Effect of Hypoglycemia on Heart Rate Variability in People with Type 1 Diabetes and Impaired Awareness of Hypoglycemia

BACKGROUND: People with impaired awareness of hypoglycemia (IAH) are at elevated risk of severe, potentially hazardous, hypoglycemia and would benefit from a device alerting to hypoglycemia. Heart rate variability (HRV) changes with hypoglycemia due to sympathetic activity. Since IAH is associated with suppressed sympathetic activity, we investigated whether hypoglycemia elicits a measurable change in HRV in patients with T1D and IAH. METHOD: Eligible participants underwent a modified hyperinsulinemic euglycemic hypoglycemic clamp (glucose nadir, 43.1 ± 0.90 mg/dl), while HRV was measured by a VitalConnect HealthPatch. Measurements of HRV included Root Mean Square of the Successive Differences (RMSSD) and low to high frequency (LF:HF) ratio. Wilcoxon rank-sum test was used for testing within-subject HRV changes. RESULTS: We included 12 participants (8 female, mean age 57 ± 12 years, mean HbA1c 57 ± 5 mmol/mol (7.4 ± 0.4%)). Symptoms increased from 4.0 (1.5-7.0) at euglycemia to 7.5 (5.0-11.0) during hypoglycemia (P = .003). In response to hypoglycemia, the LF:HF ratio and RMSSD increased when normalized for data obtained during euglycemia (both P < .01). The LF:HF ratio increased in 6 participants (50%) and declined in one other participant (8%). The RMSSD decreased in 3 (25%) and increased in 4 (33%) participants. In 2 patients, no change in HRV could be detected in response to hypoglycemia. CONCLUSIONS: This study reveals that hypoglycemia-induced changes in HRV are retained in the majority of people with T1D and IAH, and that these changes can be detected by a wearable device. Real-time HRV seems usable for detection of hypoglycemia in patients with IAH

Values that Matter: A New Method to Design and Assess Moral Mediation of Technology

In this article, we aim to strengthen the basis of designing for values, by relating it to philosophy of technology. We start by discussing several theories to understand technology-induced value mediation: mediation approach, technology assessment methods, and types of value change. We continue by connecting these theories to design practice by proposing a new design for values methodology: Values that Matter. This methodology provides the means to evaluate moral mediation of technology during the design process and to responsibly design for it. The methodology is explained by the redesign of continuous vital sign monitoring technology in hospitalized patient

The Influencing Contexts and Potential Mechanisms Behind the Use of Web-Based Self-management Support Interventions: Realistic Evaluation

Background: Self-management can increase self-efficacy and quality of life and improve disease outcomes. Effective self-management may also help reduce the pressure on health care systems. However, patients need support in dealing with their disease and in developing skills to manage the consequences and changes associated with their condition. Web-based self-management support programs have helped patients with cardiovascular disease (CVD) and rheumatoid arthritis (RA), but program use has been low.   Objective: This study aimed to identify the patient, disease, and program characteristics that determine whether patients use web-based self-management support programs or not.   Methods: A realistic evaluation methodology was used to provide a comprehensive overview of context (patient and disease characteristics), mechanism (program characteristics), and outcome (program use). Secondary data of adult patients with CVD (n=101) and those with RA (n=77) were included in the study. The relationship between context (sex, age, education, employment status, living situation, self-management [measured using Patient Activation Measure-13], quality of life [measured using RAND 36-item health survey], interaction efficacy [measured using the 5-item perceived efficacy in patient-physician interactions], diagnosis, physical comorbidity, and time since diagnosis) and outcome (program use) was analyzed using logistic regression analyses. The relationship between mechanism (program design, implementation strategies, and behavior change techniques [BCTs]) and outcome was analyzed through a qualitative interview study.   Results: This study included 68 nonusers and 111 users of web-based self-management support programs, of which 56.4% (101/179) were diagnosed with CVD and 43.6% (78/179) with RA. Younger age and a lower level of education were associated with program use. An interaction effect was found between program use and diagnosis and 4 quality of life subscales (social functioning, physical role limitations, vitality, and bodily pain). Patients with CVD with higher self-management and quality of life scores were less likely to use the program, whereas patients with RA with higher self-management and quality of life scores were more likely to use the program. Interviews with 10 nonusers, 10 low users, and 18 high users were analyzed to provide insight into the relationship between mechanisms and outcome. Program use was encouraged by an easy-to-use, clear, and transparent design and by recommendations from professionals and email reminders. A total of 5 BCTs were identified as potential mechanisms to promote program use: tailored information, self-reporting behavior, delayed feedback, providing information on peer behavior, and modeling.   Conclusions: This realistic evaluation showed that certain patient, disease, and program characteristics (age, education, diagnosis, program design, type of reminder, and BCTs) are associated with the use of web-based self-management support programs. These results represent the first step in improving the tailoring of web-based self-management support programs. Future research on the interaction between patient and program characteristics should be conducted to improve the tailoring of participants to program components.This study was funded by ZonMw, the Netherlands Organization for Health Research and Development (grant 520001001). The authors would like to thank all the patients with cardiovascular disease (CVD) and rheumatoid arthritis (RA) who contributed to this study. </p

Remnant particles are the major determinant of an increased intima media thickness in patients with familial combined hyperlipidemia (FCH)

INTRODUCTION: Familial combined hyperlipidemia (FCH) is characterized by several phenotypes, including an atherogenic lipoprotein profile, low grade inflammation, visceral obesity, insulin resistance, and hypertension. In this study, we investigated which of the clinical and biochemical characteristics of FCH patients contributes most to their increased risk of cardiovascular disease, by determining the association of a broad variety cardiovascular risk factors with the intima media thickness (IMT) of the common carotid artery (CCA) in 94 FCH patients and 216 non-affected relatives. METHODS: All subjects filled out a questionnaire about their smoking and drinking habits, medical history and medication use, and venous blood was drawn in the fasting state after discontinuation of lipid lowering medication (if used). IMT of the far wall and near wall of both CCAs was measured by high-resolution B-mode ultrasonography. RESULTS: The mean IMT in FCH patients (adjusted for age and gender) was 33 microm thicker when compared to their non-affected relatives (p=0.006). In multivariate analysis, the waist-to-hip ratio, the apoB concentration and the pulse pressure were significant and independent predictors of IMT in both FCH patients and their normolipidemic relatives. The most important independent predictor of IMT in FCH patients however, was the VLDL-c/TG ratio, explaining 32.8% of the variation in age- and gender-adjusted IMT, whereas this ratio was not an independent predictor of IMT at all in their unaffected relatives. CONCLUSION: Abdominal obesity, a higher blood pressure and dyslipidemia characterised by both an increased number of atherogenic particles and the presence of highly atherogenic remnant lipoproteins play an important role in the development of cardiovascular disease in FCH-patients

Effect of aging and obesity on the expression of dyslipidaemia in children from families with familial combined hyperlipidaemia.

Contains fulltext : 51880.pdf (publisher's version ) (Closed access)The aim of the present study was to delineate the mechanism(s) responsible for the increased secretion of VLDL (very-low-density lipoprotein) particles in patients with FCH (familial combined hyperlipidaemia). In 194 young adults (1.5 mmol/l and/or small-dense LDL, were observed only sporadically. After the 5-year follow-up, BMI increased in both groups, and this increase was associated with changes in apoB (r=0.27, P<0.05), triacylglycerol (r=0.30, P<0.01), VLDL cholesterol (r=0.22, P<0.05), VLDL triacylglycerol (r=0.25, P<0.05) and high-density lipoprotein cholesterol (r=-0.27, P<0.05). In conclusion, we have found indirect evidence of a primary, presumably genetically determined, increase in plasma apoB concentration occurring early in life of offspring from families with FCH. However, aging-related post-maturation increases in adipose tissue mass also appear to contribute to an aggravation and/or modulation of this genetically determined apoB overproduction

Prior medication adherence of participants and non participants of a randomized controlled trial to improve patient adherence in cardiovascular risk management

Poor medication adherence is a major factor in the secondary prevention of cardiovascular diseases (CVD) and contributes to increased morbidity, mortality, and costs. Interventions for improving medication adherence may have limited effects as a consequence of self selection of already highly adherent participants into clinical trials. Methods: In this retrospective cohort study, existing levels of medication adherence were examined in self-decided participants and non-participants prior to inclusion in a randomized controlled study (RCT), evaluating the effect of an intervention to improve adherence. In addition, the non-participants were further divided into ‘responders’ and ‘non responders’. All individuals had manifest cardiovascular disease and completed a questionnaire with baseline characteristics, the Beliefs about Medicines Questionnaire (BMQ) and the Modified Morisky Scale® (MMS®) as part of a regular screening program. A logistic regression was conducted to examine the relationship between study participation willingness, adherence level and the beliefs about medication. Results: According to the MMS® the adherence level was comparable in all groups. In both (non)-participants groups, 36% was classified as high adherent; 46% participants versus 44% non-participants were classified as medium adherent and 19% of the participants versus 20% of the non-participants were low adherent (p = 0.91. The necessity concern differential (NCD) from the BMQ was 3.8 for participants and 3.4 for non-participants (p = 0.32). Conclusion: This study shows that adherence to medication and beliefs about medication do not differ between participants and non-participants before consenting to participate in an RCT. The study design seems not to have led to greater adherence in the study group

A smart all-in-one device to measure vital signs in admitted patients.

Vital sign measurements in hospitalized patients by nurses are time consuming and prone to operational errors. The Checkme, a smart all-in-one device capable of measuring vital signs, could improve daily patient monitoring by reducing measurement time, inter-observer variability, and incorrect inputs in the Electronic Health Record (EHR). We evaluated the accuracy of self measurements by patient using the Checkme in comparison with gold standard and nurse measurements.This prospective comparative study was conducted at the Internal Medicine ward of an academic hospital in the Netherlands. Fifty non-critically ill patients were enrolled in the study. Time-related measurement sessions were conducted on consecutive patients in a randomized order: vital sign measurement in duplicate by a well-trained investigator (gold standard), a Checkme measurement by the patient, and a routine vital sign measurement by a nurse. In 41 patients (82%), initial calibration of the Checkme was successful and results were eligible for analysis. In total, 69 sessions were conducted for these 41 patients. The temperature results recorded by the patient with the Checkme differed significantly from the gold standard core temperature measurements (mean difference 0.1 ± 0.3). Obtained differences in vital signs and calculated Modified Early Warning Score (MEWS) were small and were in range with predefined accepted discrepancies.Patient-calculated MEWS using the Checkme, nurse measurements, and gold standard measurements all correlated well, and the small differences observed between modalities would not have affected clinical decision making. Using the Checkme, patients in a general medical ward setting are able to measure their own vital signs easily and accurately by themselves. This could be time saving for nurses and prevent errors due to manually entering data in the EHR

Sample size, female percentages and mean age of RA patients participating in the studies included in this meta-analysis.

<p>Sample size, female percentages and mean age of RA patients participating in the studies included in this meta-analysis.</p

Cytokine Inhibition in Patients With Chronic Fatigue Syndrome A Randomized Trial

Background: Interleukin-1 (IL-1), an important proinflammatory cytokine, is suspected to play a role in chronic fatigue syndrome (CFS). Objective: To evaluate the effect of subcutaneous anakinra versus placebo on fatigue severity in female patients with CFS. Design: Randomized, placebo-controlled trial from July 2014 to May 2016. Patients, providers, and researchers were blinded to treatment assignment. (ClinicalTrials.gov: NCT02108210) Setting: University hospital in the Netherlands. Patients: 50 women aged 18 to 59 years with CFS and severe fatigue leading to functional impairment. Intervention: Participants were randomly assigned to daily subcutaneous anakinra, 100 mg (n = 25), or placebo (n = 25) for 4 weeks and were followed for an additional 20 weeks after treatment (n = 50). Measurements: The primary outcome was fatigue severity, measured by the Checklist Individual Strength subscale (CIS-fatigue) at 4 weeks. Secondary outcomes were level of impairment, physical and social functioning, psychological distress, and pain severity at 4 and 24 weeks. Results: At 4 weeks, 8% (2 of 25) of anakinra recipients and 20% (5 of 25) of placebo recipients reached a fatigue level within the range reported by healthy persons. There were no clinically important or statistically significant differences between groups in CIS-fatigue score at 4 weeks (mean difference, 1.5 points [95% Cl, -4.1 to 7.2 points]) or the end of follow-up. No statistically significant between-group differences were seen for any secondary outcome at 4 weeks or the end of follow-up. One patient in the anakinra group discontinued treatment because of an adverse event. Patients in the anakinra group had more injection site reactions (68% [17 of 25] vs. 4% [1 of 25]). Limitation: Small sample size and wide variability in symptom duration; inclusion was not limited to patients with postinfectious symptoms. Conclusion: Peripheral IL-1 inhibition using anakinra for 4 weeks does not result in a clinically significant reduction in fatigue severity in women with CFS and severe fatigu