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Original Investigation | Less Is More

Intensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes

Rozalina G. McCoy, MD, MS1,2,3; Kasia J. Lipska, MD, MHS4; Xiaoxi Yao, PhD, MHS2,3; Joseph S. Ross, MD, MHS5,6,7; Victor M. Montori, MD, MS8,9; Nilay D. Shah, PhD2,3,10
[+] Author Affiliations
1Division of Primary Care Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minnesota
2Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota
3Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Rochester, Minnesota
4Section of Endocrinology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
5Section of General Medicine and Robert Wood Johnson Foundation Clinical Scholars Program, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut
6Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut
7Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut
8Division of Endocrinology Metabolism and Nutrition, Department of Medicine, Mayo Clinic, Rochester, Minnesota
9Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota
10OptumLabs, Cambridge, Massachusetts
JAMA Intern Med. 2016;176(7):969-978. doi:10.1001/jamainternmed.2016.2275.
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Importance  Intensive glucose-lowering treatment among patients with non–insulin-requiring type 2 diabetes may increase the risk of hypoglycemia.

Objectives  To estimate the prevalence of intensive treatment and the association between intensive treatment, clinical complexity, and incidence of severe hypoglycemia among adults with type 2 diabetes who are not using insulin.

Design, Setting, and Participants  Retrospective analysis of administrative, pharmacy, and laboratory data from the OptumLabs Data Warehouse from January 1, 2001, through December 31, 2013. The study included nonpregnant adults 18 years or older with type 2 diabetes who achieved and maintained a hemoglobin A1c (HbA1c) level less than 7.0% without use of insulin and had no episodes of severe hypoglycemia or hyperglycemia in the prior 12 months.

Main Outcomes and Measures  Risk-adjusted probability of intensive treatment and incident severe hypoglycemia, stratified by patient clinical complexity. Intensive treatment was defined as use of more glucose-lowering medications than recommended by practice guidelines at specific index HbA1c levels. Severe hypoglycemia was ascertained by ambulatory, emergency department, and hospital claims for hypoglycemia during the 2 years after the index HbA1c test. Patients were categorized as having high vs low clinical complexity if they were 75 years or older, had dementia or end-stage renal disease, or had 3 or more serious chronic conditions.

Results  Of 31 542 eligible patients (median age, 58 years; interquartile range, 51-65 years; 15 483 women [49.1%]; 18 188 white [57.7%]), 3910 (12.4%) had clinical complexity. The risk-adjusted probability of intensive treatment was 25.7% (95% CI, 25.1%-26.2%) in patients with low clinical complexity and 20.8% (95% CI, 19.4%-22.2%) in patients with high clinical complexity. In patients with low clinical complexity, the risk-adjusted probability of severe hypoglycemia during the subsequent 2 years was 1.02% (95% CI, 0.87%-1.17%) with standard treatment and 1.30% (95% CI, 0.98%-1.62%) with intensive treatment (absolute difference, 0.28%; 95% CI, −0.10% to 0.66%). In patients with high clinical complexity, intensive treatment significantly increased the risk-adjusted probability of severe hypoglycemia from 1.74% (95% CI, 1.28%-2.20%) with standard treatment to 3.04% (95% CI, 1.91%-4.18%) with intensive treatment (absolute difference, 1.30%; 95% CI, 0.10%-2.50%).

Conclusions and Relevance  More than 20% of patients with type 2 diabetes received intensive treatment that may be unnecessary. Among patients with high clinical complexity, intensive treatment nearly doubles the risk of severe hypoglycemia.

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Figure 1.
Study Cohort Creation

HbA1c indicates hemoglobin A1c.

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Figure 2.
Risk-Adjusted Probability of Hypoglycemia as a Function of Patient Clinical Complexity and Treatment Intensity

High clinical complexity was defined as a composite measure of age of 75 years or older or high comorbidity burden defined by presence of end-stage renal disease, dementia, or 3 or more chronic conditions (myocardial infarction, congestive heart failure, pulmonary disease, non–end-stage chronic renal disease, or cancer). Intensive treatment was defined as a composite measure of intensive baseline regimen (use of greater number of medications than recommended for a given index hemoglobin A1c [HbA1c] level) and treatment intensification despite a low index HbA1c result. Risk-adjusted probabilities are adjusted for patient sex, race, household income, residency region, index HbA1c year, and specialty of treating health care professional. Error bars indicate 95% CIs.

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Figure 3.
Risk Factors for Incident Severe Hypoglycemia During the 2 Years After the Index Hemoglobin A1c (HbA1c) Test

High clinical complexity was defined as a composite measure of age of 75 years or older or high comorbidity burden defined by the presence of end-stage renal disease, dementia, or 3 or more chronic conditions (myocardial infarction, congestive heart failure, pulmonary disease, non–end-stage chronic renal disease, or cancer). Intensive treatment was defined as a composite measure of intensive baseline regimen (use of greater number of medications than recommended for a given index HbA1c level) and treatment intensification despite a low index HbA1c result. Error bars indicate 95% CIs.

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