A remotely programmable insulin delivery system. Successful short-term implantation in man
D. S. Schade, R. P. Eaton, W. S. Edwards, R. C. Doberneck, W. J. Spencer, G. A. Carlson, R. E. Bair, J. T. Love, R. S. Urenda and J. I. Gaona Jr
A remotely controlled, programmable insulin delivery system was implanted
in a diabetic man and the feasibility of the technique was examined.
Specific problems included (1) development of an appropriate surgical
approach, (2) identification of methods to assess the integrity of the
insulin delivery system following implantation, and (3) assessment of
plasma glucose and free-insulin profiles obtained with the implanted
system. The insulin pump was implanted submuscularly through a midline
abdominal incision. The insulin reservoir was placed subcutaneously to
allow percutaneous refilling. The insulin delivery catheter terminated in
the peritoneal space. No postoperative wound infection occurred and rapid
healing of the surgical site ensued. In vivo assessment of the system
included (1) dye contrast roentgenography, (2) vasopressin stimulation, and
(3) reservoir volume monitoring. Short-acting insulin was then placed in
the implanted reservoir and delivered by the system for one month. Mean
plasma glucose concentration declined to normal levels, as did glycosylated
hemoglobin. Plasma insulin profiles were normalized with appropriate
insulin peaks with each meal. We conclude that implantation of a remotely
programmable insulin pump is feasible in type I diabetic man. Additional
studies are necessary to define which patients will benefit from this type
of insulin delivery system.
