Sebastiaan T. Houweling

Chromium Treatment Has No Effect in Patients With Type 2 Diabetes in a Western Population A randomized, double-blind, placebo-controlled trial

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.

Lower blood pressure associated with higher mortality in elderly diabetic patients (ZODIAC-12)

OBJECTIVE to investigate the relationship between blood pressure over time and mortality in elderly patients with type 2 diabetes mellitus (T2DM). DESIGN prospective observational cohort study. SETTING primary care, Zwolle, The Netherlands. SUBJECTS patients with T2DM aged 60 years and older (n = 881). The cohort was divided into two age categories: 60-75 years and older than 75 years. METHODS updated means for systolic, diastolic and pulse pressures 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. Main outcome measures were all-cause and cardiovascular mortality. RESULTS all of the blood pressure measures were inversely related to all-cause mortality in elderly diabetic patients (>75 years). Furthermore, these relationships were specifically found in elderly patients treated with antihypertensive medication at baseline. A decrease of 10 mm Hg in systolic blood pressure, diastolic blood pressure and pulse pressure led to a mortality increase of 22% [95% confidence interval (95% CI): 13-31%], 30% [95% CI: 13%-46%] and 22% [95% CI: 11%-33%], respectively. In the low age group (60-75 years), no relationship was found between blood pressure and mortality. CONCLUSIONS blood pressure is a marker for mortality in elderly T2DM patients; however, the relationship is inverse.

Can diabetes management be safely transferred to practice nurses in a primary care setting? A randomised controlled trial

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; 7.4/3.2 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. 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.

Effect of device-guided breathing exercises on blood pressure in hypertensive patients with type 2 diabetes mellitus : A randomized controlled trial

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.

Improved Glycemic Control With Intraperitoneal Versus Subcutaneous Insulin in Type 1 Diabetes: A randomized controlled trial

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.

Self-Monitoring of Blood Glucose: The Use of the First or the Second Drop of Blood

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.

A prospective observational study of quality of diabetes care in a shared care setting: trends and age differences (ZODIAC-19)

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 patients 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 <60, 60–75 and >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 patients <60 years (data not shown). Conclusions 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.

Effect of device-guided breathing exercises on blood pressure in patients with hypertension: a randomized controlled trial.

Abstract Objective. 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. Methods. 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. Results. There was no significant difference in change in BP between intervention and control; BP –4.2mmHg (95% CI –12.4 to 3.9)/–2.6mmHg (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. Conclusions. 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. Trial registration: ClinicalTrials.gov identifier: NCT00594048.

Orthostatic hypotension, diabetes, and falling in older patients: a cross-sectional study

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.

Health-Related Quality of Life, Treatment Satisfaction, and Costs Associated With Intraperitoneal Versus Subcutaneous Insulin Administration in Type 1 Diabetes: A randomized controlled trial

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.