A model of mild hypoglycemia

Abstract

Objective:

To investigate the impact associated with mild hypoglycemia among patients with type 2 diabetes (T2DM) in the United States and to identify risk factors among different subpopulations.

Methods:

We performed a literature search to gather available data allowing estimation of rates of mild hypoglycemia. Because risk factors are interdependent, risk factors included in the model were based on those reported within multivariate analyses or judged to be biologically plausible by the medical community. Based on literature search results, we built a mathematical model predicting the rates of mild hypoglycemia in individual patients as a function of the patient’s antidiabetic medications, hemoglobin A1c levels, duration of diabetes, kidney function, and body mass index.

Results:

We estimated an overall average rate of mild hypoglycemia among US patients with T2DM of 2.2 ± 0.8 events per person per year. Patients taking oral antidiabetic medications only had an average rate of 1.9 ± 0.8 events per person per year. The average rate for all patients taking insulin, including those combining it with other antidiabetic medications, was 4.9 ± 2.0 events per person per year. Mild hypoglycemia rates increased with age, with 80-year-old patients experiencing 1.5 times the risk of 40-year-old patients. Based on published values for direct and indirect medical costs for mild hypoglycemia events, we determined that the economic impact in the US of mild hypoglycemic events is approximately $900 million per year, roughly equal to that of severe hypoglycemic events. One of the key limitations to our model is that it applies to the US population under standard medical care and not to clinical trials and does not include certain known risk factors such as rigorous exercise.

Conclusions:

Understanding the benefit versus risk of glycemic control and hypoglycemia is fundamental to the successful management of patients with T2DM. Our validated hypoglycemia model is an important step in addressing this issue and may be helpful to researchers, clinicians, and payers to determine the patients who are at the highest risk for hypoglycemia, whether a patient is experiencing events at ‘higher-than-expected’ rates, and the corresponding economic burden.

Keywords: :

• Archimedes Model
• Hypoglycemia
• Mild hypoglycemia
• Model
• Type 2 diabetes

Transparency

Declaration of funding

The study was funded by Eli Lilly, and was conducted by Archimedes Inc. under contract to Eli Lilly and Company, Indianapolis, IN 46285, USA.

Declaration of financial/other relationships

S.S., D.G., K.S., and B.R. have disclosed that they are former employees of Evidera. B.C., S.C., and K.S.B. have disclosed that they are Eli Lilly employees and own stock in the company.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

All listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors. We thank Jaime Caro (Evidera) for valuable suggestions and Andrea Kress (Evidera) for assistance in the preparation of the manuscript.