DIY artificial pancreas: A narrative of the first patient and the physicians' experiences from India.

BACKGROUND AIMS: Frustrated with the slow-pace of innovations in diabetes technologies, the type 1 diabetes community have started closing the loop by themselves to automate insulin delivery. While the regulatory and ethical concerns over the systems are still high, these have contributed to enhanced glycemic control characterized by improved estimated HbA1c and time-in-range above 90% as for many users. Our objective is to provide the real-world experience of the first successful patient from India on the Do-It-Yourself Artificial Pancreas (DIYAP) and the perspective of her physicians. METHODS: A narrative recounting of a personal experience on DIYAP. The patient completed a Hypoglycemia Fear Survey II and Diabetes Quality of Life instrument before and after looping. RESULTS: The patient emphasized the personal/social benefits and the concerns of using the system. Looping has produced a clinically meaningful difference in the quality of life, better sleep patterns, and reduced the disease management burden. We also highlighted the relevant perspectives of the physicians to give deeper insights into the aspect. CONCLUSION: The patient highlighted better time-in-range, negligible time spent in hypoglycemia, and superior Quality of Life. Globally, more and more patients are adopting this technology; therefore, real-life patient stories will enlighten the medical community.

Innovative features and functionalities of an artificial pancreas system: What do youth and parents want?

AIMS: Participant-driven solutions may help youth and families better engage and maintain use of diabetes technologies. We explored innovative features and functionalities of an ideal artificial pancreas (AP) system suggested by youth with type 1 diabetes and parents. METHODS: Semi-structured interviews were conducted with 39 youth, ages 10-25 years, and 44 parents. Interviews were recorded, transcribed and coded using thematic analysis. RESULTS: Youth (72% female, 82% non-Hispanic white) were (M ± SD) ages 17.0 ± 4.7 years, with diabetes for 9.4 ± 4.9 years, and HbA1c of 68 ± 11 mmol/mol (8.4 ± 1.1%); 79% were pump-treated and 82% were continuous glucose monitor users. Of parents, 91% were mothers and 86% were non-Hispanic white, with a child 10.6 ± 4.5 years old. Youth and parents suggested a variety of innovative features and functionalities for an ideal AP system related to (1) enhancing the appeal of user interface, (2) increasing automation of new glucose management functionalities, and (3) innovative and commercial add-ons for greater convenience. Youth and parents offered many similar suggestions, including integration of ketone testing, voice activation, and location-tracking into the system. Youth seemed more driven by increasing convenience and normalcy while parents expressed more concerns with safety. CONCLUSIONS: Youth and parents expressed creative solutions for an ideal AP system to increase ease of use, enhance normalcy, and reduce burden of management. Designers of AP systems will likely benefit from incorporating the desired preferences by end users to optimize acceptance and usability by young persons with diabetes.

Do-It-Yourself (DIY) Artificial Pancreas Systems for Type 1 Diabetes: Perspectives of Two Adult Users, Parent of a User and Healthcare Professionals.

The artificial pancreas system or an automated insulin dosing system has been the 'holy grail' for patients with type 1 diabetes and their caregivers who have over the years wanted to 'close the loop' between monitoring of glucose and delivery of insulin. The launch of the Medtronic MiniMed 670G system in 2017 and the subsequent release of the Tandem t:slim with Control-IQ system, the DANA RS pump compatible-CamAPS FX app and the more recent announcement of the Medtronic MiniMed 780G system have come as answers to their prayers. However, in the time taken to develop and launch these commercial systems, creative and ebullient parents of young patients with type 1 diabetes, along with other patients, technologists and healthcare professionals have developed mathematical models as software solutions to determine insulin delivery that in conjunction with compatible hardware have helped 'close the loop'. Under an umbrella movement #WeAreNotWaiting, they have, as a community, refined and disseminated technologies that are open source and ubiquitously available as do-it-yourself (DIY) closed-loop systems or DIY artificial pancreas systems (APS). There are presently three systems-OpenAPS, AndroidAPS and Loop. We present perspectives of two patients, parent of a patient, and their healthcare providers; the users spanning an age spectrum most likely to use this technology-a child, an adolescent in transitional care and a 31-yr old adult patient, highlighting how looping has helped them self-manage diabetes within the routine of their lives and the challenges they faced.

Psychosocial Aspects of Diabetes Technology: Adult Perspective.

The success of diabetes technologies depends on the attitudes and behavior of the individuals who choose to adopt them. Real-time continuous glucose monitoring, continuous subcutaneous insulin infusion, and sensor-augmented pump systems may positively affect diabetes-related quality of life (QOL), although the influence on QOL outcomes seems to be modest and the results from randomized controlled trials are limited and controversial. In contrast, more consistently positive QOL-related responses are apparent from observational data. The newer generations of devices hold the promise for more strongly enhancing diabetes-related QOL. Appropriate training and ongoing support are likely to be the key to successful uptake.

Psychosocial Aspects of Diabetes Technology Use: The Child and Family Perspective.

This article offers a systematic review of the literature on psychosocial aspects of technology use in children and adolescents with type 1 diabetes and their families, searching for relevant articles published the past 5 years. Topics included continuous subcutaneous insulin infusion, continuous glucose monitoring, predictive low-glucose suspend, and artificial pancreas systems. The review indicates there are positive and negative psychosocial aspects to diabetes technology use among youth and their families. Although consistent findings were revealed, contradictions exist. Discussed are recommendations for future research and implications for how health care providers can collaborate with families to discuss and manage diabetes technology.

Advances in artificial pancreas systems.

The artificial pancreas for managing type 1 diabetes has progressed from research into clinical practice, revealing areas for future advancements.

Acceptance of the Artificial Pancreas: Comparing the Effect of Technology Readiness, Product Characteristics, and Social Influence Between Invited and Self-Selected Respondents.

BACKGROUND: Psychosocial factors that may affect acceptance of artificial pancreas (AP) systems have been investigated in small sample sizes of highly motivated, self-selected persons with type 1 diabetes (T1DM) with a focus on product characteristics. We aimed to develop a valid survey to investigate the association of technology readiness and social influence with AP acceptance in a larger sample, including both self-selected and invited respondents with T1DM. METHODS: An online survey was developed based on established questionnaires. Intention to use the AP was chosen as measure of AP acceptance. T1DM patients who signed up themselves for scientific research into AP systems represented the self-selected group, while patients treated at a teaching hospital represented the invited group. Questionnaire values were compared using independent t-tests and regression analyses. RESULTS: The developed survey showed reliability and validity. The survey was completed by 425 self-selected and 109 invited persons. Intention to use the AP was high in both groups, but was significantly higher among self-selected respondents. In both groups, intention to use the AP was most strongly related to product compatibility, followed by product complexity, technology readiness, and product usefulness among invited respondents; and followed by product usefulness and technology innovativeness among self-selected respondents. CONCLUSIONS: Product characteristics have a stronger relationship with AP acceptance than technology readiness, while social influence does not seem to be associated with AP acceptance. As the (strength of) factors differ between self-selected and invited persons, researchers and product developers should be cautious when relying on self-selected persons with T1DM in the design, development, and testing of AP systems.

Biopsychosocial Factors Associated With Satisfaction and Sustained Use of Artificial Pancreas Technology and Its Components: a Call to the Technology Field.

PURPOSE OF REVIEW: Summarize biopsychosocial factors associated with using continuous glucose monitors (CGMs), insulin pumps, and artificial pancreas (AP) systems and provide a "call to the field" about their importance to technology uptake and maintained use. RECENT FINDINGS: Insulin pumps and CGMs are becoming standard of care for individuals with type 1 diabetes (T1D). AP systems combining a CGM, insulin pump, and automated dosing algorithm are available for commercial use. Despite improved glycemic control with AP system use, numerous barriers exist which may limit their benefit. Studies on components of AP systems (pumps, CGMs) are limited and demonstrate mixed results of their impact on fear of hypoglycemia, adherence, quality of life, depression and anxiety, and diabetes distress. Studies examining biopsychological factors associated specifically with sustained use of AP systems are also sparse. Biological, psychological and social impacts of AP systems have been understudied and the information they provide has not been capitalized upon.

Open Source Closed-Loop Insulin Delivery Systems: A Clash of Cultures or Merging of Diverse Approaches?

Biomedical outcomes for people with diabetes remain suboptimal for many. Psychosocial care in diabetes does not fare any better. "Artificial pancreas" (also known as "closed-loop" and "automated insulin delivery") systems present a promising therapeutic option for people with diabetes (PWD)-simultaneously improving glycemic outcomes, reducing the burden of self-management, and improving health-related quality of life. In recent years there has emerged a growing movement of PWD innovators rallying behind the mantra #WeAreNotWaiting, developing "do-it-yourself artificial pancreas systems (DIY APS)." Self-reported results by DIY APS users show improved metabolic outcomes such as impressive stability of glucose profiles, significant reduction of A1c, and more time within their glycemic target range. However, the benefits remain unclear for the broader population of PWD beyond these highly engaged, highly tech-savvy users willing and able to engage in the demands of building and maintaining their DIY APS. We discuss the challenges faced by key stakeholder groups in terms of potential collaboration and open debate of these challenges.

Psychosocial impacts of hybrid closed-loop systems in the management of diabetes: a review.

There is a pressing need for new treatment regimens that enable improved glycaemic control and reduced diabetes self-management burdens. Closed-loop, or artificial pancreas, systems represent one of the most promising avenues in this regard. Closed-loop systems connect wearable continuous glucose monitor (CGM) sensors to smartphone- or tablet-mounted algorithms that process and model CGM data to deliver precise and frequently updated doses of fast-acting insulin (and glucagon in dual-hormone systems) to users via wearable pumps. Recent studies have demonstrated that closed-loop systems offer significant benefit in terms of improved glycaemic control. However, less attention has been paid to the psychosocial impact on users of closed-loop systems. This article reviews recent research on psychosocial aspects of closed-loop usage in light of preceding research on user experience of currently available technologies such as insulin pumps and CGM sensors. The small, but growing body of research in this field reports generally positive user experience and a number of experienced benefits including: reassurance and reduced anxiety, improved sleep and confidence, and 'time off' from diabetes demands. However, these benefits are counterbalanced by important challenges, ranging from variable levels of trust to concerns about physical bulk, technical glitches and difficulties incorporating closed-loop systems into everyday life. Future research should explore psychosocial aspects of closed-loop usage in more diverse groups and with regard to clinicians, as well as users, to ensure that the clinical benefits of closed-loop systems are realized at scale in routine medical care.

Evaluating the Experience of Children With Type 1 Diabetes and Their Parents Taking Part in an Artificial Pancreas Clinical Trial Over Multiple Days in a Diabetes Camp Setting.

OBJECTIVE: To explore the experiences of children with type 1 diabetes and their parents taking part in an artificial pancreas (AP) clinical trial during a 7-day summer camp. RESEARCH DESIGN AND METHODS: A semistructured interview, composed of 14 questions based on the Technology Acceptance Model, was conducted at the end of the clinical trial. Participants also completed the Diabetes Treatment Satisfaction Questionnaire (DTSQ, parent version) and the AP Acceptance Questionnaire. RESULTS: Thirty children, aged 5-9 years, and their parents completed the study. A content analysis of the interviews showed that parents were focused on understanding the mechanisms, risks, and benefits of the new device, whereas the children were focused on the novelty of the new system. The parents' main concerns about adopting the new system seemed related to the quality of glucose control. The mean scores of DTSQ subscales indicated general parents' satisfaction (44.24 ± 5.99, range 32-53) and trustful views of diabetes control provided by the new system (7.8 ± 2.2, range 3-12). The AP Acceptance Questionnaire revealed that most parents considered the AP easy to use (70.5%), intended to use it long term (94.0%), and felt that it was apt to improve glucose control (67.0%). CONCLUSIONS: Participants manifested a positive attitude toward the AP. Further studies are required to explore participants' perceptions early in the AP development to individualize the new treatment as much as possible, and to tailor it to respond to their needs and values.

Diabetes Technology: Uptake, Outcomes, Barriers, and the Intersection With Distress.

Patients managing type 1 diabetes have access to new technologies to assist in management. This manuscript has two aims: 1) to briefly review the literature on diabetes technology use and how this relates to psychological factors and 2) to present an example of human factors research using our data to examine psychological factors associated with technology use. Device/technology uptake and use has increased over the years and at present day is a common clinical practice. There are mixed results in terms of health and psychosocial outcomes, with specific subgroups doing better than others with technology. Our data demonstrated that patients have moderately elevated diabetes distress across differing types of technology used, from low-tech to high-tech options, possibly meaning that technology does not add or take away distress. In addition, users on multiple daily injections compared to all other technology groups have less positive attitudes about technology. Finally, we discuss implications for clinical practice and future research.

Psychosocial Impact of the Bionic Pancreas During Summer Camp.

BACKGROUND: The psychosocial impact of the bionic pancreas (BP) was assessed among children attending diabetes camp. METHODS: Nineteen children were randomly assigned for 5 days to the BP condition and 5 days to the control condition in a crossover design. RESULTS: Significant reductions in hypoglycemic fear and regimen burden were found. Children felt less burdened or worried about diabetes and felt freer to do things they enjoyed while using the BP. Children wished the BP responded to out of range numbers faster and expressed annoyance about carrying around the necessary equipment. CONCLUSIONS: Children may experience improved psychosocial outcomes following use of BP while expressing key areas of user concern. Future studies in less controlled environments with larger sample sizes can determine if these findings are generalizable to other groups.

Toward Development of Psychosocial Measures for Automated Insulin Delivery.

The INSPIRE study working group launched its initial workshop in February 2015 to facilitate collaboration among key stakeholders interested in automated insulin delivery (AID) systems and the psychosocial outcomes of individuals who may use these new technologies. Specifically, the INSPIRE team's goal is to facilitate measure development assessing the psychosocial factors associated with AID systems. A second working group was held to foster exchange among key stakeholders in AID system development. Patient, health care provider, engineering, industry, academic, regulatory and payer perspectives were presented. The INSPIRE working group will continue to serve as a platform to encourage open dialogue among all stakeholders with the aim of facilitating technology that offers minimal user burden and maximum benefit from both a psychological and physiologic perspective.

Reduced Worries of Hypoglycaemia, High Satisfaction, and Increased Perceived Ease of Use after Experiencing Four Nights of MD-Logic Artificial Pancreas at Home (DREAM4).

AIMS: This study assesses the impact of using an AP-system at home on fear of hypoglycaemia. In addition, satisfaction and acceptance of the new technology are evaluated. METHODS: In a multicentre, multinational study of 75 patients using the MD-Logic AP during four consecutive nights in home setting 59 of them (aged 10-54 years, 54% male, HbA1c 7.89 ± 0.69% [62.72 ± 7.51 mmol/mol], diabetes duration 11.6 ± 8.4 yrs) answered standardized questionnaires (HFS, adapted TAM, and AP satisfaction) before and after using the AP. RESULTS: After experiencing the AP in home setting worries of hypoglycaemia were significantly reduced (before 1.04 ± 0.53 versus after 0.90 ± 0.63; P = 0.017). Perceived ease of use as a measure of acceptance with the AP significantly increased after personal experience (before 4.64 ± 0.94 versus after 5.06 ± 1.09; P = 0.002). The overall satisfaction mean score after using the AP was 3.02 ± 0.54 (range 0-4), demonstrating a high level of satisfaction with this technology. CONCLUSIONS: The four-night home-based experience of using MD Logic AP was associated with reduced worries of hypoglycaemia, high level of satisfaction, and increased perceived ease of use of the new technology in children, adolescents, and adults.

PsychDT Working Group: Report Psychosocial Aspects of Artificial Pancreas Systems.

BACKGROUND: Diabetes technology is a cornerstone of diabetes management in the 21st century, with advances in available devices over recent years playing a central role in the way that health care has progressed. Psychosocial interventions have been shown to have a positive impact on glycemic control, reduce psychological distress and reduce costs of health care. Addressing and improving psychosocial outcomes that complement biomedical improvements and looking to the future are crucial to enhance patient acceptance of artificial pancreas (AP) systems. METHODS: To achieve closer collaboration and comparability across different AP research trials, a working group was established. RESULTS: Existing measures fail to adequately capture the extent to which human and psychological factors play a role in the uptake and efficient use of AP systems. Understanding these factors will ultimately lead to the most benefit for users. Reliable measures of the psychosocial impact of AP systems for users is crucial to ensure that (1) regulatory authorities are able to robustly consider these aspects as part of their approval process, (2) government and private payers are able to factor these aspects into their decisions regarding reimbursement, and (3) persons with diabetes maximize benefits in terms of both glycemic control and quality of life to minimize the burden of diabetes in everyday life. CONCLUSIONS: This working group will serve as a platform to foster exchange, identify research needs, and guide and initiate collaborative research laying the groundwork for optimal utilization of diabetes technology in clinical diabetes care. A close collaboration among all key stakeholders is crucial to ensure that devices are designed, trialed, approved, and provided with minimal user burden and maximum beneficial effect.

Future artificial pancreas technology for type 1 diabetes: what do users want?

BACKGROUND: The primary focus of artificial pancreas (AP) research has been on technical achievements, such as time in range for glucose levels or prevention of hypoglycemia. Few studies have attempted to ascertain the expectations of users of AP technology. SUBJECTS AND METHODS: Persons with type 1 diabetes and parents of children with type 1 diabetes were invited to take part in an online survey concerning future use and expectations of AP technology. The survey was advertised via Twitter, Facebook, and DiabetesMine, plus advocacy groups and charities including INPUT, Diabetes UK, and the Diabetes Research and Wellness Foundation. Quantitative responses were categorized on a 5-point Likert scale. Free text responses were analyzed using content analysis. RESULTS: Two hundred sixty-six surveys were completed over a 1-month period. Two hundred forty participants indicated they were highly likely to use a fully automated 24-h AP. Approximately half of the respondents indicated they would be likely to use a device that only functioned overnight. Size, visibility, and lack of effectiveness were the top reasons for not wanting an AP. Despite perceived potential downsides, participants expressed a strong need for a device that will help minimize the burden of disease, help facilitate improved psychosocial functioning, and improve quality of life. CONCLUSIONS: The views of people who would use an AP are crucial in the development of such devices to ensure they are fit for use alongside biomedical and engineering excellence. Without this, it is unlikely that an AP will be sufficiently successful to meet the needs of users and to achieve their ultimate goals.

Psychosocial assessment of artificial pancreas (AP): commentary and review of existing measures and their applicability in AP research.

AIM: This study aimed to systematically review the evidence base for the use of existing psychological and psychosocial measures suitable for use in artificial pancreas (AP) research. MATERIALS AND METHODS: This systematic review of published literature, gray literature, previous systematic reviews, and qualitative and economic studies was conducted using terms and abbreviations synonymous with diabetes, AP, and quality of life (QoL). RESULTS: Two hundred ninety-two abstracts were identified that reported psychosocial assessment of diabetes-related technologies. Of these, nine met the inclusion criteria and were included. Only four of 103 ongoing trials evaluated psychosocial aspects as an outcome in the trial. Of these, treatment satisfaction, acceptance and use intention of AP, fear of hypoglycemia episodes, satisfaction with AP, and an unspecified QoL measure were used. CONCLUSIONS: A better understanding of the psychosocial side of AP systems and the extent to which human factors play a role in the uptake and efficient use of these systems will ultimately lead to the most benefit for people with diabetes.