A Preliminary Trial of the Programmable Implantable Medication System for Insulin Delivery

Saudek, Christopher D.; Selam, J L; Pitt, Henry A.; Waxman, Kenneth; Rubio, Mercedes Galindo; Jeandidier, N.; Turner, Dee; Fischell, Robert E.; Charles, M. Arthur

doi:10.1056/nejm198908313210904

Cited by 122 publications

(51 citation statements)

References 25 publications

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“…Several studies have demonstrated the feasibility of using implantable programmable insulin pumps and the intraperitoneal (IP) route for insulin delivery [90][91][92][93][94][95]. The main advantage of this route is that it restores the physiological insulin gradient between the portal vein and the peripheral circulation.…”

Section: Ias and Continuous Intraperitoneal Insulin Infusionmentioning

confidence: 99%

Circulating insulin antibodies: influence of continuous subcutaneous or intraperitoneal insulin infusion, and impact on glucose control

Radermecker

Renard

Scheen

2009

Diabetes Metabolism Res

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The purification of animal insulin preparations and the use of human recombinant insulin have markedly reduced the incidence, but not completely suppressed, the development of anti-insulin antibodies (IAs). Advances in technologies concerning the mode of delivery of insulin, i.e. continuous subcutaneous insulin infusion (CSII), continuous peritoneal insulin infusion (CPII) and more recently inhaled insulin administration, appear to significantly increase circulating levels of immunoglobulin G (IgG) anti-IAs in diabetic patients. However, the increase is usually moderate and mostly transient as compared to previous observations with poorly purified animal insulin preparations. The clinical impact of these circulating anti-IAs remains unclear. Nevertheless, several studies have suggested that antibodies could retard insulin action, leading to a worsening of postprandial hyperglycaemia and/or serve as a carrier, thus leading to unexpected hypoglycaemia. CPII may be associated with more marked and sustained increase in IAs levels, possibly related to the use of an unstable insulin and the formation of immunogenic aggregates of insulin. The possible clinical consequences of these high levels of IAs remain to be evaluated because a low-glucose morning syndrome or severe insulin resistance with ketone bodies production have been reported in some cases. In conclusion, even if CSII and CPII may promote the development of circulating IAs, this increase does not lead to immunological insulin resistance, compared to that previously described with animal non-purified insulin preparations, and seems to have only marginal influence on blood glucose control or complications in most diabetic patients.

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Section: Ias and Continuous Intraperitoneal Insulin Infusionmentioning

confidence: 99%

Circulating insulin antibodies: influence of continuous subcutaneous or intraperitoneal insulin infusion, and impact on glucose control

Radermecker

Renard

Scheen

2009

Diabetes Metabolism Res

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“…However, in 1991, these pumps were exchanged for MiniMed Implantable Pumps (MIPs) and all new implantations were subsequently performed using the new system. The characteristics of these pumps, which are manufactured by MiniMed Technologies, Inc. (Sylmar, Calif., USA), have been described elsewhere [6,7].…”

Section: Insulin Pumpsmentioning

confidence: 99%

Intraperitoneal delivery of insulin via mechanical pump: surgical implications

Udelsman

Boyne

Loman

et al. 2000

Langenbeck's Arch Surg

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Between November 1986 and January 2000, 28 patients with insulin-dependent diabetes mellitus were enrolled in the implanted insulin pump study at Johns Hopkins Hospital. An additional two patients underwent pump implantation under compassionate use guidelines due to apparent resistance to subcutaneously administered insulin uptake. The mean patient age was 44 +/- 10.5 years. Eleven patients (39%) were female and the mean duration of diabetes was 25.7 +/- 8.9 years. Diabetic retinopathy, neuropathy, and nephropathy were present in 43%, 25% and 11 % of patients, respectively. The insulin pumps functioned safely for a total of 189 patient years. Mean pump life was 26 +/- 1.2 months. There was no mortality. Morbidity was limited to pump-site infections [n=y (4%) of all pumps placed], one case of pump migration and skin erosion, and one small bowel obstruction associated with the pump catheter. Mean serum hemoglobin AIC levels before and after pump placement were 9.0 +/- 2.9% and 7.5 +/- 0.7% (P=0.0023), respectively. Correspondingly, the mean daily blood glucose levels decreased from l61 +/- 40 mg/dl before placement to 141 +/- 27 mg/dl after pump placement (P=0.0063). Intraperitoneal delivery of insulin by a mechanical pump appears to be an attractive alternative for the treatment of insulin-dependent diabetes mellitus.

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“…After checking the stability of HOE21PH insulin in the Programmable Implantable Medication System (PIMS) developed by MiniMed Inc (Sylmar, CA, USA) [18], a feasibility trial was performed in 18 type 1 diabetic patients that cumulated an experience of 28 patient-years [19]. The PIMS was implanted in the subcutaneous abdominal wall, presenting as a titanium-covered disc-shaped device, and used only the IP route.…”

Section: Initial Experiences Of Treatment With Implantable Pumpsmentioning

confidence: 99%

Implantable insulin delivery pumps

Renard

2004

Minimally Invasive Therapy & Allied Technologies

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Implantable insulin delivery pumps are a response to the search for an insulin therapy that would be more physiological, more comfortable and, finally, better adapted to instantaneous insulin needs by their connection to a long term glucose sensor. The last decade has been devoted to their technical finalization and to the acquisition of the clinical knowledge on how to use them, so that these devices can be safe and reliable. The forthcoming availability on the market of the specific insulin formulation they require and the present development of glucose sensors are two favourable conditions for the diffusion of this technology aiming at an improved diabetes treatment. This review summarizes the rationale for the choice of intraperitoneal insulin route, the key-steps in assessing their feasibility and effectiveness in blood glucose control of diabetic patients, and the present development of this technique toward an implantable artificial beta-cell.

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A Preliminary Trial of the Programmable Implantable Medication System for Insulin Delivery

Cited by 122 publications

References 25 publications

Circulating insulin antibodies: influence of continuous subcutaneous or intraperitoneal insulin infusion, and impact on glucose control

Circulating insulin antibodies: influence of continuous subcutaneous or intraperitoneal insulin infusion, and impact on glucose control

Intraperitoneal delivery of insulin via mechanical pump: surgical implications

Implantable insulin delivery pumps

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