Function and Emotion in Everyday Life With Type 1 Diabetes (FEEL-T1D): Protocol for a Fully Remote Intensive Longitudinal Study (Preprint)

Abstract

BACKGROUND While short-term blood glucose (BG) levels and variability are thought to underlie diminished function and emotional well-being in people with T1D, these relationships are poorly understood. The Function and Emotion in Everyday Life with T1D (FEEL-T1D) study focuses on investigating these short-term dynamic relationships among BG, function, and emotional well-being in adults with T1D. OBJECTIVE To present the FEEL-T1D study design, methods, and study progress to date, including adaptations necessitated by the COVID-19 pandemic to implement the study fully remotely. METHODS The FEEL-T1D study will recruit 200 adults 18-75 years old with T1D. Data collection includes a comprehensive survey battery, along with 14 days of intensive longitudinal data using blinded continuous glucose monitoring (CGM), ecological momentary assessments (EMA), ambulatory cognitive tasks, and accelerometers. All study procedures are conducted remotely, through mailing study equipment and using videoconferencing for study visits. RESULTS To date, after 12 months of recruitment, 124 participants have enrolled in the FEEL-T1D study. Over 87% of EMA surveys have been completed, with minimal missing data, and about 82% of participants have provided concurrent CGM, EMA, and accelerometer data for at least 10 of the 14 days of data collection. CONCLUSIONS Thus far, our reconfiguration of the FEEL-T1D protocol to be implemented remotely during the COVID-19 pandemic has been a success. The FEEL-T1D study will elucidate the dynamic relationships between blood glucose, emotional well-being, cognitive function and participation in daily activities. In doing so, it will pave the way for innovative just-in-time interventions and produce actionable insights to facilitate tailoring of diabetes treatment to optimize function and well-being among individuals with T1D. CLINICALTRIAL