The aims of this study specifically address two of the research objectives outlined in NIDDK's Strategic Plan for the Scientific Community: 1) combine new technology for diabetes management with behavioral and translational research;and 2) mitigate psychosocial complications and comorbidities of diabetes to improve quality of life. NIDDK recognizes that research is needed to "develop behavioral approaches to improve family function, and ultimately metabolic control in the patient" and to "determine the most effective ways to translate strategies [to improve adherence] into routine pediatric care. This K23 study is significant because it addresses the critical need for improving insulin pump adherence where non-adherence has severe and potentially life threatening consequences. Continued misuse of insulin pumps compromises the health of patients with T1D and the ability of physicians to provide effective treatment. If the aims of this project are achieved, this study will change insuln pump practices by providing a comprehensive assessment approach relevant to insulin pump use. In addition, this study's use of a highly efficient experimental design to determine effective intervention components should lead to a cost-effective, clinic-based intervention to improve insulin pump adherence. This project is innovative because it: 1) objectively measures insulin pump adherence data, which is rare in the extant diabetes literature;2) develops an insulin pump assessment protocol that targets insulin pump knowledge/skills and BGM-BOLUS adherence behaviors that can be used in the clinical setting;and 3) uses a methodological approach for optimizing intervention components to be delivered at point of care. This study also explores modifiable barriers that could potentially interfere with effective insulin pump use including fear of hypoglycemia, adolescent responsibility, and depression, and could be incorporated into future interventions.
The specific aims of this study are: 1) develop an insulin pump assessment protocol focused on knowledge/skills relevant to BGM-BOLUS adherence behaviors;2) use a highly efficient experimental design to determine whether the two components of the Pump It Up! Intervention, Personalized Insulin Pump Feedback and Insulin Pump Problem-Solving, are effective at improving BGM-BOLUS adherence behaviors;and 3) identify moderators associated with BGM- BOLUS adherence behaviors. My overall goal is to become an independent, patient-oriented clinical researcher in T1D by establishing an independent line of research focused on understanding the modifiable barriers associated with suboptimal BGM and insulin adherence, which can be improved through the implementation of innovative interventions during the routine care of patients with T1D. I plan to focus on pediatric patients who use insulin pumps as this population has been understudied in the extant literature. This K23 proposal will provide the necessary foundation for my transition to an independent researcher in T1D. I have several qualifications that make me an ideal Candidate for a K23 Mentored Patient-Oriented Research Career Development Award. I am a licensed clinical psychologist with a strong scientific background in evidence-based treatments. I was a recipient of an NIDDK supported T32 postdoctoral NRSA and the NIH Pediatric Loan Repayment Program. I am fully committed to establishing my academic research career in T1D and am well-prepared to capitalize on a K23 award. I have spent the first years of my faculty position designing and conducting preliminary studies in T1D, establishing important collaborative relationships with endocrinologists, and publishing articles in T1D. I have carefully chosen a mentorship/consulting team that will facilitate my transition to an independent academic research career in T1D. My primary mentor on this award is Dr. Suzanne Bennett Johnson, a well- established pediatric psychologist with expertise in T1D, adherence, and clinical trials with more than 30 years of NIH funding. Dr. Larry Deeb, co-Mentor, is a pediatric endocrinologist and past President of the American Diabetes Association. Consultants include Dr. Roger Mazze, an expert in technological advancements associated with T1D care;Dr. Linda Collins, an expert in innovative methodologies and intervention techniques;and Dr. Daniel McGee, an expert in sophisticated measurement and statistical models and longitudinal data analysis. The environment at the Florida State University College of Medicine is rich in resources that support my early career development including space to conduct research and house research staff, state-of-the-art library and information technology facilities, and additiona funds to complete the project if necessary. The faculty in my department is prolific with regard to publications and securing extramural funding. The goals contained in my training plan include: 1) develop expertise in the pathophysiology, medical management, and psychosocial factors of T1D;2) develop expertise in the objective measurement of T1D treatment regimen adherence;3) extend knowledge of innovative statistical approaches involving BGM and insulin pump technology data;4) develop expertise in innovative methodological approaches;and 5) augment scientific writing skills. The combination of my training and research plan and mentoring/collaborative team who have a long history of NIH funding assures that the training and scientific goals of this application will be met and that I will become and independent academic T1D researcher.
The overall goal of this project is to address the critical need for improving insulin pump adherence where non- adherence has severe and potentially life threatening consequences by providing intervention to adolescents with type 1 diabetes (T1D) who use insulin pumps. This study is relevant to public health because continued misuse of insulin pumps compromises the health of patients with T1D and the ability of physicians to provide effective treatment. If the aims of this project are achieved, this study will change insuln pump practices by providing a comprehensive assessment approach relevant to insulin pump use.