Cost considerations for adoption of diabetes technology are pervasive: A qualitative study of persons living with type 1 diabetes and their families.

BACKGROUND: Cost is a major consideration in the uptake and continued use of diabetes technology. With increasing use of automated insulin delivery systems, it is important to understand the specific cost-related barriers to technology adoption. In this qualitative analysis, we were interested in understanding and examining the decision-making process around cost and diabetes technology use. MATERIALS AND METHODS: Four raters coded transcripts of four stakeholder groups using inductive coding for each stakeholder group to establish relevant themes/nodes. We applied the Social Ecological Model in the interpretation of five thematic levels of cost. RESULTS: We identified five thematic levels of cost: policy, organizational, insurance, interpersonal and individual. Equitable diabetes technology access was an important policy-level theme. The insurance-level theme had multiple subthemes which predominantly carried a negative valence. Participants also emphasized the psychosocial burden of cost specifically identifying diabetes costs to their families, the guilt of diabetes related costs, and frustration in the time and involvement required to ensure insurance coverage. CONCLUSION: We found broad consensus in how cost is experienced by stakeholder groups. Cost considerations for diabetes technology uptake extended beyond finances to include time, cost to society, morality and interpersonal relationships. Cost also reflected an important moral principle tied to the shared desire for equitable access to diabetes technology. Knowledge of these considerations can help clinicians and researchers promote equitable device uptake while anticipating barriers for all persons living with type 1 diabetes and their families.

Structured lifestyle education for people with schizophrenia, schizoaffective disorder and first-episode psychosis (STEPWISE): randomised controlled trial.

BACKGROUND: Obesity is a major challenge for people with schizophrenia.AimsWe assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia. METHOD: In this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included. RESULTS: Between 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI -1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained. CONCLUSIONS: Participants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia.Declaration of interestR.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

Barriers and facilitators to taking on diabetes self-management tasks in pre-adolescent children with type 1 diabetes: a qualitative study.

BACKGROUND: When children with type 1 diabetes approach adolescence, they are encouraged to become more involved in diabetes self-management. This study explored the challenges pre-adolescent children encounter when self-managing diabetes and the factors which motivate and enable them to take on new diabetes-related tasks. A key objective was to inform the support offered to pre-adolescent children. METHODS: In-depth interviews using age-appropriate questioning with 24 children (aged 9-12 years) with type 1 diabetes. Data were analysed using an inductive, thematic approach. RESULTS: Children reported several barriers to taking on self-management tasks. As well as seeking respite from managing diabetes, children described relying on their parents to: perform the complex maths involved in working out carbohydrate content in food; calculate insulin doses if they did not use a bolus advisor; and administer injections or insert a cannula in hard-to-reach locations. Children described being motivated to take on diabetes tasks in order to: minimise the pain experienced when others administered injections; alleviate the burden on their parents; and participate independently in activities with their peers. Several also discussed being motivated to take on diabetes-management responsibilities when they started secondary school. Children described being enabled to take on new responsibilities by using strategies which limited the need to perform complex maths. These included using labels on food packaging to determine carbohydrate contents, or choosing foods with carbohydrate values they could remember. Many children discussed using bolus advisors with pre-programmed ratios and entering carbohydrate on food labels or values provided by their parents to calculate insulin doses. Several also described using mobile phones to seek advice about carbohydrate contents in food. CONCLUSIONS: Our findings highlight several barriers which deter children from taking on diabetes self-management tasks, motivators which encourage them to take on new responsibilities, and strategies and technologies which enable them to become more autonomous. To limit the need to perform complex maths, children may benefit from using bolus advisors provided they receive regular review from healthcare professionals to determine and adjust pre-programmed insulin-to-carbohydrate ratios. Education and support should be age-specific to reflect children's changing involvement in self-managing diabetes.

Pre-adolescent children's experiences of receiving diabetes-related support from friends and peers: A qualitative study.

BACKGROUND: While pre-adolescent children with type 1 diabetes receive most support from their parents/caregivers, others also contribute to their care. This study explored pre-adolescent children's experiences of receiving diabetes-related support from friends and peers. The objective was to identify how children could be better supported by their friends and peers to undertake diabetes self-management. METHODS: In-depth interviews with 24 children (aged 9-12 years) with type 1 diabetes. Data were analysed using an inductive, thematic approach. RESULTS: Children gave mixed accounts of their experiences of speaking to their school/class about diabetes with some indicating that this had resulted in unwanted attention. Most individuals reported that other children had a limited understanding of diabetes and sometimes acted in insensitive ways or said things they found upsetting. Virtually all children described having a small number of close friends who were interested in learning about diabetes and provided them with support. These friends provided support in three overlapping ways, as "monitors and prompters," "helpers" and "normalizers." While some children described benefiting from meeting peers with type 1 diabetes, most indicated that they would prefer to develop friendships based on shared interests rather than a common disease status. DISCUSSION AND CONCLUSIONS: Friends and peers provide several kinds of support to pre-adolescent children with diabetes. Health professionals could consider ways to assist small friendship groups to undertake monitoring and prompting, helping and normalizing roles. Parents, schools and health professionals could explore ways to normalize self-management practices to better support children with diabetes in school settings.

Unsupervised overnight closed loop insulin delivery during free living: analysis of randomised cross-over home studies in adults and adolescents with type 1 diabetes.

BACKGROUND: The closed-loop system (artificial pancreas) delivers insulin in a glucose-responsive manner by the use of a control algorithm that automatically directs insulin delivery, based on real-time sensor glucose concentrations. Results from hospital-based studies have shown improved overnight glucose control and reduced risk of hypoglycaemia in type 1 diabetes. We aimed to assess whether unsupervised closed-loop systems can provide a realistic treatment option in patients with type 1 diabetes. METHODS: We combined data from two open-label, phase 2, randomised, cross-over, unsupervised home trials of people with type 1 diabetes, one in 24 adults (mean age 43 years [SD 12], HbA1c 8·0% [0·9]) and the other in 16 adolescents (15·6 [3·6], 8·1 [0·8]). In each trial, after training on study devices, participants were allocated to two periods of sensor-augmented pump therapy either with or without overnight closed loop that used a model predictive control algorithm to direct insulin delivery. Allocation sequence was done with a computer-generated random code. Each period lasted 4 weeks in adults and 3 weeks in adolescents. Primary outcome for both trials was time when sensor glucose was in the target range (3·9-8·0 mmol/L). Analysis was by intention to treat. Participants (or parents) gave written informed consent. The trials are registered with ClinicalTrials.gov, numbers NCT01440140 and NCT01221467. FINDINGS: Closed loop was started by participants on their own volition on 866 (89%) of 978 nights. The proportion of time when sensor glucose was in the target range between 0000 h and 0800 h was increased by a mean of 18·4% (95% CI 13·5-23·4, p<0·0001) during closed loop compared with no closed loop. Closed loop significantly reduced mean overnight sensor glucose by 0·9 mmol/L (95% CI 0·4-1·3, p=0·0001), and reduced the proportion of time when sensor glucose values were suggestive of hyperglycaemia (>8·0 mmol/L) (15·9%, 10·7-21·0; p<0·0001) and hypoglycaemia (<3·9 mmol/L) (median 0·9, IQR 0·2-2·2; p=0·014). Lower mean overnight glucose was associated with increased overnight insulin delivery (p<0·0001) without changing total daily insulin amount (p=0·84). INTERPRETATION: Extended use of overnight closed loop at home without supervision is feasible in adults and adolescents with type 1 diabetes. Clinically significant reduction in overnight glucose was observed accompanied by reduced time spent by patients in hypoglycaemia. To our knowledge, such combined effect has not been documented with any other means of intensified conventional insulin delivery. Longer term studies are warranted to assess its clinical potential. FUNDING: Diabetes UK, Juvenile Diabetes Research Foundation, NIHR Cambridge Biomedical Research Centre.

Parents' information and support needs when their child is diagnosed with type 1 diabetes: a qualitative study.

AIM AND OBJECTIVE: The aim of this study was to describe and explore parents' information and support needs when their child is diagnosed with type 1 diabetes, including their views about the timing and chronology of current support provision. Our objective was to identify ways in which parents could be better supported in the future. DESIGN AND PARTICIPANTS: Semi-structured interviews were conducted with 54 parents of children with type 1 diabetes in four paediatric diabetes clinics in Scotland. Data were analysed using an inductive, thematic approach. FINDINGS: Parents described needing more reassurance after their child was diagnosed before being given complex information about diabetes management, so they would be better placed psychologically and emotionally to absorb this information. Parents also highlighted a need for more emotional and practical support from health professionals when they first began to implement diabetes regimens at home, tailored to their personal and domestic circumstances. However, some felt unable to ask for help or believed that health professionals were unable to offer empathetic support. Whilst some parents highlighted a need for support delivered by peer parents, others who had received peer support conveyed ambivalent views about the input and advice they had received. CONCLUSIONS: Our findings suggest that professionals should consider the timing and chronology of support provision to ensure that parents' emotional and informational needs are addressed when their child is diagnosed and that practical advice and further emotional support are provided thereafter, which takes account of their day-to-day experiences of caring for their child.

Pathways to diagnosis: a qualitative study of the experiences and emotional reactions of parents of children diagnosed with type 1 diabetes.

OBJECTIVE: The aim of this study was to explore from parents' perspectives the circumstances and events which led to their child being diagnosed with type 1 diabetes (T1D). The objective was to understand reasons for delays in seeking treatment and parents' emotional reactions to diagnosis so others can be better informed and supported in future. METHODS: In-depth interviews with 54 parents of children (aged ≤12 yr) with T1D were conducted. Data analysis used an inductive, thematic approach. RESULTS: Parents described a 'prompt' and a 'delayed' pathway to their child being diagnosed. Parents who considered the diagnosis to be 'prompt' reported how they, or other people, had recognized their child had developed symptoms of T1D which resulted in a rapid presentation to health care professionals. In contrast, parents who perceived their child's diagnosis to be 'delayed' did not recognize signs of T1D and attributed their child's deteriorating health to other conditions, being out of routines and/or their stage of development. These parents often only sought medical help when symptoms became extreme. All parents were distressed by their child's diagnosis; however, parents in the 'delayed' pathway expressed unresolved feelings of guilt, particularly when their child was diagnosed with diabetic ketoacidosis. DISCUSSION: Parents' and other people's knowledge about T1D can affect the duration between onset of their child's symptoms and diagnosis. Campaigns to raise awareness should ensure that parents are made aware of symptoms and that T1D can develop during childhood. Health care professionals could discuss with parents the events preceding their child's diagnosis to better determine their emotional support needs.

Storylines of family medicine VII: family medicine across the lifespan.

Storylines of Family Medicine is a 12-part series of thematically linked mini-essays with accompanying illustrations that explore the many dimensions of family medicine as interpreted by individual family physicians and medical educators in the USA and elsewhere around the world. In 'VII: family medicine across the lifespan', authors address the following themes: 'Family medicine maternity care', 'Seeing children as patients brings joy to work', 'Family medicine and the care of adolescents', 'Reproductive healthcare across the lifespan', 'Men's health', 'Care of older adults', and 'Being with dying'. May readers appreciate the range of family medicine in these essays.

Automated bolus advisor control and usability study (ABACUS): does use of an insulin bolus advisor improve glycaemic control in patients failing multiple daily insulin injection (MDI) therapy? [NCT01460446].

BACKGROUND: People with T1DM and insulin-treated T2DM often do not follow and/or adjust their insulin regimens as needed. Key contributors to treatment non-adherence are fear of hypoglycaemia, difficulty and lack of self-efficacy associated with insulin dose determination. Because manual calculation of insulin boluses is both complex and time consuming, people may rely on empirical estimates, which can result in persistent hypoglycaemia and/or hyperglycaemia. Use of automated bolus advisors (BA) has been shown to help insulin pump users to more accurately meet prandial insulin dosage requirements, improve postprandial glycaemic excursions, and achieve optimal glycaemic control with an increased time within optimal range. Use of a BA containing an early algorithm based on sliding scales for insulin dosing has also been shown to improve HbA1c levels in people treated with multiple daily insulin injections (MDI). We designed a study to determine if use of an automated BA can improve clinical and psychosocial outcomes in people treated with MDI. METHODS/DESIGN: The Automated Bolus Advisor Control and Usability Study (ABACUS) is a 6-month, prospective, randomised, multi-centre, multi-national trial to determine if automated BA use improves glycaemic control as measured by a change in HbA1c in people using MDI with elevated HbA1c levels (#62;7.5%). A total of 226 T1DM and T2DM participants will be recruited. Anticipated attrition of 20% will yield a sample size of 90 participants, which will provide #62;80% power to detect a mean difference of 0.5%, with SD of 0.9%, using a one-sided 5% t-test, with 5% significance level. Other measures of glycaemic control, self-care behaviours and psychosocial issues will also be assessed. DISCUSSION: It is critical that healthcare providers utilise available technologies that both facilitate effective glucose management and address concerns about safety and lifestyle. Automated BAs may help people using MDI to manage their diabetes more effectively and minimise the risk of long-term diabetes related complications. Findings from a recent study suggest that BA use positively addresses both safety and lifestyle concerns; however, randomised trials are needed to confirm these perceptions and determine whether bolus advisor use improves clinical outcomes. Our study is designed to make these assessments. TRIAL REGISTRATION: NCT01460446.

RESCUE Collaborative Community: A New Initiative to Reduce Rates of Intended Self-Injury and Suicide Among People with Diabetes.

Suicide is the leading cause of death among young people aged 20-34 and the second leading cause of death in adolescents aged 15-19. In the general population, among those attempting suicide 7% die by suicide and 23% reattempt with nonfatal consequences. Depression, closely associated with suicidal ideation, is diagnosed in 7%-25% of the United States and European populations. Individuals with type 1 diabetes (T1D) have a two to three times higher prevalence of depression and approximately double the rate of suicide compared to the general population. Rates of self-harm and suicide among people with diabetes are likely to be considerably underestimated due to poor identification. This information is critical to create interventions to decrease rates of suicide and self-harm. This is particularly important in the setting of advanced technologies in T1D, which offer both easier methods of self-injurious behaviors through insulin misuse and can act as identification tools to identify risk insulin behaviors and provide opportunities to develop interventions and prevention efforts in those with depression and suicidal ideation/behavior/acts. To this end, our goal was to identify any literature on coding diabetes correctly in individuals who die by suicide or engage in intentional self-harm. Furthermore, to describe the Reducing Suicide Rates Among Individuals with Diabetes (RESCUE) Collaborative Community and its goals of using multiple approaches to reduce rates of intended self-injury and suicide among people with diabetes. These include detection of cases, understanding support needs, identification of risk factors, and early intervention for individuals at risk.

Developing a matrix to identify and prioritise research recommendations in HIV prevention.

BACKGROUND: HIV prevention continues to be problematic in the UK, as it does globally. The UK Department of Health has a strategic direction with greater focus on prevention as part of its World Class Commissioning Programme. There is a need for targeted evidence-based prevention initiatives. This is an exploratory study to develop an evidence mapping tool in the form of a matrix: this will be used to identify important gaps in contemporary HIV prevention evidence relevant to the UK. It has the potential to aid prioritisation in future research. METHODS: Categories for prevention and risk groups were developed for HIV prevention in consultation with external experts. These were used as axes on a matrix tool to map evidence. Systematic searches for publications on HIV prevention were undertaken using electronic databases for primary and secondary research undertaken mainly in UK, USA, Canada, Australia and New Zealand, 2006-9. Each publication was screened for inclusion then coded. The risk groups and prevention areas in each paper were counted: several publications addressed multiple risk groups. The counts were exported to the matrix and clearly illustrate the concentrations and gaps of literature in HIV prevention. RESULTS: 716 systematic reviews, randomised control trials and other primary research met the inclusion criteria for HIV prevention. The matrix identified several under researched areas in HIV prevention. CONCLUSIONS: This is the first categorisation system for HIV prevention and the matrix is a novel tool for evidence mapping. Some important yet under-researched areas have been identified in HIV prevention evidence: identifying the undiagnosed population; international adaptation; education; intervention combinations; transgender; sex-workers; heterosexuals and older age groups.

A systematic review of models to predict recruitment to multicentre clinical trials.

BACKGROUND: Less than one third of publicly funded trials managed to recruit according to their original plan often resulting in request for additional funding and/or time extensions. The aim was to identify models which might be useful to a major public funder of randomised controlled trials when estimating likely time requirements for recruiting trial participants. The requirements of a useful model were identified as usability, based on experience, able to reflect time trends, accounting for centre recruitment and contribution to a commissioning decision. METHODS: A systematic review of English language articles using MEDLINE and EMBASE. Search terms included: randomised controlled trial, patient, accrual, predict, enroll, models, statistical; Bayes Theorem; Decision Theory; Monte Carlo Method and Poisson. Only studies discussing prediction of recruitment to trials using a modelling approach were included. Information was extracted from articles by one author, and checked by a second, using a pre-defined form. RESULTS: Out of 326 identified abstracts, only 8 met all the inclusion criteria. Of these 8 studies examined, there are five major classes of model discussed: the unconditional model, the conditional model, the Poisson model, Bayesian models and Monte Carlo simulation of Markov models. None of these meet all the pre-identified needs of the funder. CONCLUSIONS: To meet the needs of a number of research programmes, a new model is required as a matter of importance. Any model chosen should be validated against both retrospective and prospective data, to ensure the predictions it gives are superior to those currently used.

Fear of hypoglycaemia in parents of young children with type 1 diabetes: a systematic review.

BACKGROUND: Many children with type 1 diabetes have poor glycaemic control. Since the Diabetes Control and Complications Trial (DCCT) showed that tighter control reduces complication rates, there has been more emphasis on intensified insulin therapy. We know that patients and families are afraid of hypoglycaemia. We hypothesised that fear of hypoglycaemia might take precedence over concern about long-term complications, and that behaviour to avoid hypoglycaemia might be at the cost of poorer control, and aimed to evaluate the effectiveness of any interventions designed to prevent that. The objective of this review was to systematically review studies concerning the extent and consequences of fear of hypoglycaemia in parents of children under 12 years of age with type 1 diabetes, and interventions to reduce it. DATA SOURCES: MEDLINE, EMBASE, PsycINFO, The Cochrane Library, Web of Science, meeting abstracts of EASD, ADA and Diabetes UK, Current Controlled Trials, ClinicalTrials.gov, UK CRN, scrutiny of bibliographies of retrieved papers and contact with experts in the field.Inclusions: Relevant studies of any design of parents of children under 12 years of age with Type 1 diabetes were included. The key outcomes were the extent and impact of fear, hypoglycaemia avoidance behaviour in parents due to parental fear of hypoglycaemia in their children, the effect on diabetes control, and the impact of interventions to reduce this fear and hypoglycaemia avoidance behaviour. RESULTS: Eight articles from six studies met the inclusion criteria. All were cross sectional studies and most were of good quality. Parental fear of hypoglycaemia, anxiety and depression were reported to be common. There was a paucity of evidence on behaviour to avoid hypoglycaemia, but there were some suggestions that higher than desirable blood glucose levels might be permitted in order to avoid hypoglycaemia. No studies reporting interventions to reduce parental fear of hypoglycaemia were found. CONCLUSIONS: The evidence base was limited. Parents of children with Type 1 diabetes reported considerable parental fear of hypoglycaemia, affecting both parental health and quality of life. There is some suggestion that hypoglycaemia avoidance behaviours by parents might adversely affect glycaemic control. Trials of interventions to reduce parental anxiety and hypoglycaemia avoidance behaviour are needed. We suggest that there should be a trial of structured education for parents of young children with Type 1 diabetes.

Diabetes Technological Revolution: Winners and Losers?

Over recent years there has been an explosion in availability of technical devices to support diabetes self-management. But with this technology revolution comes new hurdles. On paper, the available diabetes technologies should mean that the vast majority of people with type 1 diabetes have optimal glycemic control and are using their preferred therapy choices. Yet, it does not appear to be universally the case. In parallel, suboptimal glycemic control remains stubbornly widespread. Barriers to improvement include access to technology, access to expert diabetes health care professionals, and prohibitive insurance costs. Until access can be improved to ensure the technologies are available and usable by those that need them, there are many people with diabetes who are still losing out.

COPD patient education and support - Achieving patient-centredness.

BACKGROUND: The art of medicine is undergoing a dramatic shift in focus, evolving to focus on patient involvement as partners in care, transforming the traditional, prescriptive, reactive practice of healthcare into a proactive discipline. The personal and societal burden of chronic diseases is burgeoning and unsustainable in current systems, novel approaches are required to address this. DISCUSSION: Although considerable progress has been made in the development of diagnostics, therapeutics and care guidelines for patients with chronic obstructive pulmonary disease (COPD), questions remain surrounding the implementation of best practice education and support. Current educational programmes, personal limitations and preferences and patient-clinician communication in modification of coping styles and behaviour are discussed. A novel holistic model, the Kaleidoscope Model of Care is proposed to address the barriers to optimal self-care behaviours. CONCLUSION AND PRACTICE IMPLICATIONS: Holistic approaches are essential for optimal self-management and improved outcomes. Guidance on personalised goals for patients to help meeting their therapy priorities is needed to aid healthcare professionals (HCPs) and funders to minimise healthcare burden and costs. The novel KALMOD approach may optimise patient empowerment, exploring whole-life factors that impact COPD care and improve interactions between patients and HCPs for optimised outcomes.

Effect of predicted low suspend pump treatment on improving glycaemic control and quality of sleep in children with type 1 diabetes and their caregivers: the QUEST randomized crossover study.

BACKGROUND: In attempting to achieve optimal metabolic control, the day-to-day management is challenging for a child with type 1 diabetes (T1D) and his family and can have a major negative impact on their quality of life. Augmenting an insulin pump with glucose sensor information leads to improved outcomes: decreased haemoglobin A1c levels, increased time in glucose target and less hypoglycaemia. Fear of nocturnal hypoglycaemia remains pervasive amongst parents, leading to chronic sleep interruption and lack of sleep for the parents and their children. The QUEST study, an open-label, single-centre randomized crossover study, aims to evaluate the impact on time in target, in hypoglycaemia and hyperglycaemia and the effect on sleep and quality of life in children with T1D, comparing a sensor-augmented pump (SAP) with predictive low glucose suspend and alerts to the use of the same insulin pump with a flash glucose measurement (FGM) device not interacting with the pump. METHODS/DESIGN: Subjects meeting the inclusion criteria are randomized to treatment with the SAP or treatment with an insulin pump and independent FGM for 5 weeks. Following a 3-week washout period, the subjects cross over to the other study arm for 5 weeks. During the week before and in the last week of treatment, the subjects and one of their caregivers wear a sleep monitor in order to obtain sleep data. The primary endpoint is the between-arm difference in percentage of time in glucose target during the final 6 days of each treatment arm, measured by a blinded continuous glucose measurement (CGM). Additional endpoints include comparison of quantity and quality of sleep as well as quality of life perception of the subjects and one of their caregivers in the two different treatment arms. Recruitment started in February 2017. A total of 36 patients are planned to be randomized. The study recruitment was completed in April 2018. DISCUSSION: With this study we will provide more information on whether insulin pump treatment combined with more technology (SmartGuard® feature and alerts) leads to better metabolic control. The inclusion of indicators on quality of sleep with less sleep interruption, less lack of sleep and perception of quality of life in both children and their primary caregivers is essential for this study and might help to guide us to further treatment improvement. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03103867 . Registered on 6 April 2017.

Day-and-Night Closed-Loop Insulin Delivery in a Broad Population of Pregnant Women With Type 1 Diabetes: A Randomized Controlled Crossover Trial.

OBJECTIVE: Despite advances in technology, optimal glucose control remains elusive and neonatal complications remain ubiquitous in type 1 diabetes (T1D) pregnancy. Our aim was to examine the safety, efficacy, and longer-term feasibility of day-and-night closed-loop insulin delivery. RESEARCH DESIGN AND METHODS: We recruited 16 pregnant women (mean [SD]: age 32.8 [5.0] years, T1D duration 19.4 [10.2] years, HbA1c 8.0% [1.1], and BMI 26.6 [4.4] kg/m2) to an open-label, randomized, crossover trial. Participants completed 28 days of closed-loop and sensor-augmented pump (SAP) insulin delivery separated by a washout period. Afterward, participants could continue to use the closed-loop system up to 6 weeks postpartum. The primary end point was the proportion of time with glucose levels within the target range (63-140 mg/dL). RESULTS: The proportion of time with glucose levels within target was comparable during closed-loop and SAP insulin delivery (62.3 vs. 60.1% [95% CI -4.1 to 8.3]; P = 0.47). Mean glucose and time spent hyperglycemic >140 mg/dL also did not differ (131.4 vs. 131.4 mg/dL [P = 0.85] and 36.6 vs. 36.1% [P = 0.86], respectively). During closed-loop, fewer hypoglycemic episodes occurred (median 8 [range 1-17] vs. 12.5 [1-53] over 28 days; P = 0.04) and less time at <63 mg/dL (1.6 vs. 2.7%; P = 0.02). Hypoglycemia <50 mg/dL (0.24 vs. 0.47%; P = 0.03) and low blood glucose index (1.0 vs. 1.4; P = 0.01) were lower. Less nocturnal hypoglycemia (2300-0700 h) during closed-loop therapy (1.1 vs. 2.7%; P = 0.008) and a trend toward higher overnight time in target (67.7 vs. 60.6%; P = 0.06) were found. CONCLUSIONS: Closed-loop insulin delivery was associated with comparable glucose control and significantly less hypoglycemia than SAP therapy. Larger, longer-duration multicenter trials are now indicated to determine clinical efficacy of closed-loop insulin delivery in T1D pregnancy and the impact on neonatal outcomes.

Automated Insulin Delivery Systems: Hopes and Expectations of Family Members.

BACKGROUND: This study examines the hopes and expectations that children, adolescents, and adults with type 1 diabetes and their families have for new automated insulin delivery systems. The study also aims to examine how the automated insulin delivery system may impact family functioning and individual members' psychosocial adjustment. METHODS: Forty-eight semistructured focus groups (n = 195) and 89 individual interviews were conducted with children, adolescents, and adults with type 1 diabetes and parents and partners. Coders reviewed results in key themes most likely to contain references to the family system. Clusters were analyzed using thematic analysis to identify participants' salient hopes and expectations of how new technology may impact family relationships and individual psychosocial functioning. RESULTS: Three main themes emerged for participants' hopes and expectations for implementation of the automated insulin delivery system. First, there is an expectation that this diabetes technology will alleviate diabetes-specific worry and burden for the people with diabetes and other family members. Second, there is also hope that this system may reduce day-to-day stress and, third, improve family relationships. CONCLUSIONS: The unique perspective of a broad age group provides insight into how individuals and families creatively address the multiple tasks required in daily diabetes management. Study findings elucidate the very high hopes and expectations held by those managing type 1 diabetes and the impact this new technology may have on family relationships. Awareness of these hopes and expectations is important for developers and clinicians in addressing potential challenges to uptake and to ensure that expectations are set appropriately.