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Metronom Continuous Glucose Monitoring System

NCT03341026·2 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Ursula Morjaria, MSc
CONTACT
0032(0)10 23 38 80 umorjaria@metronomhealth.com
Joris Coteur, MSc
CONTACT
0032(0)10 23 38 80 jcoteur@metronomhealth.com

Lead

Metronom Health

With

Medical University of Graz

Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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

You may not be if

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

The record

StatusUnknown

PhaseNot applicable

Taking part20

StartedJun 2020

UpdatedAug 15, 2019

Conditions

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabete Mellitus

Where2

Medical University of Graz
Graz, Austria
Steno diabetes center
Copenhagen, Denmark