Multimodal In-Vehicle Hypoglycemia Warning for Drivers With Type 1 Diabetes: Design and Evaluation in Simulated and Real-World Driving.

BACKGROUND: Hypoglycemia threatens cognitive function and driving safety. Previous research investigated in-vehicle voice assistants as hypoglycemia warnings. However, they could startle drivers. To address this, we combine voice warnings with ambient LEDs. OBJECTIVE: The study assesses the effect of in-vehicle multimodal warning on emotional reaction and technology acceptance among drivers with type 1 diabetes. METHODS: Two studies were conducted, one in simulated driving and the other in real-world driving. A quasi-experimental design included 2 independent variables (blood glucose phase and warning modality) and 1 main dependent variable (emotional reaction). Blood glucose was manipulated via intravenous catheters, and warning modality was manipulated by combining a tablet voice warning app and LEDs. Emotional reaction was measured physiologically via skin conductance response and subjectively with the Affective Slider and tested with a mixed-effect linear model. Secondary outcomes included self-reported technology acceptance. Participants were recruited from Bern University Hospital, Switzerland. RESULTS: The simulated and real-world driving studies involved 9 and 10 participants with type 1 diabetes, respectively. Both studies showed significant results in self-reported emotional reactions (P<.001). In simulated driving, neither warning modality nor blood glucose phase significantly affected self-reported arousal, but in real-world driving, both did (F2,68=4.3; P<.05 and F2,76=4.1; P=.03). Warning modality affected self-reported valence in simulated driving (F2,68=3.9; P<.05), while blood glucose phase affected it in real-world driving (F2,76=9.3; P<.001). Skin conductance response did not yield significant results neither in the simulated driving study (modality: F2,68=2.46; P=.09, blood glucose phase: F2,68=0.3; P=.74), nor in the real-world driving study (modality: F2,76=0.8; P=.47, blood glucose phase: F2,76=0.7; P=.5). In both simulated and real-world driving studies, the voice+LED warning modality was the most effective (simulated: mean 3.38, SD 1.06 and real-world: mean 3.5, SD 0.71) and urgent (simulated: mean 3.12, SD 0.64 and real-world: mean 3.6, SD 0.52). Annoyance varied across settings. The standard warning modality was the least effective (simulated: mean 2.25, SD 1.16 and real-world: mean 3.3, SD 1.06) and urgent (simulated: mean 1.88, SD 1.55 and real-world: mean 2.6, SD 1.26) and the most annoying (simulated: mean 2.25, SD 1.16 and real-world: mean 1.7, SD 0.95). In terms of preference, the voice warning modality outperformed the standard warning modality. In simulated driving, the voice+LED warning modality (mean rank 1.5, SD rank 0.82) was preferred over the voice (mean rank 2.2, SD rank 0.6) and standard (mean rank 2.4, SD rank 0.81) warning modalities, while in real-world driving, the voice+LED and voice warning modalities were equally preferred (mean rank 1.8, SD rank 0.79) to the standard warning modality (mean rank 2.4, SD rank 0.84). CONCLUSIONS: Despite the mixed results, this paper highlights the potential of implementing voice assistant-based health warnings in cars and advocates for multimodal alerts to enhance hypoglycemia management while driving. TRIAL REGISTRATION: ClinicalTrials.gov NCT05183191; https://classic.clinicaltrials.gov/ct2/show/NCT05183191, ClinicalTrials.gov NCT05308095; https://classic.clinicaltrials.gov/ct2/show/NCT05308095.

Effectiveness and User Perception of an In-Vehicle Voice Warning for Hypoglycemia: Development and Feasibility Trial.

BACKGROUND: Hypoglycemia is a frequent and acute complication in type 1 diabetes mellitus (T1DM) and is associated with a higher risk of car mishaps. Currently, hypoglycemia can be detected and signaled through flash glucose monitoring or continuous glucose monitoring devices, which require manual and visual interaction, thereby removing the focus of attention from the driving task. Hypoglycemia causes a decrease in attention, thereby challenging the safety of using such devices behind the wheel. Here, we present an investigation of a hands-free technology-a voice warning that can potentially be delivered via an in-vehicle voice assistant. OBJECTIVE: This study aims to investigate the feasibility of an in-vehicle voice warning for hypoglycemia, evaluating both its effectiveness and user perception. METHODS: We designed a voice warning and evaluated it in 3 studies. In all studies, participants received a voice warning while driving. Study 0 (n=10) assessed the feasibility of using a voice warning with healthy participants driving in a simulator. Study 1 (n=18) assessed the voice warning in participants with T1DM. Study 2 (n=20) assessed the voice warning in participants with T1DM undergoing hypoglycemia while driving in a real car. We measured participants' self-reported perception of the voice warning (with a user experience scale in study 0 and with acceptance, alliance, and trust scales in studies 1 and 2) and compliance behavior (whether they stopped the car and reaction time). In addition, we assessed technology affinity and collected the participants' verbal feedback. RESULTS: Technology affinity was similar across studies and approximately 70% of the maximal value. Perception measure of the voice warning was approximately 62% to 78% in the simulated driving and 34% to 56% in real-world driving. Perception correlated with technology affinity on specific constructs (eg, Affinity for Technology Interaction score and intention to use, optimism and performance expectancy, behavioral intention, Session Alliance Inventory score, innovativeness and hedonic motivation, and negative correlations between discomfort and behavioral intention and discomfort and competence trust; all P<.05). Compliance was 100% in all studies, whereas reaction time was higher in study 1 (mean 23, SD 5.2 seconds) than in study 0 (mean 12.6, SD 5.7 seconds) and study 2 (mean 14.6, SD 4.3 seconds). Finally, verbal feedback showed that the participants preferred the voice warning to be less verbose and interactive. CONCLUSIONS: This is the first study to investigate the feasibility of an in-vehicle voice warning for hypoglycemia. Drivers find such an implementation useful and effective in a simulated environment, but improvements are needed in the real-world driving context. This study is a kickoff for the use of in-vehicle voice assistants for digital health interventions.

Machine learning for non-invasive sensing of hypoglycaemia while driving in people with diabetes.

AIM: To develop and evaluate the concept of a non-invasive machine learning (ML) approach for detecting hypoglycaemia based exclusively on combined driving (CAN) and eye tracking (ET) data. MATERIALS AND METHODS: We first developed and tested our ML approach in pronounced hypoglycaemia, and then we applied it to mild hypoglycaemia to evaluate its early warning potential. For this, we conducted two consecutive, interventional studies in individuals with type 1 diabetes. In study 1 (n = 18), we collected CAN and ET data in a driving simulator during euglycaemia and pronounced hypoglycaemia (blood glucose [BG] 2.0-2.5 mmol L-1 ). In study 2 (n = 9), we collected CAN and ET data in the same simulator but in euglycaemia and mild hypoglycaemia (BG 3.0-3.5 mmol L-1 ). RESULTS: Here, we show that our ML approach detects pronounced and mild hypoglycaemia with high accuracy (area under the receiver operating characteristics curve 0.88 ± 0.10 and 0.83 ± 0.11, respectively). CONCLUSIONS: Our findings suggest that an ML approach based on CAN and ET data, exclusively, enables detection of hypoglycaemia while driving. This provides a promising concept for alternative and non-invasive detection of hypoglycaemia.

Noninvasive Hypoglycemia Detection in People With Diabetes Using Smartwatch Data.

OBJECTIVE: To develop a noninvasive hypoglycemia detection approach using smartwatch data. RESEARCH DESIGN AND METHODS: We prospectively collected data from two wrist-worn wearables (Garmin vivoactive 4S, Empatica E4) and continuous glucose monitoring values in adults with diabetes on insulin treatment. Using these data, we developed a machine learning (ML) approach to detect hypoglycemia (<3.9 mmol/L) noninvasively in unseen individuals and solely based on wearable data. RESULTS: Twenty-two individuals were included in the final analysis (age 54.5 ± 15.2 years, HbA1c 6.9 ± 0.6%, 16 males). Hypoglycemia was detected with an area under the receiver operating characteristic curve of 0.76 ± 0.07 solely based on wearable data. Feature analysis revealed that the ML model associated increased heart rate, decreased heart rate variability, and increased tonic electrodermal activity with hypoglycemia. CONCLUSIONS: Our approach may allow for noninvasive hypoglycemia detection using wearables in people with diabetes and thus complement existing methods for hypoglycemia detection and warning.

A Scalable Risk-Scoring System Based on Consumer-Grade Wearables for Inpatients With COVID-19: Statistical Analysis and Model Development.

BACKGROUND: To provide effective care for inpatients with COVID-19, clinical practitioners need systems that monitor patient health and subsequently allow for risk scoring. Existing approaches for risk scoring in patients with COVID-19 focus primarily on intensive care units (ICUs) with specialized medical measurement devices but not on hospital general wards. OBJECTIVE: In this paper, we aim to develop a risk score for inpatients with COVID-19 in general wards based on consumer-grade wearables (smartwatches). METHODS: Patients wore consumer-grade wearables to record physiological measurements, such as the heart rate (HR), heart rate variability (HRV), and respiration frequency (RF). Based on Bayesian survival analysis, we validated the association between these measurements and patient outcomes (ie, discharge or ICU admission). To build our risk score, we generated a low-dimensional representation of the physiological features. Subsequently, a pooled ordinal regression with time-dependent covariates inferred the probability of either hospital discharge or ICU admission. We evaluated the predictive performance of our developed system for risk scoring in a single-center, prospective study based on 40 inpatients with COVID-19 in a general ward of a tertiary referral center in Switzerland. RESULTS: First, Bayesian survival analysis showed that physiological measurements from consumer-grade wearables are significantly associated with patient outcomes (ie, discharge or ICU admission). Second, our risk score achieved a time-dependent area under the receiver operating characteristic curve (AUROC) of 0.73-0.90 based on leave-one-subject-out cross-validation. CONCLUSIONS: Our results demonstrate the effectiveness of consumer-grade wearables for risk scoring in inpatients with COVID-19. Due to their low cost and ease of use, consumer-grade wearables could enable a scalable monitoring system. TRIAL REGISTRATION: Clinicaltrials.gov NCT04357834; https://www.clinicaltrials.gov/ct2/show/NCT04357834.

FLIRT: A feature generation toolkit for wearable data.

BACKGROUND AND OBJECTIVE: Researchers use wearable sensing data and machine learning (ML) models to predict various health and behavioral outcomes. However, sensor data from commercial wearables are prone to noise, missing, or artifacts. Even with the recent interest in deploying commercial wearables for long-term studies, there does not exist a standardized way to process the raw sensor data and researchers often use highly specific functions to preprocess, clean, normalize, and compute features. This leads to a lack of uniformity and reproducibility across different studies, making it difficult to compare results. To overcome these issues, we present FLIRT: A Feature Generation Toolkit for Wearable Data; it is an open-source Python package that focuses on processing physiological data specifically from commercial wearables with all its challenges from data cleaning to feature extraction. METHODS: FLIRT leverages a variety of state-of-the-art algorithms (e.g., particle filters, ML-based artifact detection) to ensure a robust preprocessing of physiological data from wearables. In a subsequent step, FLIRT utilizes a sliding-window approach and calculates a feature vector of more than 100 dimensions - a basis for a wide variety of ML algorithms. RESULTS: We evaluated FLIRT on the publicly available WESAD dataset, which focuses on stress detection with an Empatica E4 wearable. Preprocessing the data with FLIRT ensures that unintended noise and artifacts are appropriately filtered. In the classification task, FLIRT outperforms the preprocessing baseline of the original WESAD paper. CONCLUSION: FLIRT provides functionalities beyond existing packages that can address unmet needs in physiological data processing and feature generation: (a) integrated handling of common wearable file formats (e.g., Empatica E4 archives), (b) robust preprocessing, and (c) standardized feature generation that ensures reproducibility of results. Nevertheless, while FLIRT comes with a default configuration to accommodate most situations, it offers a highly configurable interface for all of its implemented algorithms to account for specific needs.

The impact of postbariatric hypoglycaemia on driving performance: A randomized, single-blind, two-period, crossover study in a driving simulator.

Postbariatric hypoglycaemia (PBH) is an increasingly recognized complication of bariatric surgery, but its effect on daily functioning remains unclear. In this randomized, single-blind, crossover trial we assessed driving performance in patients with PBH. Ten active drivers with PBH (eight females, age 38.2 ± 14.7 years, body mass index 27.2 ± 4.6 kg/m2 ) received 75 g glucose to induce PBH in the late postprandial period and aspartame to leave glycaemia unchanged, on two different occasions. A simulator was driven during 10 minutes before (D0) and 20 (D1), 80 (D2), 125 (D3) and 140 minutes (D4) after the glucose/aspartame ingestion, reflecting the expected blood glucose (BG) increase (D1), decrease (D2) and hypoglycaemia (D3, D4). Seven driving features indicating impaired driving were integrated in a Bayesian hierarchical regression model to assess the difference in driving performance after glucose/aspartame ingestion. Mean ± standard deviation peak and nadir BG after glucose were 182 ± 24 and 47 ± 14 mg/dL, while BG was stable after aspartame (85 ± 4 mg/dL). Despite the lack of a difference in symptom perception, driving performance was significantly impaired after glucose versus aspartame during D4 (posterior probability 98.2%). Our findings suggest that PBH negatively affects driving performance.