Clinical Evaluation of a Newly Designed Compliant Side Port Catheter for an Insulin Implantable Pump
The EVADIAC experience
- Henri Gin, MD,
- Vincent Melki, MD,
- Bruno Guerci, MD,
- Bogdan Catargi, MD and
- EVADIAC Study Group
- From the Service de Nutrition Diabétologie (H.G.) and the Service d'Endocrinologie (B.C.), the Centre Hospitalier Universitaire de Bordeaux, Bordeaux; the Service d'Endocrinolgie Diabétologie (V.M.), the Centre Hospitalier Universitaire de Rangueil, Toulouse; and the Service de Diabétologie (B.G.), the Centre Hospitalier Universitaire de Nancy, Nancy, France.
- Address correspondence to H. Gin, MD, Service de Nutrition Diabétologie, Centre Hospitalier Universitaire Groupe Sud, 33604 Pessac, France.
Programmable implantable insulin pumps have proven to be safe and effective for achieving good metabolic control (1) and decreasing the rate of severe hypoglycemia (2). In 1994, a change in the production of insulin resulted in insulin precipitation and recurrent events of underdelivery in the MIP 2001 models (Minimed, Sylmar, CA). A new insulin variant with improved stability in delivery systems was produced in 1997 by Hoechst Marion Roussel and evaluated by the Evaluation dans le Diabete du Traitement par Implants Actifs (EVADIAC) Study Group (3). Yet, persistent underdelivery was still observed and could not be resolved by flushing procedures through the side port catheter. Difficulties in adjusting insulin dosage remained problematic. This underdelivery was explained by the fact that the forward stroke of the piston pump occurred in 2 ms with a volume of 0.5 μl, and the catheter lumen was only 0.2 mm in diameter. Thus, its compliance was too low …
