Search

Aim: To investigate changes in body weight trajectories after the addition of individual sulphonylureas (SUs) to metformin in patients with type 2 diabetes.Materials and methods: We conducted a retrospective observational cohort study, in a primary care setting in the Netherlands. Patients aged >= 18 years with type 2 diabetes who were included in the ZODIAC cohort between 1998 and 2012 and who received metformin monotherapy at inclusion (n = 29 195), and had used metformin as monotherapy for at least 1 year before receiving dual therapy through the addition of an SU for at least 1 year were eligible for inclusion. The primary outcome was within-drug yearly change in body weight after receiving add-on therapy with individual SUs during 5 years of follow-up. The secondary outcome was within-drug yearly change in glycated haemoglobin (HbA1c). Annual changes in weight and HbA1c were estimated with linear mixed models, adjusted for age, gender and diabetes duration.Results: A total of 2958 patients were included. No significant weight changes were observed within and between any of the individual SUs after treatment intensification (p = 0.24). In addition, no significant difference in weight between the add-on therapy combinations was observed (p = 0.26). The average HbA1c the year before intensification was 7.2% (55 mmol/mol) and dropped below 7.0% (53 mmol/mol) the year after.Conclusions: In patients with type 2 diabetes treated in primary care, strict glycaemic control can be maintained with SUs used as add-on therapy to metformin, without the offset of relevant weight changes.

Background: Recent decades have seen a constant upward projection in the prevalence of diabetes. Attempts to estimate diabetes prevalence rates based on relatively small population samples quite often result in underestimation. The aim of the present study was to investigate whether the Dutch diabetes prevalence estimate of 930 000 for 2013, based on a relatively small sample, still holds true when a larger population is studied using actual prevalence data. Methods: Data were collected from 92 primary care groups, including the total number of people with and without diabetes in 2013. Patients with diabetes were identified using the International Classification of Primary Care codes T90.02 (diabetes mellitus type 2; T2DM), T90.01 (diabetes mellitus type 1) and T90 (diabetes mellitus). Prevalence data were compared with previous estimates made in 2009. Diabetes prevalence was estimated using linear extrapolation. Results: Complete data were available from 67 (73%) care groups, which together provided care for 7 922 403 subjects; 431 396 patients were coded as having diabetes, of whom 406 183 were coded as having T2DM. Based on these results, the extrapolated Dutch diabetes prevalence was 914 387 (5.45%). Conclusions The results show that the previous estimate (reported in 2009), which was based on data collected in 2007, resulted in a

Background Patients with type 2 diabetes (T2D) are at increased risk for developing cancer. As approximately 8% of the world’s population is living with T2D, even a slight increase in cancer risk could result in an enormous impact on the number of persons developing cancer. In addition, several glucose lowering drug classes for treating patients with T2D have been associated with a difference in risk of cancer overall, and especially for obesity related cancers. In what way and to what degree cancer risk is modified by the use of different sulfonylureas (SU) is unclear. The primary aim of this study will be to evaluate within-class SU differences in obesity related cancer risk. Secondary aims will be to investigate within-class SU differences in risk for all cancers combined and site-specific cancers separately (i.e. breast, colorectal, prostate, bladder and lung cancer) and to account for duration-response relationships between individual SU use and cancer risk. Methods Patients will be selected from a Dutch primary care cohort of patients with T2D linked with the Dutch Cancer Registration (ZODIAC-NCR). Within this cohort study annually collected clinical data (e.g. blood pressure, weight, HbA1c) and nationwide data on cancer incidence are available. Time-dependent cox proportional hazard analyses will be performed to evaluate SU cancer risk, adjusted for potential confounders. Discussion This study will be the first prospective cohort study investigating within-class SU differences in cancer risk and could contribute to improved decision making regarding the individual drugs within the class of SUs, and possibly improve quality of life and result in an increased cost-effectiveness of healthcare in patients with T2D. Trial registration Nederlands Trialregister ( NTR6166 ), 6 Jan 2017.

IMPORTANCE: Device-guided breathing (DGB) is recommended by the American Heart Association for its blood pressure-lowering effects. Most previous studies that showed beneficial effects on blood pressure had low methodological quality and only investigated short-term blood pressure effects.OBJECTIVE: To assess the efficacy of DGB on blood pressure in a meta-analysis of individual patient data from blinded, randomized controlled trials with an active control group.DATA SOURCES: MEDLINE, EMBASE, clinicaltrials.gov, and the Cochrane Library.STUDY SELECTION: Included were randomized studies of at least 4 weeks' duration, with a single- or double-blind design and an active control group. Bias was assessed with the Cochrane risk of bias tool, and analyses were performed with linear mixed models.DATA EXTRACTION AND SYNTHESIS: Articles were searched in MEDLINE (using PubMed), EMBASE, and the Cochrane Library.MAIN OUTCOMES AND MEASURES: Office blood pressure.RESULTS: From the 15 selected abstracts, 5 studies were suitable for inclusion. Individual patient data from 2 of 5 studies were not provided. The effect of DGB on office systolic blood pressure compared with music therapy or a sham device was 2.2 mm Hg (95% CI, -2.7 to 7.0) in favor of the control group; DGB did not significantly lower office diastolic blood pressure (0.2 mm Hg [95% CI, -2.8 to 3.1] in favor of DGB).CONCLUSIONS AND RELEVANCE: All trials included in the analysis had a short follow-up period; therefore, no recommendations could be made regarding hypertension treatment. Treatment with DGB did not significantly lower office blood pressure compared with a sham procedure or music therapy.

Van Hateren KJJ, Houweling ST, De Bock GH, Van Dijk PR, Groenier KH, Gans ROB, et al. Veiligheid en effectiviteit van gliclazide. Huisarts Wet 2014;57(8):400-3. In deze meta-analyse hebben wij de veiligheid en effectiviteit van gliclazide onderzocht en vergeleken met die van andere orale bloedglucoseverlagende middelen. Op 17 april 2013 hebben we Medline (PubMed), EMBASE en de Cochrane-database doorzocht op geschikte gerandomiseerde onderzoeken met een minimale onderzoeksduur van twaalf weken bij volwassenen met diabetes mellitus type 2, waarbij een verandering in HbA1c werd gerapporteerd en gliclazide werd vergeleken met een ander oraal middel. De primaire uitkomstmaat wat betreft veiligheid was het aantal patienten met minimaal een ernstige hypoglykemie, en ten aanzien van effectiviteit de verandering in HbA1c. We hebben 19 onderzoeken geincludeerd, bijna alle van een slechte methodologische kwaliteit. Het HbA1c daalde 0,12% (95%-BI 0,01 tot 0,23%) meer in de gliclazidegroep dan in de actieve controlegroepen. We vonden 1 ernstige hypoglykemie bij 2387 gliclazidegebruikers en 1 bij de 2430 gebruikers van een actieve controle. De ernstige hypoglykemie in de gliclazidegroep trad op bij iemand die in de weken voorafgaand aan de hypoglykemie ook was gestart met NPH-insuline. Hypoglykemieen met gliclazide zijn zeldzaam en gliclazide is ten minste zo effectief als de andere orale bloedglucoseverlagende middelen. De methodologische kwaliteit van bijna alle onderzoeken was slecht.

Background:Although orthostatic hypotension (OH) is more prevalent in old age, and in patients with diabetes, the prevalence of OH in older patients with type 2 diabetes mellitus is unknown.Aim:To establish the prevalence of OH, and its association with falling, in home-dwelling older participants with and without type 2 diabetes.Design and setting:A cross-sectional study in primary care in the Netherlands.Method:A total of 352 patients with type 2 diabetes, and 211 without participated in this study. OH was defined as a fall in blood pressure of at least 20 mmHg systolic or 10 mmHg diastolic after either 1 or 3 minutes in an upright position. Feelings of dizziness, light-headedness, or faintness during the standing period were documented as orthostatic complaints. Fall risk was assessed with a validated risk profile instrument.Results:The prevalence of OH was 28% (95% CI = 24% to 33%) and 18% (95% CI = 13% to 23%) in participants with and without type 2 diabetes, respectively. OH was not related to falling, while the presence of orthostatic complaints in itself was associated with both previous fall incidents as well as a high fall risk, even after adjustment for OH. The adjusted odds ratios were 1.65 (95% CI = 1.00 to 2.72) and 8.21 (95% CI = 4.17 to 16.19), respectively.Conclusion:OH is highly prevalent in home-dwelling older people with and without type 2 diabetes. Those with orthostatic complaints had an increased risk for falling, whereas those with OH were not.

Purpose This study investigated the advice given by diabetes educators in Europe, and the daily practice of Dutch patients with diabetes regarding the use of the first or second drop of blood and other aspects concerning self-monitoring of blood glucose (SMBG). Method During a diabetes conference in 2009, 96 European diabetes educators (including 46 Dutch educators) completed a single-item questionnaire about the use of the first or second drop of blood for glucose monitoring. A self-reported questionnaire with 20 questions about performing SMBG was filled out by 111 patients from an outpatient diabetes clinic of a Dutch hospital. Results Patients were advised to wash their hands with water and soap and use the first drop of blood by 89% of the Dutch and 72% of other European diabetes educators, while 58% of the patients reported to do this. When the patient cannot wash the hands, 85% of the Dutch and 52% of the other European educators advised to use the second drop of blood, while 26% of the patients reported always using the first drop without washing hands. Always using the side of the fingertip and using the lancet once, as advised in guidelines, was reported by only 41% and 55% of the patients, respectively. Conclusions There is no general agreement between professionals regarding the advice on aspects concerning SMBG. Patients also reported different acts in daily practice. Developing uniform international SMBG guidelines, education, and repeated evaluation of the process of collecting an accurate blood sample are needed.

Aims and objectives. To determine whether the management of type 2 diabetes mellitus in a primary care setting can be safely transferred to practice nurses. Background. Because of the increasing prevalence of type 2 diabetes mellitus and the burden of caring for individual patients, the demand type 2 diabetes mellitus patients place on primary health care resources has become overwhelming. Design. Randomised controlled trial. Methods. The patients in the intervention group were cared for by practice nurses who treated glucose levels, blood pressure and lipid profile according to a specified protocol. The control group received conventional care from a general practitioner. The primary outcome measure was the mean decrease seen in glycated haemoglobin (HbA1c) levels at the end of the follow-up period (14 months). Results. A total of 230 patients was randomised with 206 completing the study. The between-group differences with respect to reduction in HbA1c, blood pressure and lipid profile were not significant. Blood pressure decreased significantly in both groups; 7 center dot 4/3 center dot 2 mm Hg in the intervention group and 5 center dot 6/1 center dot 0 mm Hg in the control group. In both groups, more patients met the target values goals for lipid profile compared to baseline. In the intervention group, there was some deterioration in the health-related quality of life and an increase in diabetes-related symptoms. Patients being treated by a practice nurse were more satisfied with their treatment than those being treated by a general practitioner. Conclusion. Practice nurses achieved results, which were comparable to those achieved by a general practitioner with respect to clinical parameters with better patient satisfaction. Relevance to clinical practice. This study shows that diabetes management in primary care can be safely transferred to practice nurses.

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.

OBJECTIVE Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump has been available for the past 25 years. CIPII, with its specific pharmacodynamic properties, may be a viable treatment alternative to improve glycemic control in patients with type 1 diabetes for whom other therapies have failed. There have been few studies in which CIPII was compared with subcutaneous insulin treatment for patients with type 1 diabetes with poor glycemic control. RESEARCH DESIGN AND METHODS In an open-label, prospective, crossover, randomized, 16-month study, the effects of CIPII and subcutaneous insulin were compared in 24 patients. The primary outcome measure was the incidence of hypoglycemia. Secondary outcome measures were A1C, and glucose profile, including time in euglycemia, as measured by continuous glucose monitoring. RESULTS The incidence of grade 1 hypoglycemic events was 4.0 ± 2.6 per week with subcutaneous insulin compared with 3.5 ± 2.3 per week during CIPII (P = 0.13). The absolute mean difference in A1C with CIPII compared with subcutaneous treatment was −0.76% (95% CI −1.41 to −0.11) (P = 0.03). Baseline time spent in euglycemia was 45.2 ± 12.6% and increased 10.9% (4.6–17.3) with CIPII compared with subcutaneous treatment (absolute value; P = 0.003). There were no differences in the occurrence rate for severe hypoglycemic events, daily insulin use, or BMI. No pump or catheter malfunction was observed during the study. CONCLUSIONS Although we did not observe a significant reduction in hypoglycemic events, improved glycemic control was achieved with the use of CIPII. We saw a 0.8% decrease in A1C and an 11% increase in the time spent in euglycemia.

OBJECTIVE—Chromium treatment has been reported to improve glycemic control in patients with type 2 diabetes. However, concern exists about the possible toxic effects of chromium picolinate. The aim of this study was to determine the effect of chromium treatment in the form of chromium yeast on glycemic control in a Western population of patients with type 2 diabetes who were being treated with oral hypoglycemic agents. RESEARCH DESIGN AND METHODS—In this 6-month, double-blind study, patients with moderate glycemic control, being treated with oral hypoglycemic agents, were randomly assigned to receive either a placebo or treatment with 400 μg of chromium daily in the form of chromium yeast. The primary efficacy parameter was a change in A1C. Secondary end points were changes in lipid profile, BMI, blood pressure, body fat, and insulin resistance. RESULTS—No differences were found for the change in A1C between the intervention and placebo groups, nor were any differences found between the groups for the secondary end points. CONCLUSIONS—There is no evidence that chromium in the form of chromium yeast is effective in improving glycemic control in Western patients with type 2 diabetes who are taking oral hypoglycemic agents.

Recent decades have seen a constant upward projection in the prevalence of diabetes. Attempts to estimate diabetes prevalence rates based on relatively small population samples quite often result in underestimation. The aim of the present study was to investigate whether the Dutch diabetes prevalence estimate of 930 000 for 2013, based on a relatively small sample, still holds true when a larger population is studied using actual prevalence data.Data were collected from 92 primary care groups, including the total number of people with and without diabetes in 2013. Patients with diabetes were identified using the International Classification of Primary Care codes T90.02 (diabetes mellitus type 2; T2DM), T90.01 (diabetes mellitus type 1) and T90 (diabetes mellitus). Prevalence data were compared with previous estimates made in 2009. Diabetes prevalence was estimated using linear extrapolation.Complete data were available from 67 (73%) care groups, which together provided care for 7 922 403 subjects; 431 396 patients were coded as having diabetes, of whom 406 183 were coded as having T2DM. Based on these results, the extrapolated Dutch diabetes prevalence was 914 387 (5.45%).The results show that the previous estimate (reported in 2009), which was based on data collected in 2007, resulted in a2% (~16 000) overestimation in diabetes prevalence in 2013 compared with the analysis presented. These results indicate that no upward adjustment in Dutch diabetes prevalence estimates is necessary. Repeated large-scale monitoring can help develop more accurate prevalence estimates and improve future prevalence predictions.

Objective Our aim was to investigate whether trends in quality of diabetes care differ between sexes in the Netherlands from 1998 till 2013. Research Design and Methods In this prospective observational cohort study quality of care was measured using process and outcome measures in patients with type 2 diabetes in primary care. Trend and absolute differences between sexes were investigated for patients 53 mmol/mol; this decreased to approximately 29% in both sexes in 2013. Patients having a systolic blood pressure >140 mmHg decreased from 70% to 42%, and from 80% to 40% in men and women 20% over 10 years decreased from 15% to 3% in men and from 18% to 3% in women. Conclusions Quality of diabetes care has improved considerably in the period 1998–2013 in both sexes. Possibly relevant trend differences between sexes were observed for HbA1c, systolic blood pressure, BMI and smoking. The predicted mortality risk decreased over time in both sexes. Except for BMI in both age groups and systolic blood pressure in patients ≥75 years, no evident poorer risk factor control in women compared to men was found at the end of the study period.

OBJECTIVE—Chromium treatment has been reported to improve glycemic control and insulin sensitivity in specific populations of patients with type 2 diabetes. The aim of this study was to determine the effect of chromium treatment on glycemic control in a Western population of insulin-dependent patients with type 2 diabetes. RESEARCH DESIGN AND METHODS—In this 6-month double-blind study, patients with an HbA1c (A1C) >8% and insulin requirements of >50 units/day were randomly assigned to receive treatment with placebo or 500 or 1,000 μg chromium daily in the form of chromium picolinate. The primary efficacy parameter was a change in A1C. Secondary end points were changes in lipid profile, BMI, blood pressure, and insulin requirements. RESULTS—In this per-protocol analysis (n = 46), the decrease in A1C was approximately equal across the three groups (0.4%). All patients had a BMI >25 kg/m2. No differences were found in the secondary end points. We found a weak relationship between an increasing serum chromium concentration and improvement of the lipid profile. CONCLUSIONS—There is no evidence that high-dose chromium treatment is effective in obese Western patients with type 2 diabetes.

Background. Accurate blood pressure (BP) readings and correctly interpreting the obtained values are of great importance. However, there is considerable variation in the different BP measuring methods suggested in guidelines and used in hypertension trials.Objective. To compare the different methods used to measure BP; measuring once, the method used for a large study such as the UKPDS, and the methods recommended by various BP guidelines.Methods. In 223 patients with type 2 diabetes from five family practices BP was measured according to a protocol to obtain the following data: A = first reading, B = mean of two initial readings, C = at least four readings and the mean of the last three readings with less than 15% coefficient of variation difference, D = mean of the first two consecutive readings with a maximum of 5 mm Hg difference. Mean outcomes measure is the mean difference between different BP measuring methods in mm Hg.Results. Significant differences in systolic/diastolic BP were found between A and B [mean difference (MD) systolic BP 1.6 mm Hg, P Conclusion. Different methods to assess BP during one visit in the same patient lead to significantly different BP readings and can lead to overestimation of the mean BP. These differences are clinically relevant and show a gap between different methods in trials, guidelines and daily practice.

Background: To present actual data to estimate prevalence, incidence and mortality of known type 2 diabetes mellitus in all age categories in The Netherlands. Methods: Prospective population-based study between 1998 and 2000 in The Netherlands. Baseline population of 155,774 patients, registered with 61 general practitioners participating in the Zwolle Outpatient Diabetes project Integrating Available Care ( ZODIAC)-study. Results: Age- and sex-adjusted prevalence of type 2 diabetes was 2.2% at baseline and 2.9% after 2 years of follow-up; for women and men it was 3.1 and 2.7% at follow-up, respectively. Patients aged > 70 years account for almost 50% of all type 2 diabetes patients. Age- and sex-adjusted mean annual incidence per 10,000 over 3 years was 22.7 overall; for women 23.1 and for men 22.2. Incidence - even though high - decreases after the age of 70 years. The mortality rate was 47.9/1000 and standardised mortality ratio 1.40. Based on these results, the estimated total number of subjects known with type 2 diabetes was 466,000 for The Netherlands in 2000; the number of patients with newly diagnosed diabetes 36,000. Conclusions: Prevalence and incidence rates exceed all estimates regarding known type 2 diabetes for The Netherlands. Elderly patients, aged 70 years and over, account for 50% of the type 2 diabetic population. These results are important for health-care planning.

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.

OBJECTIVE AND DESIGN: Gliclazide has been associated with a low risk of hypoglycemic episodes and beneficial long-term cardiovascular safety in observational cohorts. The aim of this study was to assess in a systematic review and meta-analysis of randomized controlled trials the safety and efficacy of gliclazide compared to other oral glucose-lowering agents (PROSPERO2013:CRD42013004156). DATA SOURCES: Medline, EMBASE, Clinicaltrials.gov, Trialregister.nl, Clinicaltrialsregister.eu and the Cochrane database. SELECTION: Included were randomized studies of at least 12 weeks duration with the following outcomes: HbA1c change, incidence of severe hypoglycemia, weight change, cardiovascular events and/or mortality when comparing gliclazide with other oral blood glucose lowering drugs. Bias was assessed with the Cochrane risk of bias tool. The inverse variance random effects model was used. RESULTS: Nineteen trials were included; 3,083 patients treated with gliclazide and 3,155 patients treated with other oral blood glucose lowering drugs. There was a considerable amount of heterogeneity between and bias in studies. Compared to other glucose lowering agents except metformin, gliclazide was slightly more effective (-0.13% (95%CI: -0.25, -0.02, I(2) 55%)). One out of 2,387 gliclazide users experienced a severe hypoglycemic event, whilst also using insulin. There were 25 confirmed non-severe hypoglycemic events (2.2%) in 1,152 gliclazide users and 22 events (1.8%) in 1,163 patients in the comparator group (risk ratio 1.09 (95% CI: 0.20, 5.78, I² 77%)). Few studies reported differences in weight and none were designed to evaluate cardiovascular outcomes. CONCLUSIONS: The methodological quality of randomized trials comparing gliclazide to other oral glucose lowering agents was poor and effect estimates on weight were limited by publication bias. The number of severe hypoglycemic episodes was extremely low, and gliclazide appears at least equally effective compared to other glucose lowering agents. None of the trials were designed for evaluating cardiovascular outcomes, which warrants attention in future randomized trials.

Denkbeelden over taken en functies van de huisarts, ‘achter een bureau bedacht’, hebben grote invloed op wat zich in de spreekkamer afspeelt. Ook de filosofie komt om de hoek kijken als men een antwoord zoekt op de vraag: moet de huisarts van de toekomst ziekte- of patientgericht werken?

OBJECTIVE Evidence that midregional fragment of pro-A–type natriuretic peptide (MR-proANP) is a marker of mortality in patients with type 2 diabetes is limited. Therefore, we aimed to investigate the capabilities of MR-proANP in predicting mortality. We also investigated whether MR-proANP influences the relationship between blood pressure and mortality in old age. RESEARCH DESIGN AND METHODS In 1998, 1,143 primary care patients with type 2 diabetes participated in the ZODIAC study. Because blood was drawn for 867 patients (76%) and confounders were missing for 19 patients, the final study sample comprised 848 patients. After a follow-up time of 10 years, we used Cox proportional hazard models to evaluate the relationship between MR-proANP and (cardiovascular) mortality. Harrell C statistic was used to compare models with and without MR-proANP. The regression analyses were repeated without MR-proANP for patients aged older than 75 years. RESULTS Median MR-proANP in the total study sample was 75 pmol/L (interquartile range, 48–124 pmol/L). During follow-up, 354 (42%) out of 848 patients had died, of whom 152 (43%) deaths were attributable to cardiovascular factors. MR-proANP was independently associated with all-cause and cardiovascular mortality, irrespective of age. During old age, there was a significant inverse relationship between blood pressure and mortality. This relationship did not change after adjustment for MR-proANP. CONCLUSIONS MR-proANP is independently associated with mortality in patients with type 2 diabetes. MR-proANP did not influence the inverse relationship between blood pressure and mortality in elderly patients.

Objective: The Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC) study was initiated in 1998 to investigate the effects of shared care for patients with type 2 diabetes mellitus (T2DM) in the Netherlands, and to reduce the number of diabetes-related complications. Benchmarking the performance of diabetes care was and is an important aspect of this study. We aimed to investigate trends in diabetes care, within the ZODIAC study for a wide variety of quality indicators during a long follow-up period (1998-2008), with special interest for different age groups.Design: Prospective observational cohort study.Setting: Primary care, Zwolle, The Netherlands.Participants: Patients with T2DM.Methods: A dataset of quality measures was collected annually during the patient's visit to the practice nurse or general practitioner. Linear time trends from 1998 to 2008 were estimated using linear mixed models in which we adjusted for age and gender. Age was included in the model as a categorical variable: for each follow-up year all participants were categorised into the categories 75 years. Differences in trends between the age categories were investigated by adding an interaction term to the model.Results: The number of patients who were reported to participate increased in the period 1998-2008 from 1622 to 27 438. All quality indicators improved in this study, except for body mass index. The prevalence albuminuria decreased in an 11-year-period from 42% to 21%. No relevant differences between the trends for the three age categories were observed. During all years of follow-up, mean blood pressure and body mass index were the lowest and highest, respectively, in the group of patientsConclusions: Quality of diabetes care within the Dutch ZODIAC study, a shared care project, has considerably improved in the period 1998-2008. There were no relevant differences between trends across various age categories.

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 HbA1c, 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 HbA1c, 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.

To determine whether the management of type 2 diabetes mellitus in a primary care setting can be safely transferred to practice nurses.Because of the increasing prevalence of type 2 diabetes mellitus and the burden of caring for individual patients, the demand type 2 diabetes mellitus patients place on primary health care resources has become overwhelming.Randomised controlled trial.The patients in the intervention group were cared for by practice nurses who treated glucose levels, blood pressure and lipid profile according to a specified protocol. The control group received conventional care from a general practitioner. The primary outcome measure was the mean decrease seen in glycated haemoglobin (HbA1c) levels at the end of the follow-up period (14 months).A total of 230 patients was randomised with 206 completing the study. The between-group differences with respect to reduction in HbA1c, blood pressure and lipid profile were not significant. Blood pressure decreased significantly in both groups; 7.4/3.2 mm Hg in the intervention group and 5.6/1.0 mm Hg in the control group. In both groups, more patients met the target values goals for lipid profile compared to baseline. In the intervention group, there was some deterioration in the health-related quality of life and an increase in diabetes-related symptoms. Patients being treated by a practice nurse were more satisfied with their treatment than those being treated by a general practitioner.Practice nurses achieved results, which were comparable to those achieved by a general practitioner with respect to clinical parameters with better patient satisfaction.This study shows that diabetes management in primary care can be safely transferred to practice nurses.

OBJECTIVE There is no general agreement regarding the use of the first or second drop of blood for glucose monitoring. This study investigated whether capillary glucose concentrations, as measured in the first and second drops of blood, differed ≥10% compared with a control glucose concentration in different situations. RESEARCH DESIGN AND METHODS Capillary glucose concentrations were measured in two consecutive drops of blood in the following circumstances in 123 patients with diabetes: without washing hands, after exposing the hands to fruit, after washing the fruit-exposed hands, and during application of different amounts of external pressure around the finger. The results were compared with control measurements. RESULTS Not washing hands led to a difference in glucose concentration of ≥10% in the first and in the second drops of blood in 11% and 4% of the participants, respectively. In fruit-exposed fingers, these differences were found in 88% and 11% of the participants, respectively. Different external pressures led to ≥10% differences in glucose concentrations in 5–13% of the participants. CONCLUSIONS We recommend washing the hands with soap and water, drying them, and using the first drop of blood for self-monitoring of blood glucose. If washing hands is not possible, and they are not visibly soiled or exposed to a sugar-containing product, it is acceptable to use the second drop of blood after wiping away the first drop. External pressure may lead to unreliable readings.

OBJECTIVE To investigate the effects of continuous intraperitoneal insulin infusion (CIPII) compared with subcutaneous insulin on health-related quality of life (HRQOL) and treatment satisfaction, and to perform a cost analysis in type 1 diabetes. RESEARCH DESIGN AND METHODS We used an open-label, prospective, crossover, randomized, 16-month study (N = 24). HRQOL and patient satisfaction were assessed with questionnaires (the 36-item short-form health survey [SF-36], the World Health Organization-Five Well-Being Index [WHO-5], and the Diabetes Treatment Satisfaction Questionnaire [DTSQ]). Direct costs of CIPII and continuous subcutaneous insulin infusion (CSII) were compared. RESULTS Questionnaire scores were higher with CIPII than with subcutaneous therapy. Yearly direct pump- and procedure-associated costs for CIPII were estimated at €10,910 compared with €4,810 for CSII. CONCLUSIONS Apart from improving glycemic control, CIPII improved HRQOL and treatment satisfaction compared with subcutaneous insulin. Direct pump- and procedure-associated costs are considerably higher for CIPII, however.

OBJECTIVE To investigate the effects of continuous intraperitoneal insulin infusion (CIPII) compared with subcutaneous insulin on health-related quality of life (HRQOL) and treatment satisfaction, and to perform a cost analysis in type 1 diabetes. RESEARCH DESIGN AND METHODS We used an open-label, prospective, crossover, randomized, 16-month study (N = 24). HRQOL and patient satisfaction were assessed with questionnaires (the 36-item short-form health survey [SF-36], the World Health Organization-Five Well-Being Index [WHO-5], and the Diabetes Treatment Satisfaction Questionnaire [DTSQ]). Direct costs of CIPII and continuous subcutaneous insulin infusion (CSII) were compared. RESULTS Questionnaire scores were higher with CIPII than with subcutaneous therapy. Yearly direct pump- and procedure-associated costs for CIPII were estimated at €10,910 compared with €4,810 for CSII. CONCLUSIONS Apart from improving glycemic control, CIPII improved HRQOL and treatment satisfaction compared with subcutaneous insulin. Direct pump- and procedure-associated costs are considerably higher for CIPII, however.

Background: The precise relationship between the lipid profile and mortality in elderly patients with type 2 diabetes mellitus (T2DM) remains unclear. The aim of this study was to investigate the relationship between the lipid profile over time, and mortality in elderly patients with T2DM.Methods and Findings: In 1998, 881 primary care patients with T2DM aged 60 years and older participated in the ZODIAC study, a prospective observational study. The cohort was divided into two age categories: 60-75 years and older than 75 years. Updated means of all lipid profile indices were calculated after a median follow-up time of 9.8 years. These values were used as time dependent covariates in a Cox proportional hazard model. The cholesterol-HDL ratio and LDL-cholesterol were positively related to both all-cause and cardiovascular mortality in the low age group. In contrast, except for the triglyceride level, none of the other lipid profile indices were related to all-cause mortality in patients aged over 75 years. The mortality risk decreased by 17% (95% CI: 5% to 27%) for each 1 mmol/L higher serum level of triglycerides. The relationships between the various lipid profile indices and cardiovascular mortality were not significant. However, the results were different after stratification for diabetes duration. In the subgroup of elderly patients with a diabetes duration of 8 years and longer, higher lipids were predictive of increased cardiovascular mortality. The main limitation of this study is its observational design, which prevents us drawing conclusions about causality.Conclusion: Although the lipid profile was not predictive in the overall group of elderly patients, higher lipids were related to increased cardiovascular mortality in patients with diabetes of long duration. In order to make valid recommendations concerning lipid-lowering treatment, a randomized controlled trial or a meta-analysis concerning this specific population is mandatory.

Hypertension is a chronic disorder with a high prevalence worldwide. Despite considerable efforts, it is sometimes hard to reach treatment goals for blood pressure (BP) with classical treatment options. Reducing breathing frequency has been advocated as a method to reduce BP.A randomized, single-blind, controlled trial was conducted in 30 non-diabetic patients with hypertension over a period of 9 weeks to evaluate the effect of a device that helps to slow breathing (Resperate) on BP and quality of life (QoL). The control group listened to music and used no other therapeutic device.There was no significant difference in change in BP between intervention and control; BP -4.2 mmHg (95% CI -12.4 to 3.9)/-2.6 mmHg (95% CI -8.4 to 3.3). This result did not alter in post hoc analyses, when patients not achieving target breathing frequency (10 breaths/min) or non-compliant patients were excluded. QoL did not change over time.We found no effect of the Resperate on BP or QoL compared with the control group. We conclude that, at this moment, this device has no added value in the treatment of hypertension.

To the Editor: With interest we read the recent article in Hypertension by Agarwal et al.1 The authors conclude that blood pressure differences between arms are reproducible and that this difference is related to mortality. We have some concerns with the methods and conclusions of this study.1 First, is the blood pressure device that was used validated? Second, the conclusion about the reproducibility concerns a remeasurement after only 1 week. In a study that we performed …

Background. Decreased insulin sensitivity and beta-cell failure are the two key components in the pathogenesis of type 2 diabetes mellitus (T2DM). Secondary treatment failure is often attributed to the development of obesity-related insulin resistance in combination with continued loss of beta-cell function.Objective. Assess metabolic control, body mass index (BMI) and treatment in relationship to diabetes duration to study these mechanisms.Methods. Cross-sectional study of 7875 patients with T2DM in primary care in The Netherlands. Clinical data and laboratory results were obtained for the 2005 annual visit. Patients were grouped according to diabetes duration in 2-year intervals. Each step in the traditional treatment sequence was considered as a sign of progression of beta-cell failure.Results. Complete data regarding duration and treatment were available for 6850 patients (87%). After the initial years following diagnosis, treatment with diet alone decreases and oral hypoglycaemic agents (OHA) are prescribed to an increasing percentage of patients. Treatment with OHA diminishes after approximately 10 years following diagnosis and treatment with insulin increases until approximately two-thirds of patients with diabetes duration of more than 20 years are being treated with insulin. BMI does not increase with longer disease duration.Conclusion. The concept of beta-cell failure as the primary determinant of the chronic progression of T2DM is supported by these results, whereas a deterioration of obesity-related insulin sensitivity as indicator is not supported.

Objective In patients with type 2 diabetes mellitus (DM2), it is hard to reach treatment objectives for blood pressure (BP) with classical treatment options. Recently, reducing breathing frequency has been advocated as a method to reduce BP. We examined if an electronic device such as Resperate, by reducing breathing frequency, would lead to BP reduction in a population of patients with DM2 and hypertension. Our secondary objective was to study the effect of this device on quality of life (QOL). Methods A randomized, single-blind, controlled trial was conducted over a period of 8 weeks to evaluate the effect of this therapy on BP and QOL. The control group listened to music and used no other therapeutic device. BP and QOL changes were studied in 30 patients with DM2 and hypertension. Results There was no significant difference in change in BP between groups; -7.5 [95% confidence interval (CI) -12.7, -2.3]/-1.0 (95% CI -5.5, 3.6) mmHg in the intervention group and -12.2 (95% CI -17.4, -7.0)/-5.5 (95% CI -9.7, -1.4) mmHg in the control group. Whether or not the target breathing frequency of 10 breaths/min was reached did not affect BP. There were no significant changes in QOL. Conclusions The effects of Resperate on BP and QOL were not significantly different from those found in the control group. Furthermore, 40% of patients did not reach the target breathing frequency, making this device less suitable for clinical practice in patients with DM2.

Chromium treatment has been reported to improve glycemic control and insulin sensitivity in specific populations of patients with type 2 diabetes. The aim of this study was to determine the effect of chromium treatment on glycemic control in a Western population of insulin-dependent patients with type 2 diabetes.In this 6-month double-blind study, patients with an HbA(1c) (A1C)8% and insulin requirements of50 units/day were randomly assigned to receive treatment with placebo or 500 or 1,000 mug chromium daily in the form of chromium picolinate. The primary efficacy parameter was a change in A1C. Secondary end points were changes in lipid profile, BMI, blood pressure, and insulin requirements.In this per-protocol analysis (n = 46), the decrease in A1C was approximately equal across the three groups (0.4%). All patients had a BMI25 kg/m(2). No differences were found in the secondary end points. We found a weak relationship between an increasing serum chromium concentration and improvement of the lipid profile.There is no evidence that high-dose chromium treatment is effective in obese Western patients with type 2 diabetes.

Zelfcontrole is een belangrijk hulpmiddel om strikte glucoseregulatie te bereiken. Er is echter geen overeenstemming over het gebruik van de 1e of 2e bloeddruppel bij de uitvoering van zelfcontrole.

OBJECTIVE—To investigate the relationship between health-related quality of life (HRQOL) and mortality in type 2 diabetes. RESEARCH DESIGN AND METHODS—In 1998, 1,143 primary care patients with type 2 diabetes participated in the Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC) study. At baseline, HRQOL was assessed with the RAND-36 and, after almost 6 years, life status was retrieved. Cox proportional hazards modeling was used to investigate the association between HRQOL (continuous data) and mortality with adjustment for selected confounders (smoking, age, sex, diabetes duration, A1C, renal function, BMI, blood pressure, HDL cholesterol, and macrovascular complications). RESULTS—The Physical Component Summary of the RAND-36 was inversely associated with mortality (hazard ratio [HR] 0.979 [95% CI 0.966–0.992]), as were two separate RAND-36 dimensions. CONCLUSIONS—This study found that HRQOL is an independent marker of mortality and emphasizes the importance of looking beyond clinical parameters in patients with type 2 diabetes.

With interest, we read the article byCefalu et al [1] inwhich the effect of chromium supplementation has been studied and in which differences between responders compared with nonresponders to chromium have been investigated in a randomized, double-blinded, placebo-controlled trial. We have some concerns with the interpretation of part of the results because, in our opinion, the most important finding of this trial is that supplementation with chromium did not result in an improvement in glycemic control compared with placebo, which is in line with the findings of well-designed placebo-controlled trial in Western patients with diabetes [2]. Furthermore, when in the overall results no differences in effect have been found, then dividing the intervention group in 2 separate cohorts of responders and nonresponders seems stretching statistical possibilities by increasing the type I error, unless perhaps this data management was predefined in the study protocol. What justification can be brought forward to define subgroups of responders and nonresponders in an intervention group when the conclusion is that the patients receiving chromium compared with placebo did not respond? Unfortunately, there is still no good measure for chromium status [3]. Cefalu et al [1] defined chromium status in their article by measuring urinary and plasma chromium levels. However, we would like to ask the authors if they agree that their results contradict with their definition of chromium status, as they did not find differences in these parameters between the subjects they defined as responders and nonresponders at any time during their trial. Finally, the authors conclude that the response to chromium is more likely in insulin-resistant individuals in poor glycemic control. We have performed a trial in such patients; however, we could not show any significant effect in this 6-month double-blind study of 500 or 1000 μg chromium compared with placebo on glycemic control [4]. We agree that a measure of chromium status is of interest; but in the meantime, we have to conclude that the highest level of evidence is that chromium supplementation does not result in an improvement of glycemic control in Western patients with type 2 diabetes mellitus. Nanne Kleefstra Diabetes Centre Isala Clinics Zwolle, The Netherlands Langerhans Medical Research Group The Netherlands E-mail address: kleefstra@langerhans.com

With interest, we read the systematic review by Balk et al. (1). It reviewed the effect of chromium supplementation on glucose metabolism and lipids. It is important to have an update of the systematic review performed by Althuis et al. (2) in 2002, since many studies have been published in the years thereafter. However, we have some concerns with the conclusions of the current systematic review (1). Althuis et al. (2 …

Background: Studies investigating interventions, aimed at improving patient satisfaction by exploring the patient's request for help, show conflicting results.Objectives: To investigate whether writing down the request for help on a request card, prior to the consultation improves patient satisfaction.Methods: This study was a single-blind randomized controlled trial, in which the patients were blinded to the intervention. Patients were recruited in two rural practices (five GPs) and one urban practice (four GPs) in The Netherlands. Consecutive patients with a new request for help were asked to participate. All patients received general information about patient satisfaction. After randomization, patients in the intervention group were asked to fill in a card with their request(s) for help; the general practitioners started the consultations with these questions. We used the 'Professional Care' subscale of the Consultation Satisfaction Questionnaire (CSQ) to examine the effect of the intervention on patient satisfaction. Secondary outcomes were patient satisfaction measured with the patient's VAS score, the GP's VAS score on satisfaction, consultation time, the other subscales of the CSQ, and the number of consultations during follow-up.Results: There was no difference in patient satisfaction (CSQ, VAS) between both groups. We also did not find any differences between the other subscales of the CSQ.Conclusion: A beneficial effect of the use of a 'request card' by the patient on patient satisfaction of the consultation could not be demonstrated.