E10
Conditions
Interventions
Group 1: Visit schedule:
Visit 0 (Screening) --> Visit 1 (D1) --> Visit A (D4) --> Visit 2 (D7) --> Visit 3 (D14) --> Visit 4 (Follow-up)
Procedures:
At Visits 1, 2, 3, and A/B a meal/insulin test wi
Sponsors
Metronom HealthVP Clinical & RA, Metronom Health
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
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 treated with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months (for T1D only) - Body Mass Index (BMI) <35 kg/m² - Flash or continuous glucose monitoring (FGM, CGM) user - Willing and able to wear the Metronom CGM System 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 or treating physician 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 any 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 - Known adrenal gland problem, pancreatic tumour, or insulinoma - Known bleeding disorder - Known hypersensitivity to adhesive or skin lesions that hinder sensor insertion - Inability of the subject to comply with all study procedures - Inability of the subject to understand the subject information - Subject donated blood in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall percentage of sensor values(Metronom sensor) which fall within ± 20 mg/dl of the mean reference values at glucose (Super GL2/YSI). Measurements are performed at every in-house visit(D1, D7, D14, D4/10 of wear time) in 15 minute intervals for up to 8 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of sensor values which fall within ± 20 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 20% at glucose concentrations =100 mg/dl on different days of wear-time - Percentage of sensor values which fall within ± 15 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 15% at glucose concentrations =100 mg/dl (cf. ISO 15197: 2013, Chapter 6.3.3) (overall, on different days of wear-time) - Percentage of sensor values which fall within ± 30 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 30% at glucose concentrations =100 mg/dl (overall, on different days of wear-time) - Percentage of sensor values which fall within ± 40 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 40% at glucose concentrations =100 mg/dl (overall, on different days of wear-time) - Overall percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) =15%. - Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) =15% (overall, on different days of wear-time) - Mean (MARD) and Median Absolute Relative Difference (MedARD) (overall, on different days of wear-time) - Mean (MARD) and Median Absolute Relative Difference (MedARD) with regard to reference measurements in the hypoglycaemic (=70mg/dl), euglycaemic (70-180mg/dl), and hyperglycaemic (=180mg/dl) area (overall, on different days of wear-time) - Bland–Altman analysis comparing sensor values with reference measurements (overall, on different days of wear-time) - Distribution of data points in the Point and Rate Error Grid (overall, on different days of wear-time) | — |
Countries
Austria, Canada, Denmark
Contacts
Public ContactDaniela Schwarzenbacher
Clinical Research Center, Medizinische Universität Graz
Outcome results
None listed