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Objective: To examine whether symptoms of depression or anxiety predict glycaemia and incident diabetes complications four years later, and whether diabetes self-care behaviours mediate these associations, in adults with type 1 diabetes (T1DM). Methods: Data of 205 adults with T1DM from the 2011 and 2015 Diabetes MILES–Australia surveys were analysed. Variables of interest were: baseline depression and anxiety (PHQ-8 and GAD-7, respectively) symptoms; HbA1c and incident complications at four-year follow-up; and self-care behaviours at both time points. Longitudinal associations were analysed using structural equation modelling. Results: Forty-two participants (20.6%) reported incident complications. Baseline depressive symptoms predicted higher HbA1c at follow-up indirectly via less optimal self-care at follow-up (β = 0.19, P = 0.011). Baseline anxiety was not independently associated with HbA1c or self-care at follow-up (P ≥ 0.64). Neither depressive nor anxiety symptoms predicted incident complications, although depressive symptoms were associated with less optimal self-care at baseline (β = -0.67, P < 0.001), and this predicted microvascular complications (β = -0.38, P = 0.044); however, the indirect association via self-care was not significant (β = 0.25, P = 0.067). Limitations: Participants were self-selected; all study variables were assessed using self-report measures; and adjusting for baseline HbA1c was not possible. Conclusions: Depressive symptoms predicted suboptimal self-care behaviour and glycaemic outcome four years later, while anxiety symptoms did not. The findings suggest that tailored diabetes care should take the potential impact of comorbid depression into consideration to help people improve their diabetes self-care and achieve best possible health outcomes.

Background: Automated insulin delivery (AID) systems have been shown to be safe and effective in reducing hyper- and hypoglycaemia, but are not universally available, accessible, and affordable. Therefore, user-driven open-source AID systems are becoming increasingly popular. Methods: This study investigated motivations why people with diabetes or their caregivers decide to build and use a personalised open-source AID. A cross-sectional online survey was conducted to assess personal motivations and associated self-reported clinical outcomes. Findings: Of 897 participants from 35 countries, 80·4% were adults with diabetes and 19·6% were caregivers of children with diabetes. Primary motivations to commence open-source AID included: improving glycaemic outcomes (94% of adults, 95% of caregivers), reducing acute (87%/96%) and long-term (83%/91%) complication risk, interacting less frequently with diabetes technology (81%/76%), improving their/child’s sleep quality (72%/80%), increasing their/child’s life expectancy (72%/85%), lack of commercially available AID systems (71%/70%), and unachieved therapy goals with available therapy options (68%/69%). Improving their own sleep quality was an almost universal motivator for caregivers (94%). Significant improvements, independent of age and gender, were observed in self-reported HbA1C, 7·14±1·13% (54·5±12·4 mmol/mol) to 6·24±0·64% (44·7±7·0 mmol/mol; p

STUDY QUESTION: What is the recommended assessment and management of women with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise and consumer preference?SUMMARY ANSWER: International evidence-based guidelines, including 166 recommendations and practice points, addressed prioritized questions to promote consistent, evidence-based care and improve the experience and health outcomes of women with PCOS.WHAT IS KNOWN ALREADY: Previous guidelines either lacked rigorous evidence-based processes, did not engage consumer and international multidisciplinary perspectives, or were outdated. Diagnosis of PCOS remains controversial, and assessment and management are inconsistent. The needs of women with PCOS are not being adequately met and evidence practice gaps persist.STUDY DESIGN, SIZE, DURATION: International evidence-based guideline development engaged professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Appraisal of Guidelines for Research and Evaluation (AGREE) II-compliant processes were followed, with extensive evidence synthesis. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength.PARTICIPANTS/MATERIALS, SETTING, METHODS: Governance included a six continent international advisory and a project board, five guideline development groups, and consumer and translation committees. Extensive health professional and consumer engagement informed guideline scope and priorities. Engaged international society-nominated panels included pediatrics, endocrinology, gynecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, public health and other experts, alongside consumers, project management, evidence synthesis and translation experts. In total, 37 societies and organizations covering 71 countries engaged in the process. Twenty face-to-face meetings over 15 months addressed 60 prioritized clinical questions involving 40 systematic and 20 narrative reviews. Evidence-based recommendations were developed and approved via consensus voting within the five guideline panels, modified based on international feedback and peer review, with final recommendations approved across all panels.MAIN RESULTS AND THE ROLE OF CHANCE: The evidence in the assessment and management of PCOS is generally of low to moderate quality. The guideline provides 31 evidence based recommendations, 59 clinical consensus recommendations and 76 clinical practice points all related to assessment and management of PCOS. Key changes in this guideline include: (i) considerable refinement of individual diagnostic criteria with a focus on improving accuracy of diagnosis; (ii) reducing unnecessary testing; (iii) increasing focus on education, lifestyle modification, emotional wellbeing and quality of life; and (iv) emphasizing evidence based medical therapy and cheaper and safer fertility management.LIMITATIONS, REASONS FOR CAUTION: Overall evidence is generally low to moderate quality, requiring significantly greater research in this neglected, yet common condition, especially around refining specific diagnostic features in PCOS. Regional health system variation is acknowledged and a process for guideline and translation resource adaptation is provided.WIDER IMPLICATIONS OF THE FINDINGS: The international guideline for the assessment and management of PCOS provides clinicians with clear advice on best practice based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the guideline with an integrated evaluation program.STUDY FUNDING/COMPETING INTEREST(S): The guideline was primarily funded by the Australian National Health and Medical Research Council of Australia (NHMRC) supported by a partnership with ESHRE and the American Society for Reproductive Medicine. Guideline development group members did not receive payment. Travel expenses were covered by the sponsoring organizations. Disclosures of conflicts of interest were declared at the outset and updated throughout the guideline process, aligned with NHMRC guideline processes. Full details of conflicts declared across the guideline development groups are available at https://www.monash.edu/medicine/sphpm/mchri/pcos/guideline in the Register of disclosures of interest. Of named authors, Dr Costello has declared shares in Virtus Health and past sponsorship from Merck Serono for conference presentations. Prof. Laven declared grants from Ferring, Euroscreen and personal fees from Ferring, Euroscreen, Danone and Titus Healthcare. Prof. Norman has declared a minor shareholder interest in an IVF unit. The remaining authors have no conflicts of interest to declare. The guideline was peer reviewed by special interest groups across our partner and collaborating societies and consumer organizations, was independently assessed against AGREE-II criteria, and underwent methodological review. This guideline was approved by all members of the guideline development groups and was submitted for final approval by the NHMRC.

Aims To investigate the impact of quarterly professional-mode flash glucose monitoring on psychological outcomes in adults with type 2 diabetes in primary care. Methods The GP-OSMOTIC trial randomised 299 adults with type 2 diabetes in 25 general practices to quarterly use of professional-mode flash glucose monitoring (sensor worn for 14 days; data discussed at clinic visit) or usual care. At baseline and 12 months, participants completed validated measures: general emotional well-being (WHO-5), diabetes-specific quality of life (DIDP), satisfaction with glucose monitoring (GME-Q), self-care activities (SDSCA) and perceived involvement in clinical care (PICS). Linear mixed-effects models examined between-group differences at 12 months. Results At 12 months, there were no clinically important between-arm differences in any secondary psychological or self-care outcomes. Per protocol analyses showed no clinically significant between-group differences. Conclusions The GP-OSMOTIC intervention had no significant impact, at 12 months, on general emotional well-being, diabetes-specific quality of life or satisfaction with glucose monitoring, suggesting no added psychological burden. Lack of positive impact on self-reported self-care activities or perceived involvement in clinical care may warrant closer attention to the fidelity of intervention delivery, the context (e.g. the nature of clinician-patient interactions) and/or the sensitivity of the measures, as these will help plan future studies.

Background Diabetes distress is the negative emotional impact of living with diabetes. It has tangible clinical importance, being associated with sub-optimal self-care and glycemic control. Diabetes distress has been operationalized in various ways and several measures exist. Measurement clarity is needed for both scientific and clinical reasons. Objectives To clarify the conceptualization and operationalization of diabetes distress, identify and distinguish relevant measures, and evaluate their appropriateness for this purpose. Results Six measures were identified: Problem Areas in Diabetes (PAID) scale, Diabetes Distress Scale (DDS); Type I Diabetes Distress Scale (T1-DDS), Diabetes-specific Quality of Life Scale—Revised (DSQoLs-R) ‘Burden and Restrictions—Daily Hassles’ sub-scale, Well-being Questionnaire 28 (W-BQ 28) ‘Diabetes Well-being’ sub-scale, and Illness Perceptions Questionnaire—Revised (IPQ-R) ‘Emotional Representations’ sub-scale. Across these measures a broad spectrum of diabetes distress is captured, including distress associated with treatment regimen, food/eating, future/complications, hypoglycemia, social/interpersonal relationships, and healthcare professionals. No single measure appears fully comprehensive. Limited detail of the qualitative work informing scale design is reported, raising concerns about content validity. Conclusions Across the available measures diabetes distress is seemingly comprehensively assessed and measures should be considered in terms of their focus and scope to ensure the foci of interventions are appropriately targeted.

To assess prevalence of severe hypoglycemia, awareness and symptoms of hypoglycemia, and their associations with self-monitoring of blood glucose.Diabetes MILES-Australia Study participants completed validated questionnaires and study-specific items.Of 642 adults with type 1 diabetes, 21% reported ≥1 severe hypoglycemic event in the past six months, and 21% reported impaired awareness of hypoglycemia (IAH). Severe hypoglycemia was increased four-fold for those with IAH compared with intact awareness (1.4±3.9 versus 0.3±1.0). Of those with IAH, 92% perceived autonomic and 88% neuroglycopenic symptoms, albeit at lower glucose thresholds compared to people with intact awareness. Those with IAH were more likely to perceive both symptom types at the same glucose level or to perceive neuroglycopenic symptoms first (all p0.001). Eighteen percent with IAH treated hypoglycemia only when they perceived symptoms and another 18% only when their capillary glucose was3.0mmol/L.One in five adults with type 1 diabetes had IAH or experienced severe hypoglycemia in the past sixmonths. Total loss of hypoglycemia symptoms was rare; most people with IAH retained autonomic symptoms, perceived at relatively low glucose levels. Frequent self-monitoring of blood glucose prompted early recognition and treatment of hypoglycemia, suggesting severe hypoglycemia risk can be minimized.

To determine 'hypothetical willingness' to initiate insulin, and identify associated factors, among adults with type 2 diabetes (T2DM) in primary care for whom insulin is clinically indicated.Eligible participants were adults with T2DM with an HbA1c ≥7.5% (58mmol/mol) and prescribed maximum oral hypoglycaemic agents. A total of 261 participants were recruited from 74 Victorian general practices: mean age 62±10 years; 39% (n=103) women; diabetes duration 10±6 years; HbA1c 9.0±1.3% (75±14mmol/mol). Data collected by the Stepping Up Study: demographic and clinical characteristics, 'willingness' to initiate insulin, insulin appraisals, depressive symptoms, and diabetes-related distress. A multinomial regression investigated predictors of 'willingness'.Nineteen percent (n=50) were 'very willing' to initiate insulin, if recommended. The final regression model (R(2)=.44, χ(2)(12) 145.91, p.001) demonstrated higher socioeconomic status and less negative attitudes to insulin were associated with increased willingness to initiate insulin.Among adults with T2DM for whom insulin is clinically indicated, only one in five are 'very willing' to begin insulin therapy. Independent of demographics, clinical factors and emotional wellbeing, insulin appraisals were associated with 'willingness'. This study highlights the importance of addressing attitudinal barriers to insulin therapy among adults with T2DM in primary care to improve insulin receptiveness.

Aims Diabetes stigma and weight stigma have been identified as important but neglected issues that warrant attention among people with type 2 diabetes. This study assessed associations of diabetes stigma and weight stigma with diabetes self-care behaviors and health care in adults with type 2 diabetes. Methods U.S. adults with type 2 diabetes (N = 1,227) completed self-report questionnaires to assess their experiences of weight stigma, diabetes stigma, diabetes self-management, diabetes-specific distress, healthcare utilization, perceptions of diabetes-specific health care. They also provided sociodemographic information. Linear regressions examined relationships among stigma and diabetes self-care and related health care, controlling for participants’ age, education, income, gender, race/ethnicity, and body mass index. Results Internalized weight stigma and diabetes self-stigma were both significantly associated with higher diabetes-specific distress. Adults who expressed self-stigma for their diabetes reported less diabetes self-management and lower self-efficacy, and those who reported being judged about their weight by a doctor exhibited greater diabetes-specific distress. While a history of experienced weight stigma (in general) did not reduce frequency of seeking health care, lower quality interactions with health care professionals were reported by adults who expressed diabetes self-stigma and those who experienced weight stigma from a doctor. Conclusions Self-stigma for diabetes and body weight, as well as experiencing judgment about weight from doctors, may have negative implications for diabetes-specific self-care behaviors and perceived quality of health care. Efforts to promote wellbeing in individuals with type 2 diabetes need to consider reducing both diabetes and weight stigma and their potentially harmful consequences.

ObjectiveThis study aims to examine the associations between following of the Dutch dietary guidelines 2015 and elevated depressive and anxiety symptoms in adults with diabetes.MethodsCross-sectional data of 3174 people (47% men, mean age 55 ± 14 years) with type 1 diabetes (n = 1369) and type 2 diabetes (n = 1805) participating in Diabetes MILES-The Netherlands were analysed. Following of the Dutch dietary guidelines 2015 was quantified using the Dutch Healthy Diet 2015 (DHD15)-index (12 food components; total score range 0-120 points), calculated from a 32-item food frequency questionnaire. Cases with elevated depressive and anxiety symptoms (cutoff ≥ 10) were measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7, respectively. Cox regression models were used to estimate the prevalence ratios (PRs) adjusted for demographical, lifestyle related, clinical and biomedical factors.ResultsElevated depressive and anxiety symptoms were present in 167 (12%) and 89 (7%) of participants with type 1 diabetes and 215 (12%) and 97 (5%) of those with type 2 diabetes, respectively. In the total sample (n = 3174), a DHD15-index score in the highest quartile was associated with lower prevalence of elevated depressive symptoms, compared to the lowest quartile with an adjusted PR [95% CI] of 0.73 [0.55-0.98]. The inverse association was more pronounced among participants with type 2 diabetes and among non-smokers. There was no association with elevated anxiety symptoms (adjusted PR [95% CI]: 1.03 [0.68-1.55]).ConclusionCloser following of the Dutch dietary guidelines 2015 was associated with a lower likelihood of elevated depressive symptoms in adults with type 2 diabetes.

To investigate severe hypoglycaemia (SH) in adults with type 1 diabetes and its associations with impaired awareness of hypoglycaemia (IAH), clinical, psychological and socio-demographic factors.Attendees of three specialist diabetes clinics in Melbourne, Australia completed questions about frequency of SH in the past six months; impaired awareness of hypoglycaemia (Gold score); and measures of general emotional well-being (WHO-5), diabetes-specific positive well-being (subscale of W-BQ28), diabetes-related distress (PAID) and fear of hypoglycaemia (HFS).Of 422 participants (mean ± SD age 37.5 ± 15.0 years; 54% women), 78 (18.5%) reported at least one SH event and 86 (20.5%) had IAH. SH and IAH frequencies were similar at all clinics. In total, 194 SH events were reported, with 10 people experiencing 40% of events. Compared with those without SH, participants with SH had longer diabetes duration, were younger at diabetes onset and more likely to have IAH (p0.01). Those with SH had greater fear of hypoglycaemia and diabetes-related distress, poorer general emotional well-being, and lower diabetes-specific positive well-being, (p0.01). There were no associations with age, gender, insulin regimen or HbA1c.This study has identified that SH and IAH in Australian adults with type 1 diabetes exist at similar levels to those reported in US and European research. SH was significantly associated with IAH and fear of hypoglycaemia. Assessment of hypoglycaemia, IAH and psychological well-being as part of a routine diabetes clinic visit was well accepted by attendees and enabled identification of those who may benefit from medical, educational or therapeutic interventions.

Diabetes is the fastest growing chronic condition in Australia, affecting 1.7 million Australians, requiring daily self-care, and known to reduce quantity and quality of life. On average, people with diabetes experience greater emotional distress than those without diabetes. One source of distress can be the language used to refer to diabetes, its management and the person with diabetes. The way verbal and written language is used reflects and shapes people's thoughts, beliefs and behaviours. Language has the power to persuade, change or reinforce beliefs and stereotypes - for better or worse. Words do more than reflect people's reality: they create reality and affect how people view the world and their diabetes. Language needs to engage people with diabetes and support their self-care efforts. Importantly, language that de-motivates or induces fear, guilt or distress needs to be avoided and countered. Diabetes Australia believes optimal communication increases the motivation, health and well-being of people with diabetes, and that careless or negative language can be de-motivating, is often inaccurate, and can be harmful. Diabetes Australia developed this position statement to encourage greater awareness of the language surrounding diabetes and provide recommendations for more careful and positive language use.

Aims To explore long-term outcomes of participation in a Dose Adjustment For Normal Eating (DAFNE) training course, which provided one-off exposure to structured education in intensive insulin therapy to people with established Type 1 diabetes. Methods A cohort design follow-up of original trial participants at a mean of 44 months (range: 37–51 months) in hospital diabetes clinics in three English health districts. 104 (74%) original participants provided biomedical data; 88 (63%) completed questionnaires including the ADDQoL, measuring impact of diabetes on quality of life (QoL). Results vAt 44 months, mean improvement in HbA1c from baseline was 0.36% (9.32 ± 1.1% to 8.96 ± 1.2%, p < 0.01) remaining significant but deteriorated from 12 months (p < 0.05). Improvements in QoL seen at 12 months were sustained at 44 (e.g. impact of diabetes on dietary freedom: −1.78 ± 2.33 at 44 months versus −4.27 ± 2.94, baseline, p < 0.0001; versus 1.80 ± 2.32 at 12 months, ns). Similar results were obtained using last observation carried forward for patients not supplying follow-up data. Conclusions The impact of a single DAFNE course on glycaemic control remains apparent in the long term, although further interventions will be required to achieve recommended HbA1c. In contrast, improvements in QoL and other patient-reported outcomes are well maintained over approximately 4 years.

Objectives Generic patient-reported outcome (PRO) measures underestimate the impact of polycystic ovary syndrome (PCOS) on quality of life (QoL). The aim of this review was to identify PCOS-specific QoL measures and establish whether their development history and measurement properties support their use in clinical trials. Methods A systematic search was conducted using terms synonymous with “PCOS” and “QoL.” Following identification of measures, further searches were undertaken using the questionnaire name and abbreviation to explore its use, development history, and demonstrated measurement properties. Results Of 56 abstracts screened, 21 reported using PRO measures. One PCOS-specific QoL measure was identified: the PolyCystic Ovary Syndrome Questionnaire (PCOSQ). Nine papers show that the PCOSQ's development history is somewhat incomplete, and that it does not have good content validity. The PCOSQ subscales demonstrate acceptable levels of reliability (0.70–0.97) and partial known-groups validity as well as convergent/divergent validity with other PRO instruments. Responsiveness to change is variable and minimally important differences have not been established. Conclusions The PCOSQ is the only condition-specific measure of the impact of PCOS on QoL. Additional research is required to ensure its comprehensiveness, sensitivity, and to guide interpretation prior to including in clinical trials.

As part of our evaluation of the Diabetes UK Careline workshop “Overcoming barriers to diabetes care”, we received feedback from 18 healthcare professionals. Generally, they felt competent in identifying patients’ psychosocial issues but less knowledgeable/skilled in handling them. Lack of time, privacy and support were barriers to addressing patients’ psychosocial concerns.

OBJECTIVES: To identify and survey health care professionals (HCPs) attitudes to insulin pump therapy (CSII). METHODS: Eight specialists were interviewed to explore the attitudes and beliefs about CSII. Responses were analysed thematically and used to inform the design of a new 22-item questionnaire: the Attitudes to Pump Therapy (APT) Survey. The APT was pilottested among 95 HCPs (54% male; 75.5% diabetologists/DSNs, 13.8% general practitioners) at the International Diabetes Federation (IDF) conference, 2006. Results were analysed using non-parametric statistics with bonferroni correction. RESULTS: Analyses of interview data identified 9 themes: biomedical, perceived control of care/diabetes, technology, quality of life, financial resources, training, education & support, suitability, and evidence-base. Items were designed to reflect these themes with responses scored on a 5-point Likert scale (strongly agree—strongly disagree). No statistically significant differences were found by gender, HCP speciality, country (and continent) of origin or proportion of patients using CSII. Most notable differences were found in relation to gross domestic product (GDP) and the potential for pump therapy to achieve tight blood glucose control (lower GDP = more agreement: p = 0.001), and result in diabetic ketoacidosis (DKA) (lower GDP = less agreement: p CONCLUSION: Few subgroup differences existed, but those that did may be explained by lack of access to treatment (directly corresponding to GDP). Clinicians’ were generally clear in their attitudes regarding biomedical aspects but less so regarding patient experience. Research focusing on patient-reported outcomes is likely to offer clinicians a greater understanding of the patients’ perspective of insulin pump therapy.