Parents' experiences of using remote monitoring technology to manage type 1 diabetes in very young children during a clinical trial: Qualitative study.

AIMS: To explore parents' experiences of using remote monitoring technology when caring for a very young child with type 1 diabetes during a clinical trial. METHODS: Interviews were conducted with parents of 30 children (aged 1-7 years) participating in a trial (the KidsAP02 study) comparing hybrid closed-loop insulin delivery with sensor-augmented pump therapy. In both arms, parents had access to remote monitoring technology. Data analysis focused on identification of descriptive themes. RESULTS: Remote monitoring technology gave parents improved access to data which helped them pre-empt and manage glucose excursions. Parents observed how, when children were in their own care, they could be more absent while present, as their attention could shift to non-diabetes-related activities. Conversely, when children were others' care, remote monitoring enabled parents to be present while absent, by facilitating oversight and collaboration with caregivers. Parents described how remote monitoring made them feel more confident allowing others to care for their children. Parents' confidence increased when using a hybrid closed-loop system, as less work was required to keep glucose in range. Benefits to children were also highlighted, including being able to play and sleep uninterrupted and attend parties and sleepovers without their parents. While most parents welcomed the increased sense of control remote monitoring offered, some noted downsides, such as lack of respite from caregiving responsibilities. CONCLUSIONS: Remote monitoring can offer manifold benefits to both parents and very young children with type 1 diabetes. Some parents, however, may profit from opportunities to take 'time out'.

Parents' views about healthcare professionals having real-time remote access to their young child's diabetes data: Qualitative study.

OBJECTIVES: We explored parents' views about healthcare professionals having remote access to their young child's insulin and glucose data during a clinical trial to inform use of data sharing in routine pediatric diabetes care. RESEARCH DESIGN AND METHODS: Interviews with 33 parents of 30 children (aged 1-7 years) with type 1 diabetes participating in a randomized trial (KidsAP02) comparing hybrid closed-loop system use with sensor-augmented pump therapy. Data were analyzed using a qualitative descriptive approach. RESULTS: Parents reported multiple benefits to healthcare professionals being able to remotely access their child's glucose and insulin data during the trial, despite some initial concerns regarding the insights offered into everyday family life. Key benefits included: less work uploading/sharing data; improved consultations; and, better clinical input and support from healthcare professionals between consultations. Parents noted how healthcare professionals' real-time data access facilitated remote delivery of consultations during the COVID-19 pandemic, and how these were more suitable for young children than face-to-face appointments. Parents endorsed use of real-time data sharing in routine clinical care, subject to caveats regarding data access, security, and privacy. They also proposed that, if data sharing were used, consultations for closed-loop system users in routine clinical care could be replaced with needs-driven, ad-hoc contact. CONCLUSIONS: Real-time data sharing can offer clinical, logistical, and quality-of-life benefits and enhance opportunities for remote consultations, which may be more appropriate for young children. Wider rollout would require consideration of ethical and cybersecurity issues and, given the heightened intrusion on families' privacy, a non-judgmental, collaborative approach by healthcare professionals.

Palliative care for people with advanced liver disease: A feasibility trial of a supportive care liver nurse specialist.

BACKGROUND: Liver disease is an increasing cause of death worldwide but palliative care is largely absent for these patients. AIM: We conducted a feasibility trial of a complex intervention delivered by a supportive care liver nurse specialist to improve care coordination, anticipatory care planning and quality of life for people with advanced liver disease and their carers. DESIGN: Patients received a 6-month intervention (alongside usual care) from a specially trained liver nurse specialist. The nurse supported patients/carers to live as well as possible with the condition and acted as a resource to facilitate care by community professionals. A mixed-method evaluation was conducted. Case note analysis and questionnaires examined resource use, care planning processes and quality-of-life outcomes over time. Interviews with patients, carers and professionals explored acceptability, effectiveness, feasibility and the intervention. SETTING/PARTICIPANTS: Patients with advanced liver disease who had an unplanned hospital admission with decompensated cirrhosis were recruited from an inpatient liver unit. The intervention was delivered to patients once they had returned home. RESULTS: We recruited 47 patients, 27 family carers and 13 case-linked professionals. The intervention was acceptable to all participants. They welcomed access to additional expert advice, support and continuity of care. The intervention greatly increased the number of electronic summary care plans shared by primary care and hospitals. The Palliative care Outcome Scale and EuroQol-5D-5L questionnaire were suitable outcome measurement tools. CONCLUSION: This nurse-led intervention proved acceptable and feasible. We have refined the recruitment processes and outcome measures for a future randomised controlled trial.

Listening to Women: Experiences of Using Closed-Loop in Type 1 Diabetes Pregnancy.

Introduction: Recent high-profile calls have emphasized that women's experiences should be considered in maternity care provisioning. We explored women's experiences of using closed-loop during type 1 diabetes (T1D) pregnancy to inform decision-making about antenatal rollout and guidance and support given to future users. Methods: We interviewed 23 closed-loop participants in the Automated insulin Delivery Among Pregnant women with T1D (AiDAPT) trial after randomization to closed-loop and ∼20 weeks later. Data were analyzed thematically. Results: Women described how closed-loop lessened the physical and mental demands of diabetes management, enabling them to feel more normal and sleep better. By virtue of spending increased time-in-range, women also worried less about risks to their baby and being judged negatively by health care professionals. Most noted that intensive input and support during early pregnancy had been crucial to adjusting to, and developing confidence in, the technology. Women emphasized that attaining pregnancy glucose targets still required ongoing effort from themselves and the health care team. Women described needing education to help them determine when, and how, to intervene and when to allow the closed-loop to operate without interference. All women reported more enjoyable pregnancy experiences as a result of using closed-loop; some also noted being able to remain longer in paid employment. Conclusions: Study findings endorse closed-loop use in T1D pregnancy by highlighting how the technology can facilitate positive pregnancy experiences. To realize fully the benefits of closed-loop, pregnant women would benefit from initial intensive oversight and support together with closed-loop specific education and training. Clinical Trial Registration number: NCT04938557.

Rollout of Closed-Loop Technology to Pregnant Women with Type 1 Diabetes: Healthcare Professionals' Views About Potential Challenges and Solutions.

Aims: To explore healthcare professionals' views about the training and support needed to rollout closed-loop technology to pregnant women with type 1 diabetes. Methods: We interviewed (n = 19) healthcare professionals who supported pregnant women using CamAPS FX closed-loop during the Automated insulin Delivery Amongst Pregnant women with Type 1 diabetes (AiDAPT) trial. Data were analyzed descriptively. An online workshop involving (n = 15) trial team members was used to inform recommendations. Ethics approvals were obtained in conjunction with those for the wider trial. Results: Interviewees expressed enthusiasm for a national rollout of closed-loop, but anticipated various challenges, some specific to use during pregnancy. These included variations in insulin pump and continuous glucose monitoring expertise and difficulties embedding and retaining key skills, due to the relatively small numbers of pregnant women using closed-loop. Inexperienced staff also highlighted difficulties interpreting data downloads. To support rollout, interviewees recommended providing expert initial advice training, delivered by device manufacturers together with online training resources and specific checklists for different systems. They also highlighted a need for 24 h technical support, especially when supporting technology naive women after first transitioning onto closed-loop in early pregnancy. They further recommended providing case-based meetings and mentorship for inexperienced colleagues, including support interpreting data downloads. Interviewees were optimistic that if healthcare professionals received training and support, their long-term workloads could be reduced because closed-loop lessened women's need for glycemic management input, especially in later pregnancy. Conclusions: Interviewees identified challenges and opportunities to rolling-out closed-loop and provided practical suggestions to upskill inexperienced staff supporting pregnant women using closed-loop. A key priority will be to determine how best to develop mentorship services to support inexperienced staff delivering closed-loop. Clinical Trials Registration: NCT04938557.

Factors influencing adult carer support planning for unpaid caregiving at the end of life in Scotland: Qualitative insights from triangulated interviews and focus groups.

Caring for a relative or friend at the end of life can be rewarding but all-encompassing. These caregivers are often not identified, meaning their diverse needs remain unmet, and the lack of assessment, support and planning increases the likelihood of crisis and burnout. The Carers (Scotland) Act 2016 places responsibility on local authorities to implement such a plan, which will be fast-tracked for carers supporting someone at the end of life. Our research described the factors which might influence this planning, triangulating primary focus groups with 15 carers and secondary qualitative data from transcripts with 30 carers, all of whom who had looked after someone with a terminal illness. Analysis was iterative, and constant comparative analysis of the secondary data informed the primary focus groups. Three main themes were identified; 1. The importance of early identification as a carer to enable timely assessment and support. 2. Carers experience isolation and loneliness which limits opportunities for support. 3. Responding in a timely fashion to carer assessment and support is vital to avoid crises. This research confirms that identifying carers early in the illness trajectory, ideally at diagnosis, is vital to avoid carer burnout. Health and social care providers have a key role in identification and should ensure, where possible, that carer needs are dynamically assessed, supported and documented. Finally, caring does not end after death, it extends into bereavement. Thus, we need to consider system and cultural change to ensure the experiences and needs of carers are addressed and valued.

Parents' experiences of using a hybrid closed-loop system (CamAPS FX) to care for a very young child with type 1 diabetes: Qualitative study.

AIMS: To explore parents' experiences of using a hybrid closed-loop system (CamAPS FX) when caring for a very young child (aged 1-7 years) with type 1 diabetes. METHODS: Interviews with n = 33 parents of 30 children who used the system during a randomised controlled trial. Data analysis used a descriptive thematic approach. RESULTS: While some parents were initially reticent about handing control to the system, all reported clinical benefits to using the technology, having to do less diabetes-related work and needing less clinical input over time. Parents welcomed opportunities to enhance the system's efficacy (using Ease-off and Boost functions) as required. Parents described how the system's automated glucose control facilitated more normality, including sleeping better, worrying less about their child, and feeling more confident and able to outsource care. Parents also described more normality for the child (alongside better sleep, mood and concentration, and lessened distress) and siblings. Parents liked being able to administer insulin using a smartphone, but suggested refinements to device size and functionality. CONCLUSIONS: Using a hybrid closed-loop system in very young children can facilitate greater normality and may result in a lessened demand for health professionals' input. Systems may need to be customised for very young children.

Data Sharing While Using a Closed-Loop System: Qualitative Study of Adolescents' and Parents' Experiences and Views.

Objective: To understand and explore data sharing practices among adolescents and their parents using a closed-loop system. Methods: Eighteen adolescents (aged 11-18 years) and 19 parents were interviewed after adolescents had ∼6 months experience of using a closed-loop system, which permitted them to share glucose and insulin data with parents/caregivers. Data were analyzed thematically. Results: There was considerable variability in how parent-child dyads perceived, valued, and undertook data sharing. Parents of early adolescents (11-13 years) reported making extensive use of "real time" data to remotely manage their child's diabetes and early adolescents described needing and wanting this input. Parents of middle adolescents (14-16 years) described making greater use of retrospective data. To avoid conflict and encourage and support their son/daughter's autonomy, these individuals reported practicing watchful waiting and only intervening after concerns about a pattern of problematic behavior or their child's safety arose. Middle adolescents indicated that data sharing had been done primarily for the benefit of their parents, although they also noted quality of life benefits for themselves. Among late adolescents (17+ years), parents were simply remote because their son/daughter had not permitted access to their data. Participants recommended clear ground rules be put in place about when, and how, data sharing should be used. Conclusions: To help parent-child dyads use data sharing in ways which minimize conflict and optimize constructive parental support, we recommend tailored input and support, which takes account of family dynamics, the young person's developmental maturity, and the different ways in which data are used across the adolescent age range.

Adolescents' Experiences of Using a Smartphone Application Hosting a Closed-loop Algorithm to Manage Type 1 Diabetes in Everyday Life: Qualitative Study.

BACKGROUND: Closed-loop technology may help address health disparities experienced by adolescents, who are more likely to have suboptimal glycemic control than other age groups and, because of their age, find diabetes self-management particularly challenging. The CamAPS FX closed-loop has sought to address accessibility and usability issues reported by users of previous prototype systems. It comprises small components and a smartphone app used to: announce meal-time boluses, adjust ("boost" or "ease-off") closed-loop insulin delivery, customize alarms, and review/share data. We explored how using the CamAPS FX platform influences adolescents' self-management practices and everyday lives. METHODS: Eighteen adolescents were interviewed after having ≥6 months experience using the closed-loop platform. Data were analyzed thematically. RESULTS: Participants reported feeling less burdened and shackled by diabetes because closed-loop components were easier to carry/wear, finger-pricks were not required, the smartphone app provided a discreet and less stigmatizing way of managing diabetes in public, and they were able to customize alarms. Participants also reported checking and reviewing data more regularly, because they did so when using the smartphone for other reasons. Some reported challenges in school settings where use of personal phones was restricted. Participants highlighted how self-management practices were improved because they could easily review glucose data and adjust closed-loop insulin delivery using the "boost" and "ease-off" functions. Some described how using the system resulted in them forgetting about diabetes and neglecting certain tasks. CONCLUSIONS: A closed-loop system with small components and control algorithm on a smartphone app can enhance usability and acceptability for adolescents and may help address the health-related disparities experienced by this age group. However, challenges can arise from using a medical app on a device which doubles as a smartphone. TRIAL REGISTRATION: Closed Loop From Onset in Type 1 Diabetes (CLOuD); NCT02871089; https://clinicaltrials.gov/ct2/show/NCT02871089.

Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study): an open-label, multicentre, multinational, randomised cross-over study protocol.

INTRODUCTION: Diabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group. METHODS AND ANALYSIS: The study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1-7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1-4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants' and caregivers' experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed. ETHICS AND DISSEMINATION: Ethics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d'Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT03784027.

Emotional experience of people with advanced liver disease: Secondary data analysis.

INTRODUCTION: Patients with advanced liver disease live mainly in the community with treatment of complications provided for in-hospital. The illness trajectory of advanced liver disease is uncertain and most do not have access to end of life care. Gaps in knowledge and understanding of the patient experience of this condition have been identified. METHODS: Secondary analysis of 15 transcripts from in-depth interviews with people with advanced liver disease collected as part of a previous longitudinal study on the experience of liver disease. Transcripts were thematically analysed for emotional content. RESULTS: Fear, anger, sadness and guilt clearly featured in the person's experience of advanced liver disease. Certain causal factors were identified as provoking these emotional responses, including shock of diagnosis, uncertainty concerning illness, lack of coordinated care, worrying symptoms and sudden death. Humour emerged as a coping mechanism. CONCLUSION: People living with advanced liver disease experience distressing emotions. It is helpful for clinicians, nurses and other healthcare support staff to have an appreciation of the person's emotional concerns in order to provide holistic care typical of a palliative approach.

What Training, Support, and Resourcing Do Health Professionals Need to Support People Using a Closed-Loop System? A Qualitative Interview Study with Health Professionals Involved in the Closed Loop from Onset in Type 1 Diabetes (CLOuD) Trial.

Background: We explored health professionals' views about the training, support, and resourcing needed to support people using closed-loop technology in routine clinical care to help inform the development of formal guidance. Methods: Interviews were conducted with health professionals (n = 22) delivering the Closed Loop from Onset in Type 1 Diabetes (CLOuD) trial after they had ≥6 months' experience of supporting participants using a closed-loop system. Data were analyzed descriptively. Results: Interviewees described how, compared with other insulin regimens, teaching and supporting individuals to use a closed-loop system could be initially more time-consuming. However, they also noted that after an initial adjustment period, users had less need for initiating contact with the clinical team compared with people using pumps or multiple daily injections. Interviewees highlighted how a lessened need for ad hoc clinical input could result in new challenges; specifically, they had fewer opportunities to reinforce users' diabetes knowledge and skills and detect potential psychosocial problems. They also observed heightened anxiety among some parents due to the constant availability of data and unrealistic expectations about the system's capabilities. Interviewees noted that all local diabetes teams should be empowered to deliver closed-loop system care, but stressed that health professionals supporting closed-loop users in routine care will need comprehensive technology training and standardized clinical guidance. Conclusion: These findings constitute an important starting point for the development of formal guidance to support the rollout of closed-loop technology. Our recommendations, if actioned, will help limit the potential additional burden of introducing closed-loop systems in routine clinical care and help inform appropriate user education and support.

What is the patient experience in advanced liver disease? A scoping review of the literature.

BACKGROUND: There has been a dramatic increase in liver disease over recent decades, with morbidity and mortality rates predicted to rise significantly. In order to effectively support this growing patient population we need to understand the experiences, key issues and priorities of people living and dying with advanced liver disease. AIMS: To establish what is currently known about the patient experience of advanced liver disease. METHODS: Scoping literature review. We searched MedLine, Web of Science, CINAHL and PsychINFO databases. ELIGIBILITY CRITERIA: original research and review papers written in English since 1990 relating to the adult patient experience of advanced liver disease. Papers focusing on treatment development, acute liver failure or post liver transplantation were excluded. RESULTS: 240 abstracts were identified and 121 articles reviewed in full. Patients with advanced liver disease experience many physical and psychosocial challenges, often of a greater severity than those reported in other advanced conditions. They are affected by gastrointestinal problems and fatigue, with both linked to higher levels of depression. Socio-demographic variations in the patient experience occur. Only two studies explored the holistic patient experience. CONCLUSIONS: Our knowledge of the patient experience in advanced liver disease is mainly from quality of life instruments and quantitative research. There are methodological limitations in the existing research such that the holistic patient experience is not well described. Qualitative longitudinal research has great potential for contributing to our understanding of the complex needs and experiences of patients living with advanced liver disease.

Managing uncertainty in advanced liver disease: a qualitative, multiperspective, serial interview study.

OBJECTIVE: To understand the experiences and support needs of people with advanced liver disease and those of their lay and professional carers to inform improvements in the supportive and palliative care of this rapidly growing but currently neglected patient group. DESIGN: Multiperspective, serial interviews. We conducted up to three qualitative in-depth interviews with each patient and lay carer over 12 months and single interviews with case-linked healthcare professionals. Data were analysed using grounded theory techniques. PARTICIPANTS: Patients with advanced liver disease of diverse aetiologies recruited from an inpatient hepatology ward, and their lay carers and case-linked healthcare professionals nominated by the patients. SETTING: Primary and secondary care in South-East Scotland. RESULTS: 37 participants (15 patients, 11 lay and 11 professional carers) completed 51 individual and 13 joint patient-carer interviews. Nine patients died during the study. Uncertainty dominated experiences throughout the course of the illness, across patients' considerable physical, psychological, social and existential needs and affected patients, lay carers and professionals. This related to the nature of the condition, the unpredictability of physical deterioration and prognosis, poor communication and information-sharing, and complexities of care. The pervasive uncertainty also shaped patients' and lay carers' strategies for coping and impeded care planning. While patients' acute medical care was usually well coordinated, their ongoing care lacked structure and focus. CONCLUSIONS: Living, dying and caring in advanced liver disease is dominated by pervasive, enduring and universally shared uncertainty. In the face of high levels of multidimensional patient distress, professionals must acknowledge this uncertainty in constructive ways that value its contribution to the person's coping approach. Pervasive uncertainty makes anticipatory care planning in advanced liver disease challenging, but planning 'just in case' is vital to ensure that patients receive timely and appropriate supportive and palliative care alongside effective management of this unpredictable illness.

Different Experiences and Goals in Different Advanced Diseases: Comparing Serial Interviews With Patients With Cancer, Organ Failure, or Frailty and Their Family and Professional Carers.

CONTEXT: Quality care for people living with life-limiting illnesses is a global priority. A detailed understanding of the varied experiences of people living and dying with different conditions and their family and professional caregivers should help policymakers and clinicians design and deliver more appropriate and person-centered care. OBJECTIVES: To understand how patients with different advanced conditions and their family and professional caregivers perceive their deteriorating health and the services they need. METHODS: We used a narrative framework to synthesize eight methodologically comparable, longitudinal, and multiperspective interview studies. We compared the end-of-life experiences of people dying from cancer (lung, glioma, and colorectal cancer), organ failure (heart failure, chronic obstructive pulmonary disease, and liver failure), and physical frailty and those of their family and professional caregivers in socioeconomically and ethnically diverse populations in Scotland. RESULTS: The data set comprised 828 in-depth interviews with 156 patients, 114 family caregivers, and 170 health professionals. Narratives about cancer typically had a clear beginning, middle, and an anticipated end. Cancer patients gave a well-rehearsed account of their illness, hoping for recovery alongside fear of dying. In contrast, people with organ failure and their family caregivers struggled to pinpoint when their illness began, or to speak openly about death, hoping instead to avoid further deterioration. Frail older people tended to be frustrated by their progressive loss of independence, fearing dementia or nursing home admission more than dying. CONCLUSION: These contrasting illness narratives affect and shape the experiences, thoughts, and fears of patients and their carers in the last months of life. Palliative care offered by generalists or specialists should be provided more flexibly and equitably, responding to the varied concerns and needs of people with different advanced conditions.