Individualised targets for insulin initiation in type 2 diabetes mellitus-the influence of physician and practice: a cross-sectional study in eight European countries.

OBJECTIVES: To determine at what glycated haemoglobin (HbA1c) level physicians from eight European countries would initiate insulin in type 2 diabetes, which physician or practice related factors influenced this level and whether physicians would differentiate between a younger uncomplicated patient and an older patient with comorbidities. DESIGN: Cross-sectional study with data from the Guideline Adherence to Enhance Care study. SETTING AND PARTICIPANTS: 410 physicians from both primary and secondary care from Belgium, France, Germany, Italy, Ireland, Sweden, the Netherlands and the UK. OUTCOME MEASURES: Physicians were asked at which HbA1c level they would initiate insulin for a young, uncomplicated patient (vignette 1) and for an older, complicated patient (vignette 2). We evaluated differences in HbA1c levels between physicians from different countries using analysis of variance. To identify physician and practice related factors associated with HbA1c level at initiation of insulin, we performed multivariable linear regression. Multiple imputation was used to deal with missing data. RESULTS: In Germany, Ireland, Sweden, the Netherlands and the UK, the HbA1c levels for initiating insulin in vignette 2 (range: 60.0 to 66.0 mmol/mol; 7.6% to 8.2%) were higher than for vignette 1 (range: 57.2 to 64.2 mmol/mol; 7.4% to 8.0%). In multivariable analysis, the HbA1c level at which insulin was initiated only differed between countries (vignette 1): Dutch physicians initiated insulin at a lower HbA1c level compared with Belgium, France and the UK. No physician or practice factors were independently associated with HbA1c level at insulin initiation. CONCLUSIONS: When deciding on individualised HbA1c targets for insulin initiation, physicians from five countries took patient's age and comorbidity into account. The HbA1c level at which physicians would initiate insulin therapy differed between countries.

Patient activation in individuals with type 2 diabetes mellitus: associated factors and the role of insulin.

AIM: This study explored the relationship between insulin use and patient activation (a person's internal readiness and capabilities to undertake health-promoting actions) in individuals with type 2 diabetes mellitus and aimed to identify demographic, clinical and psychosocial factors involved in patient activation. METHODS: In this cross-sectional study, baseline data from a Dutch nationwide study were analyzed. Patient activation was assessed with the Patient Activation Measure 13. A linear mixed model was used to take clustering into account. RESULTS: In total, 1,189 persons were included (310 of whom were on insulin), enrolled via 47 general practices and six hospitals. Their mean Patient Activation Measure 13 score was 59±12. We found no association between insulin therapy and patient activation. In the multivariable analysis, individuals with a better health status, very good or very poor social support (vs good social support), individuals who felt they had greater control over their illness and those with a better subjective understanding of their illness showed higher patient activation. Individuals with a lower educational level and those who expected their illness to continue showed a lower activation level. CONCLUSION: Patient activation does not differ between individuals with type 2 diabetes mellitus on insulin therapy and those on other therapies.

Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus.

BACKGROUND: Many adults with type 2 diabetes mellitus (T2DM) experience a psychosocial burden and mental health problems associated with the disease. Diabetes-related distress (DRD) has distinct effects on self-care behaviours and disease control. Improving DRD in adults with T2DM could enhance psychological well-being, health-related quality of life, self-care abilities and disease control, also reducing depressive symptoms. OBJECTIVES: To assess the effects of psychological interventions for diabetes-related distress in adults with T2DM. SEARCH METHODS: We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, BASE, WHO ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was December 2014 for BASE and 21 September 2016 for all other databases. SELECTION CRITERIA: We included randomised controlled trials (RCTs) on the effects of psychological interventions for DRD in adults (18 years and older) with T2DM. We included trials if they compared different psychological interventions or compared a psychological intervention with usual care. Primary outcomes were DRD, health-related quality of life (HRQoL) and adverse events. Secondary outcomes were self-efficacy, glycosylated haemoglobin A1c (HbA1c), blood pressure, diabetes-related complications, all-cause mortality and socioeconomic effects. DATA COLLECTION AND ANALYSIS: Two review authors independently identified publications for inclusion and extracted data. We classified interventions according to their focus on emotion, cognition or emotion-cognition. We performed random-effects meta-analyses to compute overall estimates. MAIN RESULTS: We identified 30 RCTs with 9177 participants. Sixteen trials were parallel two-arm RCTs, and seven were three-arm parallel trials. There were also seven cluster-randomised trials: two had four arms, and the remaining five had two arms. The median duration of the intervention was six months (range 1 week to 24 months), and the median follow-up period was 12 months (range 0 to 12 months). The trials included a wide spectrum of interventions and were both individual- and group-based.A meta-analysis of all psychological interventions combined versus usual care showed no firm effect on DRD (standardised mean difference (SMD) -0.07; 95% CI -0.16 to 0.03; P = 0.17; 3315 participants; 12 trials; low-quality evidence), HRQoL (SMD 0.01; 95% CI -0.09 to 0.11; P = 0.87; 1932 participants; 5 trials; low-quality evidence), all-cause mortality (11 per 1000 versus 11 per 1000; risk ratio (RR) 1.01; 95% CI 0.17 to 6.03; P = 0.99; 1376 participants; 3 trials; low-quality evidence) or adverse events (17 per 1000 versus 41 per 1000; RR 2.40; 95% CI 0.78 to 7.39; P = 0.13; 438 participants; 3 trials; low-quality evidence). We saw small beneficial effects on self-efficacy and HbA1c at medium-term follow-up (6 to 12 months): on self-efficacy the SMD was 0.15 (95% CI 0.00 to 0.30; P = 0.05; 2675 participants; 6 trials; low-quality evidence) in favour of psychological interventions; on HbA1c there was a mean difference (MD) of -0.14% (95% CI -0.27 to 0.00; P = 0.05; 3165 participants; 11 trials; low-quality evidence) in favour of psychological interventions. Our included trials did not report diabetes-related complications or socioeconomic effects.Many trials were small and were at high risk of bias for incomplete outcome data as well as possible performance and detection biases in the subjective questionnaire-based outcomes assessment, and some appeared to be at risk of selective reporting. There are four trials awaiting further classification. These are parallel RCTs with cognition-focused and emotion-cognition focused interventions. There are another 18 ongoing trials, likely focusing on emotion-cognition or cognition, assessing interventions such as diabetes self-management support, telephone-based cognitive behavioural therapy, stress management and a web application for problem solving in diabetes management. Most of these trials have a community setting and are based in the USA. AUTHORS' CONCLUSIONS: Low-quality evidence showed that none of the psychological interventions would improve DRD more than usual care. Low-quality evidence is available for improved self-efficacy and HbA1c after psychological interventions. This means that we are uncertain about the effects of psychological interventions on these outcomes. However, psychological interventions probably have no substantial adverse events compared to usual care. More high-quality research with emotion-focused programmes, in non-US and non-European settings and in low- and middle-income countries, is needed.

Internet-based Self-Management Support for Patients With Well-Controlled Type 2 Diabetes: A Real-Life Study.

BACKGROUND: Little attention has been paid to self-management support of patients with well-controlled type 2 diabetes mellitus (T2DM). Most studies evaluated the addition of self-management support to regular diabetes care, but self-management as an alternative for part of regular diabetes care has hardly been studied. In this study, we offered patients with well-controlled T2DM the opportunity to perform the 3 quarterly monitoring sessions at home using an Internet-based self-management program, resulting in online personalized advice. OBJECTIVE: The aim of our study was to assess the reach and feasibility of an Internet-based diabetes self-management support program for patients with well-controlled T2DM, addressing both primary care providers' (PCPs) opinions and patients' willingness to participate in such a support program. METHODS: PCPs assessed patients' eligibility for Internet-based self-management, and patients were offered the opportunity to participate. Characteristics of eligible and ineligible patients were compared, as well as those of participants and nonparticipants, also with regard to quality of life, treatment satisfaction, and illness perceptions. Multivariate logistic regression models were performed and odds ratios (ORs) calculated with 95% CIs. RESULTS: Almost half (128/282, 45.4%) of the patients with well-controlled T2DM were considered ineligible by their PCPs mainly because of cognitive impairment and language barriers (8.2% and 8.9%). Older patients (OR for each year 1.06, 95% CI 1.03-1.09, P<.001), non-Western European patients (OR 3.64, 95% CI 1.67-7.92, P=.001), and patients with a longer diabetes duration (OR for each year 1.56, 95% CI 1.04-2.34, P=.03) were more often regarded as ineligible. Of the 154 patients considered eligible, 57 (37.0%) consented to participate and 30 (10.6%) started the program. Of 57 participants, 45 returned the 3 questionnaires; 21 of 97 nonparticipants returned the questionnaires. Nonparticipants less often thought that their disease would last their entire life (median 8.0 vs 10.0, P=.03) and they were more satisfied with their current treatment than participants (DTSQ total score 44.0 vs 40.0, P=.05). There was no significant difference in quality of life between the 2 groups. CONCLUSIONS: PCPs considered half of their patients with well-controlled T2DM incapable of Internet-based self-management mainly because of cognitive impairment and language barriers; of the selected patients, about 1 out of 3 was willing to participate. Older patients, non-Western European patients, and patients with a higher BMI were less likely to participate. Predominantly, practical issues (such as Internet problems) hindered implementation of the Internet-based self-management program.

Is there evidence of potential overtreatment of glycaemia in elderly people with type 2 diabetes? Data from the GUIDANCE study.

AIMS: We used data from the GUIDANCE Study to determine the care of people with type 2 diabetes according to age and accompanying cardiovascular diseases and to assess indicators of overtreatment of glycaemia. METHODS: The GUIDANCE study was a retrospective, cross-sectional study from 2009-2010 based on the records of 7597 people in France, Belgium, Italy, the Netherlands, Sweden, UK, Ireland and Germany. We analysed the level of metabolic control achieved and blood glucose-lowering medication used in different age groups and in relation to accompanying diseases. RESULTS: 4.459 patients (59.1%) were 65 years or older. Their HbA1c levels were similar to those with <65 years. 44.7% of patients ≥65 years had an HbA1c ≤7% (53 mmol/mol) and were treated with insulin or sulfonylureas, and 27.1% of them had ischaemic heart disease or congestive heart failure. Significantly more patients with heart disease had HbA1c values ≤7% (53 mmol/mol) and were treated more often with insulin or sulfonylureas compared to patients of the same age without heart disease. CONCLUSIONS: Most patients were treated according to guidelines valid at the time this large international patient sample was surveyed. Older and younger patients were at a similar level of metabolic control, and almost half of the patients with an age of ≥65 years and treated with insulin or sulfonylurea had HbA1c levels below the target range (≤7%) for younger patients. However, these patients have an increased risk of severe hypoglycaemic events with potentially dangerous complications, particularly in those with cardiovascular diseases.

Patient-centeredness and quality management in Dutch diabetes care organizations after a 1-year intervention.

BACKGROUND: More focus on patient-centeredness in care for patients with type 2 diabetes requests increasing attention to diabetes quality management processes on patient-centeredness by managers in primary care groups and outpatient clinics. Although patient-centered care is ultimately determined by the quality of interactions between patients and clinicians at the practice level, it should be facilitated at organizational level too. This nationwide study aimed to assess the state of diabetes quality management on patient-centeredness at organizational level and its possibilities to improve after a tailored intervention. METHODS: This before-after study compares the quality management on patient-centeredness within Dutch diabetes care groups and outpatient clinics before and after a 1-year stepwise intervention. At baseline, managers of 51 diabetes primary care groups and 28 outpatient diabetes clinics completed a questionnaire about the organization's quality management program. Patient-centeredness (0%-100%) was operationalized in six subdomains: facilitating self-management support, individualized care plan support, patients' access to medical files, patient education policy, safeguarding patients' interests, and formal patient involvement. The intervention consisted of feedback and benchmark and if requested a telephone call and/or a consultancy visit. After 1 year, the managers completed the questionnaire again. The 1-year changes were examined by dependent (non) parametric tests. RESULTS: Care groups improved significantly on patient-centeredness (from 47.1% to 53.3%; P=0.002), and on its subdomains "access to medical files" (from 42.0% to 49.4%), and "safeguarding patients' interests" (from 58.1% to 66.2%). Outpatient clinics, which scored higher at baseline (66.7%) than care groups, did not improve on patient-centeredness (65.6%: P=0.54) or its subdomains. "Formal patient involvement" remained low in both care groups (23.2%) and outpatient clinics (33.9%). CONCLUSION: After a simple intervention, care groups significantly improved their quality management on patient-centeredness, but outpatient clinics did not. Interventions to improve quality management on patient-centeredness in diabetes care organizations should differ between primary and secondary care.

Insulin monotherapy compared with the addition of oral glucose-lowering agents to insulin for people with type 2 diabetes already on insulin therapy and inadequate glycaemic control.

BACKGROUND: It is unclear whether people with type 2 diabetes mellitus on insulin monotherapy who do not achieve adequate glycaemic control should continue insulin as monotherapy or can benefit from adding oral glucose-lowering agents to the insulin therapy. OBJECTIVES: To assess the effects of insulin monotherapy compared with the addition of oral glucose-lowering agents to insulin monotherapy for people with type 2 diabetes already on insulin therapy and inadequate glycaemic control. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and reference lists of articles. The date of the last search was November 2015 for all databases. SELECTION CRITERIA: Randomised controlled clinical trials of at least two months' duration comparing insulin monotherapy with combinations of insulin with one or more oral glucose-lowering agent in people with type 2 diabetes. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias, extracted data and evaluated overall quality of the evidence using GRADE. We summarised data statistically if they were available, sufficiently similar and of sufficient quality. We performed statistical analyses according to the statistical guidelines in the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: We included 37 trials with 40 treatment comparisons involving 3227 participants. The duration of the interventions ranged from 2 to 12 months for parallel trials and two to four months for cross-over trials.The majority of trials had an unclear risk of bias in several risk of bias domains. Fourteen trials showed a high risk of bias, mainly for performance and detection bias. Insulin monotherapy, including once-daily long-acting, once-daily intermediate-acting, twice-daily premixed insulin, and basal-bolus regimens (multiple injections), was compared to insulin in combination with sulphonylureas (17 comparisons: glibenclamide = 11, glipizide = 2, tolazamide = 2, gliclazide = 1, glimepiride = 1), metformin (11 comparisons), pioglitazone (four comparisons), alpha-glucosidase inhibitors (four comparisons: acarbose = 3, miglitol = 1), dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) (three comparisons: vildagliptin = 1, sitagliptin = 1, saxagliptin = 1) and the combination of metformin and glimepiride (one comparison). No trials assessed all-cause mortality, diabetes-related morbidity or health-related quality of life. Only one trial assessed patients' treatment satisfaction and showed no substantial differences between the addition of either glimepiride or metformin and glimepiride to insulin compared with insulin monotherapy.Insulin-sulphonylurea combination therapy (CT) compared with insulin monotherapy (IM) showed a MD in glycosylated haemoglobin A1c (HbA1c) of -1% (95% confidence interval (CI) -1.6 to -0.5); P < 0.01; 316 participants; 9 trials; low-quality evidence. Insulin-metformin CT compared with IM showed a MD in HbA1c of -0.9% (95% CI -1.2 to -0.5); P < 0.01; 698 participants; 9 trials; low-quality evidence. We could not pool the results of adding pioglitazone to insulin. Insulin combined with alpha-glucosidase inhibitors compared with IM showed a MD in HbA1c of -0.4% (95% CI -0.5 to -0.2); P < 0.01; 448 participants; 3 trials; low-quality evidence). Insulin combined with DPP-4 inhibitors compared with IM showed a MD in HbA1c of -0.4% (95% CI -0.5 to -0.4); P < 0.01; 265 participants; 2 trials; low quality evidence. In most trials the participants with CT needed less insulin, whereas insulin requirements increased or remained stable in participants with IM.We did not perform a meta-analysis for hypoglycaemic events because the included studies used different definitions.. In most trials the insulin-sulphonylurea combination resulted in a higher number of mild episodes of hypoglycaemia, compared to the IM group (range: 2.2 to 6.1 episodes per participant in CT versus 2.0 to 2.6 episodes per participant in IM; low-quality evidence). Pioglitazone CT also resulted in more mild to moderate hypoglycaemic episodes compared with IM (range 15 to 90 episodes versus 9 to 75 episodes, respectively; low-quality evidence. The trials that reported hypoglycaemic episodes in the other combinations found comparable numbers of mild to moderate hypoglycaemic events (low-quality evidence).The addition of sulphonylureas resulted in an additional weight gain of 0.4 kg to 1.9 kg versus -0.8 kg to 2.1 kg in the IM group (220 participants; 7 trials; low-quality evidence). Pioglitazone CT caused more weight gain compared to IM: MD 3.8 kg (95% CI 3.0 to 4.6); P < 0.01; 288 participants; 2 trials; low-quality evidence. Metformin CT was associated with weight loss: MD -2.1 kg (95% CI -3.2 to -1.1), P < 0.01; 615 participants; 7 trials; low-quality evidence). DPP-4 inhibitors CT showed weight gain of -0.7 to 1.3 kg versus 0.6 to 1.1 kg in the IM group (362 participants; 2 trials; low-quality evidence). Alpha-glucosidase CT compared to IM showed a MD of -0.5 kg (95% CI -1.2 to 0.3); P = 0.26; 241 participants; 2 trials; low-quality evidence.Users of metformin CT (range 7% to 67% versus 5% to 16%), and alpha-glucosidase inhibitors CT (14% to 75% versus 4% to 35%) experienced more gastro-intestinal adverse effects compared to participants on IM. Two trials reported a higher frequency of oedema with the use of pioglitazone CT (range: 16% to 18% versus 4% to 7% IM). AUTHORS' CONCLUSIONS: The addition of all oral glucose-lowering agents in people with type 2 diabetes and inadequate glycaemic control who are on insulin therapy has positive effects on glycaemic control and insulin requirements. The addition of sulphonylureas results in more hypoglycaemic events. Additional weight gain can only be avoided by adding metformin to insulin. Other well-known adverse effects of oral glucose-lowering agents have to be taken into account when prescribing oral glucose-lowering agents in addition to insulin therapy.

A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study.

BACKGROUND: Intensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain. OBJECTIVE: To quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes. DESIGN: Pragmatic, multicentre, cluster-randomised, parallel-group trial. SETTING: Three hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK. PARTICIPANTS: Individuals aged 40-69 years with screen-detected diabetes. INTERVENTIONS: Screening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol. MAIN OUTCOME MEASURES: The primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3; (©) Isis Innovation Ltd 2010; see www.dtu.ox.ac.uk/outcomesmodel (accessed 27 January 2016)]. RESULTS: We included 3055 (RC, n = 1377; IT, n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient. CONCLUSIONS: Compared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT00237549. FUNDING DETAILS: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

Cognitive Impairment in Diabetes: Rationale and Design Protocol of the Cog-ID Study.

BACKGROUND: Cognitive impairment frequently co-occurs with type 2 diabetes but is often undiagnosed. Cognitive impairment affects self-management leading to treatment-related complications. OBJECTIVE: The aim of this study is to develop a stepped diagnostic procedure, consisting of a screening test complemented by an evaluation by a general practitioner (GP), to detect undiagnosed cognitive impairment in older people with type 2 diabetes. METHODS: The accuracy of two self-administered cognitive tests, the "Test Your Memory" (TYM) and "Self-Administered Gerocognitive Examination" (SAGE) alone, and in combination with an evaluation by a GP will be assessed. A diagnosis of mild cognitive impairment (MCI) or dementia at a memory clinic will serve as reference standard. This cognitive impairment in diabetes (Cog-ID) study will include 513 people from primary care facilities aged ≥70 with type 2 diabetes. The participants will first fill out the TYM and SAGE tests, followed by a standardized GP evaluation for cognitive impairment, including a mini mental state examination (MMSE). Subsequently, participants suspected of cognitive impairment (on either test or the GP assessment) and a random sample of 15% (65/435) of participants without suspected cognitive impairment will be referred to the memory clinic. At the memory clinic, a medical examination, neuropsychological examination, and magnetic resonance imaging (MRI) of the brain will be performed. Participants will also fill out questionnaires assessing health status and depressive symptoms at baseline and after 6 and 24 months. RESULTS: This research obtained funding and ethical approval. Enrolment started in August, 2012, and all study-related activities will be completed in September, 2016. CONCLUSIONS: With the results from this study, physicians will be able to detect cognitive impairment affecting type 2 diabetes patients through case-finding, and can use tailored care to reduce associated complications. Additionally, the results may stimulate discussions about cognitive impairment and whether early recognition is desirable.

Peer support to decrease diabetes-related distress in patients with type 2 diabetes mellitus: design of a randomised controlled trial.

BACKGROUND: Many type 2 diabetes mellitus patients face difficulties self-managing their illness, which can lead to high levels of diabetes-related distress. Diabetes distress may be decreased by peer support, as peers understand and have dealt with similar problems, and can help motivate each other. A recent systematic review concluded that evidence of benefits of peer support in patients with type 2 diabetes mellitus is too inconsistent due to weak theoretical foundation of the interventions. This study describes the design of a trial evaluating the effectiveness of a group-based, peer support programme with a strong theoretical foundation on diabetes-related distress in type 2 diabetes patients. METHODS: This is a parallel group randomised controlled trial of a six session group-based peer support intervention, delivered by peer leaders and group psychotherapists, compared with one educational meeting on diabetes. At least 152 patients with a type 2 diabetes duration of three years or more and between 50 and 70 years of age, recruited via their general practitioner, will be randomised to receive the peer support intervention or one educational meeting. The intervention is developed in line with three key stages of research development of the Medical Research Council framework. The primary outcome measure for this study is diabetes-related distress. Secondary outcomes include self-management behaviour, well-being and health-related quality of life. Perceived social support is a process measure. Outcomes will be measured one month before, and 6, and 12 months after the intervention by means of self-reported questionnaires. Analysis will be on an intention-to-treat basis. DISCUSSION: This article contains a description of the design of a study that will investigate the effect of a group-based, peer support intervention on diabetes-related distress in type 2 diabetes patients. The intervention was developed in recognition of the limited evidence, and the importance of a theoretical foundation and its implementation. Findings will contribute to knowledge in the field of peer support and patient-important outcomes in type 2 diabetes patients. TRIAL REGISTRATION: Dutch Trial Registry: NTR3474.

Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital - design and development of a randomised controlled trial.

BACKGROUND: Type 2 diabetes mellitus patients with an acute coronary event (ACE) experience decreased quality of life and increased distress. According to the American Diabetes Association, discharge from the hospital is a time of increased distress for all patients. Tailored support specific to diabetes is scarce in that period. We developed an intervention based on Bandura's Social Cognitive Theory, Leventhal's Common Sense Model, and results of focus groups. The aim of this study is to evaluate the effectiveness of the intervention to reduce distress in type 2 diabetes patients who experienced a first ACE. METHODS: Randomised controlled trial. Two hundred patients are recruited in thirteen hospitals. A diabetes nurse visits the patients in the intervention group (n = 100) at home within three weeks after discharge from hospital, and again after two weeks and two months. The control group (n = 100) receives a consultation by telephone. The primary outcome is diabetes-related distress, measured with the Problem Areas in Diabetes (PAID) questionnaire. Secondary outcomes are well-being, health status, anxiety, depression, HbA1c, blood pressure and lipids. Mediating variables are self-management, self-efficacy and illness representations. Outcomes are measured with questionnaires directly after discharge from hospital and five months later. Biomedical variables are obtained from the records from the primary care physician and the hospital. Differences between groups in change over time are analysed according to the intention-to-treat principle. The Holm-Bonferroni correction is used to adjust for multiplicity. DISCUSSION: Type 2 diabetes patients who experience a first ACE need tailored support after discharge from the hospital. This trial will provide evidence on the effectiveness of a supportive intervention in reducing distress in these patients. TRIAL REGISTRATION: NCT01801631.

Towards a more efficient diabetes control in primary care: six-monthly monitoring compared with three-monthly monitoring in type 2 diabetes - The EFFIMODI trial. Design of a randomised controlled patient-preference equivalence trial in primary care.

BACKGROUND: Scientific evidence for the frequency of monitoring of type 2 diabetes patients is lacking. If three-monthly control in general practice could be reduced to six-monthly control in some patients, this would on the one hand reduce the use of medical services including involvement of practice nurses, and thus reduce costs, and on the other hand alleviate the burden of people with type 2 diabetes. The goal of this study is to make primary diabetes care as efficient as possible for patients and health care providers. Therefore, we want to determine whether six-monthly monitoring of well-controlled type 2 diabetes patients in primary care leads to equivalent cardiometabolic control compared to the generally recommended three-monthly monitoring. METHODS AND DESIGN: The study is a randomised controlled patient-preference equivalence trial. Participants are asked if they prefer three-monthly (usual care) or six-monthly diabetes monitoring. If they do not have a preference, they are randomised to a three-monthly or six-monthly monitoring group. Patients are eligible for the study if they are between 40 and 80 years old, diagnosed with type 2 diabetes more than one year ago, treated by a general practitioner, not on insulin treatment, and with HbA1c < or = 7.5%, systolic blood pressure < or = 145 mmHg and total cholesterol < or = 5.2 mmol/l. The intervention group (six-monthly monitoring) will receive the same treatment with the same treatment targets as the control group (three-monthly monitoring). The intervention period will last one and a half year. After the intervention, the three-monthly and six-monthly monitoring groups are compared on equivalence of cardiometabolic control. Secondary outcome measures are HbA1c, blood pressure, cholesterol level, Body Mass Index, smoking behaviour, physical activity, loss of work due to illness, health status, diabetes-specific distress, satisfaction with treatment and adherence to medications. We will use intention-to-treat analysis with repeated measures. For outcomes that have only baseline and final measurements, we will use ANCOVA. Depending on the results, a cost-minimisation analysis or an incremental cost-effectiveness analysis will be done. DISCUSSION: This study will provide valuable information on the most efficient control frequency of well-controlled type 2 diabetes patients in primary care.

Randomised controlled trial of intensive multifactorial treatment for cardiovascular risk in patients with screen-detected type 2 diabetes: 1-year data from the ADDITION Netherlands study.

BACKGROUND: A growing body of evidence suggests that earlier diagnosis and treatment of diabetes may be beneficial; however, definitive evidence is lacking. AIM: To evaluate the effectiveness of an intensified multifactorial treatment on cardiovascular risk factors in patients with screen-detected type 2 diabetes. DESIGN OF STUDY: Randomised controlled trial. SETTING: Seventy-nine general practices in the southwestern region of the Netherlands. METHOD: In this randomised trial, patients diagnosed with diabetes by screen-detection were assigned to intensified (n = 255) or routine treatment (n = 243), and followed over 1 year. Intensified treatment consisted of pharmacological treatment combined with lifestyle education to achieve haemoglobin A1c (HbA1c) <7.0%, blood pressure <135/85 mmHg, and cholesterol <5.0 mmol/l (4.5 mmol/l if cardiovascular disease was present). Health-related quality of life (HRQoL) was assessed using the Short Form (SF)-36. Analyses were performed using generalised estimating equations models. RESULTS: Changes in body mass index were 0.2 (routine care) versus -1.4 kg/m(2) (intensified treatment), P<0.001; systolic blood pressure -19 versus -33 mmHg, P<0.001; diastolic blood pressure -7 versus -12 mmHg, P<0.001; HbA1c -0.9% versus -1.1%, P = 0.03; cholesterol -0.5 versus -1.2 mmol/l, P<0.001; high-density lipoprotein cholesterol 0.1 versus 0.1 mmol/l, P = 0.26; low-density lipoprotein cholesterol -0.5 versus -1.0 mmol/l, P<0.001; triglycerides -0.3 versus -0.4 mmol/l, P = 0.71. No difference in HRQoL between the two groups was reported. CONCLUSION: Intensified multifactorial treatment of patients with screen-detected diabetes in general practice reduces cardiovascular risk factor levels significantly without worsening HRQoL.