Psychosocial Outcomes Among Users and Nonusers of Open-Source Automated Insulin Delivery Systems: Multinational Survey of Adults With Type 1 Diabetes.

BACKGROUND: Emerging research suggests that open-source automated insulin delivery (AID) may reduce diabetes burden and improve sleep quality and quality of life (QoL). However, the evidence is mostly qualitative or uses unvalidated, study-specific, single items. Validated person-reported outcome measures (PROMs) have demonstrated the benefits of other diabetes technologies. The relative lack of research investigating open-source AID using PROMs has been considered a missed opportunity. OBJECTIVE: This study aimed to examine the psychosocial outcomes of adults with type 1 diabetes using and not using open-source AID systems using a comprehensive set of validated PROMs in a real-world, multinational, cross-sectional study. METHODS: Adults with type 1 diabetes completed 8 validated measures of general emotional well-being (5-item World Health Organization Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), diabetes-specific QoL (modified DAWN Impact of Diabetes Profile), diabetes-specific positive well-being (4-item subscale of the 28-item Well-Being Questionnaire), diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), diabetes distress (20-item Problem Areas in Diabetes scale), fear of hypoglycemia (short form of the Hypoglycemia Fear Survey II), and a measure of the impact of COVID-19 on QoL. Independent groups 2-tailed t tests and Mann-Whitney U tests compared PROM scores between adults with type 1 diabetes using and not using open-source AID. An analysis of covariance was used to adjust for potentially confounding variables, including all sociodemographic and clinical characteristics that differed by use of open-source AID. RESULTS: In total, 592 participants were eligible (attempting at least 1 questionnaire), including 451 using open-source AID (mean age 43, SD 13 years; n=189, 41.9% women) and 141 nonusers (mean age 40, SD 13 years; n=90, 63.8% women). Adults using open-source AID reported significantly better general emotional well-being and subjective sleep quality, as well as better diabetes-specific QoL, positive well-being, and treatment satisfaction. They also reported significantly less diabetes distress, fear of hypoglycemia, and perceived less impact of the COVID-19 pandemic on their QoL. All were medium-to-large effects (Cohen d=0.5-1.5). The differences between groups remained significant after adjusting for sociodemographic and clinical characteristics. CONCLUSIONS: Adults with type 1 diabetes using open-source AID report significantly better psychosocial outcomes than those not using these systems, after adjusting for sociodemographic and clinical characteristics. Using validated, quantitative measures, this real-world study corroborates the beneficial psychosocial outcomes described previously in qualitative studies or using unvalidated study-specific items.

Quality of life and psychological well-being among children and adolescents with diabetes and their caregivers using open-source automated insulin delivery systems: Findings from a multinational survey.

BACKGROUND: Open-source automated insulin delivery (AID) systems have shown to be safe and effective in children and adolescents with type 1 diabetes (T1D) in real-world studies. However, there is a lack of evidence on the effect on their caregivers' quality-of-life (QoL) and well-being. The aim of this study was to assess the QoL of caregivers and children and adolescents using open-source AID systems using validated measures. METHODS: In this cross-sectional online survey we examined the caregiver-reported QoL and well-being of users and non-users. Validated questionnaires assessed general well-being (WHO-5), diabetes-specific QoL (PAID, PedsQL) and sleep quality (PSQI). RESULTS: 168 caregivers from 27 countries completed at least one questionnaire, including 119 caregivers of children using open-source AID and 49 not using them. After inclusion of covariates, all measures but the PAID and one subscale of the PedsQL showed significant between-group differences with AID users reporting higher general (WHO-5: p = 0.003), sleep-related (PSQI: p = 0.001) and diabetes-related QoL (PedsQL: p < 0.05). CONCLUSIONS: The results show the potential impact of open-source AID on QoL and psychological well-being of caregivers and children and adolescents with T1D, and can therefore help to inform academia, regulators, and policymakers about the psychosocial health implications of open-source AID.

Barriers to uptake of Open-Source automated insulin delivery Systems: Analysis of socioeconomic factors and perceived challenges of adults with type 1 diabetes from the OPEN survey.

AIMS: Social and technical trends are empowering people with diabetes to co-create or self-develop medical devices and treatments to address their unmet healthcare needs, for example, open-source automated insulin delivery (AID) systems. This study aims to investigate the perceived barriers towards adoption and maintaining of open-source AID systems. METHODS: This is a multinational study based on a cross-sectional, retrospective web-based survey of non-users of open-source AID. Participants (n = 129) with type 1 diabetes from 31 countries were recruited online to elicit their perceived barriers towards building and maintaining of an open-source AID system. RESULTS: Sourcing the necessary components, lack of confidence in one's own technology knowledge and skills, perceived time and energy required to build a system, and fear of losing healthcare provider support appear to be major barriers towards the uptake of open-source AID. CONCLUSIONS: This study identified a range of structural and individual-level barriers to uptake of open-source AID. Some of these individual-level barriers may be overcome over time through the peer support of the DIY online community as well as greater acceptance of open-source innovation among healthcare professionals. The findings have important implications for understanding the possible wider diffusion of open-source diabetes technology solutions in the future.

Recommendations for empowering early career researchers to improve research culture and practice.

Early career researchers (ECRs) are important stakeholders leading efforts to catalyze systemic change in research culture and practice. Here, we summarize the outputs from a virtual unconventional conference (unconference), which brought together 54 invited experts from 20 countries with extensive experience in ECR initiatives designed to improve the culture and practice of science. Together, we drafted 2 sets of recommendations for (1) ECRs directly involved in initiatives or activities to change research culture and practice; and (2) stakeholders who wish to support ECRs in these efforts. Importantly, these points apply to ECRs working to promote change on a systemic level, not only those improving aspects of their own work. In both sets of recommendations, we underline the importance of incentivizing and providing time and resources for systems-level science improvement activities, including ECRs in organizational decision-making processes, and working to dismantle structural barriers to participation for marginalized groups. We further highlight obstacles that ECRs face when working to promote reform, as well as proposed solutions and examples of current best practices. The abstract and recommendations for stakeholders are available in Dutch, German, Greek (abstract only), Italian, Japanese, Polish, Portuguese, Spanish, and Serbian.

Emotional and Physical Health Impact in Children and Adolescents and Their Caregivers Using Open-source Automated Insulin Delivery: Qualitative Analysis of Lived Experiences.

BACKGROUND: Given the limitations in the access and license status of commercially developed automated insulin delivery (AID) systems, open-source AID systems are becoming increasingly popular among people with diabetes, including children and adolescents. OBJECTIVE: This study aimed to investigate the lived experiences and physical and emotional health implications of children and their caregivers following the initiation of open-source AID, their perceived challenges, and sources of support, which have not been explored in the existing literature. METHODS: Data were collected through 2 sets of open-ended questions from a web-based multinational survey of 60 families from 16 countries. The narratives were thematically analyzed, and a coding framework was identified through iterative alignment. RESULTS: A range of emotions and improvements in quality of life and physical health were reported, as open-source AID enabled families to shift their focus away from diabetes therapy. Caregivers were less worried about hypoglycemia at night and outside their family homes, leading to increased autonomy for the child. Simultaneously, the glycemic outcomes and sleep quality of both the children and caregivers improved. Nonetheless, the acquisition of suitable hardware and technical setup could be challenging. The #WeAreNotWaiting community was the primary source of practical and emotional support. CONCLUSIONS: Our findings show the benefits and transformative impact of open-source AID and peer support on children with diabetes and their caregivers and families, where commercial AID systems are not available or suitable. Further efforts are required to improve the effectiveness and usability and facilitate access for children with diabetes, worldwide, to benefit from this innovative treatment. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/15368.

Open-source Web Portal for Managing Self-reported Data and Real-world Data Donation in Diabetes Research: Platform Feasibility Study.

BACKGROUND: People with diabetes and their support networks have developed open-source automated insulin delivery systems to help manage their diabetes therapy, as well as to improve their quality of life and glycemic outcomes. Under the hashtag #WeAreNotWaiting, a wealth of knowledge and real-world data have been generated by users of these systems but have been left largely untapped by research; opportunities for such multimodal studies remain open. OBJECTIVE: We aimed to evaluate the feasibility of several aspects of open-source automated insulin delivery systems including challenges related to data management and security across multiple disparate web-based platforms and challenges related to implementing follow-up studies. METHODS: We developed a mixed methods study to collect questionnaire responses and anonymized diabetes data donated by participants-which included adults and children with diabetes and their partners or caregivers recruited through multiple diabetes online communities. We managed both front-end participant interactions and back-end data management with our web portal (called the Gateway). Participant questionnaire data from electronic data capture (REDCap) and personal device data aggregation (Open Humans) platforms were pseudonymously and securely linked and stored within a custom-built database that used both open-source and commercial software. Participants were later given the option to include their health care providers in the study to validate their questionnaire responses; the database architecture was designed specifically with this kind of extensibility in mind. RESULTS: Of 1052 visitors to the study landing page, 930 participated and completed at least one questionnaire. After the implementation of health care professional validation of self-reported clinical outcomes to the study, an additional 164 individuals visited the landing page, with 142 completing at least one questionnaire. Of the optional study elements, 7 participant-health care professional dyads participated in the survey, and 97 participants who completed the survey donated their anonymized medical device data. CONCLUSIONS: The platform was accessible to participants while maintaining compliance with data regulations. The Gateway formalized a system of automated data matching between multiple data sets, which was a major benefit to researchers. Scalability of the platform was demonstrated with the later addition of self-reported data validation. This study demonstrated the feasibility of custom software solutions in addressing complex study designs. The Gateway portal code has been made available open-source and can be leveraged by other research groups.

Cooling Effects Occur in Hepatic Microwave Ablation At Low Vascular Flow Rates and in Close Proximity to Liver Vessels - Ex Vivo.

Background. The impact of vascular cooling effects in hepatic microwave ablation (MWA) is controversially discussed. The objective of this study was a systematic assessment of vascular cooling effects in hepatic MWA ex vivo. Methods. Microwave ablations were performed in fresh porcine liver ex vivo with a temperature-controlled MWA generator (902-928 MHz) and a non-cooled 14-G-antenna. Energy input was set to 9.0 kJ. Hepatic vessels were simulated by glass tubes. Three different vessel diameters (3.0, 5.0, 8.0 mm) and vessel to antenna distances (5, 10, 20 mm) were examined. Vessels were perfused with saline solution at nine different flow rates (0-500 mL/min). Vascular cooling effects were assessed at the largest cross-sectional ablation area. A quantitative and semi-quantitative/morphologic analysis was carried out. Results. 228 ablations were performed. Vascular cooling effects were observed at close (5 mm) and medium (10 mm) antenna to vessel distances (P < .05). Vascular cooling effects occurred around vessels with flow rates ≥1.0 mL/min (P < .05) and a vessel diameter ≥3 mm (P < .05). Higher flow rates did not result in more distinct cooling effects (P > .05). No cooling effects were measured at large (20 mm) antenna to vessel distances (P > .05). Conclusion. Vascular cooling effects occur in hepatic MWA and should be considered in treatment planning. The vascular cooling effect was mainly affected by antenna to vessel distance. Vessel diameter and vascular flow rate played a minor role in vascular cooling effects.

Barriers to Uptake of Open-Source Automated Insulin Delivery Systems: Analysis of Socioeconomic Factors and Perceived Challenges of Caregivers of Children and Adolescents With Type 1 Diabetes From the OPEN Survey.

Background: As a treatment option for people living with diabetes, automated insulin delivery (AID) systems are becoming increasingly popular. The #WeAreNotWaiting community plays a crucial role in the provision and distribution of open-source AID technology. However, while a large percentage of children were early adopters of open-source AID, there are regional differences in adoption, which has prompted an investigation into the barriers perceived by caregivers of children with diabetes to creating open-source systems. Methods: This is a retrospective, cross-sectional and multinational study conducted with caregivers of children and adolescents with diabetes, distributed across the online #WeAreNotWaiting online peer-support groups. Participants-specifically caregivers of children not using AID-responded to a web-based questionnaire concerning their perceived barriers to building and maintaining an open-source AID system. Results: 56 caregivers of children with diabetes, who were not using open-source AID at the time of data collection responded to the questionnaire. Respondents indicated that their major perceived barriers to building an open-source AID system were their limited technical skills (50%), a lack of support by medical professionals (39%), and therefore the concern with not being able to maintain an AID system (43%). However, barriers relating to confidence in open-source technologies/unapproved products and fear of digital technology taking control of diabetes were not perceived as significant enough to prevent non-users from initiating the use of an open-source AID system. Conclusions: The results of this study elucidate some of the perceived barriers to uptake of open-source AID experienced by caregivers of children with diabetes. Reducing these barriers may improve the uptake of open-source AID technology for children and adolescents with diabetes. With the continuous development and wider dissemination of educational resources and guidance-for both aspiring users and their healthcare professionals-the adoption of open-source AID systems could be improved.

Costs and underuse of insulin and diabetes supplies: Findings from the 2020 T1International cross-sectional web-based survey.

AIMS: To investigate self-reported out-of-pocket expenses (OoPE) associated with insulin and diabetes supplies for people living with type 1 diabetes (T1D) worldwide. METHODS: A web-based, cross-sectional survey was conducted from August to December 2020. The analysis included comparisons between responses from countries with no, partial, and full healthcare coverage. RESULTS: 1,066 participants from 64 countries took part in the study. ~25% of respondents reported having underused insulin at least once within the last year due to perceived cost. A significant correlation was observed between OoPEs and reported household income for respondents with partial healthcare coverage. 63.2% of participants reported disruption of insulin supplies and 25.3% reported an increase of prices related to the COVID-19 pandemic. CONCLUSIONS: This study confirms previous reports of ~25% of people in the United States with T1D using less insulin and/or fewer supplies at least once in the last year due to cost, a trend associated with the extent of healthcare coverage. Similar trends were observed in some middle/low income countries. Moreover, patients reported an increase in insulin prices and disruption of supplies during the COVID-19 pandemic. This study highlights the importance of self-reported OoPEs and its association with underuse/rationing of insulin.

Evaluation of a numerical simulation for cryoablation - comparison with bench data, clinical kidney and lung cases.

PURPOSE: The accuracy of a numerical simulation of cryoablation ice balls was evaluated in gel phantom data as well as clinical kidney and lung cases. MATERIALS AND METHODS: To evaluate the accuracy, 64 experimental single-needle cryoablations and 12 multi-needle cryoablations in gel phantoms were re-simulated with the corresponding freeze-thaw-freeze cycles. The simulated temperatures were compared over time with the measurements of thermocouples. For single needles, temperature values were compared at each thermocouple location. For multiple needles, Euclidean distances between simulated and measured isotherms (10 °C, 0 °C, -20 °C, -40 °C) were computed. Furthermore, surface and volume of simulated 0 °C isotherms were compared to cryoablation-induced ice balls in 14 kidney and 13 lung patients. For this purpose, needle positions and relevant anatomical structures defining material parameters (kidney/lung, tumor) were reconstructed from pre-ablation CT images and fused with postablation CT images (from which ice balls were extracted by manual delineation). RESULTS: The single-needle gel phantom cases showed less than 5 °C prediction error on average. Over all multiple needle experiments in gel, the mean and maximum isotherm distance were less than 2.3 mm and 4.1 mm, respectively. Average Dice coefficients of 0.82/0.63 (kidney/lung) and mean surface distances of 2.59/3.12 mm quantify the prediction performance of the numerical simulation. However, maximum surface distances of 10.57/10.8 mm indicate that locally larger errors have to be expected. CONCLUSION: A very good agreement of the numerical simulations for gel experiments was measured and a satisfactory agreement of the numerical simulations with measured ice balls in patient data was shown.

Ablation zone geometry after CT-guided hepatic microwave ablation: evaluation of a semi-automatic software and comparison of two different ablation systems.

Purpose: The aims of this study were to evaluate a semi-automatic segmentation software for assessment of ablation zone geometry in computed tomography (CT)-guided microwave ablation (MWA) of liver tumors and to compare two different MWA systems.Material and Methods: 27 patients with 40 hepatic tumors (primary liver tumor n = 20, metastases n = 20) referred for CT-guided MWA were included in this retrospective IRB-approved study. MWA was performed using two systems (system 1: 915 MHz; n = 20; system 2: 2.45 GHz; n = 20). Ablation zone segmentation and ellipticity index calculations were performed using SAFIR (Software Assistant for Interventional Radiology). To validate semi-automatic software calculations, results (2 perpendicular diameters, ellipticity index, volume) were compared with those of manual analysis (intraclass correlation, Pearson's correlation, Mann-Whitney U test; p < 0.05 deemed significant.Results: Manual measurements of mean maximum ablation zone diameters were 43 mm (system 1) and 34 mm (system 2), respectively. Correlations between manual and semi-automatic measurements were r = 0.72 and r = 0.66 (both p < 0.0001) for perpendicular diameters, and r = 0.98 (p < 0.001) for volume. Manual analysis demonstrated that ablation zones created with system 2 had a significantly lower ellipticity index compared to system 1 (mean 1.17 vs. 1.86, p < 0.0001). Results correlated significantly with semi-automatic software measurements (r = 0.71, p < 0.0001).Conclusion: Semi-automatic assessment of ablation zone geometry using SAFIR is feasible. Software-assisted evaluation of ablation zones may prove beneficial with complex ablation procedures, especially for less experienced operators. The 2.45 GHz MWA system generated a significantly more spherical ablation zone compared to the 915 MHz system. The choice of a specific MWA system significantly influences ablation zone geometry.

Finding Optimal Ablation Parameters for Multipolar Radiofrequency Ablation.

PURPOSE: Radiofrequency ablation (RFA) for primary liver tumors and liver metastases is restricted by a limited ablation size. Multipolar RFA is a technical advancement of RFA, which is able to achieve larger ablations. The aim of this ex vivo study was to determine optimal ablation parameters for multipolar RFA depending on applicator distance and energy input. METHODS: RFA was carried out ex vivo in porcine livers with three internally cooled, bipolar applicators in multipolar ablation mode. Three different applicator distances were used and five different energy inputs were examined. Ablation zones were sliced along the cross-sectional area at the largest ablation diameter, orthogonally to the applicators. These slices were digitally measured and analyzed. RESULTS: Sixty RFA were carried out. A limited growth of ablation area was seen in all test series. This increase was dependent on ablation time, but not on applicator distance. A steady state between energy input and energy loss was not observed. A saturation of the minimum radius of the ablation zone was reached. Differences in ablation radius between the three test series were seen for lowest and highest energy input ( P < .05). No differences were seen for medium amounts of energy ( P > .05). CONCLUSIONS: The ablation parameters applicator distance and energy input can be chosen in such a way, that minor deviations of the preplanned ablation parameters have no influence on the size of the ablation area.

The vascular cooling effect in hepatic multipolar radiofrequency ablation leads to incomplete ablation ex vivo.

PURPOSE: Major limitations of conventional RFA are vascular cooling effects. However, vascular cooling effects are supposed to be less pronounced in multipolar RFA. The objective of this ex vivo study was a systematic evaluation of the vascular cooling effects in multipolar RFA. MATERIALS AND METHODS: Multipolar RFA with three bipolar RFA applicators was performed ex vivo in porcine liver (applicator distance 20 mm, energy input 40 kJ). A saline-perfused glass tube ('vessel') was placed parallel to the applicators in order to simulate a natural liver vessel. Five applicator-to-vessel geometries were tested. A liquid-filled glass tube without perfusion was used as a dry run. Ablations were orthogonally cut to the applicators at a defined height. Cooling effects were analysed qualitatively and quantitatively along these cross sectional areas. RESULTS: Thirty-six ablations were performed. A cooling effect could be seen in all ablations with perfused vessels compared to the dry run. While this cooling effect did not have any influence on the ablation areas (859-1072 mm(2) versus 958 mm(2) in the dry run, p > 0.05), it had a distinctive impact on ablation shape. A vascular cooling effect could be observed in all ablations with perfusion directly around the vessel independent of the applicator position compared to the dry run (p < 0.01). CONCLUSIONS: A vascular cooling effect occurred in all multipolar RFA with simulated liver vessels ex vivo independent of the applicator-to-vessel geometry. While the cooling effect did not influence the total ablation area, it had a distinctive impact on the ablation shape.