Type 2 Diabetes Patients' Needs and Preferences for Care Concerning Sexual Problems: A Cross-Sectional Survey and Qualitative Interviews.

Sexual dysfunction is highly prevalent among patients with type 2 diabetes; however, little is known regarding these patients' needs and preferences for care for sexual problems. A cross-sectional survey and 25 semistructured interviews were therefore conducted among 40- to 75-year-old type 2 diabetes patients to explore this. We learned from the survey and interviews that most participants were unaware of the association between type 2 diabetes and sexual problems. Although certain barriers for discussing sexual problems with a care provider were identified (e.g., feelings of embarrassment), patients still reported a need for discussing their problems, because sex was viewed as an important part of their relationship. Some patients had sought help, but were dissatisfied with the offered care. Patients experienced a lack of attention and information from diabetes care providers. Improving this, together with a care provider-initiated conversation, was suggested to lower the threshold for discussion. Moreover, patients preferred a care provider with whom they have a close relationship, whereas age, gender, and medical specialty were regarded to be less important. An important recommendation was to make care for sexual problems an integral part of routine diabetes care. Future research should look into these recommendations.

Prevalence and Correlates of Sexual Dysfunction in Men and Women With Type 2 Diabetes.

This study aimed to assess the prevalence and correlates of sexual dysfunction in a sample of Dutch men and women with type 2 diabetes. Patients with type 2 diabetes who were between the ages of 40 and 75 years from 4 Dutch diabetes centers were asked to complete self-report questionnaires covering sociodemographic characteristics, medical characteristics, clinical depression (Center for Epidemiological Studies), and sexual dysfunction (in men: International Index of Erectile Function; in women: Female Sexual Function Index). In total, 158 type 2 diabetes patients (68% men) completed the cross-sectional survey. On the basis of predefined criteria, 69% of men and 70% of women were classified with some degree of sexual dysfunction. Univariable logistic regression analyses revealed that sexual dysfunctions were associated with higher age, clinical depression (Center for Epidemiological Studies score ≥16), and one or more diabetes-related complications in both men and women. Multivariable logistic regression analyses revealed that clinical depression was most strongly associated with both male (OR = 6.87, 95% CI [1.77, 26.63]) and female (OR = 9.33, 95% CI [1.03, 84.87]) sexual dysfunction. In conclusion, sexual dysfunction is highly prevalent in men and women with type 2 diabetes and is associated with higher age, clinical depression, and diabetes-related complications. These results suggest that addressing sexual dysfunction in diabetes care is important.

Effects of a cognitive behavioural treatment in patients with type 2 diabetes when added to managed care; a randomised controlled trial.

Effects of a cognitive behavioural treatment (CBT) in type 2 diabetes patients were studied in a randomised controlled trial. Patients were recruited from a diabetes care system (DCS). The intervention group (n = 76) received managed care from the DCS and CBT. The control group (n = 78) received managed care only. Effects on risk of developing coronary heart disease (CHD), clinical characteristics, lifestyle, determinants of behaviour change, quality of life, and depression were assessed after 6 and 12 months. The intervention did not result in a significant reduction of CHD risk (difference between intervention and control group was -0.32 % (95 % CI: -2.27; 1.63). The amount of heavy physical activity increased significantly in the intervention group at 6 months [intervention versus control group was 20.14 min/day (95 % CI: 4.6; 35.70)]. Quality of life and level of depression improved as well. All effects disappeared after 6 months. No effects were found on clinical characteristics.

Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin.

BACKGROUND: Self-monitoring of blood glucose (SMBG) has been found to be effective for patients with type 1 diabetes and for patients with type 2 diabetes using insulin. There is much debate on the effectiveness of SMBG as a tool in the self-management for patients with type 2 diabetes who are not using insulin. OBJECTIVES: To assess the effects of SMBG in patients with type 2 diabetes mellitus who are not using insulin. SEARCH METHODS: Multiple electronic bibliographic and ongoing trial databases were searched supplemented with handsearches of references of retrieved articles (date of last search: 07 July 2011). SELECTION CRITERIA: Randomised controlled trials investigating the effects of SMBG compared with usual care, self-monitoring of urine glucose (SMUG) or both in patients with type 2 diabetes who where not using insulin. Studies that used glycosylated haemoglobin A(1c) (HbA(1c)) as primary outcome were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from included studies and evaluated the studies' risk of bias. Data from the studies were compared to decide whether they were sufficiently homogeneous to pool in a meta-analysis. Primary outcomes were HbA(1c), health-related quality of life, well-being and patient satisfaction. Secondary outcomes were fasting plasma glucose level, hypoglycaemic episodes, morbidity, adverse effects and costs. MAIN RESULTS: Twelve randomised controlled trials were included and evaluated outcomes in 3259 randomised patients. Intervention duration ranged from 6 months (26 weeks) to 12 months (52 weeks). Nine trials compared SMBG with usual care without monitoring, one study compared SMBG with SMUG, one study was a three-armed trial comparing SMBG and SMUG with usual care and one study was a three-armed trial comparing less intensive SMBG and more intensive SMBG with a control group. Seven out of 11 studies had a low risk of bias for most indicators. Meta-analysis of studies including patients with a diabetes duration of one year or more showed a statistically significant SMBG induced decrease in HbA(1c) at up to six months follow-up (-0.3; 95% confidence interval (CI) -0.4 to -0.1; 2324 participants, nine trials), yet an overall statistically non-significant SMBG induced decrease was seen at 12 month follow-up (-0.1; 95% CI -0.3 to 0.04; 493 participants, two trials). Qualitative analysis of the effect of SMBG on well-being and quality of life showed no effect on patient satisfaction, general well-being or general health-related quality of life. Two trials reported costs of self-monitoring: One trial compared the costs of self-monitoring of blood glucose with self-monitoring of urine glucose based on nine measurements per week and with the prices in US dollars for self-monitoring in 1990. Authors concluded that total costs in the first year of self-monitoring of blood glucose, with the purchase of a reflectance meter were 12 times more expensive than self-monitoring of urine glucose ($481 or 361 EURO [11/2011 conversion] versus $40 or 30 EURO [11/2011 conversion]). Another trial reported a full economical evaluation of the costs and effects of self-monitoring. At the end of the trial, costs for the intervention were £89 (104 EURO [11/2011 conversion]) for standardized usual care (control group), £181 (212 EURO [11/2011 conversion]) for the less intensive self-monitoring group and £173 (203 EURO [11/2011 conversion]) for the more intensive self-monitoring group. Higher losses to follow-up in the more intensive self-monitoring group were responsible for the difference in costs, compared to the less intensive self-monitoring group.There were few data on the effects on other outcomes and these effects were not statistically significant. None of the studies reported data on morbidity. AUTHORS' CONCLUSIONS: From this review, we conclude that when diabetes duration is over one year, the overall effect of self-monitoring of blood glucose on glycaemic control in patients with type 2 diabetes who are not using insulin is small up to six months after initiation and subsides after 12 months. Furthermore, based on a best-evidence synthesis, there is no evidence that SMBG affects patient satisfaction, general well-being or general health-related quality of life. More research is needed to explore the psychological impact of SMBG and its impact on diabetes specific quality of life and well-being, as well as the impact of SMBG on hypoglycaemia and diabetic complications.

Long term patterns of use after initiation of oral antidiabetic drug therapy.

BACKGROUND: The benefits of intensive and continuous antihyperglycemic drug therapy have been extensively described. Data on long-term patterns and modifications of antihyperglycemic drug use are scarce however. Moreover randomized controlled studies may not reflect actual drug use in daily clinical practice. OBJECTIVE: The aim of this study is to describe the longitudinal patterns of antidiabetic drug modifications after initiation of oral antidiabetic therapy in a large cohort of type 2 diabetes patients. The study will focus specifically on differences between patients who initiate treatment with metformin compared to patients who initiate treatment with sulfonylureas. METHODS: An observational study of longitudinal patterns of use and modification of oral antidiabetic drug therapy in 3323 patients who started with oral antidiabetic treatment between 1999 and 2007. Drug dispensing data were extracted from pharmacy information systems. RESULTS: This study shows that changes in international guidelines recommending metformin as first choice initial drug therapy in all patients were rapidly followed by prescribers. Patients starting diabetes treatment with metformin showed fewer modifications to treatment compared to patients initiating treatment with sulfonylureas. After correction for duration of follow-up, Cox regression analysis showed a hazard ratio of 0.84 for any modification in the metformin group compared to the sulfonylureas group. CONCLUSIONS: This study shows that adherence to type 2 diabetes treatment guidelines for initial treatment is implemented on a large scale. Longitudinal patterns show that the majority of patients receive a small number of modifications to their drug regimen. Discontinuation rates were relatively low.

The effectiveness of case management for comorbid diabetes type 2 patients; the CasCo study. Design of a randomized controlled trial.

BACKGROUND: More than half of the patients with type 2 diabetes (T2DM) patients are diagnosed with one or more comorbid disorders. They can participate in several single-disease oriented disease management programs, which may lead to fragmented care because these programs are not well prepared for coordinating care between programs. Comorbid patients are therefore at risk for suboptimal treatment, unsafe care, inefficient use of health care services and unnecessary costs. Case management is a possible model to counteract fragmented care for comorbid patients. It includes evidence-based optimal care, but is tailored to the individual patients' preferences.The objective of this study is to examine the effectiveness of a case management program, in addition to a diabetes management program, on the quality of care for comorbid T2DM patients. METHODS/DESIGN: The study is a randomized controlled trial among patients with T2DM and at least one comorbid chronic disease (N=230), who already participate in a diabetes management program. Randomization will take place at the level of the patients in general practices. Trained practice nurses (case managers) will apply a case management program in addition to the diabetes management program. The case management intervention is based on the Guided Care model and includes six elements; assessing health care needs, planning care, create access to other care providers and community resources, monitoring, coordinating care and recording of all relevant information. Patients in the control group will continue their participation in the diabetes management program and receive care-as-usual from their general practitioner and other care providers. DISCUSSION: We expect that the case management program, which includes better structured care based on scientific evidence and adjusted to the patients' needs and priorities, will improve the quality of care coordination from both the patients' and caregivers' perspective and will result in less consumption of health care services. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1847.

Effect of medication review and cognitive behaviour treatment by community pharmacists of patients discharged from the hospital on drug related problems and compliance: design of a randomized controlled trial.

BACKGROUND: Drug related problems (DRPs) are common among elderly patients who are discharged from the hospital and are using several drugs for their chronic diseases. Examples of drug related problems are contra-indications, interactions, adverse drug reactions and inefficacy of treatment. Causes of these problems include prescription errors and non-compliance with treatment. The aim of this study is to examine the effect of medication review and cognitive behaviour therapy of discharged patients by community pharmacists to minimize the occurrence of drug related problems. METHODS/DESIGN: A randomized controlled trial will be performed. Community pharmacists will be randomized into a control group and an intervention group. 342 Patients, aged over 60 years, discharged from general and academic hospitals, using five or more prescription drugs for their chronic disease will be asked by their pharmacy to participate in the study. Patients randomized to the control group will receive usual care according to the Dutch Pharmacy Standard. The medication of patients randomised to the intervention group will be reviewed by the community pharmacist with use of the national guidelines for the treatment of diseases, when patients are discharged from the hospital. The Pharmaceutical Care network Europe Registration form will be used to record drug related problems. Trained pharmacy technicians will counsel patients at home at baseline and at 1,3,6,9 and 12 months, using Cognitive Behaviour Treatment according to the Theory of Planned Behaviour. The patient's attitude towards medication and patient's adherence will be subject of the cognitive behaviour treatment. The counselling methods that will be used are motivational interviewing and problem solving treatment. Patients adherence towards drug use will be determined with use of the Medication Adherence Report Scale Questionnaire. There will be a follow-up of 12 months.The two primary outcome measures are the difference in occurrence of DRPs between intervention and control group and adherence with drug use. Secondary endpoints are attitude towards drug use, incidence of Re-hospitalisations related to medicines, functional status of the patient, quality of life and the cost-effectiveness of this intervention. DISCUSSION: Combining both medication review and Cognitive Behaviour Treatment may decrease DRPs and may result in more compliance with drug use among patients discharged from the hospital and using 5 or more chronic drugs. TRIAL REGISTRATION: Dutch Trial Register NTR1194.

The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial.

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) have an increased risk to develop severe diabetes related complications, especially cardiovascular disease (CVD). The risk to develop CVD can be estimated by means of risk formulas. However, patients have difficulties to understand the outcomes of these formulas. As a result, they may not recognize the importance of changing lifestyle and taking medication in time. Therefore, it is important to develop risk communication methods, that will improve the patients' understanding of risks associated with having diabetes, which enables them to make informed choices about their diabetes care.The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception, attitude and intention to change lifestyle behaviour in patients with T2DM. The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory. METHODS: A randomised controlled trial will be performed in the Diabetes Care System West-Friesland (DCS), a managed care system. Newly referred T2DM patients of the DCS, younger than 75 years will be eligible for the study. The intervention group will be exposed to risk communication on CVD, on top of standard managed care of the DCS. This intervention consists of a simple explanation on the causes and consequences of CVD, and possibilities for prevention. The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram. The control group will receive standard managed care. The primary outcome is appropriateness of risk perception. Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception. Differences between baseline and follow-up (2 and 12 weeks) between groups will be analysed according to the intention-to-treat principle. The study was powered on 120 patients in each group. DISCUSSION: This innovative risk communication method based on two behavioural theories might improve patient's appropriateness of risk perception and attitude concerning lifestyle change. With a better understanding of their CVD risk, patients will be able to make informed choices concerning diabetes care. TRIAL REGISTRATION: The trial is registered as NTR1556 in the Dutch Trial Register.

Web-based guided insulin self-titration in patients with type 2 diabetes: the Di@log study. Design of a cluster randomised controlled trial [TC1316].

BACKGROUND: Many patients with type 2 diabetes (T2DM) are not able to reach the glycaemic target level of HbA1c < 7.0%, and therefore are at increased risk of developing severe complications. Transition to insulin therapy is one of the obstacles in diabetes management, because of barriers of both patient and health care providers. Patient empowerment, a patient-centred approach, is vital for improving diabetes management. We developed a web-based self-management programme for insulin titration in T2DM patients. The aim of our study is to investigate if this internet programme helps to improve glycaemic control more effectively than usual care. METHODS/DESIGN: T2DM patients (n = 248), aged 35-75 years, with an HbA1c > or = 7.0%, eligible for treatment with insulin and able to use the internet will be selected from general practices in two different regions in the Netherlands. Cluster randomisation will be performed at the level of general practices. Patients in the intervention group will use a self-developed internet programme to assist them in self-titrating insulin. The control group will receive usual care.Primary outcome is the difference in change in HbA1c between intervention and control group. Secondary outcome measures are quality of life, treatment satisfaction, diabetes self-efficacy and frequency of hypoglycaemic episodes. Results will be analysed according to the intention-to-treat principle. DISCUSSION: An internet intervention supporting self-titration of insulin therapy in T2DM patients is an innovative patient-centred intervention. The programme provides guided self-monitoring and evaluation of health and self-care behaviours through tailored feedback on input of glucose values. This is expected to result in a better performance of self-titration of insulin and consequently in the improvement of glycaemic control. The patient will be enabled to 'discover and use his or her own ability to gain mastery over his/her diabetes' and therefore patient empowerment will increase. Based on the self-regulation theory of Leventhal, we hypothesize that additional benefits will be achieved in terms of increases in treatment satisfaction, quality of life and self-efficacy. TRIAL REGISTRATION: Dutch Trial Register TC1316.

The effectiveness of adding cognitive behavioural therapy aimed at changing lifestyle to managed diabetes care for patients with type 2 diabetes: design of a randomised controlled trial.

BACKGROUND: In patients with type 2 diabetes, the risk for cardiovascular disease is substantial. To achieve a more favourable risk profile, lifestyle changes on diet, physical activity and smoking status are needed. This will involve changes in behaviour, which is difficult to achieve. Cognitive behavioural therapies focussing on self-management have been shown to be effective. We have developed an intervention combining techniques of Motivational Interviewing (MI) and Problem Solving Treatment (PST). The aim of our study is to investigate if adding a combined behavioural intervention to managed care, is effective in achieving changes in lifestyle and cardiovascular risk profile. METHODS: Patients with type 2 diabetes will be selected from general practices (n = 13), who are participating in a managed diabetes care system. Patients will be randomised into an intervention group receiving cognitive behaviour therapy (CBT) in addition to managed care, and a control group that will receive managed care only. The CBT consists of three to six individual sessions of 30 minutes to increase the patient's motivation, by using principles of MI, and ability to change their lifestyle, by using PST. The first session will start with a risk assessment of diabetes complications that will be used to focus the intervention. The primary outcome measure is the difference between intervention and control group in change in cardiovascular risk score. For this purpose blood pressure, HbA1c, total and HDL-cholesterol and smoking status will be assessed. Secondary outcome measures are quality of life, patient satisfaction, physical activity, eating behaviour, smoking status, depression and determinants of behaviour change. Differences between changes in the two groups will be analysed according to the intention-to-treat principle, with 95% confidence intervals. The power calculation is based on the risk for cardiovascular disease and we calculated that 97 patients should be included in every group. DISCUSSION: Cognitive behavioural therapy may improve self-management and thus strengthen managed diabetes care. This should result in changes in lifestyle and cardiovascular risk profile. In addition, we also expect an improvement of quality of life and patient satisfaction. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12666286.

Effects of cardiovascular disease risk communication for patients with type 2 diabetes on risk perception in a randomized controlled trial: the @RISK study.

OBJECTIVE: Patients with type 2 diabetes mellitus (T2DM) underestimate their risk of developing severe complications, and they do not always understand the risk communication by their caregivers. The aim of this study was to investigate the effects of an intervention focused on the communication of the absolute 10-year risk of developing cardiovascular disease (CVD) in patients with T2DM. RESEARCH DESIGN AND METHODS: A randomized controlled trial was performed in T2DM patients newly referred to the Diabetes Care System (DCS) West-Friesland, a managed-care system in the Netherlands. The intervention group (n = 131) received a six-step CVD risk communication. Control subjects (n = 130) received standard managed care. The primary outcome measure was appropriateness of risk perception (difference between actual CVD risk calculated by the UK Prospective Diabetes Study risk engine and risk perception). Secondary outcome measures were illness perceptions, attitude and intention to change behavior, satisfaction with the communication, and anxiety and worry about CVD risk. Patients completed questionnaires at baseline, at 2 weeks (immediately after the intervention), and at 12 weeks. RESULTS: Appropriateness of risk perception improved between the intervention and control groups at 2 weeks. This effect disappeared at 12 weeks. No effects were found on illness perceptions, attitude and intention to change behavior, or anxiety and worry about CVD risk. Patients in the intervention group were significantly more satisfied with the communication. CONCLUSIONS: This risk communication method improved patients' risk perception at 2 weeks but not at 12 weeks. Negative effects were not found, as patients did not become anxious or worried after the CVD risk communication.

Common variants in the type 2 diabetes KCNQ1 gene are associated with impairments in insulin secretion during hyperglycaemic glucose clamp.

BACKGROUND: Genome-wide association studies in Japanese populations recently identified common variants in the KCNQ1 gene to be associated with type 2 diabetes. We examined the association of these variants within KCNQ1 with type 2 diabetes in a Dutch population, investigated their effects on insulin secretion and metabolic traits and on the risk of developing complications in type 2 diabetes patients. METHODOLOGY: The KCNQ1 variants rs151290, rs2237892, and rs2237895 were genotyped in a total of 4620 type 2 diabetes patients and 5285 healthy controls from the Netherlands. Data on macrovascular complications, nephropathy and retinopathy were available in a subset of diabetic patients. Association between genotype and insulin secretion/action was assessed in the additional sample of 335 individuals who underwent a hyperglycaemic clamp. PRINCIPAL FINDINGS: We found that all the genotyped KCNQ1 variants were significantly associated with type 2 diabetes in our Dutch population, and the association of rs151290 was the strongest (OR 1.20, 95% CI 1.07-1.35, p = 0.002). The risk C-allele of rs151290 was nominally associated with reduced first-phase glucose-stimulated insulin secretion, while the non-risk T-allele of rs2237892 was significantly correlated with increased second-phase glucose-stimulated insulin secretion (p = 0.025 and 0.0016, respectively). In addition, the risk C-allele of rs2237892 was associated with higher LDL and total cholesterol levels (p = 0.015 and 0.003, respectively). We found no evidence for an association of KCNQ1 with diabetic complications. CONCLUSIONS: Common variants in the KCNQ1 gene are associated with type 2 diabetes in a Dutch population, which can be explained at least in part by an effect on insulin secretion. Furthermore, our data suggest that KCNQ1 is also associated with lipid metabolism.

Progression and regression: distinct developmental patterns of diabetic retinopathy in patients with type 2 diabetes treated in the diabetes care system west-friesland, the Netherlands.

OBJECTIVE: To identify distinct developmental patterns of diabetic retinopathy (DR) and assess the risk factor levels of patients in these clusters. RESEARCH DESIGN AND METHODS: A cohort of 3,343 patients with type 2 diabetes mellitus (T2DM) monitored and treated in the Diabetes Care System West-Friesland, the Netherlands, was followed from 2 to 6 years. Risk factors were measured, and two-field fundus photographs were taken annually and graded according to the EURODIAB study group. Latent class growth modeling was used to identify distinct developmental patterns of DR over time. RESULTS: Five clusters of patients with distinct developmental patterns of DR were identified: A, patients without any signs of DR (88.9%); B, patients with a slow regression from minimal background to no DR (4.9%); C, patients with a slow progression from minimal background to moderate nonproliferative DR (4.0%); D, patients with a fast progression from minimal or moderate nonproliferative to (pre)proliferative or treated DR (1.4%); and E, patients with persistent proliferative DR (0.8%). Patients in clusters A and B were characterized by lower risk factor levels, such as diabetes duration, HbA(1c), and systolic blood pressure compared with patients in progressive clusters (C-E). CONCLUSIONS: Clusters of patients with T2DM with markedly different patterns of DR development were identified, including a cluster with regression of DR. These clusters enable a more detailed examination of the influence of various risk factors on DR.

The association of mitochondrial content with prevalent and incident type 2 diabetes.

CONTEXT: It has been shown that mitochondrial DNA (mtDNA) content is associated with type 2 diabetes (T2D) and related traits. However, empirical data, often based on small samples, did not confirm this observation in all studies. Therefore, the role of mtDNA content in T2D remains elusive. OBJECTIVE: In this study, we assessed the heritability of mtDNA content in buccal cells and analyzed the association of mtDNA content in blood with prevalent and incident T2D. DESIGN AND SETTING: mtDNA content from cells from buccal and blood samples was assessed using a real-time PCR-based assay. Heritability of mtDNA content was estimated in 391 twins from the Netherlands Twin Register. The association with prevalent T2D was tested in a case control study from The Netherlands (n = 329). Incident T2D was analyzed using prospective samples from Finland (n = 444) and The Netherlands (n = 238). MAIN OUTCOME MEASURES: We measured the heritability of mtDNA content and the association of mtDNA content in blood with prevalent and incident T2D. RESULTS: A heritability of mtDNA content of 35% (19-48%) was estimated in the twin families. We did not observe evidence of an association between mtDNA content and prevalent or incident T2D and related traits. Furthermore, we observed a decline in mtDNA content with increasing age that was male specific (P = 0.001). CONCLUSION: In this study, we show that mtDNA content has a heritability of 35% in Dutch twins. There is no association between mtDNA content in blood and prevalent or incident T2D and related traits in our study samples.