Impact of the severity of hypoglycemia on health - Related quality of life, productivity, resource use, and costs among US patients with type 2 diabetes

Abstract

Aims

To explore the association between hypoglycemia severity and health-related quality of life (HRQoL), productivity, health care resource utilization (HCRU), and costs among patients with type 2 diabetes mellitus (T2DM).

Methods

Data were from the 2013 US National Health and Wellness Survey. This analysis included adults with treated T2DM. Participants were categorized based upon their self-reported experience in the previous 3 months: no hypoglycemia, non-severe hypoglycemia, or severe hypoglycemia. Validated instruments were used to measure HRQoL and productivity; HCRU was based on participant-reported health care provider (HCP) and emergency department (ED) visits and hospitalizations. Multivariable models tested for trends across the severity groups.

Results

The analysis included 3630 participants—1729 (47.6%) with non-severe hypoglycemia and 172 (4.7%) with severe hypoglycemia. Mental and physical component scores and utility scores were significantly associated with hypoglycemia severity (P < 0.001 for each). Similar trends were observed for absenteeism (P < 0.001), presenteeism (P = 0.005), HCP and ED visits (P ≤ 0.002), and hospitalizations (P < 0.001). Annual HCRU costs associated with increasingly severe hypoglycemia were $6908, $7132, and $15,410, respectively (P < 0.001), and productivity costs were $7248, $7493, and $12,167, respectively (P = 0.008).

Conclusion

Hypoglycemia severity appears to be related to reduced HRQoL and productivity, which are mirrored by increased direct and indirect costs.

Introduction

In the United States, 29.1 million people—9.3% of the population—have diabetes.¹ Most diabetes cases (90–95%) are classified as type 2 diabetes mellitus (T2DM).

Guidelines from the American Diabetes Association (ADA) recommend antihyperglycemic therapy in stages (first-line, second-line, etc.),² with selection of treatment based on the characteristics and needs of the patient.^3,4 However, some second-line drugs, particularly sulfonylureas and insulin, pose a risk of reducing glucose levels too much, causing hypoglycemia.⁵ Hypoglycemia is identified in diabetes patients by the presence of adrenergic or neuroglycopenic symptoms (e.g., palpitations, tremors, hunger, sweating, behavioral changes, confusion, and seizures) and/or low concentrations of blood glucose (plasma levels ≤70 mg/dL are the typical threshold).^5,6 In addition, the ADA classifies the severity of hypoglycemia according to the need for external assistance (severe hypoglycemia), the presence of symptoms with documentation of a plasma glucose concentration below the cut-off (documented symptomatic hypoglycemia), and the presence of symptoms with no blood glucose measurement (probable symptomatic hypoglycemia).⁵

In recent population-based surveys, 14% to 71% of US T2DM patients reported experiencing hypoglycemia in the prior 2 weeks to 12 months.7., 8., 9., 10. The reported rate of hypoglycemia varies widely based on the definition of hypoglycemia and the methodology of data collection, but generally, rates of clinically confirmed hypoglycemia tend to be lower (e.g., 28% confirmed versus 43% unconfirmed in Williams et al.¹⁰). Furthermore, analyses of US administrative claims data reported that just 1–9% of T2DM patients have evidence of hypoglycemia, suggesting that only a small proportion of hypoglycemic episodes are reported to physicians and/or require medical assistance.10., 11., 12. These previous studies have shown significant associations between patient-reported hypoglycemia and decreased health-related quality of life (HRQoL), treatment dissatisfaction, low treatment adherence, and productivity impairment.7., 8., 9., 10. Hypoglycemia was also shown to be associated with increased health care resource use (HCRU) and increased costs.^9,10 However, none of these studies distinguished between severe and non-severe hypoglycemia in terms of their effects on patient-reported outcomes.

Very few US studies have assessed the impact of non-severe hypoglycemia on clinical outcomes. More research is necessary to understand the association between the severity of hypoglycemia (non-severe as well as severe) and health outcomes in US T2DM patients. Accordingly, the objective of this study was to examine the impact of the severity of hypoglycemia on HRQoL, work-related productivity, HCRU, and costs (direct and indirect) among T2DM patients in the US.