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      Assessment of severity and frequency of self-reported hypoglycemia on quality of life in patients with type 2 diabetes treated with oral antihyperglycemic agents: A survey study

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          Abstract

          Background

          Some oral antihyperglycemic agents may increase risk of hypoglycemia and thereby reduce patient quality of life. Our objective was to assess the impact of the severity and frequency of self-reported hypoglycemia on health-related quality of life (HRQoL) among patients with type 2 diabetes treated with oral antihyperglycemic agents.

          Findings

          A follow-up survey was conducted in participants with self-reported type 2 diabetes treated with oral antihyperglycemic agents from the US National Health and Wellness Survey 2007. Data were collected on the severity and frequency of hypoglycemic episodes in the 6 months prior to the survey, with severity defined as mild (no interruption of activities), moderate (some interruption of activities), severe (needed assistance of others), or very severe (needed medical attention). HRQoL was assessed using the EuroQol-5D Questionnaire (EQ-5D) US weighted summary score (utility) and Worry subscale of the Hypoglycemia Fear Survey (HFS). Of the participants who completed the survey (N = 1,984), mean age was 58 years, 57% were male, 72% reported an HbA 1c <7.0%, and 50% reported treatment with a sulfonylurea-containing regimen. Hypoglycemic episodes were reported by 63% of patients (46% mild, 37% moderate, 13% severe and 4% very severe). For patients reporting hypoglycemia, mean utility score was significantly lower (0.78 versus 0.86, p < 0.0001) and mean HFS score was significantly higher (17.5 versus 6.2, p < 0.0001) compared to patients not reporting hypoglycemia. Differences in mean scores between those with and without hypoglycemia increased with the level of severity (mild, moderate, severe, very severe) for utility (0.03, 0.09, 0.18, 0.23) and HFS (6.1, 13.9, 20.1, 25.6), respectively. After adjusting for age, gender, weight gain, HbA 1c, microvascular complications, and selected cardiovascular conditions, the utility decrement was 0.045 (by level of severity: 0.009, 0.055, 0.131, 0.208), and the HFS increase was 9.6 (by severity: 5.3, 12.4, 17.6, 23.2). HRQoL further decreased with greater frequency of hypoglycemic episodes.

          Conclusions

          Self-reported hypoglycemia is independently associated with lower HRQoL, and the magnitude of this reduction increases with both severity and frequency of episodes in patients with type 2 diabetes treated with oral antihyperglycemic agents.

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          Most cited references14

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          US valuation of the EQ-5D health states: development and testing of the D1 valuation model.

          The EQ-5D is a brief, multiattribute, preference-based health status measure. This article describes the development of a statistical model for generating US population-based EQ-5D preference weights. A multistage probability sample was selected from the US adult civilian noninstitutional population. Respondents valued 13 of 243 EQ-5D health states using the time trade-off (TTO) method. Data for 12 states were used in econometric modeling. The TTO valuations were linearly transformed to lie on the interval [-1, 1]. Methods were investigated to account for interaction effects caused by having problems in multiple EQ-5D dimensions. Several alternative model specifications (eg, pooled least squares, random effects) also were considered. A modified split-sample approach was used to evaluate the predictive accuracy of the models. All statistical analyses took into account the clustering and disproportionate selection probabilities inherent in our sampling design. Our D1 model for the EQ-5D included ordinal terms to capture the effect of departures from perfect health as well as interaction effects. A random effects specification of the D1 model yielded a good fit for the observed TTO data, with an overall R of 0.38, a mean absolute error of 0.025, and 7 prediction errors exceeding 0.05 in absolute magnitude. The D1 model best predicts the values for observed health states. The resulting preference weight estimates represent a significant enhancement of the EQ-5D's utility for health status assessment and economic analysis in the US.
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            Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II diabetes.

            P Cryer (2002)
            Hypoglycaemia is the limiting factor in the glycaemic management of diabetes. Iatrogenic hypoglycaemia is typically the result of the interplay of insulin excess and compromised glucose counterregulation in Type I (insulin-dependent) diabetes mellitus. Insulin concentrations do not decrease and glucagon and epinephrine concentrations do not increase normally as glucose concentrations decrease. The concept of hypoglycaemia-associated autonomic failure (HAAF) in Type I diabetes posits that recent antecedent iatrogenic hypoglycaemia causes both defective glucose counterregulation (by reducing the epinephrine response in the setting of an absent glucagon response) and hypoglycaemia unawareness (by reducing the autonomic and the resulting neurogenic symptom responses). Perhaps the most compelling support for HAAF is the finding that as little as 2 to 3 weeks of scrupulous avoidance of hypoglycaemia reverses hypoglycaemia unawareness and improves the reduced epinephrine component of defective glucose counterregulation in most affected patients. The mediator and mechanism of HAAF are not known but are under active investigation. The glucagon response to hypoglycaemia is also reduced in patients approaching the insulin deficient end of the spectrum of Type II (non-insulin-dependent) diabetes mellitus, and glycaemic thresholds for autonomic (including epinephrine) and symptomatic responses to hypoglycaemia are shifted to lower plasma glucose concentrations after hypoglycaemia in Type II diabetes. Thus, patients with advanced Type II diabetes are also at risk for HAAF. While it is possible to minimise the risk of hypoglycaemia by reducing risks -- including a 2 to 3 week period of scrupulous avoidance of hypoglycaemia in patients with hypoglycaemia unawareness -- methods that provide glucose-regulated insulin replacement or secretion are needed to eliminate hypoglycaemia and maintain euglycaemia over a lifetime of diabetes.
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              Fear of hypoglycemia: quantification, validation, and utilization.

              Hypoglycemia can lead to various aversive symptomatic, affective, cognitive, physiological, and social consequences, which in turn can lead to the development of possible phobic avoidance behaviors associated with hypoglycemia. On the other hand, some patients may inappropriately deny or disregard warning signs of hypoglycemia. This study presents preliminary reliability and validity data on a psychometric instrument designed to quantify this fear: the hypoglycemic fear survey. The instrument was found to have internal consistency and test-retest stability, to covary with elevated glycosylated hemoglobin, and to be sensitive to a behavioral treatment program designed to increase awareness of hypoglycemia.
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                Author and article information

                Journal
                BMC Res Notes
                BMC Research Notes
                BioMed Central
                1756-0500
                2011
                21 July 2011
                : 4
                : 251
                Affiliations
                [1 ]Global Health Outcomes, Merck Sharp & Dohme, Corp., Whitehouse Station, NJ, USA
                [2 ]Department of Epidemiology, University of Medicine and Dentistry of New Jersey - School of Public Health, Piscataway, NJ, USA
                Article
                1756-0500-4-251
                10.1186/1756-0500-4-251
                3148563
                21777428
                acd8fb8d-2b81-4b2c-a135-a8d0c119ece6
                Copyright ©2011 Zhang et al; licensee BioMed Central Ltd.

                This is an open access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 23 March 2011
                : 21 July 2011
                Categories
                Short Report

                Medicine
                Medicine

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