Epidemiologic Notes and Reports Deaths among Patients Using
Continuous Subcutaneous Insulin Infusion Pumps -- United States
Insulin infusion pumps are open loop devices that administer
insulin subcutaneously at a constant low level and deliver added
amounts before meals. They represent a new method for attaining
improved glucose control in Type I (insulin-dependent) diabetics.
Animal studies and limited information regarding humans suggest
that
improved control of blood sugar may prevent or slow the rate of
development of serious complications of diabetes such as
retinopathy,
nephropathy, neuropathy, and cardiovascular disease. There are
approximately 5 million diabetics in the United States, of whom
5%-15%
are Type I. Approximately 4,000 pumps are currently in use in the
United States, and the number is growing rapidly (1).
Three deaths among patients using these devices were reported
at
the National Diabetes Research Interchange workshop in January 1982
in
San Antonio, Texas. CDC subsequently began an active inquiry into
the
circumstances surrounding these deaths and identified additional
deaths that occurred among patients using these devices. A total
of
11 cases have been identified.
On February 17, l982, a panel* of representatives from the
National Institutes of Health, the Food and Drug Administration,
the
National Diabetes Advisory Board, and other diabetes experts met at
CDC to discuss these cases (Table 1). Only fragmentary data were
available regarding several of the cases; however, all 11 persons
died
in 1981. Patients ranged in age from 11 years to the early 60's; 6
were male. Duration of diabetes ranged from 3 to 43 years. On the
basis of preliminary information, 2 deaths were due to myocardial
infarctions, 1 to a cerebrovascular accident, and 1 to
mucormycosis.
Of 3 patients found dead or comatose in bed, 1 had documented
hypoglycemia. One patient drowned, 1 died suddenly in the middle
of
the night, and 1 died of ketoacidosis. Information was not
available
for 1 patient. In none of the cases was there any evidence of pump
malfunction or failure; patients used pumps from more than 1
manufacturer. When checked, pumps were found to be working
properly.
In several instances, patients delayed contacting a physician
despite
finding abnormal blood-sugar levels on home blood-glucose monitors.
The panel came to the following conclusions: 1) Some deaths
seem
essentially unrelated to insulin therapy. While none of the deaths
could be attributed to the infusion pumps, some deaths may have
been
due to the intensive glycemia control used as a therapeutic goal.
Until further information is available, physicians and patients
should
exercise prudence in selecting goals of therapy, in appropriately
monitoring blood-glucose levels, and in regulating insulin dosage.
The risks of intensive glycemia control must be weighed against the
potential long-term benefits. 2) A better description of the
characteristics of the population using these devices is needed, as
is
information on therapeutic complications for a comparable group of
diabetics receiving intensive therapy with multiple manual
injections
of insulin. Further investigation of the cases reported here is
warranted, and surveillance of deaths among patients using insulin
infusion pumps should be established.
Reported by RL Olson, MD, Lewiston, Idaho; S Leichter, MD,
Lexington,
Kentucky; J Warram, MD, A Krolewski, MD, Boston, Massachusetts; P
Raskin, MD, Dallas, Texas; Diabetes Control, Operation Research,
Center for Prevention Svcs, CDC.
Editorial Note
Editorial Note: No data on morbidity or mortality are currently
available from a group of diabetics under intensive control and not
using infusion pumps, i.e., comparable to patients using infusion
pumps. Because hypoglycemia is rarely given as the underlying
cause
of death on death certificates, hypoglycemia death rates are
unknown.
In Great Britain, some 4% of all deaths among diabetics under age
50
were attributed to hypoglycemia; many of these persons committed
suicide (2). A prospective study of 285 Type I diabetics seen at
the
Joslin Clinic and followed for a total of 6,37l patient years
showed
that 2 deaths had been attributed to hypoglycemia and 3 more were
possibly due to hypoglycemia. Information for metropolitan Atlanta
suggests an 8-month average duration of pump use. Thus, although
4,000 pumps are currently estimated to be in use in the United
States,
the number of patient years of insulin pump use may be
substantially
less than the number of pumps might indicate.
Hypoglycemia is a well-recognized complication of intensive
control of diabetes (3), but further information is necessary
before
conclusions can be drawn as to whether hypoglycemia was the cause
of
death in a greater-than-expected number of patients using insulin
infusion devices. CDC is initiating data collection efforts.
References
CDC. Use of continuous subcutaneous insulin infusion
pumps--Georgia, Maine, and Nebraska, MMWR 1982;31:5-6,15.
Tunbridge WM. Factors contributing to deaths of diabetics under
fifty years of age. Lancet 1981;2:569-71.
Ingelfinger FJ. Debates on diabetes. New Engl J Med
1977;296:1228-30.
*R Gatling, PhD, M Haffner, MD, Food and Drug Administration; R
Mecklenburg, MD, Mason Clinic, Seattle, Washington; N Berlin, J
Field,
MD, R Kuehne, 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; J Santiago, MD,
Washington University; P Felig, MD, Yale University; and CDC staff.
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