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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

  1. CDC. Use of continuous subcutaneous insulin infusion pumps--Georgia, Maine, and Nebraska, MMWR 1982;31:5-6,15.

  2. Tunbridge WM. Factors contributing to deaths of diabetics under fifty years of age. Lancet 1981;2:569-71.

  3. 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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