INSUMAN IMPLANTABLE (insulin human), antidiabetic

No added clinical value demonstrated in the management of patients with type 1 diabetes

• INSUMAN IMPLANTABLE has a Marketing Authorisation in the treatment of adult patients with type 1 diabetes who are not controlled by insulin administered subcutaneously (including via a pump) and displaying severe, frequent or unexplained hyperglycaemic and/or hypoglycaemic episodes.
• It has to be administered exclusively with the Medtronic MiniMed implantable insulin pump system fitted with an intraperitoneal catheter.
• The available data do not allow an assessment to be made of its effect in patients with type 1 diabetes in whom intensive, subcutaneous insulin therapy has failed.
• This is a treatment of last resort.
• The most common adverse events were hyperglycaemic episodes, hypoglycaemic loss of consciousness and pump blockages. Adverse events linked to the device (infectious or mechanical complications) may lead to the explantation of all or part of the pump system.