Study demonstrates sustained safety of intraperitoneal insulin infusion
medwireNews: Researchers have demonstrated a sustained safety profile for intraperitoneal insulin infusion with an implantable pump in patients with type 1 diabetes and initially high glucose variability.
As outlined at the virtual 56th EASD Annual Meeting, Nathalie Jeandidier (University Hospital, Strasbourg, France) and colleagues analyzed data from 262 patients with an average type 1 diabetes duration of 35.3 years who took part in a post authorization safety study of intraperitoneal insulin therapy. Participants were treated with Insuman Implantable – a fast-acting insulin solution (400 IU/mL) – in Medtronic MiniMed implantable pumps.
“The pump is fully implanted in the abdominal wall and the catheter is inserted into the peritoneal [cavity],” explained Jeandidier. She said “the benefits of the intraperitoneal route of insulin administration [are] now well-known,” noting that it is used for the treatment of type 1 diabetes that is inadequately controlled with subcutaneous insulin.
In the present study, 68% of participants initiated intraperitoneal insulin due to brittle diabetes, while 28% had frequent severe hypoglycemia.
The presenter said that there was a “very low” incidence of severe hypoglycemia over an average follow-up of 2.6 years, at 9.31 events per 100 patient–years. Rates of hyperglycemia, pump pocket infection, and skin erosion were 21.13, 1.31, and 0.48 per 100 person–years, respectively.
Overall, 36 patients discontinued treatment prematurely. There were eight deaths, none of which were related to the treatment device, seven cases of adverse events or severe adverse events, and 15 patients discontinued treatment due to pump availability.
Jeandidier noted that limited availability of pumps “is now the main barrier for use” of intraperitoneal insulin. Indeed, in July 2020 the EMA issued a communication to healthcare professionals advising that the Medtronic MiniMed implantable pumps will no longer be produced by the end of 2020, and that no new patients should be started on Insuman Implantable insulin as a result.
“We hope that new pumps which are in the research [stage] could help continue” the use of intraperitoneal insulin, concluded Jeandidier.
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