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Epidemiologic Notes and Reports Update: Deaths among Patients Using Continuous Subcutaneous Insulin Infusion Pumps -- United States

Insulin infusion pumps are small, external, battery-powered devices that administer insulin through a subcutaneous catheter. Regular insulin is administered at a slow constant rate, and additional amounts are given before meals. Continuous subcutaneous insulin infusion (CSII) pumps do not have glucose sensors, and patients using them generally monitor their own blood glucose levels. CSII pumps were introduced in the United States in the late 1970's and have been used by increasing numbers of diabetics to improve their glycemic control.

Eleven deaths among patients using these devices were reported in February 1982 (1). Since then, 24 additional deaths have been reported to CDC. Deaths were identified by physician reports, a mail survey of diabetologists conducted in April 1982, and a 10-state survey of physicians conducted in August 1982. Of the 35 deaths reported among pump users in the United States, one occurred in 1980, 20 in 1981, and 14 in 1982. The patients who died ranged in age from 11 to 66 years, and 33 were insulin-dependent (Type I) diabetics. One death has been attributed to device malfunction and one to endocarditis secondary to an abscess at the catheter insertion site. Seven patients were found dead, and three died suddenly. One died with status epilepticus, one drowned, and one died after a fall. Six deaths were related to ketoacidosis and 14 to myocardial infarction, cerebrovascular disease, and renal failure. Two-thirds of those who died had significant autonomic neuropathy, and one-third had advanced renal disease with serum creatinine levels greater than 5.0 mg/dl. The observed number of deaths was not greater than the expected number calculated from the age-specific death rates for Type I diabetics.

On November 9, 1982, a panel of experts* met at CDC to discuss these findings. After a review of the data, it was the panel's consensus that:

  1. CSII pump therapy is not associated with excess mortality.

  2. Physicians should take great care in selecting patients for intensive glycemic control.

Reported by Technology and Operational Research Br, Div of Diabetes Control, Center for Prevention Svcs, CDC.

Editorial Note

Editorial Note: The number of deaths observed among diabetic patients using CSII pumps does not appear to be excessive. Nevertheless, because of the demands that pump therapy places on both the physician and patient and because of the potential problems inherent in the device (i.e., pump slowing, pump runaway, and catheter-induced infection), great care should be used in its application. In selecting patients, physicians should be aware that pump therapy is unlikely to reverse the severe complications of diabetes once they have developed. Patients selected for pump therapy should be willing to monitor their own blood glucose levels regularly and to test their urines for ketones during intercurrent illnesses. In addition, patients should have access to local medical care and should be encouraged to seek assistance in the event of intercurrent illnesses.

Reference

  1. CDC. Deaths among patients using continuous subcutaneous insulin infusion pumps--United States. MMWR 1982;31:80-2, 87. *M Haffner, MD, Food and Drug Administration; N Berlin, J Field, MD, National Diabetes Advisory Board; E Johnson, PhD, National Institutes of Health; R Guthrie, MD, University of Kansas at Wichita; J Holcombe, MD, University of Oklahoma; R LaPorte, PhD, University of Pittsburgh; R Mecklenburg, MD, Mason Clinic, Seattle; P Raskin, MD, Southwestern Medical Center, Dallas; J Santiago, MD, Washington University, St Louis; and CDC staff.

Disclaimer   All MMWR HTML documents published before January 1993 are electronic conversions from ASCII text into HTML. This conversion may have resulted in character translation or format errors in the HTML version. Users should not rely on this HTML document, but are referred to the original MMWR paper copy for the official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.

**Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.

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