should be completed indicating the Direct and Total 
Costs for the entire proposed period of support.

of the PHS 398. It is not required and will not be accepted with the 

categorical budget table on Form Page 5 of the PHS 398. It is not required and 
will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.) At the top of the page, enter the total direct costs requested for 
each year.  This is not a Form page.

o Under Personnel, List key project personnel, including their names, percent 
of effort, and roles on the project. No individual salary information should 
be provided. However, the applicant should use the NIH appropriation language  
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the nearest 
$1,000. List the individuals/organizations with whom consortium or contractual 
arrangements have been made, the percent effort of key personnel, and the role 
on the project. Indicate whether the collaborating institution is foreign or 
domestic. The total cost for a consortium/contractual arrangement is included 
in the overall requested modular direct cost amount.  Include the Letter of 
Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall 
qualifications of the research team. A biographical sketch is required for all 
key personnel, following the instructions below. No more than three pages may 
be used for each person. A sample biographical sketch may be viewed at:  
https://grants.nih.gov/grants/funding/modular/modular.htm. Complete the 
educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects 	  ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o CHECKLIST - This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, indicate the type 
of agreement and the date. All appropriate exclusions must be applied  in the 
calculation of the F&A costs for the initial budget period and all future 
budget years.

o The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

Application kits are available at most institutional offices of sponsored 
research and 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: 

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 a signed, typewritten original of the application, including the 
Checklist, and five signed photocopies in one package to:

BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)


Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures.  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 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.

(1) 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?

(2) 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?

(3) Innovation:  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?

(4) 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)?

(5) 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 

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The 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 

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project  
proposed in the application.

Additional scientific/technical merit criteria specific to the objectives of 
the PA and the mechanism used must be included if they are to be used in the 


Applications will compete for available funds with all other recommended 
applications. The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.


Inquiries are strongly encouraged.  The opportunity to clarify any issues or 
questions from potential applicants is welcome.

Direct inquiries regarding GENERAL ISSUES to:

Dr. Nell Armstrong
Office of Extramural Activities
National Institute of Nursing Research
Building 45, Room 3AN12
45 Center Drive, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-5973
FAX:  (301) 480-8260
Email: nell_armstrong@nih.gov

Direct inquiries regarding specific PROGRAMMATIC ISSUES to the staff of the 
appropriate Institute/Center :

Dr. Nell Armstrong
Office of Extramural Activities
National Institute of Nursing Research
Building 45, Room 3AN12
45 Center Drive, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-5973
FAX:  (301) 480-8260
Email: nell_armstrong@nih.gov

Dr. Sanford Garfield
Senior Advisor for Biometry and Behavioral Research
National Institute of Diabetes and Digestive and Kidney Diseases
Building 45, Room 5AN24B
45 Center Drive, MSC 6600
Bethesda, MD 20892-6600
Telephone: (301) 594-8803
Fax: (301) 402-6271

Dr. Marcia Ory
Behavioral and Social Research
National Institute on Aging
Gateway Building, Room 533
7201 Wisconsin Ave  MSC 9205
Bethesda, MD  20892-9205
Telephone: (301) 402-4156
Fax:  (301) 402-0051
E-mail: Marcia_Ory@nih.gov

Dr. Patricia Bryant
Program Director, Behavioral and Health Promotion Research
Office of Clinical, Behavioral, and Health Promotion Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN24E
45 Center Drive, MSC 6402
Bethesda, MD 20892-6402
Telephone: (301) 594-2095
FAX: (301) 480-8318
E-mail: BryantP@de45.nidr.nih.gov 

Direct inquiries regarding FISCAL MATTERS to:

Mr. Robert Tarwater
Office of Grants Management
National Institute of Nursing Research
Building 45, Room 3AN24
45 Center Drive, MSC 6301
Bethesda, MD  20892-6301
Telephone:  (301) 594-2807
FAX:  (301) 480-8260
Email:  robert_tarwater@nih.gov

Ms. Cheryl Chick
Office of Grants Management
National Institute of Diabetes and Digestive and Kidney Diseases
Building 45, Room 6AN38J
45 Center Drive, MSC 6600
Bethesda, MD 20892-6600
Telephone: (301) 594-8825
Fax: (301) 480-4237
E-mail: chickc@extra.niddk.nih.gov

Mr. Bob Pike 
Grants and Contracts Management Office 
National Institute on Aging
7201 Wisconsin Ave, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone: (301) 496-1472
Fax:  (301) 402-3672
E-mail: Bob_Pike@nih.gov

Mr. Martin Rubinstein
Office of Grants Management
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44A
45 Center Drive, MSC 6402
Bethesda, MD 20892-6402
Telephone (301) 594-4800
FAX: (301) 480-8301
Email: Martin_Rubinstein@nih.gov


This program is described in the Catalog of Federal Domestic Assistance No. 
93.361 (NINR); 93.847 (NIDDK); 93.121 (NIDCR); 93.866 (NIA).  Awards are made 
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, and 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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