A preliminary trial of the programmable implantable medication system for insulin delivery.
We undertook a trial to determine whether an implanted insulin-delivery system, the programmable implantable medication system (PIMS), could be used to treat patients with insulin-dependent diabetes. PIMS is a pulsatile, programmable pump with a battery life expectancy of five years. The reservoir is refilled transcutaneously every two months with a surfactant-stabilized human insulin preparation containing 400 U of insulin per milliliter. Eighteen patients received PIMS-delivered insulin for 4 to 25 months (mean, 18). The total PIMS-implantation experience comprised 28 patient-years. Good glycemic control was established and sustained during treatment (mean plasma glucose level, 7.3 mmol per liter; mean glycohemoglobin level, 8 percent [upper limit of normal, 7.5 percent]), with significantly reduced glycemic fluctuations. The total mean daily insulin dose did not change. Insulin solutions withdrawn from the pump reservoirs contained 92 percent native insulin and preserved biologic activity. There were no surgical or skin complications, severe hypoglycemic episodes, or instances of diabetic ketoacidosis. One pump was replaced because of a manufacturing defect, and four patients had catheter blockages due to omental-tissue encapsulation; two withdrew from the study and two had devices that were repaired successfully. The actuarial rate of survival of catheter function was 78 percent at 1.5 years. We conclude from this pilot study that insulin treatment with an implanted, variable-rate, programmable pump is feasible for periods up to two years.
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205.
C D
CD
Saudek
J L
JL
Selam
H A
HA
Pitt
K
K
Waxman
M
M
Rubio
N
N
Jeandidier
D
D
Turner
R E
RE
Fischell
M A
MA
Charles
D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D011211:Electric Power Supplies; D004868:Equipment Failure; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007332:Insulin Infusion Systems / Q000009:adverse effects / Q000592:standards; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care
D001786:Blood Glucose