E10
Conditions
Interventions
Group 1: This study will be an open-label trial with a 26 hour active study phase. To assess eligibility a screening visit (Visit 1) will be performed (approximately 1h). Between the screening visit a
Sponsors
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Informed consent obtained after being advised of the nature of the study. Male or female aged = 18 years. Diagnosis of Diabetes Mellitus Type 1 for at least 6 months according to WHO criteria. Treatment with multiple daily injections (MDI) or continous subcutaneous insulin infusion for at least 3 months. Body Mass Index (BMI) < 35kg/m² Willing and able to wear 4 SPIDIMAN Glucosemonitoring Systems for the duration of the 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 participation in 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. Inability of subjects to understand subject information. Inability of subject to sign the subject informed consent form Intake of any medication that significantly impacts glucose metabolism (oral steroids). Subject donated blood in the last 3 months Intake of paracetamol while participatiin the the clinical study. Severe medical or psychological condition or chronic condition that in the opinion of the investigator would compromise the subject's safety or successful participation in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) =15%. Measurements from 4 SPIDIMAN sensors compared to plasma glucose values as measured by Super GL. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of sensor values which fall within ± 0.83 mmol/l (±15mg/dl) of the mean reference values at glucose concentrations 100 mg/dl). Glucagon concentrations during fasting, exercise and in the post-prandial state. Correlation of glucagon concentrations with sensor glucose values from the 4 SPIDIMAN sensors. | — |
Countries
Austria
Contacts
Public ContactJulia Mader
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie
Outcome results
None listed