Conditions: Type 1 Diabetes
Keywords: Diabetes Implantable Insulin Pump Intraperitoneal Insulin Delivery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 107
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.

Detailed description:
Implantable insulin delivery pumps have been shown to reduce the occurrence of severe hypoglycemia in Type 1 DM subjects, as demonstrated in numerous European studies. Glycemic control is difficult to attain in subjects using exogenous insulin due to the risk of severe hypoglycemia. This study is aimed at comparing the efficacy of intraperitoneal (IP) insulin therapy to intensive subcutaneous insulin therapy over a period of 12 months.

Arms:
arm 1: The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin. arm 2: The control group will remain on their current pre-study subcutaneous insulin therapy of either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used, or be required to change or modify their current diabetes therapy for the purpose of the study.

Interventions: intervention 1: Medtronic MiniMed Implantable Pump Human Recombinant Insulin intervention 2: Medtronic MiniMed Implantable Pump System intervention 3: Aventis HOE21PH U400
Intervention descriptions: intervention 1: 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements. intervention 2: The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes. intervention 3: 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Protocol document: