Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes
Status:
Not yet recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
The main objective is to determine the efficacy of Lyumjev (insulin) in a bi-hormonal
reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in
patients with diabetes mellitus type 1. In addition, safety parameters, pharmacodynamics and
AP-related parameters will be acquired.
This study is a multicenter, open-label, randomized, cross-over trial in 12 subjects. The
subjects will be randomized to receive either Lyumjev or Humalog® for a 30-day study period
and will then switch to the alternate insulin treatment after a wash-out period.