Improving Diabetes Management in Children with Type 1 Diabetes (DP3)

RFA-DK-16-003
Improving Diabetes Management in Children with Type 1 Diabetes (DP3)
Department of Health and Human Services
National Institutes of Health

Section I. Funding Opportunity Descriptionjuvenile diabetes

Diabetes management requires complex balancing of medication dosing, diet and physical activity in order to achieve good glucose control while avoiding hypoglycemia. Achievement of good glucose control is also dependent on frequent self-monitoring of blood glucose values and appropriate insulin adjustment and administration. Avoiding blood glucose monitoring and skipping, delaying or under-dosing insulin can result in hypo- and hyperglycemia and life-threatening diabetic ketoacidosis.

Even the most effective treatments for type 1 diabetes are limited when families struggle to follow the treatment regimen and the diagnosis and management of type 1 diabetes can be a highly stressful experience for parents. Treatment regimens for tight glucose control can be especially challenging for very young children and their families. For example, smaller insulin doses can be more challenging to calculate and young children are more susceptible to hypoglycemia, particularly at night. There are also challenges specific to development, such as a young child’s more limited ability to detect and communicate changes in their physical status, unpredictable/picky eating, and variable activity and sleep patterns.  Further, parents of children with type 1 diabetes often report stress related to constant vigilance and fear of hypoglycemia, difficulty differentiating between diabetes-related symptoms and normal behavior, disrupted sleep schedules due to nocturnal blood glucose testing, fear/challenges in leaving the child with other caregivers (e.g., daycare, babysitters, school personnel) and feelings of anxiety and/or depressed mood associated with caring for a child with type 1 diabetes and concern about the long term outcomes for their children.

Further, rapid advances in diabetes management technologies, such as continuous glucose monitors, technology for transmitting and sharing glycemic information, and integration of information from continuous glucose monitors with insulin pumps, represent the next generation of type 1 diabetes management. The increased precision afforded by these tools can lead to tighter glucose control and better prediction and prevention of severe hypoglycemic and hyperglycemic episodes.  Despite the rapid technological advances and the considerable promise of these technologies, there continue to be many behavioral and psychosocial barriers to effective and consistent use in routine care. To realize the full potential of these tools, research is needed to identify approaches that help mitigate some of the barriers to use.  For example, many new tools allow parents to monitor their child’s blood glucose values on their cell phones in real time. While this increase in information can potentially improve diabetes control, it can also increase stress levels, strain family relationships, and lead to discontinued use of the tool.  Also, healthcare providers need improved approaches to more effectively incorporate the data these tools provide in their clinical decision making and interactions with the family, without overwhelming them with excessive data volume or complexity. Finally, there is a rapid growth in mobile app technologies with little consistent data about their effective and safe use.

Given the unique challenges of managing type 1 diabetes in children, there is a need to develop innovative and effective interventions to help families better manage diabetes and maintain good quality of life. Improved family coping, communication, and practices around diabetes management in these earlier stages of disease management may also provide a buffer for some of the declines in  glucose control frequently seen in adolescents and young adults.

The goal of this initiative is to support research to develop, refine, and pilot test innovative strategies to improve diabetes management and quality of life in families with children with type 1 diabetes. Studies in response to this funding opportunity can focus on young children (under 5 years old) and/or school-aged children (ages 5-9 years old).  At the end of the funding period, there should be well-developed and well-characterized intervention/s that have been demonstrated to be safe, feasible to implement, effective, acceptable in the target population, and ready to be tested in a larger efficacy trial. T

The focus of research submitted to this FOA should be on improving clinical outcomes. Therefore, the primary outcome should be a clinical measure of improved diabetes management (e.g., HbA1c, hypoglycemia, DKA). Secondary outcomes can include other physiologic measures, parent and child coping and should include measurement of behavior change targeted in the intervention.

Pilot or preliminary data are not required. However, there should be a strong justification that the proposed approach has promise for improving diabetes management in children. For example, the approach has been shown to be effective with other patient populations or diseases or there is a reasonable foundation of basic behavioral or social science to suggest that the target of intervention influences relevant behavior or coping.

This FOA focuses on developing interventions to improve diabetes management. Research might address the following issues related to diabetes management:

Interventions to help families improve diabetes management such as approaches focused on the targets below or some combination:

  • Families (the parents or other caregivers) to address issues such as diabetes related stress/distress, family coping/communication, low health literacy/numeracy, or over/under prediction of risks;
  • The healthcare team including collaborative communication between the family and the health care team and family-centered diabetes management goal setting and assessment;
  • The health care system (practice level changes, health information technology tools); or
  • Other resources or tools to support family coping and improve diabetes self-management.

Interventions to improve the use of new or existing technologies, including insulin pumps, blood glucose monitors, and continuous glucose monitoring (CGM) systems to:

  • Better address nocturnal hypoglycemia such as with a CGM that may be integrated in a low glucose suspend or closed loop system; or
  • Address barriers to use of the technology and identify and test approaches that facilitate more effective and sustained use.

Exchange of ideas and collaboration between funded investigators will be encouraged though yearly investigator meetings.

Research in response to this initiative should be for human studies only.

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-DK-16-003
Funding Opportunity Title: Improving Diabetes Management in Children with Type 1 Diabetes (DP3)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Food and Nutrition
Health
Category Explanation:
Expected Number of Awards: 3
CFDA Number(s): 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research
Cost Sharing or Matching Requirement: No
Posted Date: Dec 8, 2015
Creation Date: Dec 8, 2015
Original Closing Date for Applications: Jun 22, 2016  
Current Closing Date for Applications: Jun 22, 2016  
Archive Date: Jul 23, 2016
Estimated Total Program Funding: $6,000,000
Award Ceiling: $1,400,000
Award Floor:

Eligibility

Eligible Applicants:
Private institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Native American tribal organizations (other than Federally recognized tribal governments)
Public and State controlled institutions of higher education
Small businesses
Public housing authorities/Indian housing authorities
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
For profit organizations other than small businesses
Independent school districts
Others (see text field entitled “Additional Information on Eligibility” for clarification)
State governments
County governments
City or township governments
Special district governments
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Additional Information

Agency Name: National Institutes of Health
Description: The goal of this Funding Opportunity Announcement (FOA) is to support research to develop, refine, and pilot test innovative strategies to improve management of type 1 diabetes in young children (under 5 years old) and/or school-aged children (ages 5-9 years old).At the end of the funding period, there should be a well-developed and well-characterized intervention that has been demonstrated to be safe, feasible to implement, acceptable in the target population, and, if promising, ready to be tested in a larger efficacy trial.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-16-003.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

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