insulin-dependent diabetes, type 1 diabetes type 1 diabetes
Conditions
Interventions
The intervention is a hybrid closed-loop system that consists of the CamAPS FX algorithm, a mylife YpsoPump insulin pump and a Freestyle Libre 3 Plus continuous glucose monitoring sensor. Control trea
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: Diagnosis with T1DM >= 1 year prior to screening High glucose variability (CV >= 32%) >= 4 weeks prior to screening Age between 16 and 65 years BMI between 18-30 kg/m^2 Average glucose between 4.4-12.0 mmol/L
Exclusion criteria
Exclusion criteria: Current use of hybrid closed-loop therapy Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, symptomatic peripheral arterial disease) Pregnancy or planned pregancy Diagnosis with auto-inflammatory or auto-immune diseases other than T1DM Occupations that include highly irregular working schedules (e.g. shift work)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is the difference in monocyte count between intervention and control after three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpointsThe secondary endpoints are with regards to differences between intervention and control after three months.- Proportions and counts of common leukocytes in whole blood (e.g. CD14+/CD16+ monocytes, CD56+ NK cells, CD3+ T cells)- Plasma levels of tumor necrosis factor (TNF), IL-6, IL-1ß and high sensitive C-reactive protein (hsCRP)- Production of TNF, IL-6 and IL-1ß following ex vivo stimulation of monocytes- Glycemic variability as determined by coefficient of variation (CV), standard deviation (SD), and glycemic variability percentage (GVP) Tertiary endpointsThe tertiary endpoints are exploratory in nature and/or measurement of these parameters is dependent on the results of the primary and secondary endpoints.- Paired comparisons of all endpoints between start and end of the intervention period- Plasma levels of the following parameters: - Cytokines (other than TNF, IL-6, IL-1ß) - Chemokines (e.g. MCP-1, IL-8) - Atherogenic markers (e.g. VCAM-1, ICAM-1, E-selectin) - Coagulation markers (e.g. Von Willebrand factor, factor VIII) - Lipids (e.g. LDL, HDL, cholesterol, non-HDL, triglycerides)- Proteomics on inflammatory markers measured by the Olink inflammation panel- Gene expression in leukocytes (e.g. transcriptional changes, epigenetic changes)- Functional readouts on leukocytes (e.g. metabolism, adhesion/migration capacity) - Intracellular cytokine production by leukocytes- Production of inflammatory markers (e.g. pro- and anti-inflammatory cytokines, reactive oxygen species (ROS)) following ex vivo stimulation of leukocytes- Effect of reducing GV on patient reported outcomes (PROs) (e.g. energy, diabetes distress, and diabetes management)- Urinary albumin/creatinine ratio- Markers of retinopathy as assessed with optical coherence tomography angiography (OCTA) and optical coherence tomography (OCT) | — |
Countries
Netherlands
Contacts
Public ContactT Ent
Radboud Universitair Medisch Centrum
Outcome results
None listed