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