Integrated cardiovascular risk management programme versus usual care in patients at high cardiovascular risk: an observational study in general practice.

BACKGROUND: Cardiovascular diseases (CVDs) are the leading cause of death worldwide. Despite the impact of CVDs, risk factors are often insufficiently controlled in patients at high risk. Recently, integrated multidisciplinary cardiovascular risk management (CVRM) programmes have been introduced in primary care. AIM: To investigate the effects of a CVRM programme on systolic blood pressure (SBP) and low-density lipoprotein (LDL)-cholesterol. DESIGN & SETTING: A prospective observational study was undertaken in patients at high cardiovascular (CV) risk who were aged 40-80 years. Integrated CVRM care was compared with usual care in general practice in the Netherlands. METHOD: Intervention and usual care patients were matched at baseline on age, sex, and presence of CVD. During 1 year of follow-up, patients received integrated or usual CVRM care in general practice. Primary outcomes were SBP and LDL-cholesterol. Secondary outcomes included calculated 10-year CV risk, body mass index (BMI), lifestyle (smoking, physical activity, and dietary habits), medication use, patient satisfaction, healthcare consumption, morbidity, comorbidity, and mortality. Mixed-model analyses were used to assess the outcomes. RESULTS: Totals of 372 and 317 patients were included in the intervention and usual care group, respectively. Mean age at baseline was 65.1 years and 66.2 years, respectively, and 42% were female in both groups. After 1 year, no differences were observed in: SBP (137.2 mmHg versus 139.0 mmHg in the intervention and usual care group, respectively); LDL-cholesterol (2.6 mmol/l in both groups); or in any of the secondary outcomes. CONCLUSION: Integrated CVRM care in general practice did not lead to a lower SBP or LDL-cholesterol in patients at high CV risk. Further research is needed to improve CVRM.

Impact of elevated HbA1c on long-term mortality in patients presenting with acute myocardial infarction in daily clinical practice: insights from a 'real world' prospective registry of the Zwolle Myocardial Infarction Study Group.

BACKGROUND: Long-term clinical outcome is less well known in up to presentation persons unknown with diabetes mellitus who present with acute myocardial infarction and elevated glycosylated haemoglobin (HbA1c) levels on admission. We aimed to study the prognostic impact of deranged HbA1c at presentation on long-term mortality in patients not known with diabetes, presenting with acute myocardial infarction. METHODS: A single-centre, large, prospective observational study in patients with and without known diabetes admitted to our hospital for ST-segment elevation myocardial infarction (STEMI) and non-STEMI. Newly diagnosed diabetes mellitus was defined as HbA1c of 48 mmol/l or greater and pre-diabetes mellitus was defined as HbA1c between 39 and 47 mmol/l. The primary endpoint was all-cause mortality at short (30 days) and long-term (median 52 months) follow-up. RESULTS: Out of 7900 acute myocardial infarction patients studied, 1314 patients (17%) were known diabetes patients. Of the 6586 patients without known diabetes, 3977 (60%) had no diabetes, 2259 (34%) had pre-diabetes and 350 (5%) had newly diagnosed diabetes based on HbA1c on admission. Both short-term (3.9% vs. 7.4% vs. 6.0%, p<0.001) and long-term mortality (19% vs. 26% vs. 35%, p<0.001) for both pre-diabetes patients as well as newly diagnosed diabetes patients was poor and comparable to known diabetes patients. After multivariate analysis, newly diagnosed diabetes was independently associated with long-term mortality (hazard ratio 1.72, 95% confidence interval 1.27-2.34, P=0.001). CONCLUSIONS: In the largest study to date, newly diagnosed or pre-diabetes was present in 33% of acute myocardial infarction patients and was associated with poor long-term clinical outcome. Newly diagnosed diabetes (HbA1c ⩾48 mmol/mol) is an independent predictor of long-term mortality. More attention to early detection of diabetic status and initiation of blood glucose-lowering treatment is necessary.

Prescribing quality in secondary care patients with different stages of chronic kidney disease: a retrospective study in the Netherlands.

OBJECTIVES: Insight in the prescribing quality for patients with chronic kidney disease (CKD) in secondary care is limited. The aim of this study is to assess the prescribing quality in secondary care patients with CKD stages 3-5 and possible differences in quality between CKD stages. DESIGN: This was a retrospective cohort study. SETTING: Data were collected at two university (n=569 and n=845) and one non-university nephrology outpatient clinic (n=1718) in the Netherlands. PARTICIPANTS: Between March 2015 and August 2016, data were collected from patients with stages 3a-5 CKD seen at the clinics. Blood pressure measurements, laboratory measurements and prescription data were extracted from medical records. For each prescribing quality indicator, patients with incomplete data required for calculation were excluded. OUTCOME MEASURES: Potentially appropriate prescribing of antihypertensives, renin-angiotensin-aldosterone system (RAAS) inhibitors, statins, phosphate binders and potentially inappropriate prescribing according to prevailing guidelines was assessed using prescribing quality indicators. Χ2 or Fisher's exact tests were used to test for differences in prescribing quality. RESULTS: RAAS inhibitors alone or in combination with diuretics (57% or 52%, respectively) and statins (42%) were prescribed less often than phosphate binders (72%) or antihypertensives (94%) when indicated. Active vitamin D was relatively often prescribed when potentially not indicated (19%). Patients with high CKD stages were less likely to receive RAAS inhibitors but more likely to receive statins when indicated than stage 3 CKD patients. They also received more active vitamin D and erythropoietin-stimulating agents when potentially not indicated. CONCLUSIONS: Priority areas for improvement of prescribing in CKD outpatients include potential underprescribing of RAAS inhibitors and statins, and potential overprescribing of active vitamin D. CKD stage should be taken into account when assessing prescribing quality.

Standing orthostatic blood pressure measurements cannot be replaced by sitting measurements.

As many elderly patients are not able to stand for several minutes, sitting orthostatic blood pressure (BP) measurements are sometimes used as an alternative. We aimed to investigate the difference in BP response and orthostatic hypotension (OH) prevalence between the standard postural change to the sitting and the standing position in a cross-sectional observational study. BP was measured with a continuous BP measurement device during two postural changes, from supine to the sitting and from supine to the standing position. Linear mixed models were used to investigate the differences in changes (Δ) of systolic BP (SBP) and diastolic BP (DBP) between the two postural changes. The prevalence and the positive and negative proportions of agreement of OH were calculated of the two postural changes. One hundred and four patients with a mean age of 69 years were included. ΔSBP was significantly larger in the standing position compared with the sitting between 0 and 44 s. ΔDBP was significantly larger in the sitting position compared with the standing 75-224 s after postural change. The prevalence of OH was 66.3% (95% confidence interval (CI) 57.2, 75.4) in the standing position and 67.3% (95% CI 58.3, 76.3) in the sitting position. The positive proportion of agreement was 74.8% and the negative proportion of agreement was 49.3%. A clear difference was seen in BP response between the two postural changes. Although no significant difference in prevalence of OH was observed, the positive and negative proportion of agreement of the prevalence of OH were poor to moderate, which indicates a different outcome between both postural changes.

Fifteen-year follow-up of quality of life in type 1 diabetes mellitus.

AIM: To evaluate metabolic control and health-related quality of life (HRQOL) in a type 1 diabetes mellitus (T1DM) population. METHODS: As part of a prospective cohort study, 283 T1DM patients treated with various insulin treatment modalities including multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII) were examined annually. HRQOL was measured using the SF-36 and EuroQol questionnaires. Data regarding HRQOL, glycaemic and metabolic control from baseline and follow-up measures in 2002 and 2010 were analysed. Linear mixed models were used to calculate estimated values and differences between the three moments in time and the three treatment modalities. RESULTS: Significant changes [mean Δ (95%CI)] in body mass index [2.4 kg/m(2) (1.0, 3.8)], systolic blood pressure [-6.4 mmHg (-11.4, -1.3)] and EuroQol-VAS [-7.3 (-11.4, -3.3)] were observed over time. In 2010, 168 patients were lost to follow-up. Regarding mode of therapy, 52 patients remained on MDI, 28 remained on CSII, and 33 patients switched from MDI to CSII during follow-up. Among patients on MDI, HRQOL decreased significantly over time: mental component summary [-9.8 (-16.3, -3.2)], physical component summary [-8.6 (-15.3, -1.8)] and EuroQol-VAS [-8.1 (-14.0, -2.3)], P < 0.05 for all. For patients using CSII, the EuroQol-VAS decreased [-9.6 (-17.5, -1.7)]. None of the changes over time in HRQOL differed significantly with the changes over time within the other treatment groups. CONCLUSION: No differences with respect to metabolic and HRQOL parameters between the various insulin treatment modalities were observed after 15 years of follow-up in T1DM patients.

Device-guided breathing exercises for the treatment of hypertension: An overview.

The American Heart Association considers device-guided breathing as a reasonable treatment modality in their statement on non-pharmacological options for lowering blood pressure. This review discusses all randomized controlled trials that have investigated the effects of device-guided breathing on blood pressure in patients with hypertension. Thirteen studies were included in this review. In total, 627 patients were included, of which 365 patients were allocated to device-guided breathing. Only 6 studies used acceptable control groups: listening to music, meditative relaxation exercises, or a sham-device. Two sponsored trials showed beneficial effects of device-guided breathing, both used listening to music as a control group. The remaining 4 studies, which had no employees of the manufacturer listed as co-author, observed no beneficial effects on blood pressure. There is only 1 study that used a sham device as a control group. All other studies were to some extend methodologically flawed. Based on the studies with an acceptable methodological quality, there is no clear evidence supporting a short-term beneficial effect on blood pressure by using device-guided breathing.

Chromium does not belong in the diabetes treatment arsenal: Current evidence and future perspectives.

Chromium is considered to have positive effects on insulin sensitivity and is marketed as an adjunctive therapy for inducing glucose tolerance in cases of insulin resistance ("the glucose tolerance factor"). Case reports on patients who received prolonged parenteral nutrition indeed showed that the absence of trivalent chromium caused insulin resistance and diabetes. However, whether patients with type 2 diabetes can develop a clinically relevant chromium deficiency is unclear. This review summarizes the available evidence regarding the potential effectiveness of chromium supplementation on glycemic control (Hemoglobin A1c levels) in patients with type 2 diabetes. No studies investigating the long-term safety of chromium in humans were found. All clinical trials that have been performed had a relative short follow-up period. None of the trials investigated whether the patients had risk factors for chromium deficiency. The evidence from randomized trials in patients with type 2 diabetes demonstrated that chromium supplementation does not effectively improve glycemic control. The meta-analyses showed that chromium supplementation did not improve fasting plasma glucose levels. Moreover, there were no clinically relevant chromium effects on body weight in individuals with or without diabetes. Future studies should focus on reliable methods to estimate chromium status to identify patients at risk for pathological alterations in their metabolism associated with chromium deficiency. Given the present data, there is no evidence that supports advising patients with type 2 diabetes to take chromium supplements.

Continuous intraperitoneal insulin infusion in type 1 diabetes: a 6-year post-trial follow-up.

BACKGROUND: Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump is a treatment option for patients with type 1 diabetes mellitus (T1DM). Aim of the present study was to describe the long-term course of glycaemic control, complications, health related quality of life (HRQOL) and treatment satisfaction among T1DM patients treated with CIPII. METHODS: Nineteen patients that participated in a randomized cross-over trial comparing CIPII and subcutaneous (SC) therapy in 2006 were followed until 2012. Laboratory, continuous glucose monitoring, HRQOL and treatment satisfaction measurements were performed at the start of the study, the end of the SC-, the end of the CIPII treatment phase in 2006 and during CIPII therapy in 2012. Linear mixed models were used to calculate estimated values and to test differences between the moments in time. RESULTS: In 2012, more time was spent in hyperglycaemia than after the CIPII treatment phase in 2006: 37% (95% CI 29, 44) vs. 55% (95% CI 48, 63), mean difference 19.8% (95% CI 3.0, 36.6). HbA1c was 65 mmol/mol (95% CI 60, 71) at the end of the SC treatment phase in 2006, 58 mmol/mol (95% CI 53, 64) at the end of the CIPII treatment phase and 65 mmol/mol (95% CI 60, 71) in 2012, respectively (p > 0.05). In 2012, the median number of grade 2 hypoglycaemic events per week (1 (95% CI 0, 2)) was still significantly lower than during prior SC therapy (3 (95% CI 2, 4)): mean change -1.8 (95% CI -3.4, -0.4). Treatment satisfaction with CIPII was better than with SC insulin therapy and HRQOL remained stable. Pump or catheter dysfunction of the necessitated re-operation in 7 patients. No mortality was reported. CONCLUSIONS: After 6 years of CIPII treatment, glycaemic regulation is stable and the number of hypoglycaemic events decreased compared to SC insulin therapy. Treatment satisfaction with CIPII is superior to SC insulin therapy, HRQOL is stable and complications are scarce. CIPII is a safe and effective treatment option for selected patients with T1DM, also on longer term.

Design of the e-Vita diabetes mellitus study: effects and use of an interactive online care platform in patients with type 2 diabetes (e-VitaDM-1/ZODIAC-40).

UNLABELLED: Trial registration: NCT01570140. BACKGROUND: Due to ongoing rise in need for care for people with chronic diseases and lagging increase in number of care providers, alternative forms of care provision and self-management support are needed. Empowering patients through an online care platform could help to improve patients' self-management and reduce the burden on the healthcare system. METHODS: Access to laboratory results and educational modules on diabetes will be offered through a platform for subjects with type 2 diabetes mellitus treated in primary care. Differences in socio-demographic and clinical characteristics between subjects expressing interest vs. disinterest to use the platform will be explored. Platform usage will be tracked and compared. Patient satisfaction and quality of life will be measured by validated questionnaires and economic analyses will be performed. DISCUSSION: This study is designed to assess the feasibility of use of an online platform in routine primary healthcare for subjects with type 2 diabetes mellitus in the Netherlands, and to study effects of use of the platform on treatment satisfaction, quality of life and clinical parameters. Although providing access to a online platform is not a novel intervention, usage and effects have not yet been studied in this patient population.

Web-based self-management with and without coaching for type 2 diabetes patients in primary care: design of a randomized controlled trial.

BACKGROUND: Self-management is recognized as the cornerstone of overall diabetes management. Web-based self-management programs have the potential of supporting type 2 diabetes patients with managing their diabetes and reducing the workload for the care provider, where the addition of online coaching could improve patient motivation and reduce program attrition. This study aims to test the hypothesis that a web-based self-management program with coaching will prove more effective on improving patient self-management behavior and clinical outcome measures than a web-based self-management program without coaching. METHODS: The effects of a web-based self-management program with and without coaching will be tested with a nested randomized controlled trial within a healthcare group in the Netherlands. In one year 220 type 2 diabetes patients will be randomized into an intervention group (n = 110) or a control group (n = 110). The control group will receive only the online self-management program. The intervention group will receive the online self-management program and additional online coaching. Participants will be followed for one year, with follow-up measurements at 6 and 12 months. DISCUSSION: The intervention being tested is set to support type 2 diabetes patients with their diabetes self-management and is expected to have beneficial effects on self-care activities, well being and clinical outcomes. When proven effective this self-management support program could be offered to other health care groups and their type 2 diabetes patients in the Netherlands. TRIAL REGISTRATION: Nederlands Trial Register NTR4064.

Complications of continuous intraperitoneal insulin infusion with an implantable pump.

AIM: To monitor the course of continuous intraperitoneal insulin infusion (CIPII) and to gain more insight into possible complications. METHODS: A retrospective, longitudinal observational cohort study in patients with type 1 diabetes mellitus (T1DM) was performed. Only patients with "brittle" T1DM who started CIPII between January 1, 2000 and June 1, 2011, and were treated in the only centre in The Netherlands providing CIPII treatment (Isala clinics, Zwolle) were eligible for inclusion. Outcomes were defined as operation-free period (OFP), rate and type of complications. Subanalyses were made between patients starting CIPII from 2000 to 2007 and from 2007 onwards in order to study possible changes over time in complications and/or OFP. The OFP was calculated as the time from initial implantation to the date of first documented re-operation. If patients had not experienced an operation, their data were recorded at the date of last follow up or death. Kaplan-Meier curves were constructed to visualize the OFP. A (two-sided) P value of less than 0.05 was considered statistically significant. RESULTS: Fifty-seven patients were treated with CIPII, although one patient was excluded from analyses because of self-induced complications. In the remaining 56 patients, 70 complications occurred during 283 patient years. Catheter occlusion (32.9%), pump dysfunction (17.1%), pain at the pump site (15.7%) and infections (10.0%) were the most frequent complications. This resulted in a median OFP of 4.5 years (95% confidence interval 4.1-4.8 years) without any difference between the time periods. Fifty re-operations were performed because of complications, one per 5.6 patient years, with a decrease in pump dysfunction (P = 0.04) and pump explantations (P = 0.02) after 2007. In total, 9 episodes of ketoacidosis occurred during follow up and there were 69 hospital re-admissions, with a median duration of 6 d. CIPII was ceased in five patients due to recurrent infections (n = 2), pain (n = 1), inadequate glycaemic control (n = 1) or by own choice (n = 1). No CIPII related mortality was reported. CONCLUSION: The OFP has been stable over the last decade. No CIPII related mortality was reported. A significant decrease in pump dysfunction and explantation was seen after 2007 compared to the period 2000-2007. CIPII remains a safe treatment modality for specific patient groups.

Perspectives of patients with type 1 or insulin-treated type 2 diabetes on self-monitoring of blood glucose: a qualitative study.

BACKGROUND: Self-monitoring of blood glucose (SMBG), including self-regulation, is an important tool to achieve good glycemic control. However, many patients measure their glucose concentrations less often than is recommended. This study investigates patients' perspectives of SMBG and all relevant aspects influencing SMBG in patients with type 1 and insulin-treated type 2 diabetes. METHODS: In depth interviews were conducted with 13 patients with type 1 diabetes from an outpatient clinic and 15 patients with type 2 diabetes from general practices. All interviews were transcribed verbatim and analyzed using the Grounded Theory approach. RESULTS: A wide variety of SMBG was encountered. Perceptions, goals of SMBG and personal and contextual factors were identified, influencing the respondents' perspective of SMBG, and leading to this variety. Respondents experienced a discrepancy between their own and the professionals' perceptions and goals. Respondents' perception of SMBG ranged along a continuum from 'friend' to 'foe'. With respect to the goals, the respondents experienced tension between achieving good glycemic control and quality of life, and deliberately made their own choices. The performance of SMBG was tailored to their perceptions and personal goals. Personal and contextual factors such as hypo- or hyper (un)awareness, knowledge, and contact with professionals acted as either facilitating factors or as barriers to SMBG, depending on the respondents' perspective. A SMBG model was developed providing a representation of the factors and their interrelations.Respondents with type 1 diabetes seemed more resigned to their situation and SMBG was more integrated into their lives. CONCLUSIONS: From the patients' perspective, professionals positively present SMBG as a 'friend' in order to achieve strict glycemic control. Whereas patients can also perceive SMBG as a 'foe'. They primarily seek a personal balance between achieving glycemic control and quality of life, leading them to deliberately make other choices regarding SMBG performance than was recommended. Gaining insight and discussing all factors affecting SMBG will help professionals and patients come to mutually agreed goals and to tailor the performance of SMBG to the individual patient. This should result in a more optimal use of SMBG, an improved quality of life, and improved clinical parameters.

Self-monitoring of blood glucose in noninsulin-treated type 2 diabetes: an overview.

INTRODUCTION: The effectiveness of self-monitoring of blood glucose (SMBG) in noninsulin-treated patients with type 2 diabetes (T2DM) remains unclear. We aimed to review the trials investigating the effects of SMBG in this population. METHODS: Medline was searched until June 29, 2009. Randomized controlled trials (RCTs) of at least 12 weeks' duration were included. Data on the following aspects were gathered: patient and study characteristics, effects on HbA(1c), quality of life and treatment satisfaction, and methodological quality. RESULTS: The search revealed 9 original RCTs. These studies were very heterogeneous, and 5 were classified as of high quality. The studies with the best methodology did not show an effect of SMBG on HbA(1c), the studies with the worst methodological quality did. Two out of the 4 studies that assessed quality of life showed a significant change in favor of the control group, 1 study showed a significant change in favor of SMBG. DISCUSSION AND CONCLUSION: We found an inverse relation between study quality and efficacy of SMBG. At this moment, there is no basis for general use of SMBG in noninsulin-treated T2DM patients.