Burden of Hypoglycemia in Insulin-Treated Patients With DM
Burden of Hypoglycemia in Insulin-Treated Patients With DM
Hypoglycemia is common in patients with diabetes, and any severe hypoglycemic event can increase the fear of future hypoglycemic events. To try to reduce hypoglycemic events, many patients with diabetes maintain their blood glucose levels with a 'safety margin' (i.e., at higher than recommended values) and maintain hyperglycemia. Following this strategy leads to raised glycated hemoglobin levels, which are, consequently, linked to an increased risk of diabetic complications and increased healthcare costs. In the present survey (n = 1848), conducted in Germany, France and the UK, approximately a third of the patients were very worried about hypoglycemia, and a similar proportion reported maintaining hyperglycemia. Overall, the mean number of emergency room visits and hospitalizations (excluding emergency room visits) per patient per 12 months was 0.65 and 0.47, respectively. In addition, 10% of the patients reported that they had taken days off work because of hypoglycemia during the previous 12 months. Furthermore, 80% of diabetics in the three countries said they would value a meter that tells them when their blood glucose level is getting high/low at a particular time of the day. Thus, the survey outlines the potential scale, in a real-world setting, of 'hidden' costs associated with hypoglycemia and fear of hypoglycemia; such costs are likely to have a major detrimental impact on the overall emotional and economic burden of diabetes, which may be reduced through broader use of blood-glucose monitors for self-monitoring of blood glucose.
Hypoglycemia is a frequent and potentially fatal complication in patients with Type 1 or Type 2 diabetes treated with insulin, and in patients with Type 2 diabetes treated with some oral drugs, such as sulfonylureas or meglitinides. Definitions of the disorder are heterogeneous, but basically, it is widely accepted that hypoglycemia occurs when blood glucose levels are below 70 mg/dl (3.9 mmol/l). The condition is classed as mild, moderate or severe; the American Diabetes Association (ADA) has a more complex classification system (Table 1).
The morbidity associated with hypoglycemia in patients with diabetes is marked and frequent: indeed, patients with Type 1 diabetes are reported to experience an average of two mild hypoglycemic episodes each week, and individuals with insulin-treated diabetes may experience at least one episode of severe hypoglycemia each year. A recent, large-scale analysis (n > 100,000) revealed that hospitalized diabetes patients with hypoglycemia (defined as blood glucose <70 mg/dl), compared with those without, had significantly higher healthcare charges (+39%), longer periods of hospitalization (+3 days), greater mortality (odds ratio [OR]: 1.07), and a greater likelihood of being discharged to a skilled nursing facility (OR: 1.58; all changes p < 0.01). Thus, the overall patient, payor and societal burdens of hypoglycemia in diabetes are enormous.
Worldwide, it is estimated that the annual investment in diabetes management accounts for approximately 12% of public healthcare expenses and, as discussed by Brito-Sanfiel and colleagues, in Spain, the direct costs of managing each severe hypoglycemic event (SHE) are approximately €3500. Another analysis, conducted in Germany, Spain and the UK, outlined that total hospital treatment costs (direct plus indirect) for each SHE were €1307–3298 in Type 1 diabetics, compared with €1314–3023 in Type 2 diabetics. Furthermore, recent data from the UK NHS reported that, over a 12-month period, there were >12,000 emergency hospital admissions for patients with diabetes due to hypoglycemia, resulting in >69,000 bed days due to a primary diagnosis of hypoglycemia, at an estimated cost of >GB£20.7 million to the NHS.
In several cases, cost estimates for the management of hypoglycemia focus on direct costs alone and do not consider indirect costs, such as reduced work productivity, absenteeism (from work or school), recovery times from hypoglycemic episodes and early retirement, or effects on health-related quality of life. There are also other 'hidden' costs in terms of patient self-management of the condition and fear of hypoglycemia. For example, a Canadian survey reported that among insulin-treated patients with Type 2 diabetes and hypoglycemia, approximately 85% of patients self-managed episodes, during which only 3% of patients requested an ambulance and only 6% had an emergency room or hospital visit. The overall costs of hypoglycemia in diabetes are therefore likely to be underestimated.
Clearly, a SHE is a particularly unpleasant experience, which may involve convulsions, coma and hypothermia, and which is therefore an event that a patient with diabetes will not wish to repeat; understandably, any SHE that occurs increases patient fear of future hypoglycemic episodes. Such fear places an increased psychologic burden on patients, which is often not shared or discussed with healthcare professionals. Fear of hypoglycemia is also a major barrier to the attainment of glycemic control. Patients adopt different strategies for coping with their fear, and these approaches may restrict the aggressiveness of antidiabetes therapy and reduce adherence to dietary and pharmacologic interventions. In other words, to allay any fear of hypoglycemia, many patients with diabetes deliberately include a 'safety margin' and deliberately maintain their blood glucose concentrations at higher than recommended levels.
Consequently, the hyperglycemia caused by fear of hypoglycemia may result in raised glycated hemoglobin (HbA1c) levels, which is linked in turn to an increase in long-term risks of microvascular and, potentially, macrovascular complications, and thus increased healthcare costs for diabetes. In 1998, the UK Prospective Diabetes Study reported that for each 1% decrease in HbA1c level, relative risk reductions were 37% for microvascular complications and 21% for diabetes-related end points and death. More recently, Giorda et al. outlined that the costs of diabetes-related complications are greater than the costs of diabetes management per se and represent the major constituent of healthcare expenditure on diabetes.
However, much work remains to be done regarding the full identification and quantification of overall healthcare expenditure associated with hypoglycemia in patients with diabetes. Accurate information is also needed about the actual incidence of hypoglycemia in patients with diabetes, the frequencies of emergency room visitation and hospitalization and the effects of hypoglycemia on patients' work and leisure activities. The current survey was therefore conducted to collect such information from patients with diabetes in three European countries, to outline the possible implications of hypoglycemia on healthcare expenditure, and to highlight how such expenditure might be reduced through appropriate self-monitoring of blood glucose (SMBG) and the prevention of both hypoglycemia and hyperglycemia.
Abstract and Introduction
Abstract
Hypoglycemia is common in patients with diabetes, and any severe hypoglycemic event can increase the fear of future hypoglycemic events. To try to reduce hypoglycemic events, many patients with diabetes maintain their blood glucose levels with a 'safety margin' (i.e., at higher than recommended values) and maintain hyperglycemia. Following this strategy leads to raised glycated hemoglobin levels, which are, consequently, linked to an increased risk of diabetic complications and increased healthcare costs. In the present survey (n = 1848), conducted in Germany, France and the UK, approximately a third of the patients were very worried about hypoglycemia, and a similar proportion reported maintaining hyperglycemia. Overall, the mean number of emergency room visits and hospitalizations (excluding emergency room visits) per patient per 12 months was 0.65 and 0.47, respectively. In addition, 10% of the patients reported that they had taken days off work because of hypoglycemia during the previous 12 months. Furthermore, 80% of diabetics in the three countries said they would value a meter that tells them when their blood glucose level is getting high/low at a particular time of the day. Thus, the survey outlines the potential scale, in a real-world setting, of 'hidden' costs associated with hypoglycemia and fear of hypoglycemia; such costs are likely to have a major detrimental impact on the overall emotional and economic burden of diabetes, which may be reduced through broader use of blood-glucose monitors for self-monitoring of blood glucose.
Introduction
Hypoglycemia is a frequent and potentially fatal complication in patients with Type 1 or Type 2 diabetes treated with insulin, and in patients with Type 2 diabetes treated with some oral drugs, such as sulfonylureas or meglitinides. Definitions of the disorder are heterogeneous, but basically, it is widely accepted that hypoglycemia occurs when blood glucose levels are below 70 mg/dl (3.9 mmol/l). The condition is classed as mild, moderate or severe; the American Diabetes Association (ADA) has a more complex classification system (Table 1).
The morbidity associated with hypoglycemia in patients with diabetes is marked and frequent: indeed, patients with Type 1 diabetes are reported to experience an average of two mild hypoglycemic episodes each week, and individuals with insulin-treated diabetes may experience at least one episode of severe hypoglycemia each year. A recent, large-scale analysis (n > 100,000) revealed that hospitalized diabetes patients with hypoglycemia (defined as blood glucose <70 mg/dl), compared with those without, had significantly higher healthcare charges (+39%), longer periods of hospitalization (+3 days), greater mortality (odds ratio [OR]: 1.07), and a greater likelihood of being discharged to a skilled nursing facility (OR: 1.58; all changes p < 0.01). Thus, the overall patient, payor and societal burdens of hypoglycemia in diabetes are enormous.
Worldwide, it is estimated that the annual investment in diabetes management accounts for approximately 12% of public healthcare expenses and, as discussed by Brito-Sanfiel and colleagues, in Spain, the direct costs of managing each severe hypoglycemic event (SHE) are approximately €3500. Another analysis, conducted in Germany, Spain and the UK, outlined that total hospital treatment costs (direct plus indirect) for each SHE were €1307–3298 in Type 1 diabetics, compared with €1314–3023 in Type 2 diabetics. Furthermore, recent data from the UK NHS reported that, over a 12-month period, there were >12,000 emergency hospital admissions for patients with diabetes due to hypoglycemia, resulting in >69,000 bed days due to a primary diagnosis of hypoglycemia, at an estimated cost of >GB£20.7 million to the NHS.
In several cases, cost estimates for the management of hypoglycemia focus on direct costs alone and do not consider indirect costs, such as reduced work productivity, absenteeism (from work or school), recovery times from hypoglycemic episodes and early retirement, or effects on health-related quality of life. There are also other 'hidden' costs in terms of patient self-management of the condition and fear of hypoglycemia. For example, a Canadian survey reported that among insulin-treated patients with Type 2 diabetes and hypoglycemia, approximately 85% of patients self-managed episodes, during which only 3% of patients requested an ambulance and only 6% had an emergency room or hospital visit. The overall costs of hypoglycemia in diabetes are therefore likely to be underestimated.
Clearly, a SHE is a particularly unpleasant experience, which may involve convulsions, coma and hypothermia, and which is therefore an event that a patient with diabetes will not wish to repeat; understandably, any SHE that occurs increases patient fear of future hypoglycemic episodes. Such fear places an increased psychologic burden on patients, which is often not shared or discussed with healthcare professionals. Fear of hypoglycemia is also a major barrier to the attainment of glycemic control. Patients adopt different strategies for coping with their fear, and these approaches may restrict the aggressiveness of antidiabetes therapy and reduce adherence to dietary and pharmacologic interventions. In other words, to allay any fear of hypoglycemia, many patients with diabetes deliberately include a 'safety margin' and deliberately maintain their blood glucose concentrations at higher than recommended levels.
Consequently, the hyperglycemia caused by fear of hypoglycemia may result in raised glycated hemoglobin (HbA1c) levels, which is linked in turn to an increase in long-term risks of microvascular and, potentially, macrovascular complications, and thus increased healthcare costs for diabetes. In 1998, the UK Prospective Diabetes Study reported that for each 1% decrease in HbA1c level, relative risk reductions were 37% for microvascular complications and 21% for diabetes-related end points and death. More recently, Giorda et al. outlined that the costs of diabetes-related complications are greater than the costs of diabetes management per se and represent the major constituent of healthcare expenditure on diabetes.
However, much work remains to be done regarding the full identification and quantification of overall healthcare expenditure associated with hypoglycemia in patients with diabetes. Accurate information is also needed about the actual incidence of hypoglycemia in patients with diabetes, the frequencies of emergency room visitation and hospitalization and the effects of hypoglycemia on patients' work and leisure activities. The current survey was therefore conducted to collect such information from patients with diabetes in three European countries, to outline the possible implications of hypoglycemia on healthcare expenditure, and to highlight how such expenditure might be reduced through appropriate self-monitoring of blood glucose (SMBG) and the prevention of both hypoglycemia and hyperglycemia.
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