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: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inreda Diabetic B.V.
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Diagnosed with diabetes mellitus type 1;

• Treated with the Inreda AP system for a minimum of 1 month;

• Age between 18 and 75 years;

• Willing and able to sign informed consent.

Since subjects are treated with the Inreda AP, the following inclusion criteria will be met:

• Treated with sensor augmented pump (SAP) or CSII for a minimum of 6 months;

• HbA1c < 97 mmol/mol;

• BMI < 35 kg/m^2;

• No use of acetaminophen, as this may influence the sensor glucose measurements.

Exclusion Criteria:

• Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire;

• Pregnancy and/or breastfeeding;

• Use of oral antidiabetic agents;

• Insulinoma;

• Hypersensitivity reactions to Lyumjev or any of the excipients.