Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial.

BACKGROUND: Clinical trials often suffer from recruitment barriers and poor adherence, which increases costs and affects trial outcomes. OBJECTIVE: To investigate the feasibility of Decentralized Clinical Trial (DCT) design elements to recruit, enroll, and engage patients with type 2 diabetes mellitus (T2DM). METHODS: Patients with T2DM were recruited through a pharmacy and online recruitment using advert on Facebook, to 3 weeks monitoring of glucose and behaviometric parameters. Subjects recruited online could either complete an informed consent conversation in the pharmacy or through live video call managed by the study app.A continuous glucose monitoring (CGM) device to collect glucose data, and a hybrid smartwatch to monitor heart rate, track activity and sleep pattern were delivered by postal service to the participants' home address. The devices were connected to a study specific app on the participant's smartphone also capturing GPS data and questionnaire answers. RESULTS: Twenty-six subjects (3 pharmacy, 23 online) with T2DM were recruited, 85% preferred online informed consent conversation. All participants were able to self-apply the CGM device, use the smartwatch, and download the app. GPS location was captured more than 100 times for each participant, and more than 90% completed all 3 questionnaires. All the participants felt safe with the informed consent process and they felt confident in participating from home. Three participants dropped-out during the study period leaving a retention rate at 87%. CONCLUSIONS: Use of DCT design elements to conduct a T2DM study is feasible regarding recruitment, data collection from various electronic devices, and participant engagement.

Machine Learning-Based Adherence Detection of Type 2 Diabetes Patients on Once-Daily Basal Insulin Injections.

BACKGROUND: Lack of treatment adherence can lead to life-threatening health complications for people with type 2 diabetes (T2D). Recent improvements and availability in continuous glucose monitoring (CGM) technology have enabled various possibilities to monitor diabetes treatment. Detection of missed once-daily basal insulin injections can be used to provide feedback to patients, thus improving their diabetes management. In this study, we explore how machine learning (ML) based on CGM data can be used for detecting adherence to once-daily basal insulin injections. METHODS: In-silico CGM data were generated to simulate a cohort of T2D patients on once-daily insulin injection (Tresiba®). Deep learning methods within ML based on automatic feature extraction including convolutional neural networks were explored and compared with simple feature-engineered ML classification models for adherence detection. It was further investigated whether fused expert-dependent and automatically learned features could improve performance, resulting in a comparison of six different detection models. Adherence was detected throughout each day with an increasing amount of CGM data available. RESULTS: The adherence detection accuracy improved as more CGM data became available on the day of classification. The three classification models based on expert-engineered features obtained mean accuracies of 78.6%, 78.2%, and 78.3%. The classification model based purely on learned features obtained a mean accuracy of 79.7%. The two classification models fusing expert-engineered and learned features obtained mean accuracies of 79.7% and 79.8%. All the mentioned results were obtained 16 hours after time of injection. CONCLUSION: The results suggest that adherence detection based on CGM data is feasible. Even though our study based on in-silico data indicates only slightly improved performance of more complex models, the question remains whether advanced models would outperform the simple in a real-world setting. Thus, future studies on adherence monitoring using real CGM data are relevant.

Are helmeted cyclists taking more risk at signalized intersections?

OBJECTIVE: The aim of the present study was to investigate the relationship between bicycle helmet use and safety behavior at signalized intersections. Two hypotheses were investigated: The first states that bicycle helmet use leads to risker behavior because of the increased sense of protection (risk compensation), the other states that helmeted cyclists have a general inclination toward safer behavior (safety package) and that helmet use is one of several behaviors for improving safety. METHOD: Based on video recordings of 1031 cyclists at 12 signalized intersections in Denmark, two indicators of risky behavior were compared between helmeted and unhelmeted cyclists: Speed and time after the onset of yellow at which the cyclists crossed the stop line. Linear regression models were developed with gender, type of bicycle, and intersection characteristics as predictor variables, in addition to helmet use. RESULTS: Helmeted and unhelmeted cyclists do not differ in how many seconds after the onset of yellow they cross the stopping line. This is consistent with the absence of both risk compensation and safety package, alternatively with a general inclination of helmeted cyclists toward safer behavior which is about offset by risk compensation. Helmeted cyclists had higher speed on average, which indicates that risk compensation may occur. However, the higher speed may also be due to the generally better fitness of helmeted cyclists which is likely to result from larger cycling volumes. Moreover, the effect of helmet use on speed may be overestimated because of a lack of control for potential confounding variables. The results show further that, regardless of helmet use, before-red (lights on a separate bicycle signal shift to red before the main signal) is related to later crossings of the stop lane after the onset of yellow and that cyclists stop earlier on average at intersections with right-turn signals. CONCLUSIONS: The results do not provide support for the position that promoting or mandating bicycle helmet use will have adverse safety effects because of more risky behavior among helmeted cyclists.

Real-World Evidence of User Engagement With Mobile Health for Diabetes Management: Longitudinal Observational Study.

BACKGROUND: Patient support apps have risen in popularity and provide novel opportunities for self-management of diabetes. Such apps offer patients to play an active role in monitoring their condition, thereby increasing their own treatment responsibility. Although many health apps require active user engagement to be effective, there is little evidence exploring engagement with mobile health (mHealth). OBJECTIVE: This study aims to analyze the extent to which users engage with mHealth for diabetes and identify patient characteristics that are associated with engagement. METHODS: The analysis is based on real-world data obtained by Novo Nordisk's Cornerstones4Care Powered by Glooko diabetes support app. User engagement was assessed as the number of active days and using measures expressing the persistence, longevity, and regularity of interaction within the first 180 days of use. Beta regressions were estimated to assess the associations between user characteristics and engagement outcomes for each module of the app. RESULTS: A total of 9051 individuals initiated use after registration and could be observed for 180 days. Among these, 55.39% (5013/9051) used the app for one specific purpose. The average user activity ratio varied from 0.05 (medication and food) to 0.55 (continuous glucose monitoring), depending on the module of the app. Average user engagement was lower if modules required manual data entries, although the initial uptake was higher for these modules. Regression analyses further revealed that although more women used the app (2075/3649, 56.86%), they engaged significantly less with it. Older people and users who were recently diagnosed tended to use the app more actively. CONCLUSIONS: Strategies to increase or sustain the use of apps and availability of health data may target the mode of data collection and content design and should take into account privacy concerns of the users at the same time. Users' engagement was determined by various user characteristics, indicating that particular patient groups should be targeted or assisted when integrating apps into the self-management of their disease.

User Satisfaction and Insulin Pump Handling With a Prefilled Insulin Cartridge in Adults and Adolescents With Type 1 Diabetes.

BACKGROUND: This comparative handling study investigated user satisfaction and insulin pump handling with a prefilled insulin cartridge versus a self-filled insulin reservoir in insulin pump users with type 1 diabetes (T1D). METHODS: Adult (n = 105) and adolescent (n = 25) participants performed insulin pump preparations using a prefilled insulin cartridge and self-filled insulin reservoir. User satisfaction, insulin pump preparation time, and residual air in infusion set tubing were assessed for each insulin filling method. Post hoc analysis evaluated training time. RESULTS: User satisfaction scores were statistically significantly different in favor of the prefilled insulin cartridge versus the self-filled insulin reservoir (mean [SD]: overall, 4.0 [0.5] vs 3.3 [0.9]; burden on the user, 1.8 [0.6] vs 2.9 [1.0]; user inconvenience, 2.0 [0.7] vs 2.8 [1.1]; device effectiveness, 3.9 [0.7] vs 3.6 [0.9]; all P < .001). Insulin pump preparation time and residual air measurements were significantly different and numerically lower for the prefilled insulin cartridge versus the self-filled insulin reservoir (mean [SD]: preparation time, 124.4 [30.3] vs 237.8 [64.2] seconds, P < .001; residual air, 2.3 [26.3] vs 10.0 [63.3] mm, P = .007). Training time was shorter with the prefilled insulin cartridge versus the self-filled insulin reservoir (mean [min; max]: 193.1 [36; 453] vs 535.8 [124; 992] seconds). CONCLUSIONS: Adult and adolescent insulin pump users were more satisfied with the prefilled insulin cartridge versus the self-filled insulin reservoir when preparing an insulin pump. The prefilled insulin cartridge was associated with reduced insulin pump preparation time and reduced training time versus the self-filled insulin reservoir.

Injection Technique and Pen Needle Design Affect Leakage From Skin After Subcutaneous Injections.

BACKGROUND: After a subcutaneous injection fluid might leak out of the skin, commonly referred to as leakage or backflow. The objective was to examine the influence of needle design and injection technique on leakage after injections in the subcutaneous tissue of humans and pigs. METHOD: Leakage data were obtained from a post hoc analysis of clinical trial data and from a pig study. Data from the clinical study were used to determine leakage as a function of injection volume, speed and region. Data from the pig study were used to determine leakage as a function of needle wall thickness, needle taper, injection angle, and wait time from end of injection to withdrawal of needle from skin. RESULTS: Leakage volume was positively related to injection volume. Injections in the abdomen caused less leakage than thigh injections. A 32G needle caused less leakage than a 31G and a 32G tip (tapered) needle, and a "straight in" 90° needle insertion angle caused less leakage than an angled (~45°) insertion. Wait times of minimum 3 seconds caused less leakage than immediate withdrawal of the needle after injection. Needle wall thickness and injection speed did not influence leakage. CONCLUSIONS: Leakage will be minimized using a thin needle, using 90° needle insertion in the abdomen, injecting maximum 800 µL at a time, and waiting at least 3 seconds after the injection until the needle is withdrawn from the skin.

Transfer from point-of-care Ultrasonography training to diagnostic performance on patients--a randomized controlled trial.

BACKGROUND: Clinicians are increasingly using point-of-care ultrasonography for bedside examinations of patients. However, proper training is needed in this technique, and it is unknown whether the skills learned from focused Ultrasonography courses are being transferred to diagnostic performance on patients. METHODS: Thirty-one physicians were randomized to participate in a focused Ultrasonography course or control circumstances before they examined 4 patients with different abdominal conditions by ultrasonography. Performance scores and diagnostic accuracy were compared using independent samples t test and binary logistic regression, respectively. RESULTS: There was a significant difference in the performance score between the intervention group (27.4%) and the control group (18.0%, P = .004) and the diagnostic accuracy between the intervention group (65%) and the control group (39%, P = .014). CONCLUSIONS: Clinicians could successfully transfer learning from an Ultrasonography course to improve diagnostic performance on patients. However, our results also indicate a need for more training when new technologies such as point-of-care ultrasonography are introduced.

Reliable and valid assessment of point-of-care ultrasonography.

OBJECTIVE: To explore the reliability and validity of the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale for point-of-care ultrasonography (POC US) performance. BACKGROUND: POC US is increasingly used by clinicians and is an essential part of the management of acute surgical conditions. However, the quality of performance is highly operator-dependent. Therefore, reliable and valid assessment of trainees' ultrasonography competence is needed to ensure patient safety. METHODS: Twenty-four physicians, representing novices, intermediates, and experts in POC US, scanned 4 different surgical patient cases in a controlled set-up. All ultrasound examinations were video-recorded and assessed by 2 blinded radiologists using OSAUS. Reliability was examined using generalizability theory. Construct validity was examined by comparing performance scores between the groups and by correlating physicians' OSAUS scores with diagnostic accuracy. RESULTS: The generalizability coefficient was high (0.81) and a D-study demonstrated that 1 assessor and 5 cases would result in similar reliability. The construct validity of the OSAUS scale was supported by a significant difference in the mean scores between the novice group (17.0; SD 8.4) and the intermediate group (30.0; SD 10.1), P = 0.007, as well as between the intermediate group and the expert group (72.9; SD 4.4), P = 0.04, and by a high correlation between OSAUS scores and diagnostic accuracy (Spearman ρ correlation coefficient = 0.76; P < 0.001). CONCLUSIONS: This study demonstrates high reliability as well as evidence of construct validity of the OSAUS scale for assessment of POC US competence. Hence, the OSAUS scale may be suitable for both in-training as well as end-of-training assessment.

Using e-learning for maintenance of ALS competence.

CONTEXT: A well-suited e-learning program might be a feasible strategy to maintain competence following a resuscitation course. AIM: This study had 2 aims: (1) to examine the effect of an e-learning program as a booster of competence acquired from an Advanced Life Support (ALS) course. (2) To identify factors related to the use of the e-learning program. MATERIALS AND METHODS: The study contained two parts pertaining to the two aims. The first part was a prospective single blinded randomised controlled study on junior doctors. The intervention was the monthly use of an e-learning program during one year and effect was measured as ALS-competence, a composite of a knowledge and skills test. The second part was a telephone interview of the intervention group. An interview guide was constructed based on existing knowledge of e-learning. In order to identify factors explaining the use of e-learning a univariate correlation was used to select significant variables to be included in a multiple regression analysis. RESULTS: Of the 134 invited to participate, 103 accepted the invitation. There were 79/103 (77%) participants, 40/51 in the intervention group and 39/52 in the control group. There was no difference between the groups with regards to ALS competence. Only 'social interaction' was an individually significant factor influencing the use of the e-learning program. CONCLUSIONS: This study did not demonstrate an effect of an e-learning program as a booster of competence acquired from an ALS course. The primary factor influencing the use of e-learning was the lack of social interaction.

The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study.

CONTEXT: The impact of clinical experience on learning outcome from a resuscitation course has not been systematically investigated. AIM: To determine whether half a year of clinical experience before participation in an Advanced Life Support (ALS) course increases the immediate learning outcome and retention of learning. MATERIALS AND METHODS: This was a prospective single blinded randomised controlled study of the learning outcome from a standard ALS course on a volunteer sample of the entire cohort of newly graduated doctors from Copenhagen University. The outcome measurement was ALS-competence assessed using a validated composite test including assessment of skills and knowledge. INTERVENTION: The intervention was half a year of clinical work before an ALS course. The intervention group received the course after a half-year of clinical experience. The control group participated in an ALS course immediately following graduation. RESULTS: Invitation to participate was accepted by 154/240 (64%) graduates and 117/154 (76%) completed the study. There was no difference between the intervention and control groups with regard to the immediate learning outcome. The intervention group had significantly higher retention of learning compared to the control group, intervention group mean 82% (CI 80-83), control group mean 78% (CI 76-80), P=0.002. The magnitude of this difference was medium (effect size=0.57). CONCLUSIONS: Half a year of clinical experience, before participation in an ALS course had a small but statistically significant impact on the retention of learning, but not on the immediate learning outcome.

Newly graduated doctors' competence in managing cardiopulmonary arrests assessed using a standardized Advanced Life Support (ALS) assessment.

AIM OF THE STUDY: Several studies using a variety of assessment approaches have demonstrated that young doctors possess insufficient resuscitation competence. The aims of this study were to assess newly graduated doctors' resuscitation competence against an internationally recognised standard and to study whether teaching site affects their resuscitation competence. MATERIALS AND METHODS: The entire cohort of medical students from Copenhagen University expected to graduate in June 2006 was invited to participate in the study. Participants' ALS-competence was assessed using the Advanced Life Support Provider (ALS) examination standards as issued by the European Resuscitation Council (ERC). The emergency medicine course is conducted at three different university hospital teaching sites and teaching and assessment might vary across sites, despite the common end objectives regarding resuscitation teaching issued by the university. RESULTS: Participation was accepted by 154/240 (64%) graduates. Only 23% of the participants met the ALS pass criteria. They primarily lacked skills in managing cardiopulmonary arrest. There were significant differences in ALS-competence between teaching sites. CONCLUSION: Newly graduated doctors do not have sufficient competence in managing cardiopulmonary arrests according to the current guidelines published by ERC. There were significant differences in ALS-competence between sites. Change in teaching and assessment practice in undergraduate emergency medicine courses is needed in order to increase the level of ALS-competence of newly graduated doctors.