At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with type 1 diabetes mellitus
- ✓Currently using Inreda AP (automated pump) system for at least 1 month
- ✓Prior experience with sensor-augmented pump or continuous subcutaneous insulin infusion for at least 6 months
- ✓Age 18–75 years
- ✕Impaired awareness of hypoglycemia (score ≥4 on Gold and/or Clarke questionnaire)
- ✕Pregnancy or breastfeeding
- ✕Current use of oral antidiabetic agents
- ✕History of insulinoma
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Fully Automated Glycemic Control With Ultrarapid Insulin in a Bihormonal Closed Loop System in Patients With Type 1 Diabetes
In Brief
A clinical study evaluating Insulin Lispro Cartridge [Lyumjev] and Insulin Lispro Cartridge for Type 1 Diabetes. Completed, enrolled 12 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Administration of Lyumjev in combination with the AP system
Administration of Humalog in combination with the AP system (standard therapy)