Assessing the Content Validity, Acceptability, and Feasibility of the Hypo-METRICS App: Survey and Interview Study.

BACKGROUND: The Hypoglycaemia - MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone app was developed to investigate the impact of hypoglycemia on daily functioning in adults with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus. The app uses ecological momentary assessments, thereby minimizing recall bias and maximizing ecological validity. It was used in the Hypo-METRICS study, a European multicenter observational study wherein participants wore a blinded continuous glucose monitoring device and completed the app assessments 3 times daily for 70 days. OBJECTIVE: The 3 aims of the study were to explore the content validity of the app, the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study, and suggestions for future versions of the app. METHODS: Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to participate in a brief web-based survey and an interview (approximately 1h) to explore their experiences with the app during the Hypo-METRICS study. Thematic analysis of the qualitative data was conducted using both deductive and inductive methods. RESULTS: A total of 18 adults with diabetes (type 1 diabetes: n=10, 56%; 5/10, 50% female; mean age 47, SD 16 years; type 2 diabetes: n=8, 44%; 2/8, 25% female; mean age 61, SD 9 years) filled out the survey and were interviewed. In exploring content validity, participants overall described the Hypo-METRICS app as relevant, understandable, and comprehensive. In total, 3 themes were derived: hypoglycemia symptoms and experiences are idiosyncratic; it was easy to select ratings on the app, but day-to-day changes were perceived as minimal; and instructions could be improved. Participants offered suggestions for changes or additional questions and functions that could increase engagement and improve content (such as providing more examples with the questions). In exploring acceptability and feasibility, 5 themes were derived: helping science and people with diabetes; easy to fit in, but more flexibility wanted; hypoglycemia delaying responses and increasing completion time; design, functionality, and customizability of the app; and limited change in awareness of symptoms and impact. Participants described using the app as a positive experience overall and as having a possible, although limited, intervention effect in terms of both hypoglycemia awareness and personal impact. CONCLUSIONS: The Hypo-METRICS app shows promise as a new research tool to assess the impact of hypoglycemia on an individual's daily functioning. Despite suggested improvements, participants' responses indicated that the app has satisfactory content validity, overall fits in with everyday life, and is suitable for a 10-week research study. Although developed for research purposes, real-time assessments may have clinical value for monitoring and reviewing hypoglycemia symptom awareness and personal impact.

Reduced heart rate variability in people with type 1 diabetes and elevated diabetes distress: Results from the longitudinal observational DIA-LINK1 study.

AIMS: People with type 1 diabetes have a higher risk for cardiovascular disease (CVD). Reduced heart rate variability (HRV) is a clinical marker for CVD. In this observational study using continuous HRV measurement across 26 days, we investigated whether psychological stressors (diabetes distress, depressive symptoms) and glycaemic parameters (hypo- and hyperglycaemic exposure, glycaemic variability and HbA1c ) are associated with lower HRV in people with type 1 diabetes. METHODS: Data from the non-interventional prospective DIA-LINK1 study were analysed. At baseline, depressive symptoms and diabetes distress were assessed. Glucose values and HRV were recorded daily for 26 days using continuous glucose monitoring (CGM) and a wrist-worn health tracker respectively. Multilevel modelling with participant as nesting factor was used to analyse associations between day-to-day HRV and diabetes distress, depressive symptoms and CGM-derived parameters. RESULTS: Data from 149 participants were analysed (age: 38.3 ± 13.1 years, HbA1c : 8.6 ± 1.9%). Participants with elevated diabetes distress had a significantly lower HRV across the 26 days compared to participants without elevated distress (ß = -0.28; p = 0.004). Elevated depressive symptoms were not significantly associated with HRV (ß = -0.18; p = 0.074). Higher daily exposure to hyperglycaemia (ß = -0.44; p = 0.044), higher average exposure to hypoglycaemia (ß = -0.18; p = 0.042) and higher HbA1c (ß = -0.20; p = 0.018) were associated with reduced HRV across the 26 days. Sensitivity analysis with HRV averaged across all days corroborated these results. CONCLUSIONS: Diabetes distress is a clinically meaningful psychosocial stressor that could play a role in the cardiovascular health of people with type 1 diabetes. These findings highlight the need for integrated psychosocial care in diabetes management.

Mindfulness and music interventions in the workplace: assessment of sustained attention and working memory using a crowdsourcing approach.

BACKGROUND: Occupational stress has huge financial as well as human costs. Application of crowdsourcing might be a way to strengthen the investigation of occupational mental health. Therefore, the aim of the study was to assess Danish employees' stress and cognition by relying on a crowdsourcing approach, as well as investigating the effect of a 30-day mindfulness and music intervention. METHODS: We translated well-validated neuropsychological laboratory- and task-based paradigms into an app-based platform using cognitive games measuring sustained attention and working memory and measuring stress via. Cohen's Perceived Stress Scale. A total of 623 healthy volunteers from Danish companies participated in the study and were randomized into three groups, which consisted of a 30-day intervention of either mindfulness or music, or a non-intervention control group. RESULTS: Participants in the mindfulness group showed a significant improvement in the coefficient of sustained attention, working memory capacity and perceived stress (p < .001). The music group showed a 38% decrease of self-perceived stress. The control group showed no difference from pre to post in the survey or cognitive outcome measures. Furthermore, there was a significant correlation between usage of the mindfulness and music app and elevated score on both the cognitive games and the perceived stress scale. CONCLUSION: The study supports the nascent field of crowdsourcing by being able to replicate data collected in previous well-controlled laboratory studies from a range of experimental cognitive tasks, making it an effective alternative. It also supports mindfulness as an effective intervention in improving mental health in the workplace.