A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach.

AIMS: To select a core list of standard outcomes for diabetes to be routinely applied internationally, including patient-reported outcomes. METHODS: We conducted a structured systematic review of outcome measures, focusing on adults with either type 1 or type 2 diabetes. This process was followed by a consensus-driven modified Delphi panel, including a multidisciplinary group of academics, health professionals and people with diabetes. External feedback to validate the set of outcome measures was sought from people with diabetes and health professionals. RESULTS: The panel identified an essential set of clinical outcomes related to diabetes control, acute events, chronic complications, health service utilisation, and survival that can be measured using routine administrative data and/or clinical records. Three instruments were recommended for annual measurement of patient-reported outcome measures: the WHO Well-Being Index for psychological well-being; the depression module of the Patient Health Questionnaire for depression; and the Problem Areas in Diabetes scale for diabetes distress. A range of factors related to demographic, diagnostic profile, lifestyle, social support and treatment of diabetes were also identified for case-mix adjustment. CONCLUSIONS: We recommend the standard set identified in this study for use in routine practice to monitor, benchmark and improve diabetes care. The inclusion of patient-reported outcomes enables people living with diabetes to report directly on their condition in a structured way.

Assessing the impact of diabetes on quality of life: what have the past 25 years taught us?

Over the past 25 years, there has been significant acknowledgement of the importance of assessing the impact of diabetes on quality of life. Yet, despite the development of several diabetes-specific quality of life measures, the challenges we faced in 1995 remain. There is little consensus on the definition of quality of life because of the complexity and subjectivity of the concept. General quality of life comprises several domains of life, and these are highly individualized. Assessing the impact of diabetes on these life domains adds to the complexity. While comprehensive diabetes-specific quality-of-life measures typically increase respondent burden, brief questionnaires may not capture all relevant/important domains. Today, the lack of resolution of these challenges may explain why the impact of diabetes on quality of life is not systematically assessed in research or clinical care. Few researchers report detailed rationales for assessment, there is often a mismatch between the concept of interest and the measure selected, and data are misinterpreted as assessing the impact of diabetes on quality of life when, in reality, related but distinct constructs have been assessed, such as diabetes distress, treatment satisfaction or health status. While significant efforts are being made to increase routine monitoring of psychological well-being and understand the lived experience, no guidelines currently recommend routine clinical assessment of diabetes-specific quality of life, and there is no consensus on which questionnaire(s) to use. The gaps identified in this review need urgent attention, starting with recognition that assessment of diabetes-specific quality of life is as important as biomedical markers, if we are to improve the lives of people with diabetes.

Deficiencies in postgraduate training for healthcare professionals who provide diabetes education and support: results from the Diabetes Attitudes, Wishes and Needs (DAWN2) study.

AIMS: To consider the global provision of self-management diabetes education and training for healthcare professionals using data from the second Diabetes Attitudes, Wishes and Needs (DAWN2) study. METHODS: A total of 4785 healthcare professionals caring for people with diabetes were surveyed in 17 countries to assess diabetes healthcare provision, self-management support and training. RESULTS: Of the healthcare professionals surveyed, 33.5% received formal postgraduate training in self-management (19.3-51.4% across countries) and 62.9% received training for medical management of diabetes (47.6-70.6% variation). Training in psychological management was low (19.1%), ranging from 3.6 to 36.5%, while 20.4% (a range of 3.6-36.4% across countries) had received no postgraduate training. Overall, the greatest training need was in the management of psychological aspects of diabetes (59.5%). For some, training in a domain was positively associated with a perceived need for further training. Communication skills, for example, listening (76.9%) and encouraging questions (76.1%), were the skills most widely used. Discussion of emotional issues was limited; 31-60% of healthcare professionals across the different countries reported that this only occurred if initiated by patients. Approximately two-thirds of participants reported a need for major improvements in emotional/psychological support, but few had received training in this area, with consistent findings across professional affiliations. CONCLUSIONS: The present study shows that healthcare professionals report being insufficiently equipped to provide diabetes self-management education, including emotional and psychological aspects of diabetes, and many are not receiving postgraduate training in any part (including medical care) of the management of diabetes. It is paramount that those responsible for the continuing professional development of healthcare professionals address this skills gap.

Correlates of psychological outcomes in people with diabetes: results from the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study.

AIMS: To assess country- and individual-level correlates of psychological outcomes, and differences among countries in the associations of individual characteristics with psychological outcomes among adults with diabetes. METHODS: The second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study assessed self-reported characteristics of people with diabetes in 17 countries, including 1368 adults with Type 1 diabetes and 7228 with Type 2 diabetes. In each country, a sample of 500 adults, stratified by diabetes type and treatment, completed a questionnaire incorporating the validated WHO-5 wellbeing index, the WHOQOL-BREF, and the five-item Problem Areas in Diabetes Scale, as well as the newly developed Diabetes Impact on Life Dimensions that assessed impact ranging from very positive to very negative, with no impact as the midpoint. Multilevel regression analyses identified significant (P < 0.05) independent correlates of psychological outcomes. RESULTS: There were significant variations in all outcomes across countries before adjustment for individual-level factors; adjustment reduced between-country disparities. Worse psychological outcomes were associated with more complications, incidence of hypoglycaemia, hypoglycaemic medication, perceived burden of diabetes, family conflict and experience of discrimination. Better psychological outcomes were associated with higher self-rated health, greater access to diabetes education and healthcare, and more psychosocial support from others. The associations of many factors with the outcomes were mediated by modifiable factors. The association of all factors with the outcomes varied across (interacted with) countries, highlighting the need for country-specific analyses. CONCLUSIONS: Improvements in modifiable risk factors (reductions in burden and increases in support) may lead to better psychological outcomes in adults with diabetes.

Correlates of psychological outcomes among family members of people with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study.

AIMS: To conduct a second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study, examining the experiences of family members caring for adults with diabetes in order to identify correlates of family member psychological outcomes (generic psychological well-being, perceived quality of life, and diabetes-related burden, impact and distress). METHODS: A total of 2057 family members living with a person with diabetes and involved in their care participated in an online, telephone or in-person survey. Samples of 120 respondents were recruited in each of 17 countries. Significant (P < 0.05) correlates of psychological outcomes were identified by multi-level multiple regression. RESULTS: Outcomes were worse for family members not working because of diabetes or those who had other competing obligations. Outcomes were worse if the person with diabetes was not a partner or parent, used injected diabetes medication, or had more frequent hypoglycaemia. Outcomes were worse for family members who believed that diabetes was more severe, were more involved in diabetes care, had more conflict over diabetes care or were frustrated about not knowing how to help the person with diabetes. Outcomes were better for those who had greater support from others and felt they found good ways to help the person with diabetes. There were significant differences in outcomes among countries before and after adjustment for individual characteristics, and correlates of outcomes varied by country. CONCLUSIONS: Several modifiable risk and protective factors for family member psychological outcomes were identified in this study. Diabetes education and social support were associated with improved outcomes, especially if they were helpful in supporting people with diabetes.

Correlates of psychological care strategies for people with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study.

AIMS: To assess the ways in which healthcare professionals address psychological problems of adults with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study. METHODS: Approximately 120 primary care physicians, 80 diabetes specialists and 80 nurses and dietitians providing diabetes care participated in each of 17 countries (N=4785). Multiple regression analyses were used to evaluate independent statistically significant associations of respondent attributes concerning psychological care strategies, including assessment of diabetes impact on the patient's life, assessment of depression, provision of psychological assessment and support, and coordination with mental health professionals. RESULTS: Psychological care strategies were positively associated with each other but differed by healthcare practice site and discipline; nurses and dietitians were less likely to assess depression than other healthcare professionals, while primary care physicians were less likely to coordinate with mental health specialists or ask patients how diabetes affects their lives. Psychological care was positively associated with healthcare professionals' beliefs that patients need help dealing with emotional issues and that clinical success depends on doing so, and also with level of psychological care training, multidisciplinary team membership and availability of resources for psychological care. There were significant between-country variations in psychological care strategies, before and after adjustment for individual-level factors, and significant country-by-covariate interactions for almost all individual-level factors investigated. CONCLUSIONS: Improvements in training and resources, recognition and assessment of psychological problems, and increased belief in the efficacy of psychological support may enhance healthcare professionals' efforts to address psychological problems in adults with diabetes.

Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking indicators for family members living with people with diabetes.

AIMS: The second Diabetes Attitudes, Wishes and Needs (DAWN2) study examined the experiences of family members of people with diabetes for benchmarking and identifying unmet needs or areas for improvement to assist family members and those with diabetes to effectively self-manage. METHODS: In total, 2057 family members of people with diabetes participated in an online, telephone or in-person survey designed to assess the impact of diabetes on family life, family support for people with diabetes and educational and community support. RESULTS: Supporting a relative with diabetes was perceived as a burden by 35.3% (range across countries 10.6-61.7%) of respondents. Over half of respondents [51.4% (22.5-76.0%)] rated their quality of life as 'good' or 'very good'. However, distress about the person with diabetes was high, with 61.3% (31.5-86.4%) worried about hypoglycaemia. The impact of diabetes on aspects of life was felt by 51.8% (46.9-58.6%). The greatest negative effect was on emotional well-being [44.6% (31.8-63.0%)], although depression was less common [11.6% (4.2-20.0%)]. Many respondents did not know how to help the person with diabetes [37.1% (17.5-53.0%)] and wanted to be more involved in their care [39.4% (15.5-61.7%)]. Participation in diabetes educational programmes was low [23.1% (9.4-43.3%)], although most of those who participated found them helpful [72.1% (42.1-90.3%)]. CONCLUSIONS: Diabetes has a negative impact on family members of people with diabetes. DAWN2 provides benchmarking indicators of family members' psychosocial needs that will help identify the support required for, and from, them to improve the lives of people with diabetes and their families.

Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national comparisons on barriers and resources for optimal care--healthcare professional perspective.

AIMS: The second Diabetes Attitudes, Wishes and Needs (DAWN2) study sought cross-national comparisons of perceptions on healthcare provision for benchmarking and sharing of clinical practices to improve diabetes care. METHODS: In total, 4785 healthcare professionals caring for people with diabetes across 17 countries participated in an online survey designed to assess diabetes healthcare provision, self-management and training. RESULTS: Between 61.4 and 92.9% of healthcare professionals felt that people with diabetes needed to improve various self-management activities; glucose monitoring (range, 29.3-92.1%) had the biggest country difference, with a between-country variance of 20%. The need for a major improvement in diabetes self-management education was reported by 60% (26.4-81.4%) of healthcare professionals, with a 12% between-country variance. Provision of diabetes services differed among countries, with many healthcare professionals indicating that major improvements were needed across a range of areas, including healthcare organization [30.6% (7.4-67.1%)], resources for diabetes prevention [78.8% (60.4-90.5%)], earlier diagnosis and treatment [67.9% (45.0-85.5%)], communication between team members and people with diabetes [56.1% (22.3-85.4%)], specialist nurse availability [63.8% (27.9-90.7%)] and psychological support [62.7% (40.6-79.6%)]. In some countries, up to one third of healthcare professionals reported not having received any formal diabetes training. Societal discrimination against people with diabetes was reported by 32.8% (11.4-79.6%) of participants. CONCLUSIONS: This survey has highlighted concerns of healthcare professionals relating to diabetes healthcare provision, self-management and training. Identifying between-country differences in several areas will allow benchmarking and sharing of clinical practices.

Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking of diabetes-related psychosocial outcomes for people with diabetes.

AIMS: The second Diabetes Attitudes, Wishes and Needs (DAWN2) study aimed to assess psychosocial outcomes in people with diabetes across countries for benchmarking. METHODS: Surveys included new and adapted questions from validated questionnaires that assess health-related quality of life, self-management, attitudes/beliefs, social support and priorities for improving diabetes care. Questionnaires were conducted online, by telephone or in person. RESULTS: Participants were 8596 adults with diabetes across 17 countries. There were significant between-country differences for all benchmarking indicators; no one country's outcomes were consistently better or worse than others. The proportion with likely depression [WHO-5 Well-Being Index (WHO-5) score ≤ 28] was 13.8% (country range 6.5-24.1%). Diabetes-related distress [Problem Areas in Diabetes Scale 5 (PAID-5) score ≥ 40] was reported by 44.6% of participants (17.2-67.6%). Overall quality of life was rated 'poor' or 'very poor' by 12.2% of participants (7.6-26.1%). Diabetes had a negative impact on all aspects investigated, ranging from 20.5% on relationship with family/friends to 62.2% on physical health. Approximately 40% of participants (18.6-64.9%) reported that their medication interfered with their ability to live a normal life. The availability of person-centred chronic illness care and support for active involvement was rated as low. Following self-care advice for medication and diet was most common, and least common for glucose monitoring and foot examination, with marked country variation. Only 48.8% of respondents had participated in diabetes educational programmes/activities to help manage their diabetes. CONCLUSIONS: Cross-national benchmarking using psychometrically validated indicators can help identify areas for improvement and best practices to drive changes that improve outcomes for people with diabetes.

Psychometric and screening properties of the WHO-5 well-being index in adult outpatients with Type 1 or Type 2 diabetes mellitus.

OBJECTIVE: The 5-item World Health Organization well-being index is a commonly used measure of emotional well-being, but research on psychometric properties in outpatients with diabetes is scarce. We examined psychometric and screening properties for depression of this index in a large sample of Dutch outpatients with diabetes. METHODS: Patients with Type 1 (n = 384) and Type 2 (n = 549) diabetes from three outpatient clinics completed the WHO-5 index, the nine-item Patient Health Questionnaire, the Problem Areas in Diabetes survey and the Short Form-12 health survey. Internal consistency of the WHO-5 index was determined by Cronbach's alpha. The factor structure was tested by confirmatory factor analysis. Concurrent validity was assessed by correlations with the Patient Health Questionnaire, Problem Areas in Diabetes and the Short Form-12 mental component scores. Sensitivity and specificity of the WHO-5 index as depression screener were tested against two existing Patient Health Questionnaire cut-off scores for depression using receiver operating characteristic curves. RESULTS: A one-factor structure of the WHO-5 index was verified by confirmatory factor analysis for patients with Type 1 and Type 2 diabetes. Moderate to strong correlations were observed between the WHO-5 index and the Patient Health Questionnaire scores, the Problem Areas in Diabetes scores and the Short Form-12 mental component scores (r = 0.55-0.69, P < 0.001). Receiver operating characteristic curves showed that a WHO-5 index cut-off of < 50 performed best as an indication for likely depression, with sensitivity compared with a Patient Health Questionnaire score ≥ 10 and ≥ 12 of 79% and 88%, respectively, and specificity of 88% and 76%, respectively. CONCLUSIONS: The WHO-5 index is a short, psychometrically sound measure of emotional well-being that appears suitable for use as screening test for likely depression in outpatients with Type 1 and Type 2 diabetes.

Target setting in intensive insulin management is associated with metabolic control: the Hvidoere childhood diabetes study group centre differences study 2005.

OBJECTIVE: To evaluate glycaemic targets set by diabetes teams, their perception by adolescents and parents, and their influence on metabolic control. METHODS: Clinical data and questionnaires were completed by adolescents, parents/carers and diabetes teams in 21 international centres. HbA1c was measured centrally. RESULTS: A total of 2062 adolescents completed questionnaires (age 14.4 +/- 2.3 yr; diabetes duration 6.1 +/- 3.5 yr). Mean HbA 1c = 8.2 +/- 1.4% with significant differences between centres (F = 12.3; p < 0.001) range from 7.4 to 9.1%. There was a significant correlation between parent (r = 0.20) and adolescent (r = 0.21) reports of their perceived ideal HbA1c and their actual HbA1c result (p < 0.001), and a stronger association between parents' (r = 0.39) and adolescents' (r = 0.4) reports of the HbA1c they would be happy with and their actual HbA1c result. There were significant differences between centres on parent and adolescent reports of ideal and happy with HbA1c (8.1 < F > 17.4;p < 0.001). A lower target HbA1c and greater consistency between members of teams within centres were associated with lower centre HbA1c (F = 16.0; df = 15; p < 0.001). CONCLUSIONS: Clear and consistent setting of glycaemic targets by diabetes teams is strongly associated with HbA1c outcome in adolescents. Target setting appears to play a significant role in explaining the differences in metabolic outcomes between centres.

Short-form measures of diabetes-related emotional distress: the Problem Areas in Diabetes Scale (PAID)-5 and PAID-1.

AIMS/HYPOTHESIS: We wanted to identify a five-item short form of the Problem Areas in Diabetes Scale and a single-item measure for rapid screening of diabetes-related emotional distress. METHODS: Using an existing database of 1,153 patients with diabetes, we conducted a principal-components analysis to identify a set of five items and then conducted a reliability analysis and validity checks. From those five items, we identified the item with the strongest psychometric properties as a one-item screening tool. RESULTS: We identified a reliable and valid short version of the Problem Areas in Diabetes Scale (PAID) comprising five of the emotional-distress questions of the full PAID items (PAID-5, with items 3, 6, 12, 16, 19). The PAID-5 has satisfactory sensitivity (94%) and specificity (89%) for recognition of diabetes-related emotional distress. We also identified a one-item screening tool, the PAID-1 (Question 12: Worrying about the future and the possibility of serious complications), which has concurrent sensitivity and specificity of about 80% for the recognition of diabetes-related emotional distress. CONCLUSIONS/INTERPRETATION: The PAID-5 and PAID-1 appear to be psychometrically robust short-form measures of diabetes-related emotional distress.

Symptoms of depression and diabetes-specific emotional distress are associated with a negative appraisal of insulin therapy in insulin-naïve patients with Type 2 diabetes mellitus. A study from the European Depression in Diabetes [EDID] Research Consortium.

AIMS: A meta-analysis concluded that depression is associated with poor glycaemic control in Type 2 diabetes (DM2). In DM2 patients with deteriorating glycaemic control, the initiation of insulin therapy is often postponed. The aim of the present study was to determine whether symptoms of depression and diabetes-specific emotional distress are associated with a more negative appraisal of insulin therapy. METHODS: We collected cross-sectional data in two outpatient university clinics in Istanbul, Turkey. The study sample consisted of 154 insulin-naïve patients with DM2. A self-report questionnaire was used to obtain demographic and clinical data. Main instruments were the Centre for Epidemiologic Studies Depression Scale, (CES-D), the Problem Areas In Diabetes scale (PAID) and the Insulin Treatment Appraisal Scale (ITAS). RESULTS: Analysis of variance revealed that patients with a higher depression score rated insulin therapy significantly more negative then patients with lower depression scores. Moreover, 47% of patients with a high depression score had a negative appraisal of insulin therapy on 7 or more of the 20 ITAS-items, compared to 25 to 29% of those with low-moderate depression scores. Multiple regression analyses showed that a negative appraisal of insulin therapy was significantly associated with higher depression and diabetes-distress scores and low education, but not with sex, age or duration of diabetes. CONCLUSIONS: Our results suggest that in insulin-naïve Type 2 diabetes patients, higher levels of depression and diabetes-distress tend to be associated with more negative beliefs about insulin. Whether these negative attitudes translate into postponing initiation of insulin therapy needs to be tested in longitudinal research.

Are family factors universally related to metabolic outcomes in adolescents with Type 1 diabetes?

AIMS: To assess the importance of family factors in determining metabolic outcomes in adolescents with Type 1 diabetes in 19 countries. METHODS: Adolescents with Type 1 diabetes aged 11-18 years, from 21 paediatric diabetes care centres, in 19 countries, and their parents were invited to participate. Questionnaires were administered recording demographic data, details of insulin regimens, severe hypoglycaemic events and number of episodes of diabetic ketoacidosis. Adolescents completed the parental involvement scale from the Diabetes Quality of Life for Youth--Short Form (DQOLY-SF) and the Diabetes Family Responsibility Questionnaire (DFRQ). Parents completed the DFRQ and a Parental Burden of Diabetes score. Glycated haemoglobin (HbA(1c)) was analysed centrally on capillary blood. RESULTS: A total of 2062 adolescents completed a questionnaire, with 2036 providing a blood sample; 1994 parents also completed a questionnaire. Family demographic factors that were associated with metabolic outcomes included: parents living together (t = 4.1; P < 0.001), paternal employment status (F = 7.2; d.f. = 3; P < 0.001), parents perceived to be over-involved in diabetes care (r = 0.11; P < 0.001) and adolescent-parent disagreement on responsibility for diabetes care practices (F = 8.46; d.f. = 2; P < 0.001). Although these factors differed between centres, they did not account for centre differences in metabolic outcomes, but were stronger predictors of metabolic control than age, gender or insulin treatment regimen. CONCLUSIONS: Family factors, particularly dynamic and communication factors such as parental over-involvement and adolescent-parent concordance on responsibility for diabetes care appear be important determinants of metabolic outcomes in adolescents with diabetes. However, family dynamic factors do not account for the substantial differences in metabolic outcomes between centres.

A short form of the Diabetes Quality of Life for Youth questionnaire: exploratory and confirmatory analysis in a sample of 2,077 young people with type 1 diabetes mellitus.

AIMS/HYPOTHESIS: The aim of this study was to test the construct validity of the Diabetes Quality of Life for Youth (DQOLY) questionnaire in a large representative sample of young people with type 1 diabetes mellitus. METHODS: The 52-item DQOLY questionnaire was completed by 2,077 adolescent individuals (aged 10-18 years) with type 1 diabetes. Participants were recruited from 22 paediatric diabetes centres in 18 countries across Europe, Asia and North America. HbA(1c) levels were determined once and analysed centrally. RESULTS: Exploratory factor analysis generated three possible measurement models of a revised questionnaire, two with four factors and one with six factors with all models indicating the presence of one satisfaction scale, but with many of the impact and worry scale items either double loading or not loading on any factors. Subsequent confirmatory analysis indicated that compared with the original DQOLY scales, the six-factor solution was the best-fitting model. CONCLUSIONS/INTERPRETATION: The DQOLY factor structure does not show construct validity in a large, diverse representative sample of young people with type 1 diabetes. However, a revised (short-form) version of the DQOLY is proposed that has improved construct validity, adequate internal consistency, and more precise and hypothesised association with HbA(1c). It is anticipated that this shorter version will enhance the acceptability and clinical utility of the measure, making it more feasible to introduce as part of routine care.

Patient and provider perceptions of care for diabetes: results of the cross-national DAWN Study.

AIMS/HYPOTHESIS: We assessed country-level and individual-level patterns in patient and provider perceptions of diabetes care. METHODS: The study used a cross-sectional design with face-to-face or telephone interviews of diabetic patients and healthcare providers in 13 countries from Asia, Australia, Europe and North America. Participants were randomly selected adults with type 1 or type 2 diabetes (n=5,104), and randomly selected diabetes-care providers, including primary-care physicians (n=2,070), diabetes specialist physicians (n=635) and nurses (n=1,122). Multivariate analysis was used to examine the relationships between outcomes and both country and respondent characteristics, and the interaction between these two factors. RESULTS: Providers rated chronic-care systems and remuneration for chronic care as mediocre. Patients reported that ease of access to care was high, but not without financial barriers. Patients reported moderate levels of collaboration among providers, and providers indicated that several specialist disciplines were not readily available to them. Patients reported high levels of collaboration with providers in their own care. Provider endorsement of primary prevention strategies for type 2 diabetes was high. Patients with fewer socio-economic resources and more diabetes complications had lower access (and/or higher barriers) to care and lower quality of patient-provider collaboration. Countries differed significantly for all outcomes, and the relationships between respondent characteristics and outcomes varied by country. CONCLUSIONS/INTERPRETATION: There is much need for improvement in applying the chronic-care model to the treatment and prevention of diabetes in all of the countries studied. Each country must develop its own priorities for improving diabetes care and comparison with other countries can help identify strengths as well as weaknesses.

InDuo, a novel combined insulin injection and blood glucose monitoring device - effective and save as other devices, and patient preference.

BACKGROUND AND AIM: Frequent blood glucose (BG) monitoring and insulin administration are necessary in intensive insulin regimes. A new integrated system, InDuo is a compact and portable combined insulin doser and BG monitor, designed to overcome some of the limitations of current insulin therapy. The aim of the study was to compare InDuo and a non-integrated system (HumaPen Ergo and Accu-Chek Sensor Meter) for efficacy and safety, and to evaluate patients preference. MATERIALS AND METHODS: The trial design was a multicentre, randomised, 12-week, open-label, comparative, two period crossover. One hundred and ten patients with diabetes, treated with a basal bolus regime, were included. The subjects were assigned to use either InDuo or the non-integrated system. After six weeks of treatment, the subjects were transferred to the alternative system. To assess efficacy, fasting plasma glucose (FBG), 7-point blood glucose profile, serum fructosamine and HbA1c were measured. Serum fructosamine and FBG were measured at baseline and at six and 12 weeks; HbA1c was measured at baseline and week 12. Safety endpoints were number and severity of hypoglycaemic episodes, adverse events and adverse device effects. Patient preference was assessed by a comparative device questionnaire at 12 weeks. RESULTS: Analysis with an ANOVA mixed model showed no difference after each treatment between serum fructosamine or between FBG levels. HbA1c decreased during the trial from 7.5 % +/- 1.2 to 7.1 % +/- 0.8 at 12 weeks. The safety profiles were similar for both treatments for hypoglycaemic episodes. The incidence of adverse events was also similar. There were 10 adverse device effects reported: eight for the Innovo device in the InDuo, one for the InDuo device and one for the Accu-Chek Sensor Meter. The comparative device questionnaire at 12 weeks showed patients strongly preferred InDuo to HumaPen Ergo and Accu-Chek Sensor Meter (all p < 0.0001). Of those preferring InDuo, more than 60 % classified their choice as very or extremely strong. Both memory functions in InDuo(R) (i. e., for insulin dosage and for blood glucose readings) were used by more than 70 % of the patients. CONCLUSION: Treatment with the InDuo system was as effective and safe as treatment with the non-integrated system. Almost 75 % preferred using InDuo to the non-integrated HumanPen Ergo and Accu-Chek Sensor Meter.

Psychosocial problems and barriers to improved diabetes management: results of the Cross-National Diabetes Attitudes, Wishes and Needs (DAWN) Study.

AIMS: To examine patient- and provider-reported psychosocial problems and barriers to effective self-care and resources for dealing with those barriers. METHODS: Cross-sectional study using face-to-face or telephone interviews with diabetic patients and health-care providers in 13 countries in Asia, Australia, Europe and North America. Participants were randomly selected adults (n = 5104) with Type 1 or Type 2 diabetes, and providers (n = 3827), including primary care physicians, diabetes specialist physicians and nurses. RESULTS: Regimen adherence was poor, especially for diet and exercise; provider estimates of patient self-care were lower than patient reports for all behaviours. Diabetes-related worries were common among patients, and providers generally recognized these worries. Many patients (41%) had poor psychological well-being. Providers reported that most patients had psychological problems that affected diabetes self-care, yet providers often reported they did not have the resources to manage these problems, and few patients (10%) reported receiving psychological treatment. CONCLUSIONS: Psychosocial problems appear to be common among diabetic patients worldwide. Addressing these problems may improve diabetes outcomes, but providers often lack critical resources for doing so, particularly skill, time and adequate referral sources.

Effect of the rapid-acting insulin analogue insulin aspart on quality of life and treatment satisfaction in patients with Type 1 diabetes.

AIMS: To compare quality of life (QoL) and treatment satisfaction in patients with Type 1 diabetes receiving the rapid-acting insulin analogue, insulin aspart (IAsp), with that in patients receiving soluble human insulin (HI). METHODS: In this 6-month, multinational, randomized, open-label trial, 424 patients from German-speaking countries were subjected to psychometric assessment before and after randomization (ratio 2 : 1) to basal-bolus treatment with either IAsp (n = 283) or HI (n = 141). Patients on HI were advised to keep an injection-meal interval of 30 min, whereas patients on IAsp were advised to inject immediately before meals. Treatment satisfaction and diabetes-related QoL were assessed using validated instruments to measure the domains of patients' individual treatment goals, physical complaints, worries about the future, social relations, leisure time flexibility, daily hassles, diet restrictions, burdens and fear of hypoglycaemia, blood glucose fluctuations, self-efficacy, and fear of insulin analogues. RESULTS: After 6 months, IAsp was associated with significantly greater improvement in treatment satisfaction than HI in two different scales (P < 0.01), and in QoL with respect to diet restrictions (P < 0.01). Improved satisfaction was mainly due to increased dietary and leisure time flexibility (P < 0.0001). Twenty-three percent of the IAsp group vs. 14% of the HI group achieved small but important improvements of total QoL (between-group difference, P < 0.06). The number needed to treat (NNT) with IAsp for an important increase in QoL was calculated to be 10. Regression analyses of potential predictors of improvement in QoL highlighted patients intensely striving for physical strength (P < 0.01; NNT = 7) and patients feeling less protected against hypoglycaemia (P < 0.005; NNT = 8) as being the most likely to benefit from IAsp. CONCLUSIONS: Under these study conditions, IAsp improved treatment satisfaction and quality of life regarding diet restrictions when compared with human insulin. The 'numbers needed to treat' for important quality of life benefits indicate that the effect of IAsp in this regard is not trivial.