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 Narrative The 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 address fear of hypoglycemia to adolescents with type 1 diabetes (T1D) who use insulin pumps and their parents. This study is relevant to public health because continued misuse of insulin pumps because of fear of hypoglycemia compromises the health of patients with T1D and the ability of physicians to provide effective treatment.