N/A
Completed N=12
Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes
Source: ClinicalTrials.gov NCT05508061 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Percentage of Time the Glucose Level is Above 10 mmol/l — 17.2; 16.2 percentage of time spent above range
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time the Glucose Level is Above 10 mmol/l |
17.2; 16.2 | — |
| SECONDARY Side Effects of Insulin |
5; 1 | — |
| SECONDARY Pharmacodynamic Parameters: Euglycemia |
81.7; 83.4 | — |
| SECONDARY Pharmacodynamic Parameters: Hypoglycemia |
1.11; 0.49 | — |
| SECONDARY Pharmacodynamic Parameters: Mean Glucose Value |
7.8; 7.8 | — |
| SECONDARY Pharmacodynamic Parameters: Standard Deviation of Glucose Value |
2.2; 2.1 | — |
| SECONDARY Pharmacodynamic Parameters: Glycemic Variability (CoV) |
29.5; 27.7 | — |
| SECONDARY Pharmacodynamic Parameters: Glycemic Variability (IQR) |
3.0; 2.9 | — |
| SECONDARY AP-related Parameters: Daily Insulin Usage (Units) |
46.1; 47.8 | — |
| SECONDARY AP-related Parameters: Glucagon Usage |
0.52; 0.40 | — |
| SECONDARY AP-related Parameters: Algorithm Activity |
93.3; 93.4 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT05508061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.