S. J. J. Logtenberg

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.

Pre- and Postoperative Accuracy and Safety of a Real-Time Continuous Glucose Monitoring System in Cardiac Surgical Patients: A Randomized Pilot Study

BACKGROUND Our objective was to evaluate the accuracy and safety of a real-time (RT) continuous glucose monitoring system (CGMS) in patients before and after cardiothoracic surgery and to investigate whether activation of the alarm function of the RT-CGMS had an effect on glucose control. METHODS Patients scheduled for elective cardiothoracic procedures, without a history of insulin-requiring diabetes, were perioperatively monitored with RT-CGMS for 72 h and were randomized into two groups: with or without the alarm function (set at 4 and 10 mmol/L) of the device activated. Sensor values were compared with capillary, arterial, and venous blood glucose values. Percentages of time spent in various glucose ranges were compared between groups. RESULTS There were no adverse effects of the RT-CGMS. Of the 1,001 sensor value comparisons with capillary or arterial measurements, 96.6% fell within Clarke Error Grid zones A and B, with relative absolute differences ranging from 15% (preoperative period) to 12% (intensive care unit period) to 14% (postoperative period on the ward). Seventeen (7.9%) arterial and 16 (2.0%) capillary comparisons fell within zone D or E. Whether or not the alarm function, as used in this pilot study, was activated did not affect time spent in different glucose ranges. CONCLUSIONS Although the RT-CGMS is safe and accurate according to accepted standards, there are still small aberrations, which in our opinion preclude unlimited use in its present form in a clinical setting. The effect of the alarm function at different glucose levels remains to be investigated.

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.

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.

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.

Device-Guided Breathing as Treatment for Hypertension in Type 2 Diabetes Mellitus A Randomized, Double-blind, Sham-Controlled Trial

IMPORTANCE Biofeedback with device-guided lowering of breathing frequency could be an alternate nonpharmacologic treatment option for hypertension. Evidence from trials with high methodologic quality is lacking. OBJECTIVE To evaluate the effects of device-guided lowering of breathing frequency on blood pressure in patients with type 2 diabetes mellitus and hypertension. DESIGN Single-center, double-blind, sham-controlled trial. SETTING A large nonacademic teaching hospital in the Netherlands. PARTICIPANTS Patients with type 2 diabetes mellitus and hypertension. INTERVENTION Fifteen-minute sessions with either the device that guides breathing through musical tones to a lower breathing frequency (aiming at <10 breaths/min) or a sham device (music without aiming at lowering of breathing frequency) for an 8-week study period. MAIN OUTCOMES AND MEASURES Systolic and diastolic blood pressure measured in the physicians office. RESULTS Forty-eight patients were randomized; 21 patients (88%) in the intervention group and 24 patients (100%) in the control group completed the study. There were no significant changes in systolic and diastolic blood pressure, with a difference in systolic blood pressure of 2.35 mm Hg (95% CI, -6.50 to 11.20) in favor of the control group and a difference in diastolic blood pressure of 2.25 mm Hg (95% CI, -2.16 to 6.67) in favor of the intervention group. Three patients in the intervention group experienced adverse events. CONCLUSIONS AND RELEVANCE This high methodologic quality study shows no significant effect of device-guided lowering of breathing frequency on office-measured blood pressure in patients with type 2 diabetes. On the basis of this study, together with results from all but one previous trial, device-guided lowering of breathing frequency does not appear to be a viable nonpharmacologic option for hypertension treatment.

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

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.

The Lipid Profile and Mortality Risk in Elderly Type 2 Diabetic Patients : A Ten-Year Follow-Up Study (ZODIAC-13)

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.

The Cockcroft-Gault: A Better Predictor of Renal Function in an Overweight and Obese Diabetic Population

Background: The performance of the Cockcroft-Gault (CG) equation, the Modification of Diet in Renal Disease (MDRD) formula, and the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) was evaluated in body mass index (BMI) categories. Material and Methods: In this retrospective cohort study in diabetic patients, creatinine clearance was measured by collecting 24-hour urines. Renal function was estimated using the CG, MDRD, and CKD-EPI. The performance of the equations was evaluated using correlation, Krippendorff’s coefficient, bias, precision, andaccuracy. Results: The bias of the MDRD and CKD-EPI increased from –13.9 ml/min/1.73 m2 and –14.0 ml/min/1.73 m2 (BMI < 25 kg/m2), respectively, to –31.7 ml/min/1.73 m2 and –29.6 ml/min/1.73 m2 (BMI > 30 kg/m2), respectively. Bias of the CG decreased from –13.4 ml/min (BMI < 25 kg/m2) to –3.2 ml/min (BMI > 30 kg/m2). With an accepted 30% dispersion, CG had the largest accuracy in the overweight and obese group (76.9 and 76.8%, respectively). The MDRD and CKD-EPI had an accuracy of 45.8 and 34.0% (overweight group), respectively,and 51.9 and37.3% (obese group), respectively. Conclusions: All renal function prediction equations are biased when used in overweight or obese diabetic populations with preserved renal function. The CG provides the best estimate of kidney function. The limitations of renal function prediction equations should be kept in mind when making clinical decisions.