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.

Glycaemic patterns of male professional athletes with type 1 diabetes during exercise, recovery and sleep: Retrospective, observational study over an entire competitive season.

AIMS: To analyse glycaemic patterns of professional athletes with type 1 diabetes during a competitive season. MATERIALS AND METHODS: We analysed continuous glucose monitoring data of 12 professional male cyclists with type 1 diabetes during exercise, recovery and sleep on days with competitive exercise (CE) and non-competitive exercise (NCE). We assessed whether differences exist between CE and NCE days and analysed associations between exercise and dysglycaemia. RESULTS: The mean glycated haemoglobin was 50 ± 5 mmol/mol (6.7 ± 0.5%). The athletes cycled on 280.8 ± 28.1 days (entire season 332.6 ± 18.8 days). Overall, time in range (3.9-10 mmol/L) was 70.0 ± 13.7%, time in hypoglycaemia (<3.9 mmol/L) was 6.4 ± 4.7% and time in hyperglycaemia (>10 mmol/L) was 23.6 ± 12.5%. During the nights of NCE days, athletes spent 10.1 ± 7.4% of time in hypoglycaemia, particularly after exercise in the endurance zones. The CE days were characterized by a higher time in hyperglycaemia compared with NCE days (25.2 ± 12.5% vs. 22.2 ± 12.1%, p = .012). This was driven by the CE phase, where time in range dropped to 60.4 ± 13.0% and time in hyperglycaemia was elevated (38.5 ± 12.9%). Mean glucose was higher during CE compared with NCE sessions (9.6 ± 0.9 mmol/L vs. 7.8 ± 1.1 mmol/L, p < .001). The probability of hyperglycaemia during exercise was particularly increased with longer duration, higher intensity and higher variability of exercise. CONCLUSIONS: The analysis of glycaemic patterns of professional endurance athletes revealed that overall glycaemia was generally within targets. For further improvement, athletes, team staff and caregivers may focus on hyperglycaemia during competitions and nocturnal hypoglycaemia after NCE.

Understanding the Interactions Between Driving Behavior and Well-being in Daily Driving: Causal Analysis of a Field Study.

BACKGROUND: Investigating ways to improve well-being in everyday situations as a means of fostering mental health has gained substantial interest in recent years. For many people, the daily commute by car is a particularly straining situation of the day, and thus researchers have already designed various in-vehicle well-being interventions for a better commuting experience. Current research has validated such interventions but is limited to isolating effects in controlled experiments that are generally not representative of real-world driving conditions. OBJECTIVE: The aim of the study is to identify cause-effect relationships between driving behavior and well-being in a real-world setting. This knowledge should contribute to a better understanding of when to trigger interventions. METHODS: We conducted a field study in which we provided a demographically diverse sample of 10 commuters with a car for daily driving over a period of 4 months. Before and after each trip, the drivers had to fill out a questionnaire about their state of well-being, which was operationalized as arousal and valence. We equipped the cars with sensors that recorded driving behavior, such as sudden braking. We also captured trip-dependent factors, such as the length of the drive, and predetermined factors, such as the weather. We conducted a causal analysis based on a causal directed acyclic graph (DAG) to examine cause-effect relationships from the observational data and to isolate the causal chains between the examined variables. We did so by applying the backdoor criterion to the data-based graphical model. The hereby compiled adjustment set was used in a multiple regression to estimate the causal effects between the variables. RESULTS: The causal analysis showed that a higher level of arousal before driving influences driving behavior. Higher arousal reduced the frequency of sudden events (P=.04) as well as the average speed (P=.001), while fostering active steering (P<.001). In turn, more frequent braking (P<.001) increased arousal after the drive, while a longer trip (P<.001) with a higher average speed (P<.001) reduced arousal. The prevalence of sunshine (P<.001) increased arousal and of occupants (P<.001) increased valence (P<.001) before and after driving. CONCLUSIONS: The examination of cause-effect relationships unveiled significant interactions between well-being and driving. A low level of predriving arousal impairs driving behavior, which manifests itself in more frequent sudden events and less anticipatory driving. Driving has a stronger effect on arousal than on valence. In particular, monotonous driving situations at high speeds with low cognitive demand increase the risk of the driver becoming tired (low arousal), thus impairing driving behavior. By combining the identified causal chains, states of vulnerability can be inferred that may form the basis for timely delivered interventions to improve well-being while driving.

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.

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.

Increase of PEth after Single Consumption of Alcohol and Evaluation of a Volumetric DBS Filter Paper Device.

Direct alcohol biomarkers are of growing interest for the assessment of alcohol consumption, with particular interest in phosphatidylethanol (PEth) in recent years. PEth is only formed when alcohol is present in the body. However, there is no statement about how much the PEth concentration increases after single moderate alcohol consumption. This study was conducted to determine the increase in PEth concentrations after a single drinking event. Additionally, a new volumetric sampling device (volumetric dried blood spot cards (DBSV)) was evaluated, which was designed to simplify further sampling processes and to allow for easy self-sampling. Dried blood samples from 31 volunteers were collected before and after single alcohol consumption with a mean maximum breath alcohol concentration of 0.4 mg/L (range: 0.30-0.55 mg/L). PEth concentrations were determined after automated extraction by liquid chromatography--tandem mass spectrometry. PEth 16:0/18:1 and PEth 16:0/18:2 concentrations increased to an average of 45 ng/mL each in patients starting below 20 ng/mL (range: 25.0-57.0 ng/mL for PEth 16:0/18:1; range 26.8-62.3 ng/mL for PEth 16:0/18:2). PEth concentrations in patients starting above 20 ng/mL increased by a mean of 30 ng/mL (range: 6.2-71.3 ng/mL for PEth 16:0/18:1; range 8.8-65.3 ng/mL for PEth 16:0/18:2). In addition, the comparison of the new sampling device DBSV with a standard filter paper card (with volumetrically applied 20 µL of blood samples) yielded a close agreement for the determined PEth concentrations in 24 forensic samples and three external controls. Therefore, the sampling device DBSV proved to be suitable for the determination of PEth concentrations in blood.

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.

When Do Drivers Interact with In-Vehicle Well-being Interventions? An Exploratory Analysis of a Longitudinal Study on Public Roads.

Recent developments of novel in-vehicle interventions show the potential to transform the otherwise routine and mundane task of commuting into opportunities to improve the drivers' health and well-being. Prior research has explored the effectiveness of various in-vehicle interventions and has identified moments in which drivers could be interruptible to interventions. All the previous studies, however, were conducted in either simulated or constrained real-world driving scenarios on a pre-determined route. In this paper, we take a step forward and evaluate when drivers interact with in-vehicle interventions in unconstrained free-living conditions. To this end, we conducted a two-month longitudinal study with 10 participants, in which each participant was provided with a study car for their daily driving needs. We delivered two in-vehicle interventions - each aimed at improving affective well-being - and simultaneously recorded the participants' driving behavior. In our analysis, we found that several pre-trip characteristics (like trip length, traffic flow, and vehicle occupancy) and the pre-trip affective state of the participants had significant associations with whether the participants started an intervention or canceled a started intervention. Next, we found that several in-the-moment driving characteristics (like current road type, past average speed, and future brake behavior) showed significant associations with drivers' responsiveness to the intervention. Further, we identified several driving behaviors that "negated" the effectiveness of interventions and highlight the potential of using such "negative" driving characteristics to better inform intervention delivery. Finally, we compared trips with and without intervention and found that both interventions employed in our study did not have a negative effect on driving behavior. Based on our analyses, we provide solid recommendations on how to deliver interventions to maximize responsiveness and effectiveness and minimize the burden on the drivers.

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.