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.

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.

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.

Structured lifestyle education to support weight loss for people with schizophrenia, schizoaffective disorder and first episode psychosis: the STEPWISE RCT.

BACKGROUND: Obesity is twice as common in people with schizophrenia as in the general population. The National Institute for Health and Care Excellence guidance recommends that people with psychosis or schizophrenia, especially those taking antipsychotics, be offered a healthy eating and physical activity programme by their mental health care provider. There is insufficient evidence to inform how these lifestyle services should be commissioned. OBJECTIVES: To develop a lifestyle intervention for people with first episode psychosis or schizophrenia and to evaluate its clinical effectiveness, cost-effectiveness, delivery and acceptability. DESIGN: A two-arm, analyst-blind, parallel-group, randomised controlled trial, with a 1 : 1 allocation ratio, using web-based randomisation; a mixed-methods process evaluation, including qualitative case study methods and logic modelling; and a cost-utility analysis. SETTING: Ten community mental health trusts in England. PARTICIPANTS: People with first episode psychosis, schizophrenia or schizoaffective disorder. INTERVENTIONS: Intervention group: (1) four 2.5-hour group-based structured lifestyle self-management education sessions, 1 week apart; (2) multimodal fortnightly support contacts; (3) three 2.5-hour group booster sessions at 3-monthly intervals, post core sessions. Control group: usual care assessed through a longitudinal survey. All participants received standard written lifestyle information. MAIN OUTCOME MEASURES: The primary outcome was change in weight (kg) at 12 months post randomisation. The key secondary outcomes measured at 3 and 12 months included self-reported nutrition (measured with the Dietary Instrument for Nutrition Education questionnaire), objectively measured physical activity measured by accelerometry [GENEActiv (Activinsights, Kimbolton, UK)], biomedical measures, adverse events, patient-reported outcome measures and a health economic assessment. RESULTS: The trial recruited 414 participants (intervention arm: 208 participants; usual care: 206 participants) between 10 March 2015 and 31 March 2016. A total of 341 participants (81.6%) completed the trial. A total of 412 participants were analysed. After 12 months, weight change did not differ between the groups (mean difference 0.0 kg, 95% confidence interval -1.59 to 1.67 kg; p = 0.964); physical activity, dietary intake and biochemical measures were unchanged. Glycated haemoglobin, fasting glucose and lipid profile were unchanged by the intervention. Quality of life, psychiatric symptoms and illness perception did not change during the trial. There were three deaths, but none was related to the intervention. Most adverse events were expected and related to the psychiatric illness. The process evaluation showed that the intervention was acceptable, with participants valuing the opportunity to interact with others facing similar challenges. Session feedback indicated that 87.2% of participants agreed that the sessions had met their needs. Some indicated the desire for more ongoing support. Professionals felt that the intervention was under-resourced and questioned the long-term sustainability within current NHS settings. Professionals would have preferred greater access to participants' behaviour data to tailor the intervention better. The incremental cost-effectiveness ratio from the health-care perspective is £246,921 per quality-adjusted life-year (QALY) gained and the incremental cost-effectiveness ratio from the societal perspective is £367,543 per QALY gained. CONCLUSIONS: Despite the challenges of undertaking clinical research in this population, the trial successfully recruited and retained participants, indicating a high level of interest in weight management interventions; however, the STEPWISE intervention was neither clinically effective nor cost-effective. Further research will be required to define how overweight and obesity in people with schizophrenia should be managed. The trial results suggest that lifestyle programmes for people with schizophrenia may need greater resourcing than for other populations, and interventions that have been shown to be effective in other populations, such as people with diabetes mellitus, are not necessarily effective in people with schizophrenia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN19447796. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 65. See the NIHR Journals Library website for further project information.

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.

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.

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.

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.

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.

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.

Acceptability of Implantable Continuous Glucose Monitoring Sensor.

BACKGROUND: Real-time continuous glucose monitoring is associated with significant benefits for diabetes management. Implantable sensors could overcome some challenges reportedly associated with device visibility, psychosocial functioning and sensor durability. METHODS: A psychosocial assessment was conducted to determine acceptability and impact of an implantable continuous glucose monitoring (CGM) sensor as part of the PRECISE trial. Questionnaires were administered to participants comprising the Diabetes Distress Scale, the CGM impact scale, and bespoke device satisfaction. RESULTS: Fifty-one participants across the United Kingdom (n = 10) and Germany (n = 41) completed the questionnaires. Of these, 90% had T1D, 50% followed an insulin pump therapy regimen, and 45% of the participants were previous CGM users. CGM Impact Scale results show 86% (n = 44) of participants reported feeling better (14% neutral) about their diabetes control with 90% CGM naïve participants and 81% previous CGM users reporting increased confidence about their diabetes management. Furthermore, 73% (n = 37) felt more safe (27% neutral) while sleeping and 78% (n = 39) more confident (22% neutral) about avoiding serious hypoglycemia. Responses correspond with an average improvement in HbA1c from 7.51 to 7.05 ( P < .0001) over the 90 days use of the CGM. Overall, the system was rated highly on ease of use, convenience and comfort. 84% would choose to be inserted again with 93% of CGM naïve participants (86% previous CGM users) reporting minimized burden of diabetes. CONCLUSIONS: Implantable CGM devices are acceptable to users and are evaluated favorably. The considerable majority of participants (93% of first time users and 77% previous CGM users) would like to continue using the system to help manage their diabetes more effectively.

What End Users and Stakeholders Want From Automated Insulin Delivery Systems.

OBJECTIVE: The purpose of this study was to rigorously explore psychosocial factors associated with automated insulin delivery systems among people living with type 1 diabetes. RESEARCH DESIGN AND METHODS: Across four sites in the U.S. and U.K., 284 participants completed structured interviews or focus groups on expectations, desired features, potential benefits, and perceived burdens of automated insulin delivery systems. Recorded audio files were transcribed and analyzed using NVivo. RESULTS: Three themes were identified as critical for uptake of automated insulin delivery: considerations of trust and control, system features, and concerns and barriers to adoption. Children and adolescents with type 1 diabetes primarily identified needs specific to their life stage and social contexts (e.g., school). Adults with type 1 diabetes, parents of youth with type 1 diabetes, and partners of adults with type 1 diabetes were most concerned about the accuracy, adaptability, and algorithm quality alongside expectations that systems stabilize glucose levels and reduce risk for long-term complications. CONCLUSIONS: Incorporating stakeholder perspectives on use of automated insulin delivery systems will improve the adoption of devices, quality of life, and likelihood of optimal health. Efforts to build trust in systems, optimize user-system interactions, and provide clear guidance about device capabilities and limitations may help potential users achieve optimal glycemic outcomes.

Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting.

Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have been available since around the year 2000 and used primarily in people with type 1 diabetes. In contrast to self-measured glucose, CGM can provide continuous real-time measurement of glucose levels, alerts for hypoglycemia and hyperglycemia, and a detailed assessment of glycemic variability. Through a broad spectrum of derived glucose data, CGM should be a useful tool for clinical evaluation of new glucose-lowering medications and strategies. It is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Other advantages of current CGM systems include the opportunity for improved self-management of glycemic control, with particular relevance to those at higher risk of or from hypoglycemia. We therefore summarize the current status and limitations of CGM from the perspective of clinical trials and derive suggested recommendations for how these should facilitate optimal CGM use and reporting of data in clinical research.

A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial.

BACKGROUND: Insulin is generally administered to people with type 1 diabetes mellitus (T1DM) using multiple daily injections (MDIs), but can also be delivered using infusion pumps. In the UK, pumps are recommended for patients with the greatest need and adult use is less than in comparable countries. Previous trials have been small, of short duration and have failed to control for training in insulin adjustment. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy. DESIGN: Pragmatic, multicentre, open-label, parallel-group cluster randomised controlled trial, including economic and psychosocial evaluations. After participants were assigned a group training course, courses were randomly allocated in pairs to either pump or MDI. SETTING: Eight secondary care diabetes centres in the UK. PARTICIPANTS: Adults with T1DM for > 12 months, willing to undertake intensive insulin therapy, with no preference for pump or MDI, or a clinical indication for pumps. INTERVENTIONS: Pump or MDI structured training in flexible insulin therapy, followed up for 2 years. MDI participants used insulin analogues. Pump participants used a Medtronic Paradigm® VeoTM (Medtronic, Watford, UK) with insulin aspart (NovoRapid, Novo Nordisk, Gatwick, UK). MAIN OUTCOME MEASURES: Primary outcome - change in glycated haemoglobin (HbA1c) at 2 years in participants whose baseline HbA1c was ≥ 7.5% (58 mmol/mol). Key secondary outcome - proportion of participants with HbA1c ≤ 7.5% at 2 years. Other outcomes at 6, 12 and 24 months - moderate and severe hypoglycaemia; insulin dose; body weight; proteinuria; diabetic ketoacidosis; quality of life (QoL); fear of hypoglycaemia; treatment satisfaction; emotional well-being; qualitative interviews with participants and staff (2 weeks), and participants (6 months); and ICERs in trial and modelled estimates of cost-effectiveness. RESULTS: We randomised 46 courses comprising 317 participants: 267 attended a Dose Adjustment For Normal Eating course (132 pump; 135 MDI); 260 were included in the intention-to-treat analysis, of which 235 (119 pump; 116 MDI) had baseline HbA1c of ≥ 7.5%. HbA1c and severe hypoglycaemia improved in both groups. The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI. The mean difference (MD) in HbA1c change at 2 years, at which the baseline HbA1c was ≥ 7.5%, was -0.24% [95% confidence interval (CI) -0.53% to 0.05%] in favour of the pump (p = 0.098). The per-protocol analysis showed a MD in change of -0.36% (95% CI -0.64% to -0.07%) favouring pumps (p = 0.015). Pumps were not cost-effective in the base case and all of the sensitivity analyses. The pump group had greater improvement in diabetes-specific QoL diet restrictions, daily hassle plus treatment satisfaction, statistically significant at 12 and 24 months and supported by qualitative interviews. LIMITATION: Blinding of pump therapy was not possible, although an objective primary outcome was used. CONCLUSION: Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM. RESEARCH PRIORITY: To understand why few patients achieve a HbA1c of < 7.5%, particularly as glycaemic control is worse in the UK than in other European countries. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61215213. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 20. See the NIHR Journals Library website for further project information.