Type 1 diabetes
Conditions
Interventions
The intervention entails use of Lyumjev administered by the Inreda AP system.
The subjects will be randomized to receive either Lyumjev or Humalog during the
first study period of thirty days. After
Sponsors
Inreda Diabetic B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Diagnosed with type 1 diabetes - Treated with the Inreda Artificial Pancreas for a minimum of 1 month - Age between 18 and 75 years - Willing and able to sign informed consent
Exclusion criteria
Exclusion criteria: - Impaired awareness of hypoglycemia (score >= 4) according to the Gold and/or Clarke questionnaire - Pregnancy and/or breastfeeding - Use of oral antidiabetic agents - Insulinoma - Hypersensitivity reactions to Lyumjev insulin or any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main parameter to express efficacy is the time above range (>10 mmol/l), which will be compared between Lyumjev and Humalog. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters - Side effects of Lyumjev Pharmacodynamic parameters - Percentage of time spent in range (3.9-10.0 mmol/l) - Percentage of time spent below range ( 13.9 mmol/l) - Mean/median glucose value - Glycemic variability expressed as coefficient of variation (CV) and interquartile range (IQR) AP-related parameters - Daily administered dosage of glucagon - Daily administered dosage of insulin - The percentage of time that the closed loop algorithm is active | — |
Countries
Netherlands
Outcome results
None listed