This FOA invites applications for Clinical Centers to carefully characterize the course of glycemia over the entire duration of pregnancy. Centers selected to participate must agree to be part of a consortium that will collaboratively develop and implement a uniform protocol.

Observational studies have clearly demonstrated that varying degrees of dysglycemia during pregnancy, including pre-existing diabetes and gestational diabetes (GDM), are associated with adverse perinatal outcomes (e.g., macrosomia, large for gestational age [LGA], shoulder dystocia, congenital anomalies and fetal loss), as well as long-term sequelae for offspring, including the development of obesity and type 2 diabetes. Trials of GDM treatment have demonstrated improvement in some, but not all, perinatal outcomes and results have been inconsistent across trials; generally, trials have not been conducted to examine effects of GDM treatment on long-term sequelae.

Current clinical guidelines recommend screening for pre-existing diabetes at the first prenatal visit for high risk women, and screening for GDM at approximately 28 weeks of gestation. Given evidence that the intrauterine environment can have profound consequences for metabolic programming in the fetus, it is possible that beginning treatment of dysglycemia in the 3rd trimester may be too late to completely reverse "developmental origins of health and disease." However, the optimal time of screening and treatment for GDM is not known. Although there have been small, short-term physiologic studies of glucose metabolism in pregnant women, a comprehensive, longitudinal description of changes in glucose over the course of pregnancy and how glycemic levels earlier in pregnancy relate to traditional 3rd trimester GDM screening and perinatal outcomes is lacking.

This FOA will create a clinical consortium to characterize longitudinal changes in glycemia during pregnancy.  The availability of non-burdensome, continuous glucose monitoring (CGM) technology provides new opportunities to accomplish this goal. For example, CGM could be used to obtain detailed glucose profiles during usual daily activities at multiple time points (e.g., 12, 20, and 28 weeks of gestation) and correlate glycemia earlier in pregnancy with traditional GDM screening as well as perinatal outcomes and, potentially, longer-term outcomes if the cohort is followed longitudinally. Samples could also be obtained that may be useful in identifying mechanisms underlying dysglycemia, as well as predictors of GDM. Such samples could potentially also be useful in advancing the mechanistic understanding of how dysglycemia, as well as other metabolic abnormalities (e.g., lipids, immune factors), contribute to metabolic programming, if longer term follow-up of offspring is conducted. Information obtained from this study is expected to lead to improved approaches for screening for GDM, and inform the timing and approach for future clinical trials to decrease adverse perinatal outcomes and long-term sequelae of dysglycemia during pregnancy in both mother and offspring.   

This FOA invites applications from Clinical Centers to recruit and study pregnant women starting in the first trimester and continuing at least through delivery. A separate FOA (RFA-DK-18-019) will solicit applications for a Biostatistics Research Center (BRC) to provide additional scientific input as well as coordinate study design and protocol development, protocol implementation, and data analysis. Each Clinical Center applicant is expected to provide a detailed description of a proposed study that will accomplish the scientific aims described above, as well as detailed information about his/her own site's recruitment capacity. The proposed research study will enable reviewers to evaluate the applicant's ability to identify the critical issues to be addressed in the study and rigorously design such a study. Peer review will consider both the scientific merit of the application as well as the ability to recruit and conduct the study. The Awardees will then assemble to form a Steering Committee (see below), which will meet to develop a common protocol and manual(s) of procedures. The submitted applications will serve as a starting point for the Steering Committee's deliberations. It is expected that the Steering Committee will meet a minimum of three times at the NIH and have frequent contact by telephone during the planning phase, which is expected to take at least six months. 

It is anticipated that there may be a pilot or vanguard phase before the study is fully launched. If additional sites are needed to recruit adequate numbers of patients, subcontracts may be added to individual study sites or the BRC.

 Consortium Organization

1. Clinical Centers

Clinical Centers (CC) will recruit pregnant women in their first trimester and retain them during the course of the study. It is anticipated that women with pre-existing diabetes will be excluded. The population recruited should have racial and ethnic diversity, and it is expected that the population recruited will be enriched for women at particularly high risk of developing GDM. Recruitment will take place over 2-3 years.

The PD/PI and key co-investigators at each CC will be expected to collaborate in designing and implementing the uniform study protocol. It is expected that each CC will include a scientific team that represents a collaboration between a diabetologist and an obstetrician or maternal-fetal medicine expert. Centers must not only have the requisite number of deliveries but also proven experience in recruiting and retaining pregnant women in research studies, including recruitment of women during the first trimester. Centers must also have expertise in utilizing CGM technology. The CC will collect data in accordance with established study procedures and submit all samples and data to the Biostatistics Research Center (BRC) and central laboratory and central reading centers, as appropriate and required by the protocol.

Investigators at the CC will conduct analyses in conjunction with the BRC. The study group will have exclusive access to data from the study population for a defined period, according to NIDDK and NIH data sharing policies. All study data analyzed for publication of the primary and secondary study outcome(s) are expected to be provided to the NIDDK Repository so that it can be shared as appropriate per NIDDK policy and consistent with achieving the goals of the program.  The Steering Committee (see below) will establish policies under which ancillary studies may be conducted while the study is ongoing, consistent with applicable laws, regulations, and policies.

 2. Biostatistics Research Center (BRC)

There will be a single BRC. The BRC biostatisticians will work with the Clinical Center investigators to develop the scientific design of the study. The BRC investigators will have primary responsibility for ensuring that the design of the study, including the primary outcome, is scientifically sound and is supported by appropriate power calculations.  The BRC will also provide biostatistical and analytic expertise and conduct analysis and interpretation of the laboratory and clinical data in conjunction with investigators at the Clinical Centers. The BRC will be responsible for guiding development of the statistical analysis plan for the study as a whole and for each manuscript reporting pre-specified primary and secondary outcomes. The BRC will also be responsible for establishing all scientific collaborations for specialized outcomes.

In addition to these research functions, the BRC is responsible for the collection, management and analysis of all clinical and laboratory data, including establishment of any central laboratories or cores needed.. The BRC will be responsible for ensuring participant confidentiality and safety, and quality control. The BRC will conduct training and certification of study staff, and maintain and update the manual of operations. The BRC will oversee implementation of and adherence to the study protocol. The BRC will coordinate communication among and with the CC. The BRC will also be responsible for establishing and maintaining activities related to the single IRB. In addition, the BRC will develop procedures to require study investigators and other relevant personnel associated with the study to identify and manage financial and other conflicts of interest at least annually and share this information with NIDDK staff.

The BRC will coordinate the movement of biologic samples from the CC to the central laboratory and, subsequently, to the NIDDK repository, where samples will be stored for future analysis. The BRC will similarly coordinate with the CC to ensure the flow of CGM and other collected data to the appropriate central reading center. The BRC will also coordinate work with the NIDDK Data Repository to prepare all study data for eventual archiving and distribution.

The BRC will provide biostatistical, data management and analytic expertise. The BRC will prepare appropriately detailed reports to the Steering Committee and to the Observational Study Monitoring Board (OSMB), and to the NIDDK staff at regular intervals. The BRC will be responsible for the planning and logistics of meetings of the Steering Committee and its subcommittees, and will assist NIDDK with the logistics for OSMB meetings.

3. Steering Committee

The primary governing body of the study will be the Steering Committee, comprised of the PDs/PIs of the BRC and each CC, and the NIDDK Project Scientist.

The Steering Committee will develop policies and procedures for the study group, and ensure that these policies are properly implemented. These may include procedures for modification of study design, use of study samples and data, approval of ancillary studies, publication and presentation of study findings, monitoring study progress, determining completeness and quality of data collection, and other performance measures. NIDDK expects the investigators to develop robust ancillary study policies to provide opportunities for outside investigators to leverage collected data and biospecimens, as well as the recruited cohort, to expand the scientific output of the group.

4. Project Scientist

The NIDDK Project Scientist will assist the Steering Committee in designing and carrying out the study. The Project Scientist will provide scientific support to awardees' activities, including protocol development, quality control, interim data monitoring, final data analysis, preparation of publications, and overall performance monitoring.   

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

• Eligible Agencies of the Federal Government

• U.S. Territory or Possession

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

3. Additional Information on Eligibility

Number of Applications  

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity
   

The letter of intent should be sent to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKletterofintent@mail.nih.gov

Clinical Protocol Synopsis :  The file name "Clinical Protocol Synopsis.pdf" must be used.

Large multi-center clinical studies, even those that are not clinical trials, require a formal protocol to lay out a rigorous scientific design, and, to achieve standardization and fidelity of activities across all sites. The Clinical Protocol Synopsis must provide a narrative description of the protocol, briefly describing the objectives of the protocol and including:

• Identification of the primary and key secondary outcomes.
• Descriptions of all clinical, laboratory, physiological, and/or behavioral tests that will be collected to enable the research questions to be answered. Please provide a table showing the timepoints at which each measure will be collected.
• A description of each enrollment site.

Applications that lack the Clinical Protocol Synopsis are incomplete and will not be peer reviewed.

Statistical Analysis Plan: The filename "Statistical Analysis Plan.pdf" must be used.

The applicant must describe the statistical methods to be used, including the sample size and power calculations, plans for the primary and secondary analyses, and pre-specified interim analyses. This plan is critical to knowing whether applicants have selected the correct cohort size based on proper power calculations and/or are using the most appropriate methods to analyze the resulting data and make correct conclusions at the end of the study. The sample size and statistical power calculations should contain enough detail, including a discussion of assumptions made, so that a reviewer can readily duplicate the sample size projection. The power analysis should include a discussion of the anticipated rates of follow-up (i.e., drop out/lost to follow up) during key outcome collection contacts.  A discussion of how missing data will be handled should be included. Any planned interim analyses should also be described.

 Applications that lack the Statistical Analysis Plan are incomplete and will not be peer reviewed.
 

Milestone Plan: The filename "Milestone Plan.pdf" must be used.

Applicants are required to provide detailed interim performance measures and timelines for completing key objectives and administrative functions for the proposed clinical study, as applicable. The Milestone Plan is separate and distinct from the Study Timeline attachment. Milestones should be easily measurable and realistic. Milestones may include, as applicable, but are not limited to:

• Finalization of the study protocol(s) and informed consent/assent forms (with program director agreement, if applicable) and establishment of a single IRB and provision of IRB approval
• Contracts/third party agreements
• Training of study staff
• Anticipated date of enrollment of the first participant
• Enrollment of 25%, 50%, 75% and 100% of the target sample size
• Follow-up visit completion, if applicable, of 25%, 50%, 75% and 100% of the enrolled study population, including women, minorities and children
• Expected drop-out or lost-to-follow-up rate
• Completion of data collection
• Completion of primary endpoint and secondary endpoint data analyses
• Completion of final study report and manuscript submission
• Closeout plans/communication of results to participants
   

These milestones will be negotiated at the time of the award, as appropriate. Future year support is contingent on satisfactory achievement of performance milestones. If milestones are not achieved fully, NIDDK may request development of a remedial plan and more frequent monitoring of progress, or take other remedial actions.

Applications that lack the Milestone Plan are considered incomplete and will not be peer reviewed.

Consortium Assurance The filename "Consortium Assurance.pdf" must be used.

The PD/PI should provide a letter stating his/her willingness to participate in Consortium activities, including sharing the scientific portion of the application, participating in meetings at the NIH and regular conference calls and abiding by approved Consortium policies, and following the common protocol agreed to during the planning phase. In the letter, the PD/PI should also discuss past experiences participating in multi-center studies.

In addition, the PD/PI and an authorized Institutional Official must provide evidence that the Institution is willing to sign a standard reliance agreement and use the single IRB proposed by the BRC as part of its application, in accordance with NIH policy on the use of a single Institutional Review Board for multi-site research, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-076.html.

All instructions in the SF424 (R&R) Application Guide must be followed.

Research Strategy:

The applicant should clearly articulate the significance of the proposed study, including why the study is needed and what evidence gap the study will address, including a discussion of how the results will be used to impact clinical or public health.

The application must include a detailed description and scientific rationale for the study design, addressing the population to be studied and the outcomes being assessed. The applicant should discuss the timing of CGM and OGTTs (and other proposed measures), and how tests performed earlier in the pregnancy will be correlated and compared with traditional GDM screening measures.

The application should include a discussion of potential biases or challenges in the protocol and how they will be addressed.

Preliminary data addressing the need for and supporting the feasibility of the study should be discussed. The discussion of supporting data that provide the basis for the study's design must address the adequacy and quality of previous studies.

Letters of Support:

Letters of support must be provided from all participating clinics and/or hospitals, well as collaborators at other sites.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data and Resource (biological Sample) Sharing Plan.

The NIDDK has established Central Biosample, Genetic, and Data Repositories for the archiving and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. The investigator(s) should be prepared to transfer all data and samples to the Repository at the conclusion of the study. The study group will have exclusive access to data for a defined period, according to NIDDK data sharing policies (https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers).

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

Section 2 -Study Population Characteristics

2.5 Recruitment and Retention Plan

The applicant must indicate how many participants he/she expects to be able to recruit. Please include a specific, detailed discussion of the availability of potential participants for the proposed study and anticipated yield from recruitment and screening efforts. The plan should address not only the total number of deliveries per year but the demographics of the population, including key characteristics relevant to various degrees of GDM risk (e.g., race/ethnicity, BMI, SES, etc.). The number of women evaluated per year in the 1st trimester of pregnancy and their characteristics (e.g., race/ethnicity, BMI, SES, etc.) should be included as well. Moreover, the number of pregnant women admitted or discharged with a diagnosis of GDM should be reported. Ideally, these estimates should be based on careful queries of the electronic medical record system. If there is more than one site, please discuss recruitment efforts at each site and overall. The plan must also include a detailed discussion of past experience in recruiting and retaining similar populations, expected challenges to recruitment and retention, and possible contingency plans. The plan must specifically address past experience and any special approaches/procedures necessary to recruit women in the 1st trimester and women at high risk of developing GDM.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Applicants to this RFA must include a Data and Safety Monitoring Plan. In addition to the description of safety monitoring, address plans to monitor trial performance, including plans to assure fidelity to the protocol and integrity of the data. Information about Data and Safety Monitoring Plans is available on the NIDDK website: https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers/data-safety-monitoring-plans.

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Significance  

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)  

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Specific to this FOA: Do the PD/PI(s) and key personnel have the expertise, experience, and ability to conduct research in pregnant women, and to    organize, manage and implement the proposed multi-center clinical study? Is there a multi-disciplinary team including a diabetologist and obstetrician or maternal-fetal medicine expert?

Innovation  

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?