Dataset Information

Function and Emotion in Everyday Life with Type 1 Diabetes (FEEL-T1D): A fully remote intensive longitudinal study of blood glucose, function, and emotional well-being in adults with type 1 diabetes.

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

SUBMITTER: Pyatak EA

PROVIDER: S-EPMC8544739 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundSleep bruxism (SB) is an oral behavior characterized by high levels of repetitive jaw muscle activity during sleep, leading to teeth grinding and clenching, and may develop into a disorder. Despite its prevalence and negative outcomes on oral health and quality of life, there is currently no cure for SB. The etiology of SB remains poorly understood, but recent research suggests a potential role of negative emotions and maladaptive emotion regulation (ER).ObjectiveThis study's primary aim investigates whether ER is impaired in individuals with SB, while controlling for affective and sleep disturbances. The secondary aim tests for the presence of cross-sectional and longitudinal mediation pathways in the bidirectional relationships among SB, ER, affect, and sleep.MethodsThe study used a nonrandomized repeated-measures observational design and was conducted remotely. Participants aged 18-49 years underwent a 14-day ambulatory assessment. Data collection was carried out using electronic platforms. We assessed trait and state SB and ER alongside affect and sleep variables. We measured SB using self-reported trait questionnaires, ecological momentary assessment (EMA) for real-time reports of SB behavior, and portable electromyography for multinight assessment of rhythmic masticatory muscle activity. We assessed ER through self-reported trait questionnaires, EMA for real-time reports of ER strategies, and heart rate variability derived from an electrocardiography wireless physiological sensor as an objective physiological measure. Participants' trait affect and real-time emotional experiences were obtained using self-reported trait questionnaires and EMA. Sleep patterns and quality were evaluated using self-reported trait questionnaires and sleep diaries, as well as actigraphy as a physiological measure. For the primary objective, analyses will test for maladaptive ER in terms of strategy use frequency and effectiveness as a function of SB using targeted contrasts in the general linear model. Control analyses will be conducted to examine the persistence of the SB-ER relationship after adjusting for affective and sleep measures, as well as demographic variables. For the secondary objective, cross-sectional and longitudinal mediation analyses will test various competing models of directional effects among self-reported and physiological measures of SB, ER, affect, and sleep.ResultsThis research received funding in April 2017. Data collection took place from August 2020 to March 2022. In all, 237 participants were eligible and completed the study. Data analysis has not yet started.ConclusionsWe hope that the effort to thoroughly measure SB and ER using gold standard methods and cutting-edge technology will advance the knowledge of SB. The findings of this study may contribute to a better understanding of the relationship among SB, ER, affect, and sleep disturbances. By identifying the role of ER in SB, the results may pave the way for the development of targeted interventions for SB management to alleviate the pain and distress of those affected.International registered report identifier (irrid)DERR1-10.2196/41719.

Project description:Longitudinal clinical studies traditionally require in-person study visits which are well documented to pose barriers to participation and contribute challenges to enrolling representative samples. Remote trial models may reduce barriers to research engagement, improve retention, and reach a more representative cohort. As remote trials become more common following the COVID-19 pandemic, a critical evaluation of this approach is imperative to optimize this paradigm shift in research. The TestBoston study was launched to understand prevalence and risk factors for COVID-19 infection in the greater Boston area through a fully remote home-testing model. Participants (adults, within 45 miles of Boston, MA) were recruited remotely from patient registries at Brigham and Women's Hospital and the general public. Participants were provided with monthly and "on-demand" at-home SARS-CoV-2 RT-PCR and antibody testing using nasal swab and dried blood spot self-collection kits and electronic surveys to assess symptoms and risk factors for COVID-19 via an online dashboard. Between October 2020 and January 2021, we enrolled 10,289 participants reflective of Massachusetts census data. Mean age was 47 years (range 18-93), 5855 (56.9%) were assigned female sex at birth, 7181(69.8%) reported being White non-Hispanic, 952 (9.3%) Hispanic/Latinx, 925 (9.0%) Black, 889 (8.6%) Asian, and 342 (3.3%) other and/or more than one race. Lower initial enrollment among Black and Hispanic/Latinx individuals required an adaptive approach to recruitment, leveraging connections to the medical system, coupled with community partnerships to ensure a representative cohort. Longitudinal retention was higher among participants who were White non-Hispanic, older, working remotely, and with lower socioeconomic vulnerability. Implementation highlighted key differences in remote trial models as participants independently navigate study milestones, requiring a dedicated participant support team and robust technology platforms, to reduce barriers to enrollment, promote retention, and ensure scientific rigor and data quality. Remote clinical trial models offer tremendous potential to engage representative cohorts, scale biomedical research, and promote accessibility by reducing barriers common in traditional trial design. Barriers and burdens within remote trials may be experienced disproportionately across demographic groups. To maximize engagement and retention, researchers should prioritize intensive participant support, investment in technologic infrastructure and an adaptive approach to maximize engagement and retention.