The burden of severe hypoglycemia in type 2 diabetes

Abstract

Aims: More than 29 million people in the US have type 2 diabetes mellitus (T2DM), a chronic metabolic disorder characterized by a progressive deterioration of glucose control, which eventually requires insulin. Abnormally low levels of blood glucose, a feared side-effect of insulin treatment, may cause severe hypoglycemia (SHO), leading to emergency department (ED) admission, hospitalization, and long-term complications; these, in turn, drive up the costs of T2DM. This study’s objective was to estimate the prevalence and costs of SHO-related hospitalizations and their additional longer-term impacts on patients with T2DM using insulin.

Methods: Using Truven MarketScan claims, we identified adult T2DM patients using basal and basal-bolus insulin regimens who were hospitalized for SHO (inpatient SHO patients) during 2010–2015. Two comparison groups were defined: those with outpatient SHO-related encounters only, including ED visits without hospitalization (outpatient SHO patients), and those with no SHO- or acute hyperglycemia-related events (comparison patients). Lengths of stay and SHO-related hospitalization costs were estimated, and propensity score and inverse probability weighting methods were used to adjust for baseline differences across the groups to evaluate longer-term impacts.

Results: We identified 66,179 patients using basal and 81,876 patients using basal-bolus insulin, of which ∼1.1% (basal) to 3.2% (basal-bolus) experienced at least one SHO-related hospitalization. Among those who experienced SHO (i.e. those in the inpatient and outpatient SHO groups), 27% (basal) and 40% (basal-bolus) experienced at least one SHO-related hospitalization. One-third of basal and about one-quarter of basal-bolus patients were admitted directly to the hospital; the remainder were first assessed or treated in the ED. Inpatient SHO patients using basal insulin stayed in the hospital, including time in the ED, for 2.8 days and incurred $6896 in costs; patients using basal-bolus insulin stayed in the hospital for 2.6 days and incurred costs of $5802. Forty-to-fifty percent of inpatient SHO patients were hospitalized again for SHO. Inpatient SHO patients using basal insulin incurred significantly higher monthly costs after their initial SHO-related hospitalization than patients in the other two groups ($2935 vs $1819 and $1638), corresponding to 61% and 79% higher monthly costs; patients using basal-bolus insulin also incurred significantly higher monthly costs than patients in the other groups ($3606 vs $2731 and $2607), corresponding to 32% and 38% higher monthly costs.

Limitations: These analyses excluded patients who did not seek ED or hospital care when faced with SHO; events may have been miscoded; and we were not able to account for clinical characteristics associated with SHO, such as insulin dose and duration of diabetes, or unmeasured confounders.

Conclusions: The burden associated with SHO is not negligible. Nearly one in three patients using only basal insulin and one in four patients using basal-bolus regimens who experienced SHO were hospitalized at least once due to SHO. Not only did those patients incur the costs of their SHO hospitalization, but they also incurred at least $1,116 (62%) and $875 (70%) more per month than outpatient SHO or comparison patients. Reducing SHO events can help decrease the burden associated with SHO among patients with T2DM.

Keywords:

• Type 2 diabetes mellitus
• Burden of illness
• Severe hypoglycemia
• Costs
• Hospitalization
• Basal insulin
• Basal-bolus insulin

Transparency

Declaration of funding

Novo Nordisk Inc., a pharmaceutical company that manufactures, markets, and/or distributes more than a dozen drugs for diabetes in the US, provided the funding for this study and article.

Declaration of financial/other relationships

JL and MLG are employed by Evidera Inc., an independent research company that provides consulting and other research services to the biopharmaceutical industry. In their salaried positions, they work with a variety of client companies and are precluded from receiving payment or honoraria directly from these organizations for services rendered. Evidera received payment from Novo Nordisk Inc. for the conduct of this study and the development of this manuscript. RW was an employee of Evidera Inc. when this manuscript was written. YP is an employee of Novo Nordisk Inc. JW was an employee of Novo Nordisk Inc. when this manuscript was written; he is a minor shareholder of Novo Nordisk Inc. DS has served on advisory boards for, and received honoraria from, Novo Nordisk Inc. and Intarcia Therapeutics, Inc. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Previous presentations

Liu J, Wang R, Ganz ML, Paprocki Y, Weatherall J. The burden of severe hypoglycemia in type 1 diabetes. Poster presented at the AMCP Managed Care Specifically Pharmacy Annual Meeting 2017; March 27–30, 2017; Denver, Colorado.