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Background With the rapid development of technologies for type 1 diabetes, economic evaluations are integral in guiding cost-effective clinical and policy decisions. We therefore aimed to review and synthesise the current economic literature for available diabetes management technologies and outline key determinants of cost-effectiveness. Methods A systematic search was conducted in April 2019 that focused on modelling or trial based economic evaluations. Searched databases included Medline, Medline in-process and other non-indexed citations, EMBASE, PubMed, All Evidenced Based Medicine Reviews, EconLit, Cost-effectiveness analysis Registry, Research Papers in Economics, Web of Science, PsycInfo, CINAHL, and PROSPERO from inception. We assessed quality of included studies with the Questionnaire to Assess Relevance and Credibility of Modeling Studies for Informing Health Care Decision Making an ISPOR-AMCP-NPC good practice task force report. Screening of abstracts and full-texts, appraisal, and extraction were performed by two independent researches. Results We identified 16,772 publications, of which 35 were analysed and included 11 health technologies. Despite a lack of consensus, most studies reported that insulin pumps (56%) or interstitial glucose sensors (62%) were cost-effective, although incremental cost-effectiveness ratios ranged widely ($14,266–$2,997,832 USD). Cost-effectiveness for combined insulin pumps and glucose sensors was less clear. Determinants of cost-effectiveness included treatment effects on glycosylated haemoglobin and hypoglycaemia, costing of technologies and complications, and measures of utility. Conclusions Insulin pumps or glucose sensors appeared cost-effective, particularly in populations with higher HbA1c levels and rates of hypoglycaemia. However, cost-effectiveness for combined insulin pumps and glucose sensors was less clear. Registration The study was registered with PROSPERO, number CRD42017077221.

People living with diabetes and chronic kidney disease (CKD) experience compromised quality of life. Consequently, it is critical to identify and understand factors influencing their health-related quality of life (HRQoL). This study examined factors associated with HRQoL among patients with diabetes and CKD. A cross sectional study among adults with comorbid diabetes and CKD (eGFR <60 mL/min/1.73m2) recruited from renal and diabetes clinics of four large tertiary referral hospitals in Australia was performed. Each participant completed the Kidney Disease Quality of Life (KDQoL ™ -36) questionnaire, which is comprised of two composite measures of physical and mental health and 3 kidney disease specific subscales with possible scores ranging from 0 to 100 with higher values indicating better HRQoL. Demographic and clinical data were also collected. Regression analyses were performed to determine the relationship between HRQoL and potential predictor factors. A total of 308 patients were studied with a mean age of 66.9 (SD = 11.0) years and 70% were males. Mean scores for the physical composite summary, mental composite summary, symptom/problem list, effects of kidney disease and burden of kidney disease scales were 35.2, 47.0, 73.8, 72.5 and 59.8 respectively. Younger age was associated with lower scores in all subscales except for the physical composite summary. Female gender, obese or normal weight rather than overweight, and smoking were all associated with lower scores in one or more subscales. Scores were progressively lower with more advanced stage of CKD (p<0.05) in all subscales except for the mental composite summary. In patients with diabetes and CKD, younger age was associated with lower scores in all HRQoL subscales except the physical composite summary and female gender, obese or normal weight and more advanced stages of CKD were associated with lower scores in one or more subscales. Identifying these factors will inform the timely implementation of interventions to improve the quality of life of these patients.

Background Maternal obesity is associated with health risks for women and their babies and is exacerbated by excess gestational weight gain. The aim of this study was to describe women’s experiences and perspectives in attending a Healthy Pregnancy Service designed to optimise healthy lifestyle and support recommended gestational weight gain for women with obesity. Methods An explanatory sequential mixed methods study design utilised two questionnaires (completed in early and late pregnancy) to quantify feelings, motivation and satisfaction with the service, followed by semi-structured interviews that explored barriers and enablers of behaviour change. Data were analysed separately and then interpreted together. Results Overall, 49 women attending the service completed either questionnaire 1, 2 or both and were included in the analysis. Fourteen women were interviewed. Prior to pregnancy, many women had gained weight and attempted to lose weight independently, and reported they were highly motivated to achieve a healthy lifestyle. During pregnancy, diet changes were reported as easier to make and sustain than exercise changes. Satisfaction with the service was high. Key factors identified in qualitative analysis were: service support enabled change; motivation to change behaviour, social support, barriers to making change (intrinsic, extrinsic and clinic-related), post-partum lifestyle and needs. On integration of data, qualitative and quantitative findings aligned. Conclusions The Healthy Pregnancy service was valued by women. Barriers and enablers to the delivery of an integrated model of maternity care that supported healthy lifestyle and recommended gestational weight gain were identified. These findings have informed and improved implementation and further scale up of this successful service model, integrating healthy lifestyle into routine antenatal care of women with obesity. Trial registration This trial is registered with the Australian New Zealand Clinical Trials Registry (no.12620000985987). Registration date 30/09/2020, retrospectively registered. http://www.anzctr.org.au/

Multi-morbidity due to diabetes and chronic kidney disease (CKD) remains challenging for current health-systems, which focus on single diseases. As a first step toward health-care improvement, we explored the perspectives of patients and their carers on factors influencing the health-care of those with co-morbid diabetes and CKD. In this qualitative study participants with co-morbid diabetes and CKD were purposively recruited using maximal variation sampling from 4 major tertiary health-services from 2 of Australia's largest cities. Separate focus groups were conducted for patients with CKD stages 3, 4 and 5. Findings were triangulated with semi-structured interviews of carers of patients. Discussions were transcribed verbatim and thematically analysed. Twelve focus groups with 58 participants and 8 semi-structured interviews of carers were conducted. Factors influencing health-care of co-morbid diabetes and CKD grouped into patient and health service level factors. Key patient level factors identified were patient self-management, socio-economic situation, and adverse experiences related to co-morbid diabetes and CKD and its treatment. Key health service level factors were prevention and awareness of co-morbid diabetes and CKD, poor continuity and coordination of care, patient and carer empowerment, access and poor recognition of psychological co-morbidity. Health-service level factors varied according to CKD stage with poor continuity and coordination of care and patient and carer empowerment emphasized by participants with CKD stage 4 and 5, and access and poor recognition of psychological co-morbidity emphasised by participants with CKD stage 5 and carers. According to patients and their carers the health-care of co-morbid diabetes and CKD may be improved via a preventive, patient-centred health-care model which promotes self-management and that has good access, continuity and coordination of care and identifies and manages psychological morbidity.

Background Self-management support interventions may potentially delay kidney function decline and associated complications in patients with comorbid diabetes and chronic kidney disease. However, the effectiveness of these interventions remains unclear. We investigated the effectiveness of current self-management support interventions and their specific components and elements in improving patient outcomes. Methods Electronic databases were systematically searched from January 1, 1994, to December 19, 2017. Eligible studies were randomized controlled trials on self-management support interventions for adults with comorbid diabetes and chronic kidney disease. Primary outcomes were systolic blood pressure, diastolic blood pressure, estimated glomerular filtration rate, and glycated hemoglobin. Secondary outcomes included self-management activity, health service utilization, health-related quality of life, medication adherence, and death. Results Of the 48 trials identified, eight studies (835 patients) were eligible. There was moderate-quality evidence that self-management support interventions improved self-management activity (standard mean difference 0.56, 95% CI 0.15 to 0.97, p  < 0.007) compared to usual care. There was low-quality evidence that self-management support interventions reduced systolic blood pressure (mean difference − 4.26 mmHg, 95% CI − 7.81 to − 0.70, p  = 0.02) and glycated hemoglobin (mean difference − 0.5%, 95% CI − 0.8 to − 0.1, p  = 0.01) compared to usual care. Conclusions Self-management support interventions may improve self-care activities, systolic blood pressure, and glycated hemoglobin in patients with comorbid diabetes and chronic kidney disease. It was not possible to determine which self-management components and elements were more effective, but interventions that utilized provider reminders, patient education, and goal setting were associated with improved outcomes. More evidence from high-quality studies is required to support future self-management programs. Systematic review registration PROSPERO CRD42015017316 .

BackgroundLittle is known about the relationship between patients' cultural and linguistic backgrounds and patient activation, especially in people with diabetes and chronic kidney disease (CKD). We examined the association between culturally and linguistically diverse (CALD) background and patient activation and evaluated the impact of a codesigned integrated kidney and diabetes model of care on patient activation by CALD status in people with diabetes and CKD.MethodsThis longitudinal study recruited adults with diabetes and CKD (Stage 3a or worse) who attended a new diabetes and kidney disease service at a tertiary hospital. All completed the patient activation measure at baseline and after 12 months and had demographic and clinical data collected. Patients from CALD backgrounds included individuals who spoke a language other than English at home, while those from non-CALD backgrounds spoke English only as their primary language. Paired t-tests compared baseline and 12-month patient activation scores by CALD status.ResultsPatients from CALD backgrounds had lower activation scores (52.1 ± 17.6) compared to those from non-CALD backgrounds (58.5 ± 14.6) at baseline. Within-group comparisons showed that patient activation scores for patients from CALD backgrounds significantly improved by 7 points from baseline to 12 months follow-up (52.1 ± 17.6–59.4 ± 14.7), and no significant change was observed for those from non-CALD backgrounds (58.5 ± 14.6–58.8 ± 13.6).ConclusionsAmong patients with diabetes and CKD, those from CALD backgrounds report worse activation scores. Interventions that support people from CALD backgrounds with comorbid diabetes and CKD, such as the integrated kidney and diabetes model of care, may address racial and ethnic disparities that exist in patient activation and thus improve clinical outcomes.Patient or Public ContributionPatients, caregivers and national consumer advocacy organisations (Diabetes Australia and Kidney Health Australia) codesigned a new model of care in partnership with healthcare professionals and researchers. The development of the model of care was informed by focus groups of patients and healthcare professionals and semi-structured interviews of caregivers and healthcare professionals. Patients and caregivers also provided a rigorous evaluation of the new model of care, highlighting its strengths and weaknesses.

To address guideline-practice gaps and improve management of patients with both diabetes and chronic kidney disease (CKD), we involved patients, health professionals and patient advocacy groups in the co-design and implementation of an integrated diabetes-kidney service. In this study, we explored the experiences of patients and health-care providers, within this integrated diabetes and kidney service. 5 focus groups and 2 semi-structured interviews were conducted amongst attending patients, referring primary health professionals, and attending specialist health professionals. Maximal variation sampling was used for both patients and referring primary health professionals to ensure an equal representation of males and females, and patients of different CKD stages. All discussions were audiotaped and transcribed verbatim, before being thematically analysed independently by 2 researchers. The mean age (SD) for specialist health professionals, primary care professionals and patients who participated was 45 (11), 44 (15) and 68 (5) years with men being 50%, 80% and 76% of the participants respectively. Key strengths of the diabetes and kidney service were noted to be better integration of care and a perception of improved health and management of health. Whilst some aspects of access such as time between referral and initial appointment and having fewer appointments improved, other aspects such as in-clinic waiting times and parking remained problematic. Specialist health professionals noted that health professional education could be improved. Patient self-management was also noted by to be an issue with some patients requesting more information and some health professionals expressing difficulty in empowering some patients. Health professionals and patients reported that a co-designed integrated diabetes kidney service improved integration of care and improved health and management of health. However, some aspects of the process of care, health professional education and patient self-management remained challenging.

Background Self-management education needs have not been assessed in patients with complex co-morbid conditions such as diabetes and chronic kidney disease (CKD). The objectives of this study were to 1) determine the self-management education needs for patients with co-morbid diabetes and CKD and 2) co-develop an educational resource meeting the self-management education needs of patients with co-morbid diabetes and CKD. Methods Patients with co-morbid diabetes and CKD attending a co-designed, patient-centred outpatient diabetes and kidney clinic at a tertiary metropolitan hospital were recruited for semi-structured interviews. Maximal variation sampling was used, ensuring adequate representation of different gender, age, diabetes duration and stage of CKD. Data were thematically analysed using grounded theory. Results Forty-two patients participated. Most were male (67%) and the mean age was 64.8 (11.1) years. The majority of patients preferred an educational resource in the form of a Digital Versatile Disc (DVD) and they thought that current education could be improved. In particular patients wanted further education on 1) management of diabetes and kidney disease (including nutrition and lifestyle, and prevention of the progression of kidney disease) and 2) complications of comorbid diabetes and kidney disease. Conclusion Patients with co-morbid diabetes and kidney disease have education gaps on the management of, and complications of diabetes and kidney disease. Interventions aimed at improving patient education need to be delivered through education resources co-developed by patients and health staff. A targeted education resource in the form of a DVD, addressing these needs, may potentially close these gaps.

Background Technology has been implemented since the 1970s with the hope of improving glycaemic control and reducing the burden of complications for those living with type 1 diabetes. A clinical and cost-effectiveness comparison of all available technologies including continuous subcutaneous insulin infusion (CSII), continuous glucose monitors (CGMs), sensor-augmented pump therapy (including either low-glucose suspend or predictive low-glucose suspend), hybrid closed-loop systems, closed-loop (single-hormone or dual-hormone) systems, flash glucose monitoring (FGM), insulin bolus calculators, and ‘smart-device’ applications is currently lacking. This systematic review, network meta-analysis, and narrative synthesis aims to summarise available evidence regarding the clinical and cost-effectiveness of available technologies in the management of patients with type 1 diabetes. Methods Relevant studies will be searched using a comprehensive strategy through MEDLINE, MEDLINE in-process and other non-indexed citations, EMBASE, PubMed, all evidenced-based medicine reviews, EconLit, Cost-effectiveness Analysis Registry, Research Papers in Economics, Web of Science, PsycInfo, CINAHL, and PROSPERO for randomised controlled trials and economic evaluations. The search strategy will assess if there are combinations of currently available technologies that are superior to each other or to insulin injections and capillary blood glucose testing with regard to glycaemic control, morbidity/mortality, quality of life, and cost-effectiveness. Two reviewers will screen all articles for eligibility and then independently evaluate risk of bias, complete quality assessment, and extract data for included studies. Network meta-analyses will be performed where there is sufficient homogenous clinical data. Narrative synthesis will be performed for heterogeneous clinical data that cannot be pooled for network meta-analysis with critical appraisal of economic evaluations. Discussion This systematic review protocol utilises rigorous methodology and pre-determined eligibility criteria to provide a uniquely comprehensive search for a broad spectrum of clinical and economic outcomes in comparing multiple currently available technologies for managing type 1 diabetes. Evidence on which technologies may be most appropriate for particular patient groups will be examined as well as the economic justification for funding of different technologies. Systematic review registration PROSPERO ( CRD42017077221 )

Background Little is known about how patient reported barriers to health care impact the quality of life (HRQoL) of patients with comorbid disease. We investigated patient reported barriers to health care and low physical and mental well-being among people with diabetes and chronic kidney disease (CKD). Methods Adults with diabetes and CKD (estimated Glomerular Filtration Rate < 60 ml/min/1.73m 2 ) were recruited and completed a questionnaire on barriers to health care, the 12-Item HRQoL Short Form Survey and clinical assessment. Low physical and mental health status were defined as mean scores < 50. Logistic regression models were used. Results Three hundred eight participants (mean age 66.9 ± 11 years) were studied. Patient reported ‘impact of the disease on family and friends’ (OR 2.07; 95% CI 1.14 to 3.78), ‘feeling unwell’ (OR 4.23; 95% CI 1.45 to 12.3) and ‘having other life stressors that make self-care a low priority’ (OR 2.59; 95% CI 1.20 to 5.61), were all associated with higher odds of low physical health status. Patient reported ‘feeling unwell’ (OR 2.92; 95% CI 1.07 to 8.01), ‘low mood’ (OR 2.82; 95% CI 1.64 to 4.87) and ‘unavailability of home help’ (OR 1.91; 95% CI 1.57 to 2.33) were all associated with higher odds of low mental health status. The greater the number of patient reported barriers the higher the odds of low mental health but not physical health status. Conclusions Patient reported barriers to health care were associated with lower physical and mental well-being. Interventions addressing these barriers may improve HRQoL among people with comorbid diabetes and CKD.