Diabete Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
The aim of the present study is to investigate the clinical performance of the Metronom CGM system in patients with type 1 diabetes over a period of 14 days. In this study, the CGM sensor will be tested in an inpatient setting (meal/insulin test with frequent plasma glucose monitoring) at different days of wear-time. Sensor data will be compared to gold standard reference (Super GL2 analyser or YSI) and stability of sensor performance will be assessed over time. Additionally, safety and tolerability of the sensor will be investigated by regular assessment of the insertion site.
Interventions
OTHERMetronom CGM device
Patient receives three Metronom CGM devices on day 1. On day 1, 4, 7 and 14, a hypo- or hyperglycaemic experiment will start according to allocation by randomizer.
Sponsors
Medical University of Graz
Metronom Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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 | Description |
|---|---|---|
| Accuracy | 14 days | Overall 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reliability | 14 days | 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 |
| Accuracy | 14 days | Overall percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15%. |
Countries
Austria, Denmark
Contacts
Primary ContactUrsula Morjaria, MSc
Backup ContactJoris Coteur, MSc
Outcome results
None listed