Kimberly A. Driscoll, Ph.D. - US grants

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.

Project Summary/Abstract NIDDK describes hypoglycemia as ?an Achilles heel in therapy to prevent diabetes complications.? Hypoglycemia causes ?difficulties with meeting blood glucose targets because [patients' and parents'] immediate fear of hypoglycemia overshadows their fear of long-term complications.? Hypoglycemia is the most common acute side effect (e.g., unpleasant physical symptoms such as sweating and heart palpitations) of intensive insulin therapy and it significantly interferes with achieving optimal glycemic control in patients with type 1 diabetes (T1D). Severe hypoglycemia is life-threatening and occurs when a shortage of glucose in the brain results in cognitive impairment, unconsciousness, or seizure. The experience of hypoglycemic episodes as a patient or a parent of a child with T1D can be psychologically traumatizing. Many studies have documented that fear of hypoglycemia increases anxiety about the T1D treatment regimen leading to engagement in ?hypoglycemia avoidance behaviors,? including over-vigilant blood glucose monitoring, treating low blood glucose levels with excessive amounts of carbohydrates, and maintaining high blood glucose by intentionally withholding insulin. Ultimately, inappropriate behaviors to counteract hypoglycemia can lead to poor glycemic control and long-term complications. Thus, it is critically important to assist patients with T1D and their parents to adopt adaptive behaviors to counteract hypo- and hyperglycemia. The overall objective and Primary Aim of this project is to address the critical need of identifying and providing intervention for fear of hypoglycemia, which will be accomplished by conducting a pilot, randomized clinical trial to evaluate the efficacy of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in adolescents with T1D who use insulin pumps and their parents. In addition, we will establish cutoff scores that may increase the clinical utility of the Child and Parent Versions of the Hypoglycemia Fear Survey, the only existing questionnaires to assess fear of hypoglycemia. If the aims of this project are achieved clinical care of pediatric patients with T1D and their parents will be substantially improved by 1) establishing an evidence-based intervention to treat fear of hypoglycemia; and 2) improving the clinical utility of the Hypoglycemia Fear Survey. This project is innovative and significant because it will test an intervention specifically developed for those with high fear of hypoglycemia, a potential cause of insulin pump nonadherence and a significant impediment to full utilization of the technological advances insulin pumps offer. This intervention has the potential to become more widely disseminated into a manualized treatment and training materials so that a variety of diabetes care providers will be able to implement the intervention techniques with patients with T1D and their parents.

Project Summary/Abstract The severity of T1D complications warrants an urgent need to improve glycemic control since 22% and 17% of children and adolescents with T1D, respectively, have suboptimal A1C >9.5%. Moreover, the T1D Exchange recently showed that an average A1C of 9% in 13-17 year olds is not much lower than the A1C average of 9.5% seen in the same age group at the beginning of the DCCT over 30 years ago. In fact, youth ages 2-17 years have an average A1C of 8.6%. In addition, there is an alarmingly high rate of pediatric DKA in the United States, with 7% of youth <18 years of age hospitalized for DKA. NIDDK recognizes that diabetic ketoacidosis (DKA), a serious acute complication, in youth must be addressed and strategies to reduce it developed, including significantly reducing time spent in hyperglycemia. Suboptimal adherence to critical T1D management behaviors (e.g., blood glucose monitoring, insulin dosing), either alone or in combination with psychosocial stressors, may lead to suboptimal glycemic control. Indeed, individuals with T1D and mental health comorbidities are 2x as likely to be in suboptimal glycemic control, yet 30% of T1D care teams do not have access to onsite mental health services. Moreover, mental health comorbidities are associated with worsening long-term complications. One possible pathway to improving glycemic control is to increase access via home telehealth This study is novel as it will use home telehealth intervention to address suboptimal T1D management and glycemic control by integrating medical and behavioral health (i.e., psychological) interventions to reduce negative and costly physical health outcomes in high-risk youth with T1D. The primary objective of this study is to address the critical need of providing intervention to high-risk (A1C=9-12%) youth with T1D. If achieved, T1D care practices will change by providing high-risk youth with T1D and their parents medical and behavioral health support via home telehealth intervention, which has the potential to significantly change access to T1D care, decrease time spent in hyperglycemia, reduce the frequency of hospital admissions, and improve glycemic control. In addition, use of Multiphase Optimization Strategy (MOST), a highly efficient experimental strategy to determine effective intervention components, should be generalizable to all individuals with T1D, leading to cost-effective, home telehealth intervention programs. Innovative aspects include: 1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.

Project Summary Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. T1D treatment adherence is challenging, especially during adolescence, which can lead to suboptimal blood glucose levels that severely compromises health, and in some cases, leads to premature death. Several interventions for adolescents with T1D exist, but none have focused on adherence barriers. The Barriers to Diabetes Adherence scale assesses these important targets for tailored adherence interventions, including stress/burnout and time pressure/planning. These adherence barriers are significantly associated with non-adherence, higher glycemic levels, and lower quality of life; however, no interventions address these two barriers in research or clinical practice. The overall objective of this study is to use patient-report of adherence barriers to identify intervention targets that will guide the integration of a novel tailored intervention into clinical care to improve adherence, glycemic levels, and quality of life. There are four aims of our multi-site R01. First, we plan to reliably integrate patient-reported questionnaires, including the Barriers to Diabetes Adherence scale and PedsQL-Diabetes Module, into routine care in two, large T1D centers. Second, our existing intervention, Epilepsy Journey will be modified to Diabetes Journey. This intervention includes mobile health modules addressing stress and executive functioning (i.e., the skills needed to start and complete tasks, remember things, and be organized) with accompanying telemedicine sessions with a therapist. We will use expert feedback to modify the modules and then conduct usability testing with 10 adolescents with T1D to ensure the modules are easy to navigate, engaging, and relevant to teens with T1D. Third, we will conduct a pilot clinical trial of Diabetes Journey. Our goal is to evaluate how well Diabetes Journey helps to improve stress/burnout and time pressure/planning (e.g., executive dysfunction) in 256 adolescents with T1D and whether adolescents think Diabetes Journey is helpful and acceptable. Adolescents who experience elevated adherence barriers during routine T1D clinic visits will be randomized to: 1) Diabetes Journey or 2) enhanced standard of care (i.e., handouts and 4 phone calls from a certified diabetes educator). Both interventions will be tailored to each adolescent's reported barrier(s). We will also examine the impact of Diabetes Journey on adherence, glycemic control, and quality of life. Finally, we will examine how family conflict, depressive symptoms, executive functioning, and distress affect adherence barriers and behaviors for future studies. If our study is successful, we will expand Diabetes Journey to include additional adherence barriers and modify to other age groups, leading to larger multi-site T1D clinical studies.