Diabetes mellitus type 1 E10
Conditions
Interventions
Group 1: During the active phase continuous subcutaneous glucose monitoring using four SPIDIMAN CGM (continuous glucose monitoring) sensor systems will be performed throughout the study. Study duratio
Sponsors
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Informed consent obtained after being advised of the nature of the study; Male or female aged =18 years; Type 1 diabetes for at least 6 months according to the WHO definition; Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months; Body Mass Index (BMI) < 35 kg/m²; Willing and able to wear 4 CGM devices for the duration of the study and undergo all study procedures; HbA1c = 86 mmol/mol
Exclusion criteria
Exclusion criteria: Any disease or condition which the investigator feels would interfere with the trial or the safety of the subject Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods Any mental condition rendering the subject incapable of giving his consent Subject is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject’s safety or successful participation in the study. Subject is actively enrolled in another clinical trial Subject donated blood in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) =15%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Percentage of sensor values which fall within ± 0,83 mmol/l (±15mg/dl) of the mean reference values at glucose concentrations (100 mg/dl) Safety: Evaluation of skin reactons, iritations of insertion site | — |
Countries
Austria
Contacts
Public ContactJulia Mader
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie
Outcome results
None listed